Radiology · 510(k) · 2022
BoneView
Gleamer. Cleared by FDA on 1 March 2022 under submission K212365, product code QBS (radiological computer assisted detection/diagnosis software for fracture). What FDA's record says, in FDA's words.
Device record · K212365
- Device. BoneViewDEVICE
- Company. Gleamer (FR)COMPANY
- Decision. 1 March 2022, 510(k), substantially equivalent (traditional review); received 30 July 2021DECISION
- Panel. RadiologyPANEL
- Product code. QBS, Radiological Computer Assisted Detection/Diagnosis Software For FractureCODE
- Regulation. 21 CFR 892.2090, Class IIREG
- Source. FDA database entry · decision document (14 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
of BoneView The training of BoneView was performed on a training dataset of 44,649 radiographs, representing 151,096 images (52.4% of males, with age: range [0 – 109]; mean 42.4 +/- 24.6) for all anatomical areas of interest in the Indications for Use and from various manufacturers. BoneView has been designed to solve the problem of missed fractures includin g subtle fractures, and thus detects fractures with a high sensitivity. In this regard, the display of findings is triggered by a “high-sensitivity operating point” (DOUBT FRACT) that will enable the display of a dotted-line bounding box around the region of interest. Additionally, the users need to be confident that when BoneView identifies a fracture, it is actually a fracture. In this regard, an additional information is introduced to the user with a “high -specificity operating point” (FRACT). These two operating points are implemented in the User Interface as follow: • Dotted-line Bounding Box : suspicious area / subtle fracture ( when the level of confidence of the AI algorithm associated with the finding is above “high-sensitivity BoneView 510(k) Summary Page 4 GLEAMER 5 avenue du Général de Gaulle, 94160 Saint-Mandé - FRANCE SAS au capital de 115 372 euros – RCS Créteil 834 105 470 SIRET : 834 105 470 00027 – [email protected] operating point ” and below “high-specificity operating point”) displayed as a dotted bounding box around the area of interest • Solid-line Bounding Box : d efinite or unequivocal […]
The product code's definition, from FDA's classification record. A radiological computer assisted detection and diagnostic software for suspected fracture is an image processing device intended to aid in the detection, localization, and/or characterization of fracture on acquired medical images (e.g. radiography, MR, CT). The device detects, identifies and/or characterizes fracture based on features or information extracted from images, and may provide information about the presence, location, and/or characteristics of the fracture to the user. Primary diagnostic and patient management decisions are made by the clinical user.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedradiographs (X-ray)
- Mentionsdetection or identification of findings
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QBS. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QBS, in Radiology, from Gleamer, or cleared in 2022. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.