(247 days)
Not Found
Yes
The device description explicitly states that it uses "machine learning techniques" and an "AI algorithm" to process radiographs and calculate Cobb angles. It also mentions the use of "Convolutional neural networks".
No
The device is described as image processing software intended to aid in measurement, not for treatment or therapy. It explicitly states, "It should not be used instead of full patient evaluation or solely relied upon to make or confirm a diagnosis."
Yes.
Explanation: The "Intended Use / Indications for Use" section states that the device is "intended to aid users in the measurement of Cobb angles on frontal spine radiographs...for patients with suspected or present spinal deformities, such as scoliosis." This measurement provides information about a patient's condition, which aligns with the definition of a diagnostic device, even though it explicitly states it "should not be used instead of full patient evaluation or solely relied upon to make or confirm a diagnosis." It's a tool providing data for diagnosis.
Yes
The device is described as "a fully automated radiological image processing software device" and its function is solely to analyze and process existing radiographic images using software algorithms. It does not include or require any specific hardware components for its primary function beyond standard computing platforms and imaging systems (PACS, X-ray systems) which are external to the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- BoneMetrics US Function: BoneMetrics US analyzes radiological images (radiographs), which are external images of the body, not specimens taken from the body. It processes these images to measure anatomical features (Cobb angles) to aid in the assessment of spinal deformities.
The device falls under the category of medical image processing software or radiological image analysis software, which are distinct from IVD devices.
No
The letter does not state that the FDA has reviewed and cleared a PCCP for this specific device.
Intended Use / Indications for Use
BoneMetrics US is a fully automated radiological image processing software device intended to aid users in the measurement of Cobb angles on frontal spine radiographs of individuals of at least 4 years old for patients with suspected or present spinal deformities, such as scoliosis. It should not be used instead of full patient evaluation or solely relied upon to make or confirm a diagnosis. The software device is to be used by healthcare professionals trained in radiology.
Product codes (comma separated list FDA assigned to the subject device)
OIH
Device Description
BoneMetrics US is intended to analyze radiographs using machine learning techniques to provide fully automated measurements of cobb angles during the review of frontal spine radiographs.
BoneMetrics US can be deployed on cloud and be connected to several computing platforms and X-ray imaging platforms such as radiographic systems, or PACS. More precisely, BoneMetrics US can be deployed in the cloud connected to a DICOM Source/Destination with a DICOM Viewer, i.e. a PACS.
After the acquisition of the radiographs on the patient and their storage in the DICOM Source, the radiographs are automatically received by BoneMetrics US from the user's DICOM Source through intermediate DICOM node(s) (for example, a specific Gateway, or a dedicated API). The DICOM Source can be the user's image storage system (for example, the Picture Archiving and Communication System, or PACS), or other radiological equipment (for example X-ray systems).
Once received by BoneMetrics US, the radiographs are automatically processed by the Al algorithm without requiring any user inputs. The algorithm identifies the keypoints corresponding to the corners of all the vertebras that are seen on the images and calculates all possible angles between vertebras. Only Cobb Angles that are above 7° are retained. Based on the processing result, BoneMetrics US generates result files in DICOM format. These result files consist of annotated images with the measurements plotted on a copy of all images (as an overlay) and angle values displayed in degrees. BoneMetrics US does not alter the original images, nor does it change the order of original images or delete any image from the DICOM Source.
Once available, the result files are sent by BoneMetrics US to the DICOM Destination through the same intermediate DICOM node(s). Similar to the DICOM Source, the DICOM Destination can be the user's image storage system (for example, the Picture Archiving and Communication System, or PACS), or other radiological equipment (for example X-ray systems). The DICOM Source and the DICOM Destination are not necessarily identical.
The DICOM Destination can be used to visualize the result files provided by BoneMetrics US or to transfer the results to another DICOM host for visualization. The users are then able to use them as a concurrent reading aid to provide their diagnosis.
The displayed result for the BoneMetrics US is a summary in a unique Secondary Capture with the following information:
- The image with the angle(s) in degree drawn as an overlay (if any),
- . A table with the angle(s) measurement(s) and value(s) in degree (if any),
- . At the bottom, the "Gleamer" logo and the "BoneMetrics" mention
Mentions image processing
Yes
Mentions AI, DNN, or ML
Mentions "machine learning techniques" and "AI algorithm". Mentions "Convolutional neural networks" under Technology.
Input Imaging Modality
DICOM compliant plain radiographs collected in other devices in the CR, DX formats.
Anatomical Site
Frontal Spine
Indicated Patient Age Range
individuals of at least 4 years old
Intended User / Care Setting
healthcare professionals trained in radiology.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
A Clinical Standalone Performance Study was conducted on a dataset of 345 frontal spine radiographs of children and adults obtained from US data providers to validate the performance of BoneMetrics US.
The ground truth was determined by the expertise of two US board-certified musculoskeletal radiologists and one US board-certified orthopedic surgeon. These experts were kept unaware of the outputs from BoneMetrics US, findings from clinical reports, and readings from other truthers. The ground truth was defined as the mean of the Cobb angles measured by the 3 ground truthers to establish a consensus-based ground truth. Any cases with discrepancies exceeding the predetermined threshold were subjected to an adjudication process, where the three experts mutually agreed on a value for the ground truth.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Standalone Performance Study:
- Sample Size: 345 frontal spine radiographs (212 for Cobb angle with largest curvature, 189 for Minor Cobb angle in overall analysis; further broken down for subgroup analysis: Adults n=100 for largest curvature, n=90 for minor; Children n=32 for largest curvature, n=18 for minor; Adolescent n=80 for largest curvature, n=81 for minor).
- Standalone Performance: The study compared the performance of BoneMetrics US in the measurements of Cobb angles against a ground truth by computing the Mean Absolute Error (MAE) and an acceptance criteria.
- Key Results:
- Cobb angle with the largest curvature (n = 212): Mean Absolute Error (°) of 2.56 (95% CI: 2.0 - 3.28). Acceptance criteria: Upper bound of the MAE 95% CI
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Gleamer SAS Antoine Tournier Chief Compliance Officer 47bis, rue des Vinaigriers PARIS, 75010 FRANCE
February 5, 2025
Re: K241593
Trade/Device Name: BoneMetrics (US) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: OIH Dated: January 7, 2025 Received: January 7, 2025
Dear Antoine Tournier:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Re"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
2
the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Lamb
Jessica Lamb, PhD Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
BoneMetrics (US)
Indications for Use (Describe)
BoneMetrics US is a fully automated radiological image processing software device intended to aid users in the measurement of Cobb angles on frontal spine radiographs of individuals of at least 4 years old for patients with suspected or present spinal deformities, such as scoliosis. It should not be used instead of full patient evaluation or solely relied upon to make or confirm a diagnosis. The software device is to be used by healthcare professionals trained in radiology.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/1 description: The image contains the logo for Gleamer. On the left side of the image is a blue circle with a pattern of dots. To the right of the circle is the word "Gleamer" in a sans-serif font. The word is also blue, matching the color of the circle.
Date prepared: February 4th, 2025
In accordance with 21 CFR 807.87(h) and 21 CFR 807.92 the 510(k) Summary for BoneMetrics US is provided below.
1. Submitter
| Submitter | GLEAMER SAS
47bis, rue des Vinaigriers
75010, Paris 10, FRANCE |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact Person | Antoine Tournier
Chief Compliance Officer
Tel: 0033 6 15 81 23 45
Email: antoine.tournier@gleamer.ai
Alternate email: qara@gleamer.ai |
2. Device
| Trade Name | BoneMetrics (US) |
|---|---|
| 510(k) reference | K241593 |
| Common Name | Automated Radiological Image Processing Software |
| Regulation | 21 CFR 892.2050 |
| Product Code | QIH |
| Classification | Class II |
3. Predicate Device
| Predicate Device | IB Lab LAMA |
|---|---|
| 510(k) Reference | K223646 |
4. Device Description
BoneMetrics US is intended to analyze radiographs using machine learning techniques to provide fully automated measurements of cobb angles during the review of frontal spine radiographs.
BoneMetrics US can be deployed on cloud and be connected to several computing platforms and X-ray imaging platforms such as radiographic systems, or PACS. More precisely, BoneMetrics US can be deployed in the cloud connected to a DICOM Source/Destination with a DICOM Viewer, i.e. a PACS.
After the acquisition of the radiographs on the patient and their storage in the DICOM Source, the radiographs are automatically received by BoneMetrics US from the user's DICOM Source through intermediate DICOM node(s) (for example, a specific Gateway, or a dedicated API). The DICOM Source can be the user's image storage system (for example, the Picture Archiving and Communication System, or PACS), or other radiological equipment (for example X-ray systems).
5
Image /page/5/Picture/1 description: The image shows the logo for Gleamer. The logo consists of a blue sphere made up of many small dots on the left, followed by the word "Gleamer" in black, bold font on the right. The sphere has a lighter area in the center, giving it a three-dimensional appearance.
Once received by BoneMetrics US, the radiographs are automatically processed by the Al algorithm without requiring any user inputs. The algorithm identifies the keypoints corresponding to the corners of all the vertebras that are seen on the images and calculates all possible angles between vertebras. Only Cobb Angles that are above 7° are retained. Based on the processing result, BoneMetrics US generates result files in DICOM format. These result files consist of annotated images with the measurements plotted on a copy of all images (as an overlay) and angle values displayed in degrees. BoneMetrics US does not alter the original images, nor does it change the order of original images or delete any image from the DICOM Source.
Once available, the result files are sent by BoneMetrics US to the DICOM Destination through the same intermediate DICOM node(s). Similar to the DICOM Source, the DICOM Destination can be the user's image storage system (for example, the Picture Archiving and Communication System, or PACS), or other radiological equipment (for example X-ray systems). The DICOM Source and the DICOM Destination are not necessarily identical.
The DICOM Destination can be used to visualize the result files provided by BoneMetrics US or to transfer the results to another DICOM host for visualization. The users are then able to use them as a concurrent reading aid to provide their diagnosis.
The displayed result for the BoneMetrics US is a summary in a unique Secondary Capture with the following information:
- The image with the angle(s) in degree drawn as an overlay (if any),
- . A table with the angle(s) measurement(s) and value(s) in degree (if any),
- . At the bottom, the "Gleamer" logo and the "BoneMetrics" mention
5. Intended use/ Indications for Use
BoneMetrics US is a fully automated radiological image processing software device intended to aid users in the measurement of Cobb angles on frontal spine radiographs of individuals of at least 4 years old for patients with suspected or present spinal deformities, such as scoliosis. It should not be used instead of full patient evaluation or solely relied upon to make or confirm a diagnosis. The software device is to be used by healthcare professionals trained in radiology.
6
Image /page/6/Picture/1 description: The image contains the word "Gleamer" in bold, black font. To the left of the word is a blue circle with a white center. The circle is made up of many small dots. The word "Gleamer" is written in a sans-serif font.
6. Substantial equivalence
| Features and
Characteristics | Subject Device
Gleamer- BoneMetrics US | Predicate Device
Ib Lab GmbH - Ib Lab LAMA (K223646) | Discussion of Differences and Comments |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation Information | | | |
| Classification
regulation | 21 CFR 892.2050- Medical image management
and processing system | Same | N/A |
| Product Code | QIH | Same | N/A |
| Regulation
Description | A medical image management and processing
system is a device that provides one or more
capabilities relating to the review and digital
processing of medical images for the purposes of
interpretation by a trained practitioner of
disease detection, diagnosis, or patient
management. The software components may
provide advanced or complex image processing
functions for image manipulation, enhancement,
or quantification that are intended for use in the
interpretation and analysis of medical images.
Advanced image manipulation functions may
include image segmentation, multimodality
image registration, or 3D visualization. Complex
quantitative functions may include semi-
automated measurements or time-series
measurements. | Same | N/A |
| Indications for use | | | |
| Features and
Characteristics | Subject Device | Predicate Device | Discussion of Differences and Comments |
| | Gleamer- BoneMetrics US | Ib Lab GmbH - Ib Lab LAMA (K223646) | |
| Indications for
use | BoneMetrics US is a fully automated radiological
image processing software device intended to
aid users in the measurement of Cobb angles on
frontal spine radiographs of individuals of at
least 4 years old for patients with suspected or
present spinal deformities, such as scoliosis. It
should not be used instead of full patient
evaluation or solely relied upon to make or
confirm a diagnosis. The software device is to be
used by healthcare professionals trained in
radiology. | IB Lab LAMA is a fully-automated radiological
image processing software device intended to aid
users in the measurement of limb-length
discrepancy and quantitative knee alignment
parameters on uni- and bilateral AP full leg
radiographs of individuals at least 22 years of age.
It should not be used in-lieu of full patient
evaluation or solely relied upon to make or
confirm a diagnosis. The software device is
intended to be used by healthcare professionals
trained in radiology. IB Lab LAMA is not indicated
for use on radiographs on which Ankle
Arthroplasties and/or Unicompartmental Knee
Arthroplasties are present. | The subject device performs measurements of
Cobb angles on frontal spine images for patients
of at least 4 years old. The predicate device
performs measurements of lengths and angles
on full leg images on patients of at least 22
years of age.
This difference in anatomical measurements,
anatomical locations, and patient population
does not raise new types of questions for safety
or effectiveness and therefore does not induce
changes in the intended use. For both devices,
the key question is whether the software is able
to generate accurate and reproducible
anatomical measurements within the target
population.
This is confirmed through additional controls
that are in place to mitigate any risk for this
difference:
dedicated training of the algorithm for
the indications and the patient
population performance testing for all indications
and populations |
| Features and
Characteristics | Subject Device
Gleamer- BoneMetrics US | Predicate Device
Ib Lab GmbH - Ib Lab LAMA (K223646) | Discussion of Differences and Comments |
| Human
Intervention for
interpretation | Required | Same | N/A |
| Image
requirements | DICOM compliant plain radiographs collected in
other devices in the CR, DX formats. | Same | N/A |
| Anatomical area | Frontal Spine | Full leg | The anatomical area supported by the subject
device (frontal spine) is different from the
predicate device (full leg).
This difference does not raise new questions
regarding safety or effectiveness with respect to
the technological characteristics. The
techniques used for capturing full leg images
and frontal spine images are both standard
procedures.
However, additional controls are in place to
mitigate any risk for this difference:
dedicated training of the algorithm for
●
the indications and the patient
population
performance testing for all indications
●
and populations |
| Features and
Characteristics | Subject Device
Gleamer- BoneMetrics US | Predicate Device
Ib Lab GmbH - Ib Lab LAMA (K223646) | Discussion of Differences and Comments |
| Workflow/
Principle of
Operaion | 1. User or PACS send image to the device
2. Device performs analysis
3. Image is sent back to PACS
4. User reviews the results | 1. User or PACS send image to the device
2. Device performs analysis
3. Image is sent back to PACS
4. User reviews and accepts/rejects the results | N/A |
| Processing
Architecture | 1. Pre-process the input image
2. Classification of the image
3. Detect landmarks
4. Compute angles
5. Generate results | 1. Pre-process the input image
2. Classify uni or bilateral image
3. Compute regions of interest for each side.
4. Detect landmarks and segmentations
5. Compute lines and distances
6. Compute angles
7. Generate reports | The Processing architecture is different betwee the subject and the predicate device:
- The subject device does not perform a classification of uni or bilateral images.
BMUS only process unilateral frontal spine images - The subject device does not compute regions of interest nor detected segmentations
- The subject device only computes and does not compute distances or lines
These differences are linked with the difference of indications for use mentionned above and the same additional controls are in place to mitigate these differences: - dedicated training of the algorithm for the indications and the patient population
|
| Features and
Characteristics | Subject Device
Gleamer- BoneMetrics US | Predicate Device
Ib Lab GmbH - Ib Lab LAMA (K223646) | Discussion of Differences and Comments |
| Technology | Convolutional neural networks for:
• classification
• landmarking
Classical methods for computing:
• angles | Convolutional neural networks for:
• classification
• landmarking
• segmentation
Classical methods for computing:
• auxiliary points
• lengths
• angles | The technology behind the subject and the
reference device is different:
• The subject device does not provide
segmentation or auxiliary points and
lengths computing technology
These differences are linked with the difference
of indications for use mentionned above and
the same additional controls are in place to
mitigate these differences:
• dedicated training of the algorithm for
the indications and the patient
population
• performance testing for all indications
and populations |
| Output | Human and machine readable results in the
DICOM format. | Human and machine readable reports in the
DICOM format. | N/A |
| Physical
Characteristics | Software application. | Software application operated on OTS software. | N/A |
| Safety | Displayed warnings
Intended Users: qualified and trained healthcare
professionals
Automated input checks: DICOM Tags check | Same | N/A |
7
Image /page/7/Picture/1 description: The image contains the logo for Gleamer. The logo consists of a blue circle with a white center on the left and the word "Gleamer" in black on the right. The circle is made up of many small blue dots.
8
Image /page/8/Picture/1 description: The image contains the word "Gleamer" in bold, sans-serif font. To the left of the word is a blue circle with a white center. The circle is made up of many small dots.
Technological Information
9
Image /page/9/Picture/1 description: The image shows the word "Gleamer" in black font next to a blue circle. The circle is made up of many small dots, and there is a white space in the center of the circle. The word "Gleamer" is in a sans-serif font and is aligned to the right of the circle.
10
Image /page/10/Picture/1 description: The image shows the word "Gleamer" in a bold, sans-serif font. To the left of the word is a blue, circular logo with a pattern of dots. The logo appears to be a stylized representation of a globe or sphere. The text and logo are aligned horizontally.
11
Image /page/11/Picture/1 description: The image contains the word "Gleamer" in bold black font next to a blue circle. The circle is made up of many small blue dots, with a white circle in the center. The word "Gleamer" is written in a sans-serif font and is aligned to the right of the circle.
7. Performance data
Note: no animal testing or clinical testing is included in the current 510(k) submission.
7.1. Bench Testing - Nonclinical Tests
Product verification and validation testing were conducted and documented as per the requirements of the FDA guidance "Content of Premarket Submissions for Device Software Functions" for a Basic Documentation Level. Nonclinical tests include unit, integration and system levels testing for the final software version. BoneMetrics US performed as intended and all results observed were as expected. All software requirements and risk analysis have been successfully verified and traced.
7.2. Bench Testing - Clinical Performance Tests
A Clinical Standalone Performance Study was conducted on a dataset of 345 frontal spine radiographs of children and adults obtained from US data providers to validate the performance of BoneMetrics US.
The ground truth was determined by the expertise of two US board-certified musculoskeletal radiologists and one US board-certified orthopedic surgeon. These experts were kept unaware of the outputs from BoneMetrics US, findings from clinical reports, and readings from other truthers. The ground truth was defined as the mean of the Cobb angles measured by the 3 ground truthers to establish a consensus-based ground truth. Any cases with discrepancies exceeding the predetermined threshold were subjected to an adjudication process, where the three experts mutually agreed on a value for the ground truth.
The clinical standalone performance study compared the performance of BoneMetrics US in the measurements of Cobb angles against a ground truth by computing the Mean Absolute Error (MAE) and an acceptance criteria.
| Endpoint | Metric | Mean (95% CI) | Lower Bound | Upper Bound | Acceptance criteria |
|---|---|---|---|---|---|
| Cobb angle with the largest curvature | |||||
| n = 212 | Mean Absolute Error (°) | 2.56 | 2.0 | 3.28 | Upper bound of the MAE |
| 95% CI |