Who is the manufacturer of BoneMetrics (US)?

Gleamer Sas filed the 510(k) submission for BoneMetrics (US) (K241593).

What is the FDA product code for BoneMetrics (US)?

QIH. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for BoneMetrics (US)?

510(k) clearance (submission type: Traditional).

Does BoneMetrics (US) use AI or machine learning?

Yes. BoneMetrics (US) (K241593) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like BoneMetrics (US)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like BoneMetrics (US) get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

BoneMetrics (US)

K241593 · Gleamer Sas · QIH · Feb 5, 2025 · Radiology

Device Facts

Record ID	K241593
Device Name	BoneMetrics (US)
Applicant	Gleamer Sas
Product Code	QIH · Radiology
Decision Date	Feb 5, 2025
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device, Pediatric

Intended 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.

Device Story

BoneMetrics US is a fully automated radiological image processing software that analyzes frontal spine radiographs to measure Cobb angles. It receives DICOM images from a PACS or X-ray system, processes them using machine learning to identify vertebral corner keypoints, and calculates Cobb angles (>7°). The device outputs annotated DICOM images (overlays) and a summary report with angle measurements. It is intended for use by radiologists as a concurrent reading aid to assist in diagnosis. The software does not alter original images. It is deployed via cloud, connecting to DICOM sources and destinations. By providing automated, reproducible measurements, it supports clinical decision-making for spinal deformity management.

Clinical Evidence

Clinical standalone performance study using 345 frontal spine radiographs. Ground truth established by consensus of two board-certified musculoskeletal radiologists and one board-certified orthopedic surgeon. Primary endpoint: Mean Absolute Error (MAE) of Cobb angle measurements. Results: Largest curvature Cobb angle MAE 2.56° (95% CI: 2.0–3.28°); Minor Cobb angle MAE 2.78° (95% CI: 2.29–3.33°). Subgroup analysis performed for adults, children, and adolescents. All results met pre-defined acceptance criteria (upper bound of MAE 95% CI < 6.34°).

Technological Characteristics

Software-only device. Uses convolutional neural networks (CNNs) for image classification and landmarking, and classical methods for angle computation. DICOM-compliant. Cloud-deployed, connected to PACS/X-ray systems via DICOM nodes. No physical materials or energy sources. Software documentation level: Basic.

Indications for Use

Indicated for measurement of Cobb angles on frontal spine radiographs in patients aged 4 years and older with suspected or present spinal deformities (e.g., scoliosis). For use by radiology-trained healthcare professionals.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

IB Lab LAMA (K223646)

Related Devices

K231668 — Spine CAMP (1.1) · Medical Metrics, Inc. · Jul 7, 2023
K250367 — CoLumboX · Smart Soft Healthcare AD · May 28, 2025
K222361 — AI-Rad Companion (Musculoskeletal) · Siemens Medical Solutions USA, Inc. · Oct 20, 2022
K221632 — Spine CAMP · Medical Metrics, Inc. · Oct 18, 2022
K113344 — STEREOS WORKSTATION · Eos Imaging · Nov 16, 2012

Submission Summary (Full Text)

{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) K241593 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 < 6.34° | | Minor Cobb angle n = 189 | Mean Absolute Error (°) | 2.78 | 2.29 | 3.33 | Upper bound of the MAE 95% CI < 6.34° | {12}------------------------------------------------ Image /page/12/Picture/1 description: The image contains the logo for Gleamer. The logo consists of a blue circle with a pattern of dots inside, followed by the word "Gleamer" in a bold, sans-serif font. The word "Gleamer" is black and positioned to the right of the blue circle. A subgroup analysis was performed for the performance accuracy of BoneMetrics US in adults, and children and pediatrics population. | Population | Endpoint | Metric | Mean (95% CI) | Lower Bound | Upper Bound | Acceptance criteria | |------------|--------------------------------------------------------|-------------------------------|---------------------|----------------|----------------|------------------------------------------| | Adults | Cobb angle with the largest curvature (n=100) | Mean Absolute Error (°) | 3.31 | 2.21 | 4.87 | Upper bound of the MAE 95% Cl < 6.34° | | | Minor Cobb angle (n=90) | Mean Absolute Error (°) | 2.91 | 2.29 | 3.68 | Upper bound of the MAE 95% Cl < 6.34° | | Children | Cobb angle with the largest curvature (n=32) | Mean Absolute Error (°) | 1.34 | 0.88 | 1.86 | Upper bound of the MAE 95% Cl < 6.34° | | | Minor Cobb angle (n=18) | Mean Absolute Error (°) | 1.95 | 1.01 | 3.21 | Upper bound of the MAE 95% Cl < 6.34° | | Adolescent | Cobb angle with the largest curvature (n=80) | Mean Absolute Error (°) | 2.11 | 1.71 | 2.56 | Upper bound of the MAE 95% Cl < 6.34° | | | Minor Cobb angle (n=81) | Mean Absolute Error (°) | 2.83 | 1.96 | 3.85 | Upper bound of the MAE 95% Cl < 6.34° | The standalone results indicates that BoneMetrics US was able to meet the pre-defined performance acceptance criteria for Cobb angle measurements, thereby demonstrating its ability to provide clinically relevant measurements. The performance achieved by the device confirms that BoneMetrics US is an effective imaging device capable of providing measurements of Cobb angles on frontal spine radiographs. Consequently, BoneMetrics US perform as intended and is considered substantially equivalent to the predicate device. ## 7.3. Conclusion BoneMetrics US is as safe and effective as the predicate device. BoneMetrics US and the predicate device are both fully-automated radiological image processing software device intended to aid users perform measurements of interests on radiographs. The overall design of the software and the basic functionality that it provides to the end user are the same. The minor differences between the subject and the predicate device in indications do not alter the intended use of the device and do not raise new or different questions regarding its {13}------------------------------------------------ Image /page/13/Picture/1 description: The image contains the word "Gleamer" in a bold, sans-serif font. To the left of the word is a blue circle with a pattern of dots, creating a visual element that complements the text. The overall design is clean and modern, suggesting a professional or corporate identity. safety and effectiveness when used as labelled. Verification and validation testing, including the clinical standalone software performance tests, supports the safety and demonstrates that BoneMetrics US performs as intended. Therefore BoneMetrics US is substantially equivalent.