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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.

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.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of acceptance criteria and the reported device performance:

Subgroup Analysis for Acceptance Criteria and Performance:

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: 345 frontal spine radiographs.
• Data Provenance: Obtained from US data providers. The text doesn't explicitly state whether the data was retrospective or prospective, but for regulatory studies, it is typically well-defined.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Three (3) experts.
• Qualifications of Experts: Two US board-certified musculoskeletal radiologists and one US board-certified orthopedic surgeon.

4. Adjudication method for the test set:

• The ground truth was initially defined as the mean of the Cobb angles measured by the 3 ground truthers to establish a consensus-based ground truth.
• For cases with discrepancies exceeding a predetermined threshold, an adjudication process was implemented where the three experts mutually agreed on a value for the ground truth. This is a 3-expert consensus with adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No MRMC comparative effectiveness study was done in this submission. The study described is a "Clinical Standalone Performance Study" comparing the device's measurements against a ground truth.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Yes, a standalone performance study was done. The text explicitly states, "A Clinical Standalone Performance Study was conducted..." The experts establishing ground truth were kept unaware of the outputs from BoneMetrics US.

7. The type of ground truth used:

• The ground truth was established by expert consensus (mean of three expert measurements with adjudication for discrepancies).

8. The sample size for the training set:

• The document does not specify the sample size for the training set. It only mentions "dedicated training of the algorithm for the indications and the patient population" as a control in the discussion of differences from the predicate device.

9. How the ground truth for the training set was established:

• The document does not specify how the ground truth for the training set was established. It only mentions "dedicated training of the algorithm" without details on the ground truth process for training data.

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