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The DXAVIEW™ Hip and Spine bone densitometry options are intended to estimate bone mineral content (BMC) and bone mineral density (BMD) in the proximal femur and spine. The BMD may be compared to DXA reference data. T-Scores and Z-Scores are calculated with respect to young normal and age matched reference data, and can be used by the physician in determining fracture risk.

The DXAVIEW™ Hip and Spine bone densitometry Options are intended to provide estimates of bone mineral density (BMD) and bone mineral content (BMC) in the proximal femur and spine. Young normal reference data taken from caucasian populations can be used to calculate T-Scores. Age matched normal reference data arc used to calculate Z-Scores. The BMD results, along with the T- and Z-Scores, can be used by physicians in their determination of fracture risk and therapy effectivencss.

The DXAView" Hip and Spine are software Options to the Image Analysis QCT-3D Plus product, which provides 3D projection measurements similar to conventional DXA. The product Options provide estimates of bone mineral content (BMC) and bone density (BMD) of the proximal femur and spine. BMC is expressed in grams and BMD in g/cm2 of calcium hydroxyapatite. DXAView™ uses phantom calibration by Quantitative Computed Tomography (QCT) on all compatible CT scanners. The computations are preformed on 3D CT volumetric image sets obtained with conventional CT protocols and radiation doses.

Here's a breakdown of the acceptance criteria and study information for the DXAView™ Hip and Spine device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state numerical "acceptance criteria" but rather describes the "Summary of Clinical Performance Data" and "Conclusions" from the validation studies, which implicitly serve as the criteria for deemed substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The document refers to "Patient validation studies" and "Clinical studies comparing DXA and DXAVIEW™ for BMD of the hip." However, the exact numerical sample size for these clinical studies (test set) is not specified.
• Data Provenance: Not explicitly stated. It refers to "clinical comparison studies," but neither the country of origin nor whether the data was retrospective or prospective is mentioned.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• This information is not provided in the document. The studies focused on comparing the DXAView™ software to DXA results, implying DXA itself served as a reference, but no mention of human experts establishing ground truth for the test set is given.

4. Adjudication Method for the Test Set

• This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study is not mentioned. The document focuses on comparing the algorithm's output (DXAVIEW™) to a reference standard (DXA), not on how human readers' performance might improve with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone performance study was done. The "Clinical Performance Data" and "Conclusions" describe the performance of the DXAVIEW™ software directly (e.g., its precision, correlation with DXA), without mentioning a human-in-the-loop component. The device itself is described as "software Options to the Image Analysis QCT-3D Plus product."

7. Type of Ground Truth Used

• The ground truth used was comparison to a predicate device (DXA). The document states, "Clinical studies comparing DXA and DXAVIEW™ for BMD of the hip showed correlation coefficients R of 0.93-0.94." It also mentions the new device provides "estimates of bone mineral content (BMC) and bone mineral density (BMD) values similar to those obtained from the predicate DXA device." This implies DXA measurements served as the reference standard (ground truth) for the clinical validation.

8. Sample Size for the Training Set

• The document does not specify a separate training set sample size. It describes the validation studies. Since the device uses reference data (NHANES III) for T-Scores and Z-Scores, this reference data itself could be considered a form of "training" or foundational data, but its sample size is not stated in relation to the device's development.

9. How the Ground Truth for the Training Set Was Established

• The document does not detail how a training set's ground truth was established, as it primarily focuses on the validation against DXA. It mentions that "NHANES III Standardized Reference Data are used to calculate T-Scores and Z-Scores." The ground truth for such standardized reference data like NHANES III would typically be established through large-scale, cross-sectional population studies using direct measurements (e.g., DXA) from a diverse cohort to establish population norms.

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