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The EXPERT-XL Orthopedic Hip Acquisition and Analysis Software is used with the EXPERT-XL Bone Mineral Densitometry system. This new software feature allows for estimation of periprosthetic BMD of an orthopedic hip implant in sub-regions called Gruen zones. These zones are a typical radiographic labeling technique for orthopedic hip implants.

The Orthopedic Hip Acquisition and Analysis Software is an accessory software option for the EXPERT-XL Bone Densitometer that allows estimation of Bone Mineral Density BMD (in g/cm2) of periprosthetic bone adjacent to an orthopedic hip implant.

Here's an analysis of the provided text regarding the acceptance criteria and study for the EXPERT-XL Orthopedic Hip Acquisition and Analysis Software:

Note: The provided document is a 510(k) summary and FDA clearance letter, which typically focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical trial results with detailed acceptance criteria and standalone performance metrics. Therefore, some of the requested information, particularly regarding specific performance acceptance criteria, expert adjudication, MRMC studies, and detailed ground truth methodology, is not explicitly present in this type of regulatory submission.

Acceptance Criteria and Study for EXPERT-XL Orthopedic Hip Acquisition and Analysis Software

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The acceptance criteria for this 510(k) submission are primarily based on demonstrating substantial equivalence to the predicate device (K914404 Orthopedic Software for Lunar DPX Series densitometers). This means the new device should perform similarly or better than the predicate without raising new safety or efficacy concerns. The "reported device performance" are the metrics provided to support this claim of substantial equivalence.

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

• Test Set Sample Size: Not explicitly stated in the provided document. The correlation (r=0.97) and precision (CV) values are given, implying a test was performed, but the number of subjects or scans is not specified.
• Data Provenance: Not explicitly stated. Given the company (Lunar Corporation) is located in Madison, WI, USA, it is highly probable the data was collected in the USA, but this is an inference. It's also not specified if the data was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.

Explanation: For a 510(k) submission focused on substantial equivalence for a bone densitometry device, the "ground truth" for BMD measurements is typically established through direct measurement by the device itself or by comparison to another validated device (the predicate). Expert consensus or pathologist review is less common for establishing the primary ground truth in this specific application, as the output is a quantitative measure (BMD). The comparison is to another device's measurements.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/not mentioned. The study likely involved direct comparison of quantitative BMD output rather than subjective interpretation requiring adjudication among multiple readers.

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

• MRMC Study: No, an MRMC comparative effectiveness study is not described or indicated for this device. The device provides a quantitative measurement (BMD) and is not intended for subjective interpretation by human readers. Therefore, an "improvement with AI vs. without AI assistance" effect size is not relevant in this context.

6. Standalone Performance Study (Algorithm Only)

• Standalone Study: Yes, the described performance metrics (correlation r=0.97, precision CV=3%) are indicative of a standalone performance study. The device's software (algorithm) produces these quantitative results, and they are compared to those of the predicate device. There is no mention of a human-in-the-loop component in the evaluation of these specific metrics.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth appears to be the results obtained from the predicate device, the Lunar DPX series densitometers. The study establishes a high correlation between the EXPERT-XL Orthopedic Hip software results and the DPX series results. For precision, the in vivo CV is compared to that shown on DPX series densitometers.

8. Sample Size for the Training Set

• Training Set Sample Size: Not mentioned. 510(k) summaries generally do not detail the development or training process for the algorithm unless it's critical to establishing substantial equivalence for a novel aspect.

9. How Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not mentioned. As with the test set, it's highly probable that if any training was involved in the software development, it would have been based on BMD measurements from established, validated bone densitometry systems, likely including the predicate device or similar systems. Given the nature of a 510(k) in 1997, sophisticated AI/ML training paradigms as understood today might not have been applicable, or if they were, the details are not required in this summary.

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