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The Hip Structural Analysis (HSA) Option for QDR X-Ray Bone Densitometers uses data from conventional Dual Energy X-Ray Absorptiometry (DXA) scans to measure the distribution of bone mineral mass at specific cross sections of the hip and allows the physician to estimate structural properties of the hip, such as CSA, CSMI, Z and Buckling Ratio.

The Hip Structural Analysis (HSA) Option for QDR X-Ray Bone Densitometers uses data from conventional Dual Energy X-Ray Absorptiometry (DXA) scans to measure the distribution of bone mineral mass at specific cross sections of the hip and allows the physician to estimate structural properties of the hip, such as CSA, CSMI, Z and Buckling Ratio.

The provided text is a 510(k) summary for the Hologic Hip Structural Analysis (HSA) Software Option for QDR X-Ray Bone Densitometers. While it details the device's intended use and substantial equivalence to predicate devices, it does not contain information on specific acceptance criteria, a detailed study proving performance against those criteria, or the methodology typically associated with such studies (e.g., sample sizes, ground truth establishment, expert qualifications, or MRMC studies).

The "Conclusion" section (H.4) states that the device is "substantially equivalent to the presently marketed Discovery Package for QDR Densitometers software (K023398) and the Advanced Hip Assessment (AHA) Software for GE Prodigy x-ray bone densitometers (K011917). No new safety and efficacy questions are raised with the HSA Software Option." This strongly suggests that the regulatory submission relied on substantial equivalence rather than a detailed performance study with explicit acceptance criteria for this specific device.

Therefore, most of the requested information cannot be extracted from the provided document.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Not Available: The document does not specify any quantitative acceptance criteria for device performance (e.g., accuracy thresholds for CSA, CSMI, Z, or Buckling Ratio). It only states the device "allows the physician to estimate structural properties."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not Available: The document does not mention any specific test set, its sample size, or the provenance of the data used for any testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not Available: Since no specific test set or ground truth establishment process is described, information about the number or qualifications of experts is not present.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not Available: No adjudication method is mentioned as no specific test set evaluation process is detailed.

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

• Not Available: The document does not describe any MRMC study or any assessment of human reader improvement with or without AI assistance. This device is a software option for bone densitometers, providing measurements of structural properties, not necessarily an AI-assisted diagnostic tool that would typically undergo MRMC studies in this context.

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

• Implied Standalone (but no performance metrics): The software itself is the algorithm, providing measurements. Therefore, its performance would inherently be "standalone" in generating these structural properties. However, there are no reported performance metrics for this standalone operation. The "Intended Use" states it "allows the physician to estimate structural properties," implying the software provides data to the physician, rather than fully automating a diagnostic conclusion.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not Available: No ground truth type is specified, as no detailed performance study or validation against a ground truth is described.

8. The sample size for the training set

• Not Available: The document does not mention a training set or its size.

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

• Not Available: No information is provided regarding the establishment of ground truth for a training set.

Summary Table of Available Information:

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