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The bone density estimates from Norland X-Ray Bone Densitometers can be used as an aid to the physician in determining risk of fracture.

This fracture risk assessment capability provides information that aids the physician in determining risk of fracture, risk of bone disease, or treatment effectiveness. This fracture risk assessment capability interprets the results of the bone density tests performed by Norland bone densitometers in accordance with methods in general use in the medical community. In general they use the bone densitometer values (usually BMD and T-Score) and patient information (usually gender, age, and ethnic background). The interpretation is based on the World Health Organization's (WHO) criteria relating bone density to risk of fracture and diagnosis of osteoporosis. In general, the WHO criteria means that patients with T-Scores from +1 to -1 are considered to be normal; with T-Scores from -1 to -2.5 are considered to have low bone mass and have an increased risk of fracture; and with T-Scores below -2.5 are considered to be osteoporotic and have a high risk of fracture. This information is presented graphically and as verbiage on the screens and reports.

This fracture risk capability does not require any modifications to the Norland bone densitometers besides adding the fracture risk information to the screens and printouts. In particular, it does not increase the scanning time, patient dose, or scatter radiation.

The provided text is a 510(k) summary for a "Fracture Risk Assessment Capability" for Norland X-Ray Bone Densitometers. This device is an interpretation capability that uses existing bone densitometer values (BMD and T-Score) and patient information (gender, age, ethnic background) to assess fracture risk based on World Health Organization (WHO) criteria.

The document states that the device "does not require any modifications to the Norland bone densitometers besides adding the fracture risk information to the screens and printouts" and "does not increase the scanning time, patient dose, or scatter radiation." It also asserts that "This Norland Fracture Risk Assessment Capability is comparable to fracture risk assessment capabilities in use with other bone densitometers in the industry. No new safety or effectiveness issues are raised."

However, this document does not contain specific acceptance criteria, study details, or performance metrics for the device itself. It focuses on the substantial equivalence argument, stating that the device is comparable to existing predicate devices and does not raise new safety or effectiveness issues. Therefore, I cannot provide a table of acceptance criteria and reported device performance from the given text, nor can I detail specific study parameters for this particular device.

The FDA's letter (K980569) confirms that the device is substantially equivalent to a predicate device, meaning it doesn't require new clinical studies to prove safety and effectiveness if it meets the criteria of being essentially the same as a legally marketed device.

Based on the provided text, the following information is available or can be inferred, but many points requested in your prompt are explicitly not available:

Acceptance Criteria and Study Details (Based on available information in the document)

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 a predicate device and confirming that the new capability does not introduce new safety or effectiveness concerns. There are no quantitative performance metrics (e.g., sensitivity, specificity, AUC) detailed in this summary.

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

• Not provided. The document states the device interprets existing bone density test results but does not describe any specific test set or clinical study conducted for this 510(k) submission. The argument is based on substantial equivalence, implying that the underlying science of fracture risk assessment based on WHO criteria is already established.

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

• Not applicable. No specific test set with ground truth established by experts is described for this submission. The "ground truth" for the interpretation method itself is the established World Health Organization (WHO) criteria for T-Scores and their relation to fracture risk and osteoporosis diagnosis.

4. Adjudication method for the test set:

• Not applicable. No specific test set requiring adjudication is described.

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. The provided text does not describe an MRMC study or any study involving human readers' improvement with or without AI assistance. The device is described as an "interpretation capability" that presents information, not as an AI-assisted diagnostic tool for readers.

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

• Yes, implicitly. The device itself is an "interpretation capability" that processes bone densitometer values and patient information to generate a fracture risk assessment based on predefined WHO criteria. This operates in a standalone manner to generate its output, which is then presented to a physician. No human interpretation is built into the algorithm's output generation. However, this is not a diagnostic device in itself, but an aid to the physician.

7. The type of ground truth used:

• Expert Consensus / Clinical Guidelines: The ground truth for the fracture risk assessment interpretation is based on the World Health Organization's (WHO) criteria for relating bone density (T-Scores) to the risk of fracture and diagnosis of osteoporosis.

8. The sample size for the training set:

• Not applicable / Not provided. The device is not described as an AI/ML model that undergoes a "training" phase in the conventional sense. It applies established WHO criteria. The WHO criteria themselves were developed based on extensive medical and scientific research, but that's foundational knowledge, not a training set for this specific device.

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

• Not applicable. As described above, there's no "training set" in the context of an AI/ML algorithm. The underlying "ground truth" (WHO criteria) was established through scientific consensus and epidemiological studies in the medical community.

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