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The Fracture Risk option is used with the LUNAR DPX Series of bone densitometer systems. This option provides an assessment of relative fracture risk based on the patient's T-score value using the categories of fracture risk defined by the World Health Organization (WHO). Physician and patient information is provided to indicate that although bone density is the single most important factor in the assessment of fracture risk and the diagnosis of osteoporosis, the physician should also consider other factors.

The use of the Fracture Risk option for DPX Series is restricted to prescription use only.

The Fracture Risk Option for DPX Series Bone Densitometers provides fracture risk assessment based on patient's bone mineral density T-score.

The Fracture Risk option for DPX Series is a software accessory to aid the physician in assessing fracture risk from the results of a DPX Series bone density examination. The Fracture Risk Assessment Feature does not cause any changes to the scan parameters used in the examination, and it does not affect the results produced.

The provided text does not contain detailed information about specific acceptance criteria or an analytical study with performance metrics in the format requested.

Here's an analysis of what is available based on the provided text, and what is missing:

What is present in the document:

• This is a 510(k) Pre-market Notification for the "Fracture Risk option for DPX Series Bone Densitometers."
• The device is a software accessory that provides fracture risk assessment based on a patient's bone mineral density T-score.
• It does not involve a comparative effectiveness study with human readers or standalone algorithm performance. Instead, it relies on substantiating equivalency to a predicate device.
• The ground truth for the device's assessment is stated to be "the categories of fracture risk defined by the World Health Organization (WHO)" using the patient's T-score value. This indicates a reliance on established medical guidelines rather than a new empirical study for establishing fracture risk.
• The submission document is a summary of safety and effectiveness, and the FDA's clearance letter. It concludes that "No new safety and effectiveness questions are raised" because the device is substantially equivalent to a pre-amendment device (Norland-Cameron Model 178 Bone Mineral Analyzer).

Missing Information (not found in the provided text):

• A table of acceptance criteria and reported device performance (e.g., sensitivity, specificity, accuracy, precision). The document states no new safety or efficacy concerns and relies on substantial equivalence.
• Sample size used for the test set.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Information on a multi-reader, multi-case (MRMC) comparative effectiveness study, including effect size.
• Information on standalone (algorithm-only) performance.
• Sample size for the training set.
• How ground truth for the training set was established (beyond reliance on WHO guidelines for T-score interpretation).

Summary of available information:

1. Table of acceptance criteria and reported device performance: Not applicable in the context of this 510(k) submission, as it focuses on substantial equivalence rather than new performance claims from an analytical study. The "performance" is implicitly tied to compliance with WHO guidelines for T-score interpretation.

2. Sample size used for the test set and data provenance: No test set is described. The device leverages existing interpretations of T-scores based on WHO guidelines.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as reliance is on WHO-defined categories of fracture risk, not a specific expert interpretation for a test set.

4. Adjudication method for the test set: Not applicable.

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 study was mentioned or performed as part of this submission. The device is a software accessory providing information based on existing measurements.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No specific standalone performance study is described. The device's function is to apply established WHO criteria to T-scores, which are generated by the bone densitometer.

7. The type of ground truth used: World Health Organization (WHO) definitions and categories of fracture risk based on T-score values. This is a form of established clinical guideline or consensus.

8. The sample size for the training set: Not applicable. This device is not described as using a machine learning model that requires a training set. It applies a rule-based algorithm (T-score to WHO fracture risk category).

9. How the ground truth for the training set was established: Not applicable, for the same reason as above.

In essence, this device's regulatory review focused on its classification and the absence of new safety or efficacy concerns given its function as a software accessory applying established medical guidelines to existing data (bone density T-scores). It was determined to be "substantially equivalent" to a predicate device, meaning it did not require novel performance studies against specific acceptance criteria for a new clinical claim.

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