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The Fracture Risk option is used with the LUNAR PIXI bone densitometer system. 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 PIXI is restricted to prescription use only.

The Fracture Risk option for EXPERT-XL is a new software feature, providing fracture risk assessment based on the patient's bone mineral density T-score.

This document is a 510(k) premarket notification for a software feature called "Fracture Risk option for EXPERT-XL Bone Densitometer," which assesses fracture risk based on a patient's bone mineral density T-score. The submission aims to establish substantial equivalence to a predicate device.

Here's an analysis of the provided text regarding acceptance criteria and the study:

Key Takeaways:

• No specific acceptance criteria or performance study is reported in this document. The submission relies on establishing substantial equivalence to a predicate device (Norland-Cameron Model 178 Bone Mineral Analyzer) rather than providing a new performance study with explicit acceptance criteria.
• The core argument is that the new software option does not introduce new safety or effectiveness concerns and does not change scan parameters or results produced by the bone densitometer.

Given this, I will answer the questions based on the absence of this information in the provided document, where applicable.

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

   Acceptance Criteria	Reported Device Performance
   Not stated.	Not stated.

   Explanation: The document does not provide specific acceptance criteria (e.g., target accuracy, sensitivity, specificity) for the Fracture Risk option, nor does it report any performance metrics against such criteria. The submission's focus is on substantial equivalence, implying that its performance is implicitly considered equivalent to the predicate device because it doesn't alter diagnostic output.

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

   • Sample Size: Not applicable. No test set or performance study is described.
   • Data Provenance: Not applicable. No data or study is described.

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 applicable. No ground truth establishment for a test set is described.

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

   • Not applicable. No test set and no adjudication method are 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

   • Was an MRMC study done? No. The document does not describe any MRMC comparative effectiveness study.
   • Effect size of improvement: Not applicable.

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

   • No. The document does not describe a standalone performance study. The device is a "software accessory to aid the physician," implying human-in-the-loop use. However, no performance data for this aid is provided.

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

   • Not applicable. No ground truth is described as part of a performance study for this submission. The device provides "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)." This implies that the 'ground truth' for its classification logic is based on established WHO guidelines, not a newly gathered dataset with independent ground truthing.

8. The sample size for the training set

   • Not applicable. The document does not describe a training set as part of a machine learning or AI algorithm development process. The "Fracture Risk option" appears to be a rule-based software feature applying WHO criteria to existing bone density T-scores.

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

   • Not applicable. No training set is described. The "ground truth" for the device's function is the established WHO categories for fracture risk based on T-scores.

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The PIXI Bone provides an estimation of Bone Mineral Density (BMD in g/cm2) for the regions of the forearm and heel (os calcis).

The provided text is a 510(k) summary for the LUNAR PIXI Bone Densitometer. It discusses the device's technical characteristics and claims comparability to predicate devices. However, it does not include a study that defines explicit acceptance criteria and then presents results showing the device meets those criteria.

Instead, the document focuses on demonstrating that the PIXI device's performance metrics (BMD estimation correlation, in vitro precision, and in vivo precision) are "comparable" to previously cleared devices. It does not set a specific threshold or target value that the PIXI must meet to be considered acceptable.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide details about the study proving it meets acceptance criteria, because such information is not present in the provided text.

Here's what can be extracted based on the information given, highlighting the missing elements:

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

Missing Information:

• Explicit, quantitative acceptance criteria (e.g., "BMD correlation must be > 0.99", "In vivo precision must be

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