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The Fracture Risk option is used with the LUNAR EXPERT-XL 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 EXPERT-XL 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.

The Fracture Risk option for EXPERT-XL is a software accessory to aid the physician in assessing fracture risk from the results of an EXPERT-XL 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 include details about acceptance criteria, device performance, study design, or ground truth establishment. This specific 510(k) summary focuses on establishing substantial equivalence for a software feature (Fracture Risk option for EXPERT-XL Bone Densitometer) to a pre-amendment predicate device (Norland-Cameron Model 178 Bone Mineral Analyzer).

The summary explicitly states: "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." and "The Fracture Risk option for EXPERT-XL poses no new safety or efficacy concerns."

Essentially, the manufacturer is arguing that because the new software feature only processes existing bone mineral density T-scores into WHO-defined categories of fracture risk, and does not alter how the bone densitometer collects data or produces the primary T-score, no new performance studies are required to demonstrate safety or effectiveness beyond the existing predicate device.

Therefore, I cannot populate the requested table or answer the questions regarding acceptance criteria, study details, human reader performance, or ground truth from the provided text.

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