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The expanded reference BMD values described in the present submission include both male and female data from white adults in the U.S. and northern Europe. These new reference values are for BMD measurements taken at the AP Spine, Lateral Spine, Proximal Femur, Total Body and Radius Shaft sites. Male data for lateral spine BMD measurements are not available. The Operator's Manual contains tabulated summaries of these updated reference values and citations to published sources of these materials.

The provided text describes an addition of expanded reference BMD (Bone Mineral Density) values for the LUNAR DPX Series Bone Densitometer. It's important to note that this submission adds to existing reference values and does not describe a study to prove the device itself meets acceptance criteria in the traditional sense of a new diagnostic algorithm or a device requiring performance evaluation for sensitivity/specificity.

Instead, the submission is focused on the acceptability of incorporating new reference data. Therefore, the "acceptance criteria" and "study" are interpreted in that context.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the exact sample size for the expanded reference values. It only states that they include "both male and female data."
• Data Provenance: The data are from "white adults in the U.S. and northern Europe." The text does not specify if the data is retrospective or prospective, but given it refers to "published sources," it is likely these are compiled retrospective datasets.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This is not applicable in the traditional sense. The "ground truth" here refers to the validity of the reference data itself, which is established through medical research, epidemiological studies, and statistical methods to define normative BMD ranges. The submission indicates these are from "published sources," implying they have undergone peer review and scientific scrutiny. The document does not detail the process of establishing these original reference values or the number/qualifications of experts involved in the original studies.

4. Adjudication Method for the Test Set

• Not applicable. There is no "test set" in the context of a diagnostic adjudication process. The current submission is about adding reference data, not evaluating the performance of a diagnostic algorithm against a gold standard.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

• No. This type of study is not described or indicated. This submission is not evaluating human reader performance with or without AI assistance but rather providing additional reference data for a bone densitometer.

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

• No. This is not a standalone algorithm performance evaluation. The DPX Series Bone Densitometer is a device that measures BMD, and these are reference values used with the device by a clinician.

7. The Type of Ground Truth Used

• The "ground truth" for the expanded reference values is essentially expert consensus and robust statistical analysis derived from large population studies that establish normative bone mineral density values for different demographics. The document states these are from "published sources," indicating they are based on established medical literature and research.

8. The Sample Size for the Training Set

• Not applicable in the context of a machine learning algorithm. The "training set" here would refer to the population data used to establish the reference values themselves. The exact sample size is not provided, but it is implied to be a substantial dataset given it represents "male and female data from white adults in the U.S. and northern Europe."

9. How the Ground Truth for the Training Set Was Established

• The ground truth for these reference values was established through medical research and population-based studies that measure BMD in large cohorts, categorize individuals by age, sex, and ethnicity, and determine statistical distributions to define "normal" ranges. The document refers to "citations to published sources of these materials," indicating that standard scientific methods were used to collect and analyze this data.

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