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Ten-Year Fracture Risk Option: The Ten-Year Fracture Risk Option for the Norland DXA Bone Densitometeters uses the femoral neck T-Score, along with certain clinical risk factors, to estimate the patient's ten-year risk of a hip fracture and/or a major osteoporotic fracture, based on the FRAX algorithm developed by the World Health Organization (WHO). This information is useful to health care professional as they manage diseases or conditions relating to bone health. This option does not diagnose disease or recommend treatment.

SIRI Table Option: The SIRI Table Option for the Norland DXA Bone Densitometers uses the SIRI UWE % Fat value, and plots it on the industry standard body fat charts. The chart used depends on the patient's gender and age, and it indicates whether the patient is Underfat, Healthy, Overfat, or Obese. These charts are the result of work done by the National Institute of Health (National Heart, Lung, and Blood Institute), who assigned underfat to obese classifications to the BMI value; and by Tanita Corporation, who related BMI to % body fat based on DXA bone densitometry. This option also calculates the patient's Body Mass Index (BMI) based solely on the height and weight data inputted by the operator, as a convenience. This information is useful to health care professional as they manage diseases or conditions relating to or affected by the patient's relative amount of fat tissue. This option does not diagnose disease or recommend treatment.

The Ten-Year Fracture Risk Option and the SIRI Table Option for the Norland DXA Bone Densitometers are software options that use presently provided scan results and related industry standards to provide additional information to the medical professional as they diagnose and treat bone related and body fat related diseases and conditions.

Here's a breakdown of the acceptance criteria and study information for the "Ten-Year Fracture Risk and SIRI Table Options for Norland DXA Bone Densitometers," based on the provided document:

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample sizes used for the test set and data provenance:

   • Ten-Year Fracture Risk: 150 patients. Data provenance is "Previously acquired data." Specific country of origin is not mentioned, but "Norland customers" are referenced for the broader testing. The data is retrospective as it refers to "previously acquired data."
   • SIRI Table Option: 150 patients. Data provenance is "Previously acquired data." Specific country of origin is not mentioned. The data is retrospective.

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

   • No expert "ground truth" establishment is described for the test set. For the Ten-Year Fracture Risk option, the comparison was made against the "charts on the FRAX website" and the "FRAX publication." For the SIRI Table Option, the verification was against the "proper chart" and the "SIRI UWE % Fat value." The comparison for the Ten-Year Fracture Risk chart values was done "by a person different from the one who entered the data," suggesting an internal verification process rather than external expert consensus.

3. Adjudication method for the test set:

   • Adjudication methods like 2+1 or 3+1 are not mentioned. The testing described focuses on direct comparison and verification against established standards (FRAX website/publication, industry-standard body fat charts). For the Ten-Year Fracture Risk chart values, there was a double-check by a different person.

4. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size:

   • No MRMC comparative effectiveness study was done. The document explicitly states: "Clinical testing was not required for either of these options to establish safety or effectiveness, because they do not cause changes to the scanning or analysis processes. Instead, they just use the values presently generated to produce their results."

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

   • Yes, the performance described is standalone. The software options "use presently provided scan results and related industry standards to provide additional information" and "do not affect the technology... No physical changes are required and the scanning and analysis functions are not impacted." The "proper operation of both options with real patient data was tested" which describes the standalone algorithm's output.

6. The type of ground truth used:

   • Ten-Year Fracture Risk: The ground truth used was the World Health Organization (WHO) Fracture Risk Assessment algorithm (FRAX) accessible via its website charts and publication.
   • SIRI Table Option: The ground truth used was industry-standard Body Fat Charts developed by Tanita from the work by D. Galligher, and classifications from the National Institute of Health (National Heart, Lung, and Blood Institute) relating BMI to % body fat.

7. The sample size for the training set:

   • The document does not mention a separate "training set" for the device. The device is a software option that applies existing algorithms (FRAX, Tanita/Galligher body fat charts) to pre-existing DXA scan results. Hence, the algorithms themselves would have been developed and "trained" on their respective datasets by WHO/FRAX and Tanita/Galligher/NIH over time, not by Norland for this specific device submission.

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

   • As there's no training set for this specific device, the ground truth for the underlying FRAX algorithm and body fat charts was established externally by the World Health Organization (WHO), Tanita Corporation, and the National Institute of Health (National Heart, Lung, and Blood Institute) respectively, based on their research and epidemiological studies. The document does not describe their ground truth establishment methods.

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