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The PIXI™ young adult reference population for os calcis and forearm provides the ability to compare the BMD result of the PIXI™ to the value of an average young adult, age 20-45 years old, of the same sex. The results from this comparison are expressed as a percentage of young adults, or as a T-score, defined as a number of standard deviations from the young adult value.

This additional feature is highly comparable to similar features in the Norland pDEXA as well as the Osteon Osteoanalyzer densitometers.

The use of the PIXI™ young adult reference population for os calcis and forearm, is restricted to prescription use only.

The reference BMD values incorporated in this submission, provides the ability to compare the BMD result of the PIXI™, to the value of an average young adult, age 20 - 45 years old, of the same sex. The results from this comparison are expressed as a percentage of young adult, or as a T-Score, defined as number of standard deviations from the young adult value.

The provided text describes a 510(k) submission (K972053) for the PIXI™ young adult reference population for os calcis and forearm, which is an enhancement to a bone densitometer. The submission focuses on establishing descriptive reference data rather than a device's diagnostic performance against a specific disease. Therefore, the traditional acceptance criteria and study design for diagnostic devices (e.g., sensitivity, specificity, reader studies with AI assistance) are not directly applicable in the same way.

Instead, the "acceptance criteria" here relate to the adequacy and representativeness of the reference population data for calculating T-scores and percentage comparisons. The "study" is the data collection process for this reference population.

Here's an attempt to structure the information based on your request, adapting where necessary given the nature of the submission:

Acceptance Criteria and Study for PIXI™ Young Adult Reference Population for Os Calcis and Forearm (K972053)

This 510(k) submission describes the integration of a new reference population into the PIXI™ bone densitometer. The primary "performance" being evaluated is the generation of statistically sound and representative normative data for young adults (20-45 years old) to allow for the calculation of T-scores (number of standard deviations from the young adult mean) and percentage comparisons. Since this is a reference dataset for a measurement device, traditional diagnostic performance metrics (e.g., sensitivity, specificity, AUC) are not presented.

1. Table of Acceptance Criteria and Reported Device Performance

• Female: n=143, Mean=0.556, SD=0.089
• Male: n=107, Mean=0.682, SD=0.106

Forearm:

• Female: n=126, Mean=0.523, SD=0.062
• Male: n=91, Mean=0.623, SD=0.085 |
  | Demographic Representativeness: Data collected from a "normal white young adult" population as appropriate for the intended use. | Data collected on "normal white young adult men and women, age 20 to 45 years." (Specific country of origin not stated but implied to be North America given the submitter's location). |
  | Comparability to Predicate Devices: The method of using reference values is consistent with existing, legally marketed bone densitometers. | "The use of reference values with the PIXI™ bone densitometer is comparable to how reference values are utilized on other commercially available bone densitometers." The feature is also stated to be "highly comparable to similar features in the Norland pDEXA as well as the Osteon Osteoanalyzer densitometers" (identified as predicate devices). This indicates functional equivalence. |
  | No New Safety and Effectiveness Questions: The addition of this reference population does not introduce new risks or concerns. | "No new safety and effectiveness questions are raised with PIXIM young adult reference population for os calcis and forearm." |

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

In this context, the "test set" is the population from which the reference data was collected.

• Sample Size:
  • Os Calcis: 143 females and 107 males.
  • Forearm: 126 females and 91 males.
• Data Provenance:
  • Country of Origin: Not explicitly stated but the company (LUNAR Corporation) is based in Madison, WI, USA, strongly implying US-based data collection.
  • Retrospective or Prospective: Not explicitly stated. However, the phrasing "Data were collected on normal white young adult men and women" suggests a prospective collection of data for the purpose of establishing this reference.

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 for this submission. The "ground truth" here is the measured BMD values themselves from the healthy young adult population. There is no diagnostic classification being made that would require expert consensus for ground truth. The expertise would lie in the design of the study, proper operation of the densitometer, and statistical analysis of the collected data. The submission does not detail who designed or executed the data collection.

4. Adjudication Method for the Test Set

• Not applicable. There is no diagnostic uncertainty or disagreement requiring adjudication in the collection of these normative BMD values.

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

• Not applicable. This submission is for a reference population used in a bone densitometer feature, not an AI-based diagnostic tool that assists human readers in interpreting images.

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

• This concept doesn't directly apply here. The "algorithm" in this case is the statistical calculation of T-scores and percentage comparisons using the collected reference data. The device's primary function (measuring BMD) is standalone, and the reference population provides comparative context to that measurement. There isn't an "algorithm only" performance separate from the reported means and standard deviations of the reference data.

7. The Type of Ground Truth Used

• The "ground truth" is the measured Bone Mineral Density (BMD) values from a defined population of "normal white young adult men and women, age 20 to 45 years." It's not clinical outcomes, pathology, or expert consensus on a diagnostic finding. It represents a statistical description of a healthy population.

8. The Sample Size for the Training Set

• In this context, the "training set" is essentially the same as the "test set" described for the reference population. The data collected constitutes the reference (training) data for future comparisons.
  • Os Calcis: 143 females and 107 males.
  • Forearm: 126 females and 91 males.

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

• The ground truth (i.e., the BMD values themselves) for this reference population was established through direct measurement using a bone densitometer (presumably the PIXI™ device itself or a similar predicate device). The data was collected from "normal white young adult men and women, age 20 to 45 years," implying a recruitment process for healthy individuals within this demographic range. The submission does not detail the specific methodology for subject recruitment or measurement protocols beyond stating the demographic and the measured sites.

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