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The bone density estimates from the pDEXATN and Discovery™ Bone Densitometers can be compared to gender and ethnic matched reference populations as an aid in determining the presence of bone disease other than agerelated bone loss. T-Score, % Young Reference, Z-Score, % Age Matched, and long and short term change values are provided. These reference populations include Caucasian, Afro-American, Hispanic, and Asian men and women.

The bone density estimates from the pDEXA™ and Discovery™ bone densitometers can be used as an aid to physicians in determining fracture risk.

In general, the Multi-Racial Reference Population capability for the pDEXA and Discovery bone densitometers compares the pDEXA and Discovery scan results to average values for people without bone related disease, who have the same gender and ethnic background as the patient. Its purpose is to aid the physician in determining the presence of bone disease other than age related bone loss. Both age matched and young reference comparisons are made. T-Score, Z-Score, % Young Reference, % Age Matched, and a graphical representation are presented.

The Norland pDEXA and Discovery bone densitometers scan the forearm using the industry standard DXA pencil beam technology to assess bone density of the distal and proximal radius plus ulna sites. The Discovery is a newer, smaller version of the pDEXA with faster scan speeds and lower dose. The Discovery dose is

The provided text describes the 510(k) summary for the "Multi-Racial Reference Population for pDEXA™ and Discovery™ Bone Densitometers." The device is not an AI/ML algorithm in the modern sense but rather a reference population used for interpreting bone density measurements. Therefore, many of the typical acceptance criteria and study design elements for AI/ML devices, such as performance metrics, ground truth establishment, training sets, and expert adjudication, are not directly applicable.

Instead, the "acceptance criteria" here relate to the validation of the multi-racial reference population's comparability and appropriateness for use with the pDEXA and Discovery bone densitometers. The study demonstrates that this new reference population is comparable to existing ones and does not raise new safety or effectiveness concerns.

Here's an attempt to structure the information as requested, adapting for the nature of this device:

Acceptance Criteria and Study to Prove Device Meets Criteria

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided 510(k) summary does not detail the specific sample size used to construct or validate the multi-racial reference population, nor does it specify the data provenance (e.g., country of origin, retrospective/prospective). This type of information is typically found in the full 510(k) submission, not the summary document. However, given the nature of a reference population, it would typically be derived from a large, representative, and prospectively collected cohort study or a collection of such studies.

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

Not applicable in the typical sense for this device. A "ground truth" for a reference population is established through epidemiological studies defining normal bone mineral density across different demographics. This involves large-scale data collection, statistical analysis, and potentially clinical consensus on thresholds (e.g., WHO criteria for fracture risk) rather than individual expert review of cases for algorithm performance.

4. Adjudication Method for the Test Set

Not applicable. This is not a device that processes individual cases requiring human adjudication for performance evaluation. The "adjudication" for a reference population would be the scientific and statistical rigor applied to its construction and validation against established medical standards.

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 device is a reference dataset, not an AI/ML 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

The device is a "standalone" reference population. It processes bone density measurements from the hardware (pDEXA/Discovery) and provides comparative metrics (T-Score, Z-Score, etc.) without a human-in-the-loop interpretation being part of the function of the reference population itself. Physicians then use these metrics to aid their diagnosis.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for a bone mineral density reference population is based on:

• Epidemiological data: Large-scale population studies that define normal bone mineral density across various age, gender, and ethnic groups.
• Clinical outcomes data: Particularly for fracture risk assessment, the "truth" is often derived from longitudinal studies correlating bone mineral density values with actual fracture incidence (e.g., the basis for WHO criteria).
• Expert consensus: Derived from scientific bodies (like the WHO) establishing diagnostic thresholds (e.g., T-scores for osteoporosis).

8. The Sample Size for the Training Set

Not explicitly stated in the 510(k) summary but would typically be large, encompassing thousands or tens of thousands of individuals to create a robust and representative reference population. For AI/ML, this would be the "training set." For a reference population, it's the "derivation cohort."

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

For a reference population, the "ground truth" (or normative data) is established through rigorous epidemiological studies:

• Participant Selection: Healthy individuals, representative of the target demographics (age, gender, ethnicity), are recruited, often excluding those with conditions or medications known to affect bone metabolism.
• Data Collection: Bone mineral density measurements are performed using standardized DXA techniques.
• Statistical Analysis: The collected data is statistically analyzed to determine mean BMD and standard deviations for each demographic subgroup (age, gender, ethnicity).
• Clinical Validation: The derived reference values are often cross-referenced with established clinical guidelines and, for fracture risk, validated against observed clinical outcomes.

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The bone density estimates from the Apollo™ bone densitometer can be compared to gender and ethnic matched reference populations as an aid in determining the presence of bone disease other than age-related bone loss. T-Score, % Young Reference, Z-Score, % Age Matched, and long and short term change values are provided. These reference populations include Caucasian, Afro-American, Hispanic, and Asian men and women.

The Apollo bone density estimates can be used as an aid to physicians in determining fracture risk.

The Apollo™ Multi-Racial Reference Population capability compares patient values to average values for people without bone related disease, who have the same gender and ethnic background as the patient. Its purpose is to aid the physician in determining the presence of bone disease other than age related bone loss. Both age matched and young reference comparisons are made. T-Score, Z-Score, % Young Reference, % Age Matched, and a graphical representation are presented. This reference population also includes Fracture Risk assessment based on the World Health Organization (WHO) criteria. In general, this means that patients with T- Scores between +1 to -1 are considered to be normal with a low risk of fracture. Patients with T-Scores from -1 to -2.5 have low bone mass and an increased risk of fracture. Likewise, patients with T- Scores below -2.5 are considered to be osteoporotic and have a high risk of fracture. The Apollo™ scans the heel using the industry standard DXA pencil beam technology to assess bone density of the Os Calcis. A water bath is NOT used; and gels are not necessary. The dose to the patient is 0.2 mRem and the scatter/leakage radiation is

This 510(k) summary for the Apollo™ Multi-Racial Reference Population does not contain the detailed study information typically found in a clinical trial report. The document primarily focuses on establishing substantial equivalence to previously cleared devices rather than presenting a standalone performance study with specific acceptance criteria and results.

However, based on the information provided, we can infer some details and highlight what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the provided 510(k) summary. The document focuses on establishing comparability to existing reference populations rather than setting novel performance thresholds for accuracy or diagnostic efficacy. The "Safety and Effectiveness" section merely states: "This Apollo Multi-Racial Reference Population is comparable to reference population capabilities in use with other bone densitometers in the industry. No new safety or effectiveness issues are raised with this capability."

Therefore, a table with specific acceptance criteria (e.g., accuracy, precision) and corresponding reported performance metrics cannot be constructed from this document.

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

This information is not provided in the 510(k) summary. The document describes the purpose of the reference population (comparing patient values to average values for people without bone-related disease, of the same gender and ethnic background) but does not detail the specific population used to create or test this "Multi-Racial Reference Population." It only states that the reference populations include "Caucasian, Afro-American, Hispanic, and Asian men and women." No sample sizes, geographical origin, or whether the data was retrospective or prospective is mentioned.

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

This information is not provided in the 510(k) summary. Given that this is a reference population for a bone densitometer, the "ground truth" would likely relate to the bone density measurements themselves and the health status of the individuals in the reference population. However, the exact methodology and expert involvement in establishing this "ground truth" for the reference data are not described.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not provided in the 510(k) summary. An adjudication method would typically be relevant for studies involving human interpretation or subjective assessments. For a reference population based on objective bone density measurements, this might not be directly applicable in the same way it would be for a diagnostic image analysis algorithm. However, any process for selecting or classifying the individuals within the reference population for inclusion or exclusion would involve some form of consensus or criteria, which is not detailed here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This information is not applicable and therefore not provided in this 510(k) summary. The Apollo™ Multi-Racial Reference Population is a reference database used by a bone densitometer (DXA pencil beam technology) to interpret bone density values (T-scores, Z-scores). It is not an AI-powered diagnostic algorithm that assists human readers in interpreting images or making a diagnosis in a comparative effectiveness study. Therefore, an MRMC study and effect size related to AI assistance would not be part of this submission. The device is a database, not an AI model.

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

This information is not applicable in the typical sense of an algorithm's standalone performance. The "device" here is a reference population database. Its "performance" is implicitly tied to the accuracy and representativeness of the data it contains, which then allows the interpretation of bone density measurements from the Apollo™ densitometer. The 510(k) focuses on the comparability of this reference population to others in the industry, implying its utility is recognized rather than presenting a novel standalone performance study for the database itself.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The document mentions that the reference population compares patient values to "average values for people without bone related disease." This implies that the "ground truth" for the individuals included in the reference population is their lack of bone-related disease, and their actual bone density measurements (from DXA). The method for determining "without bone related disease" is not specified but would likely involve clinical assessments, medical history, and potentially other diagnostic tests, all contributing to a clinical "truth" of health status.

8. The Sample Size for the Training Set

This information is not provided in the 510(k) summary. The document describes a "reference population," which implies a dataset used to establish normal ranges. This would be analogous to a "training" or "development" dataset if it were an AI model, but for a reference population, it's the fundamental data itself. The size of this population for each gender and ethnic group (Caucasian, Afro-American, Hispanic, and Asian men and women) is not disclosed.

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

The document states the reference population includes "average values for people without bone related disease, who have the same gender and ethnic background as the patient." Therefore, the implicitly established "ground truth" for the individuals whose data forms this reference population is that they were identified as healthy (i.e., "without bone related disease") and their demographics (gender, ethnicity) were recorded. The specific diagnostic criteria or medical evaluations used to confirm the absence of bone-related disease for inclusion in this reference data are not detailed in this summary.

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The XR 46 performs DXA scans of the AP Spine, Hip, Forearm, Lateral Spine, and Whole Body, as well as other user selectable sites. It provides BMD (g/cm2), Area (cm2), and BMC (g) values. It compares these values to gender and ethnic matched reference populations and provides T-Score and % Young Reference, Z-Score and % age matched, and long term and short term change values. This includes sBMD (mg/cm2).

The XR 46 performs soft tissue assessment and provides lean mass, fat mass, percent fat, and total soft tissue values for all scan sites, including Whole Body.

The XR 46 includes a Report Writer that allows the operator to customize the appearance of their reports and to automate the tedious part of the report. It also allows the user to enter ranges of patient values and the specific statements they want to be printed on their reports for each of these ranges.

The bone density measurements from the XR 46 can be used as an aid to physicians in determining fracture risk.

The XR 46 is a full featured, pencil beam, DXA, table bone densitometer that scans the Hip, Spine, Forearm, Whole Body, and other user selectable sites. It provides values for BMD, BMC, and Area. It trends follow-up scan values to provide long and short term % change. It also provides sideby-side comparison images and angulated cursors.

The XR 46 compares patient values to gender and ethnic matched reference populations and provides T-Score, Z-Score, % Young Reference, and % Age Matched values.

The XR 46 includes Fracture Risk assessment based on the World Health Organization (WHO) criteria. In general, this means that patients with T-Scores above -1 are considered to be normal; with T-Scores from -1 to -2.5 are considered to be osteopenic and have an increased risk of fracture; and T-Scores below -2.5 are considered to be osteoporotic and have a high risk of fracture.

The XR 46 includes Body Composition assessment and provides lean, fat, and % fat values. It also provides hydrostatic weighing values based on the Siri and Brozek equations.

The XR 46 includes a Report Writer that allows the operator to customize the appearance of their reports and to automate the tedious part of the report. It also allows the user to enter ranges of patient values and the specific statements they want to be printed on their reports for each of these ranges.

The provided 510(k) summary for the Norland XR 46 DXA Bone Densitometer does not contain information about specific acceptance criteria, a study that proves the device meets those criteria, or details regarding ground truth, expert involvement, or sample sizes related to performance evaluation.

The submission focuses on establishing substantial equivalence to predicate devices (XR 26 DXA bone densitometer, Body Composition Assessment, Reference Population, and Fracture Risk Assessment for Norland bone densitometers) rather than presenting a detailed performance study with acceptance criteria.

The document states that the "XR 46 is comparable to other DXA bone densitometers currently in the market. It does not raise any new safety or effectiveness issues." This suggests that the substantial equivalence argument relies on the inherent capabilities and established performance of the predicate devices.

Therefore, I cannot provide the requested table and information as these details are not present in the provided text.

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