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The Pediatric Reference Database is a software option used with Hologic QDR Series X-Ray Bone Densitometers. The software expands the range of bone densitometry reference data to include ages 3-20 years of age. The software provides a comparison of measured Bone Mineral Density (BMD) measurements obtained by dual energy x-ray absorptiometry to a database of BMD reference values in children. These data may be used for comparative purposes at the discretion of the physician.

The Pediatric Reference Database is a software option which simply extends the existing, commercially available reference databases' ability to generate a Z-score for younger subjects. The Pediatric Reference Database for the Hologic QDR Series X-Ray Bone Densitometers provides AP Spine, Hip and "Total" body bone densitometry reference data for male, white American children. This software is used in conjunction with previously existing software in the QDR Series Densitometers which calculates and reports results relative to sex, ethnicity and age-matched values. The reference database is used to expand the range of bone densitometry reference values to include age 3-20 years of age. The software provides a comparison of Bone Mineral Density (BMD) measurements obtained by dual energy x-ray absorptiometry to a database of BMD reference values. Patient results for each analysis region can be compared to reference values both graphically and numerically to each category of the age dependent reference Bone Mineral Density (BMD) values. The sex and ethnicity of the patient are generated with a marker placed at the position corresponding to the estimated patient BMD and age. Deviation "scores," are computed, quantifying (in standard deviation units) the difference between the patient's estimated BMD and the mean population standard (Z-score) reference data. In addition, the patient BMD is expressed in percent of the age matched mean in percent of the pediatric mean.

The provided text describes a Pediatric Reference Database for Hologic QDR Series X-Ray Bone Densitometers, a software option that extends the existing reference databases to include ages 3-20 years.

Here's an analysis of the acceptance criteria and the study as per your request:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in the typical sense of a target performance metric (e.g., sensitivity, specificity, accuracy) with thresholds. Instead, the "acceptance criteria" appear to be met by demonstrating substantial equivalence to predicate devices. The study's reported "performance" is implicitly that the device functions as intended by providing a Z-score and comparison to age-matched values for pediatric populations, which is consistent with the function of the predicate devices.

Note: The document focuses on demonstrating substantial equivalence, which is a regulatory pathway. It does not provide a traditional performance study with explicit numerical metrics (e.g., accuracy, precision of the Z-score calculation itself, or clinical outcomes). The "study" here is the collection and presentation of reference data.

Detailed Study Information:

The provided text does not describe a traditional study in the sense of an experiment to test the performance of the device against a cohort. Instead, it describes a reference database that enhances an existing device's functionality. Therefore, many of the requested details about a "study" (like test sets, ground truth establishment for test sets, expert adjudication methods, MRMC studies, standalone performance, and training sets) are not directly applicable or are not explicitly stated in the provided text.

Based on the information given, here's what can be inferred or explicitly stated:

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

   • Test Set Sample Size: Not applicable in the context of a "test set" for performance evaluation, as this document is about establishing a reference database. The database itself comprises the reference data. The size of the population from which the reference data was collected is not stated.
   • Data Provenance: The reference data is for "male, white American children." This indicates the data origin is from the United States and is retrospective in the sense that it represents a collected population. It's not a prospective study to test a hypothesis about the device's performance.

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

   • Not explicitly stated/Not applicable. The "ground truth" here is the reference data itself, representing a healthy pediatric population's BMD values. The process of collecting and validating this reference data (e.g., how the healthy population was defined, how measurements were ensured to be accurate) is not detailed. There's no mention of experts establishing a "ground truth" for individual cases in a test set.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. There is no "test set" in the context of diagnostic performance requiring adjudication of results.

4. 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:

   • No, an MRMC study was not done. This device is a reference database, not an AI-assisted diagnostic tool.

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

   • Not applicable, but the device inherently functions "standalone" as a reference. The software provides Z-scores based on the input BMD measurement and patient demographics. It's a computational tool, not an AI algorithm that makes diagnostic interpretations. Its "performance" is its ability to correctly reference the input BMD against its stored database.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Reference Database Values derived from a healthy population. The "ground truth" is the established set of age-, sex-, and ethnicity-matched Bone Mineral Density values for healthy children. The methodology for establishing this healthy population baseline is not detailed in the provided text, but it would typically involve anthropometric measurements, medical history, and DEXA scans from a large, representative cohort of healthy children.

7. The sample size for the training set:

   • Not explicitly stated. The term "training set" is not used, as this is a reference database, not a machine learning model. The size of the population from which the "Pediatric Reference Database" data was derived is not provided.

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

   • Not explicitly stated, but implied as a collected reference population. The "ground truth" for this reference database would have been established through a systematic collection of Bone Mineral Density (BMD) measurements from a cohort of healthy male, white American children across the age range of 3-20 years, using validated DEXA scanning protocols. The process would involve defining inclusion/exclusion criteria for "healthy," performing scans, and statistically characterizing the BMD distribution to create age-specific means and standard deviations.

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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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