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The Infant Whole Body software option for QDR X-Ray Bone Densitometers is an optional data acquisition and analysis method that provides estimates of bone mineral content (BMC, in grams), bone mineral density (BMD, in grams/cm²), and body composition (lean body mass and fat mass of non-osseous tissues) in human infants from birth to one year of age. These data may be used at the discretion of a physician where medically necessary.

The Infant Whole Body software option for QDR X-Ray Bone Densitometers is an optional data acquisition and analysis method that provides estimates of bone mineral content (BMC. in grams), bone mineral density (BMD, in grams/cm²), and body composition (lean body mass and fat mass of non-osseous tissues) in human infants from birth to one year of age. These data may be used at the discretion of a physician where medically necessary. The Infant Whole Body software option adds an optional scan type to the QDR XP Scan Module, and an optional analysis type to the QDR XP Analysis Module of the QDR for Windows software operating system. The only differences between the Infant Whole Body software option and the adult Whole Body Software Option are: A modification to the Scan Module (data acquisition module) to enable a smaller region of interest (due to smaller subject size), thinner x-ray beam and slower scan speed to improve spatial resolution and bone edge detection, and A modification to the Analysis Module (data analysis module) include an algorithm that employs lower bone and soft tissue detection thresholds suitable for detecting and evaluating low bone densities and low soft tissue masses found in human infants.

The provided document is a 510(k) Summary of Safety and Effectiveness for the Hologic Infant Whole Body Software Option for QDR Densitometers, dated October 29, 2004. It describes the device and claims substantial equivalence to predicate devices. However, it does not contain detailed information about specific acceptance criteria or a study proving the device meets those criteria, as typically found in clinical validation studies.

The document focuses on comparing the new device's features and intended use to existing, legally marketed predicate devices (K023398 Discovery Package and K961787 Body Composition Analysis Software). The primary argument for substantial equivalence is that the Infant Whole Body software performs the same functions with minor modifications to optimize for infants (smaller region of interest, thinner x-ray beam, slower scan speed, and lower bone/soft tissue detection thresholds). This is a regulatory filing for premarket notification, not a clinical trial report.

Therefore, many of the requested details are not present in this document.

Here's a breakdown of the information that can be extracted or inferred, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific acceptance criteria (e.g., specific accuracy thresholds for BMC, BMD, or body composition measurements) or numerical device performance results from a validation study. The comparison table (F.8) lists attributes of the devices but does not quantify performance.

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

This information is not provided in the document. No specific test set or clinical study data is reported.

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

This information is not provided in the document, as no specific test set requiring expert ground truth is described.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study is not mentioned or described in the document. This type of study would compare human reader performance with and without AI assistance, which is not the focus of this 510(k) filing.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study for the algorithm itself (demonstrating its accuracy in measuring BMC, BMD, and body composition in infants) is not explicitly detailed or referenced in terms of specific metrics or a study. The document states that the software provides "estimates" and relies on its similarity to predicate devices, which are already cleared for measuring these parameters. The modifications are described as improving spatial resolution and bone edge detection and employing suitable detection thresholds for infants, but no quantitative performance improvement or validation is provided.

7. Type of Ground Truth Used

The document does not specify the type of ground truth used for any performance evaluation, as no such evaluation is detailed. For bone densitometry, "ground truth" would typically involve precise physical measurements, possibly validated by phantoms or alternative highly accurate methods, but no such details are furnished.

8. Sample Size for the Training Set

This information is not provided in the document. The filing describes the product as a "software option," implying algorithmic changes rather than a deep learning model that would typically require a training set in the modern sense. Given the 2004 date, it's more likely referring to adjustments in established algorithms rather than training a machine learning model on a dataset.

9. How Ground Truth for the Training Set Was Established

This information is not provided in the document.

Summary of Document's Content Regarding Performance/Validation:

The document asserts that the Infant Whole Body Software Option is substantially equivalent to predicate devices. It achieves this by:

• Modifying the Scan Module: To enable a smaller region of interest, thinner x-ray beam, and slower scan speed to improve spatial resolution and bone edge detection for smaller subjects.
• Modifying the Analysis Module: To include an algorithm that employs lower bone and soft tissue detection thresholds suitable for infants.

The basis for regulatory clearance (510(k)) is this claim of substantial equivalence, meaning it performs the same essential functions as previously cleared devices, with modifications appropriate for its specific user population (infants), and without raising new issues of safety or effectiveness. The filing does not include a new clinical study to establish specific performance metrics or acceptance criteria for the new software option. It relies on the established safety and effectiveness of the predicate devices and the design modifications tailored for infants.

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