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The device is intended for use to estimate bone mineral density ("BMD") in the forearm and to assess increased risk of osteoporotic fracture according to World Health Organization ("WHO") criteria.

The device is indicated specifically for use to: (1) assist the physician in diagnosing subjects who already have been identified to be at risk for suffering from osteoporosis, together with other known risk factors (e.g., prior history of fractures, advanced age, low body weight, lack of physical exercise, lack of exposure to sunlight, insufficient dietary intake of vitamin D and/or calcium, and smoking); and (2) compare the BMD estimate with a reference population comprised of young normals and age-matched normals to compute T-scores and Z-scores, respectively.

The Sectra Osteoporosis Package is intended for use to estimate bone mineral densitv (BMD) in the forearm and to assess increased risk of osteoporotic fracture according to World Health Organization (WHO) criteria.

Sectra Osteoporosis Package features:

• indirect "DICOM capability" via the Sectra IDS5 Radiology workstation, i.e. it uses digital image data according to the DICOM standard.
• . single screen user interface reached via a right click on an image in a Sectra IDS5 Radiology Workstation.
• operates in two modes: Clinical mode and Research mode.

Here's a summary of the acceptance criteria and study information for the Sectra Osteoporosis Package Bone Densitometer, based on the provided text:

Lack of Information:
It's important to note that the provided text is a 510(k) summary for a substantial equivalence determination. As such, it does not contain detailed performance study results, acceptance criteria, or ground truth methodologies in the way a clinical study report or more comprehensive technical documentation would. The submission focuses on demonstrating substantial equivalence to a predicate device, primarily by showing that differences in image source (digital CR vs. digitized conventional X-ray) do not raise new safety or effectiveness concerns.

The document explicitly states: "Both in vitro and in vivo performance testing has been conducted to verify that this design difference does not impact either safety or efficacy." However, it does not provide the specific details of these tests, including acceptance criteria, sample sizes, or how performance was measured against a ground truth.

1. Table of Acceptance Criteria and Reported Device Performance

Given the limitations of the provided document, specific numerical acceptance criteria and detailed performance metrics are not explicitly stated. The document primarily focuses on demonstrating "substantial equivalence" to a predicate device rather than providing quantitative performance against pre-defined acceptance criteria.

The implied "acceptance criterion" is that the device's performance in estimating Bone Mineral Density (BMD) and assessing osteoporotic fracture risk is equivalent to that of the predicate device, the X-Posure System Version 2 RAD (K002500), despite using different image sources.

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

The document states: "Both in vitro and in vivo performance testing has been conducted". However, no specific sample sizes for either the in vitro or in vivo test sets are provided.

Data Provenance: The country of origin of the data is not specified. It is also not specified whether the data was retrospective or prospective.

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

Not specified. The document does not provide any information on experts or how ground truth was established for the performance testing.

4. Adjudication Method for the Test Set

Not specified. The document does not describe any adjudication method.

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

Not applicable/Not mentioned. The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss human readers improving with or without AI assistance. The device is a bone densitometer, an automated analysis tool for BMD, not an AI-assisted diagnostic aid for human readers in the typical sense of an MRMC study.

6. Standalone (Algorithm Only) Performance Study

The primary performance assessment described is a standalone (algorithm only) evaluation, as the device is an automated analysis tool. The document states the device "analyzes computed radiography ('CR') images obtained directly in digital format" and "uses essentially the same DXR techniques to analyze the given images" as the predicate device. The in vitro and in vivo tests were conducted to verify the algorithm's performance with the new image source.

7. Type of Ground Truth Used

Not specified. The document does not explicitly state the type of ground truth used for the in vitro or in vivo performance testing (e.g., bone mineral density measured by a gold standard, pathology, clinical outcomes, etc.). For BMD, a common ground truth in such studies might be a highly accurate densitometry method or phantoms with known BMDs for in vitro studies. However, this is not detailed in the provided text.

8. Sample Size for the Training Set

Not applicable/Not mentioned. The document describes the device as using "DXR techniques" and being "essentially the same as the predicate device". This implies a deterministic algorithm or a known analytical method, rather than a machine learning model that would typically require a distinct training set. Therefore, a "training set" in the context of machine learning is not mentioned as being used for this device.

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

Not applicable/Not mentioned. As a training set is not indicated, the method for establishing its ground truth is also not provided.

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