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AutoDensity is a post-processing software intended to estimate spine Bone Mineral Density (BMD) from EOSedge dual energy images for orthopedic pre-surgical assessment applications. It is an opportunistic tool that enables immediate assessment of bone density from EOSedge images acquired for other purposes.

AutoDensity is not intended to replace DXA screening. Suspected low BMD should be confirmed by a DXA exam.

Clinical judgment and experience are required to properly use the software.

Based on EOSedge™ system's images acquired with the dual energy protocols cleared in K233920, AutoDensity software provides an estimate of the Bone Mineral Density (BMD) for L1-L4 in EOSedge AP radiographs of the spine. These values are used to aid in BMD estimation in orthopedic surgical planning workflows to help inform patient assessment and surgical decisions. AutoDensity is opportunistic in nature and provides BMD information with equivalent radiation dose compared to the EOSedge images concurrently acquired and used for general radiographic exams. AutoDensity is not intended to replace DXA screening.

Here's a breakdown of the acceptance criteria and the study details for the AutoDensity device, based on the provided FDA 510(k) clearance letter:

1. Acceptance Criteria and Reported Device Performance

Device Name: AutoDensity
Intended Use: Post-processing software to estimate spine Bone Mineral Density (BMD) from EOSedge dual energy images for orthopedic pre-surgical assessment applications.

2. Sample Sizes and Data Provenance

Test Set (for ROI Performance Evaluation):

• Sample Size: 129 patients.
• Data Provenance: All cases obtained from EOSedge systems (K233920). The document does not specify the country of origin but mentions a clinical study with 65% US subjects and 35% French subjects for clinical performance testing, which might suggest a similar distribution for the test set, though it's not explicitly stated for the ROI test set. The data was retrospective as it was "obtained from EOSedge systems."

3. Number of Experts and Qualifications for Ground Truth

For ROI Performance Evaluation Test Set:

• Number of Experts: At least 3 (implied by "3 truther majority voting principle") plus one senior US board certified expert radiologist who acted as the gold standard adjudicator.
• Qualifications:
  • Two trained technologists (for initial ROI and level identification).
  • One senior US board-certified expert radiologist (for supervision, review, selection of most accurate set, and final adjustments).

4. Adjudication Method for the Test Set

For ROI Performance Evaluation Test Set:

• Adjudication Method: A "3 truther majority voting principle" was used, with input from a senior US board-certified expert radiologist (acting as the "gold standard"). The radiologist reviewed results, selected the more accurate set, and made necessary adjustments. This combines elements of majority voting with expert adjudication.

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

• Was an MRMC study done? No, the provided document does not mention an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The performance data presented focuses on the standalone performance of the AI algorithm and its agreement/precision with a reference device or clinical measurements.

6. Standalone Performance Study (Algorithm Only)

• Was a standalone study done? Yes. The "Region of Interest (ROI) Performance Evaluation" section explicitly states: "To assess the standalone performance of the AI algorithm of AutoDensity, the test was performed with..." This section details the evaluation of the algorithm's predictions against ground truth for vertebral level identification and spine ROI accuracy.

7. Type of Ground Truth Used

For ROI Performance Evaluation Test Set:

• Type of Ground Truth: Expert consensus with adjudication. Ground truths for ROIs and level identification were established by two trained technologists under the supervision of a senior US board-certified radiologist. The radiologist made the final informed decision, often described as a "gold standard."

8. Sample Size for the Training Set

• Training Set Sample Size: The AI algorithm was trained using 4,679 3D reconstructions and 9,358 corresponding EOS (K152788) or EOSedge (K233920) biplanar 2D X-ray images.

9. How Ground Truth for the Training Set was Established

• The document implies that the training data was "selected to only keep relevant images with the fields of view of interest." However, it does not explicitly detail how the ground truth for the training set was established (e.g., whether it used expert annotations, a similar adjudication process, or other methods). It primarily focuses on the test set ground truth establishment.

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The Hologic Whole Body DXA Reference Database software used on Hologic QDR bone densitometers measures the regional and whole body bone mineral density, lean and fat tissue mass and calculates derivative values of bone mineral content, area, soft tissue mass, regional soft tissue mass, total soft tissue mass, fat free mass, regional and total soft tissue mass ratios, % fat, regional % fat, total body % fat, android % fat, gynoid % fat, android/gynoid ratio, and body mass index. The values can be displayed in user-defined statistical formats and trends with color image mapping, and compared to reference populations at the sole discretion of the health care professional.

These body composition values are useful to health care professionals in their management of diseases and conditions where the disease or conditions itself, or its treatment, can affect the relative amounts of fat and lean tissue. The Hologic Whole Body DXA Reference Database software does not diagnose disease, recommend treatment regimens, or quantify treatment effectiveness. Only the health care professional can make these judgments. Some of the diseases and conditions for which body composition values are useful include chronic renal failure, anorexia nervosa, obesity, AIDS/HIV, and cystic fibrosis. DXA body composition is a useful alternative to hydrostatic weighting and skin fold measurements.

The Hologic Whole Body DXA Reference Database software used on Hologic QDR bone densitometers measures the regional and whole body bone mineral density, lean and fat tissue mass and calculates derivative values of bone mineral content, area, soft tissue mass, regional soft tissue mass, total soft tissue mass, fat free mass, regional and total soft tissue mass ratios, % fat, regional % fat, total body % fat, android % fat, gynoid % fat, android/gynoid ratio, and body mass index. The values can be displayed in user-defined statistical formats and trends with color image mapping, and compared to reference populations at the sole discretion of the health care professional.

The provided text is a 510(k) summary for the Hologic Whole Body DXA Reference Database. It does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device.

Here's a breakdown of what is in the document, and what is missing based on your request:

What is present in the document:

• Device Identification: Hologic Whole Body DXA Reference Database.
• Intended Use: Measures regional and whole body bone mineral density, lean and fat tissue mass, and calculates derivative values for comparison to reference populations. It's for healthcare professionals to manage diseases/conditions affecting fat and lean tissue, not for diagnosis or treatment effectiveness quantification.
• Classification: Class II, Bone Densitometer, Product Code KGI.
• Predicate Device: Body Composition Software Option for GE Lunar DEXA Bone Densitometers (K071570).
• Conclusion of Substantial Equivalence: The Hologic Whole Body DXA Reference Database does not change algorithms/measured values from previously cleared software (APEX 2.0 Software K072847), fundamental scientific technology, or raise new safety/efficacy concerns. It is substantially equivalent to the predicate device.

What is NOT present in the document, and therefore cannot be reported:

1. A table of acceptance criteria and the reported device performance: This document explicitly states that the device "does not change any of the algorithms or measured values" from a previously cleared software (APEX 2.0 Software, K072847). This 510(k) is based on demonstrating substantial equivalence because no changes were made to the core algorithms, rather than presenting new performance data against specific acceptance criteria for a new or modified device.
2. Sample size used for the test set and the data provenance: No new test set data is provided, as the submission relies on the unchanged algorithms from a previously cleared device.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no new test set is presented.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: No MRMC study is mentioned. The submission is based on the system's underlying algorithms being unchanged and previously cleared.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) study: No new standalone study is performed or reported in this document for the reasons stated above.
7. The type of ground truth used: Not applicable, as no new study requiring ground truth establishment is described.
8. The sample size for the training set: Not applicable, as this submission is not about training a new algorithm or presenting new performance metrics.
9. How the ground truth for the training set was established: Not applicable.

In summary: The provided document is a 510(k) summary demonstrating substantial equivalence based on the lack of change to previously cleared software algorithms and measured values, rather than presenting new performance data against specific acceptance criteria for the "Hologic Whole Body DXA Reference Database" as a new or modified device with altered performance. Therefore, the information requested regarding acceptance criteria and performance studies is not contained within this particular submission.

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