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The Genadyne A4-XLR8 Wound Vacuum System is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of excess exudates, infectious material and tissue debris.

The product is a portable suction device that may promote wound healing when used with accessory wound sealing kits.

The provided text describes a Special 510(k) Summary for the Genadyne A4-XLR8 Wound Vacuum System, which is a modification of a legally marketed predicate device (Genadyne A4 Wound Vacuum System, K082676).

This type of submission focuses on demonstrating substantial equivalence to an existing device rather than a comprehensive study proving a device meets specific acceptance criteria in the context of AI/machine learning. Therefore, many of the requested categories are not applicable or cannot be extracted from this document, as it outlines a regulatory pathway for a conventional medical device modification, not an AI-powered diagnostic or predictive tool.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify quantitative acceptance criteria or reported device performance in the manner typically seen for AI/ML device evaluations (e.g., sensitivity, specificity, AUC thresholds). Instead, the "performance" is demonstrated through equivalence testing against a predicate device.

2. Sample size used for the test set and the data provenance

• Sample Size: Not applicable. This document refers to "performance testing" and "device comparison" as part of demonstrating substantial equivalence, but it does not specify a clinical "test set" in the context of an AI/ML algorithm. The evaluation would have involved engineering and functional tests rather than a patient data test set.
• Data Provenance: Not applicable. No patient data is referred to in this summary.

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

• Not applicable. There is no mention of expert-established ground truth for a test set, as this is not an AI/ML device requiring such evaluation.

4. Adjudication method for the test set

• Not applicable. No test set requiring adjudication in the context of AI/ML evaluation is mentioned.

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 negative pressure wound therapy system, not an AI-assisted diagnostic tool.

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

• Not applicable. This is not an algorithm-based device.

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

• Not applicable. The concept of "ground truth" in the context of clinical AI/ML validation is not applicable here. The "truth" for this device is its functional compliance with specifications and its substantial equivalence to the predicate device in terms of design, materials, and intended use as assessed through engineering and bench testing.

8. The sample size for the training set

• Not applicable. No training set for an AI/ML algorithm is mentioned or relevant to this device.

9. How the ground truth for the training set was established

• Not applicable. No training set for an AI/ML algorithm is mentioned or relevant to this device.

Summary of the Study/Evaluation described in the document:

The provided document describes a Special 510(k) submission for a modified medical device. The "study" referenced is the performance testing and device comparison conducted to demonstrate that the new device (Genadyne A4-XLR8 Wound Vacuum System) is substantially equivalent to its predicate device (Genadyne A4 Wound Vacuum System, K082676).

The key aspects of this evaluation, as stated in the document, involved assessing:

• Indications for Use
• Material
• Technology
• Product Specifications
• Energy Requirements

The conclusion is that the new device is "substantially equivalent to the predicate device, and is safe and effective for the intended use" based on these evaluations. This is a regulatory pathway for modifications to existing devices, where the primary "proof" is the demonstration of equivalence to a device already cleared by the FDA, rather than novel clinical trials or extensive AI/ML performance validation.

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