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The Negative Pressure Surgical Incision Management System (npSIMS)™ is indicated for patients who may benefit from wound management via application of negative pressure, as the device may promote wound healing through the removal of excess exudate, infectious material and tissue debris. The npSIMS is indicated for removal of small amounts of exudate from closed surgical incisions.

The npSIMS Negative Pressure Surgical Incision Management System™ by Aatru Medical, LLC is a single-use medical device consisting of a non-sterile vacuum chamber and sterile dressing and tubing kit. The npSIMS is intended for use with closed incisions with low exudate up to 10ml, or over a period of up to 7 days. The disposable vacuum chamber initially generates a peak negative pressure of -100±5mmHg at the wound surface, and maintains a continuous, linear rate of pressure decline to -60mmHg over 7 days (nominally, 80mmHg ± 20mmHg). Wound exudate is managed by the absorptive dressing technology. The tubing can be cut to length based upon patient needs. Making use of a fully pre-assembled wound contact dressing, the npSIMS operates silently without the use of an external electromechanical pump nor collection canister, enabling discrete patient portability. The duration of treatment is dependent upon the recommendation of the treating physician. After use, all components of the npSIMS are disposed of as clinical waste in accordance with local protocols and regulations.

The provided text is a 510(k) summary for the npSIMS Negative Pressure Surgical Incision Management System. It primarily focuses on demonstrating substantial equivalence to a predicate device through technological characteristic comparisons and non-clinical performance testing against recognized consensus standards.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a discrete "acceptance criteria" table with corresponding "reported device performance" values for a clinical study comparing an AI device against a specific benchmark. Instead, it refers to non-clinical tests that ensure the device meets product performance specifications and complies with FDA Recognized Consensus Standards.

Important Note: The provided text is for a non-powered medical device (npSIMS Negative Pressure Surgical Incision Management System), not an AI or software as a medical device (SaMD). Therefore, many of the subsequent questions related to AI device evaluation (sample sizes for test/training sets, experts for ground truth, adjudication methods, MRMC studies) are not applicable to this document. The study described is primarily a set of non-clinical functional and safety performance tests.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not applicable. The document describes non-clinical in vitro performance tests and compliance with recognized standards, not a clinical study with human subjects or a test set of data in the context of AI.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not applicable. Ground truth in the context of expert consensus is relevant for diagnostic AI/imaging devices. This document describes the performance of a physical medical device. The "ground truth" here would be the physical and chemical properties of the device and its operational parameters, assessed against engineering specifications and regulatory standards.

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

• Not applicable. Adjudication methods like 2+1 are used for resolving discrepancies among human readers in interpreting data for ground truth establishment, which is not described for this device's evaluation.

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 not an AI or software assistance tool for human readers. It's a wound care system.

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

• Not applicable. This is a physical non-powered medical device, not an algorithm.

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

• For the non-clinical performance tests, the "ground truth" is defined by engineering specifications, established physical and chemical principles, and the requirements of the referenced FDA Recognized Consensus Standards (e.g., ISO, ASTM standards). For biocompatibility, this involves laboratory tests with established protocols. For negative pressure delivery, it's about meeting specified pressure ranges.

8. The sample size for the training set

• Not applicable. This document describes the evaluation of a physical medical device, not an AI model that requires a training set.

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

• Not applicable. As described above, there is no AI training set for this device.

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