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The NEXA NPWT system is intended for patients who may benefit from the application of negative pressure to the wound to promote wound healing through the removal of excess exudate, infectious material and tissue debris.

It is intended for use in long-term care and acute settings only when prescribed by a Health Care Professional.

Appropriate wound types include:

• Chronic wounds
• · Pressure ulcers
• · Diabetic foot ulcers
• · Venous leg ulcers

The NEXA NPWT System is an integrated negative pressure wound management system for use in acute and extended care settings. The system applies a negative pressure to a sealed wound dressing and promotes wound healing through the removal of exudates into a disposable fluid container.

The system consists of the following key components:

• NEXA Device: A portable device that contains a pump and a rechargeable Battery and is supplied with a Power Supply and a Carry Case.
• NEXA Fluid Container Pack: A single use polymeric flexible fluid container that stores the exudate removed from the wound.
• NEXA Dressing: Sterile single use wound dressing components that are in contact with the wound tissue and a means of sealing to the periwound area. Interconnect tubing includes an integrated negative pressure relief valve that limits the maximum pressure able to be applied to the wound and are pre-set and not adjustable by the user.

The provided document is a 510(k) premarket notification for the Nexa Negative Pressure Wound Therapy System. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain information about a study proving the device meets specific acceptance criteria in the way a clinical trial or AI performance study would.

The "Performance data" section (Page 7) describes non-clinical bench testing undertaken to demonstrate substantial equivalence to the predicate device, not a study against predefined clinical acceptance criteria. There is a specific note on Page 8: "Summary of clinical tests conducted for determination of substantial equivalence or of clinical information [21 CFR 807.92(b)(2)] - Not applicable." This confirms that no clinical studies were performed or are being reported in this submission for determining substantial equivalence or clinical performance.

Therefore, for your requests regarding acceptance criteria and a study proving the device meets them, the answer based on this document is that the document does not provide this information in the context of clinical performance or AI-related metrics.

However, I can extract information related to the bench testing that was conducted to support the substantial equivalence claim.

Based on the provided document, here's what can be extracted regarding the non-clinical bench testing used to demonstrate substantial equivalence:

1. A table of acceptance criteria and the reported device performance

The document describes bench testing objectives rather than specific quantitative acceptance criteria with reported numerical device performance in the format requested. The objectives served as the "criteria" for demonstrating substantial equivalence to the predicate device.

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

The document describes "bench performance testing conducted using simulated wound exudates using wound models over a range of clinically relevant conditions." It does not specify the sample size (e.g., number of tests, number of devices tested) for these bench tests. Data provenance is not detailed beyond the general statement of "bench testing."

Regarding biocompatibility, an "independent test facility" was used, certified to international standards. The country of origin for this testing or data is not specified.

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)

For the non-clinical bench testing, the concept of "ground truth" and "experts" as typically understood in clinical or AI studies (e.g., radiologists interpreting images) is not applicable. The bench tests are objective measurements against defined physical/engineering parameters.

For biocompatibility, an "expert review was completed by an independent test facility" to evaluate test requirements. The number and qualifications of these experts are not specified beyond being from a certified independent test facility.

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

Not applicable, as this was non-clinical bench testing, not an observational or clinical study requiring adjudication of findings.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Summary of clinical tests conducted... Not applicable." (Page 8)

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

This device is a physical medical device (Negative Pressure Wound Therapy system), not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance is not applicable.

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

For the bench testing, the "ground truth" would be the expected physical performance parameters (e.g., target negative pressure, defined flow rate for fluid removal, specified battery life) according to the device's design specifications and comparison to the predicate device's known performance characteristics. These are objective engineering measurements rather than clinical ground truth like pathology or outcomes data.

8. The sample size for the training set

Not applicable, as this is a physical medical device, not an AI system that requires a training set.

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

Not applicable, as this is a physical medical device, not an AI system.

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The Prevena Plus Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment, and removing exudate via the application of negative pressure wound therapy.

The Prevena Plus Incision Management System provides surgical incision management via the application of negative pressure wound therapy over an incision site that has been surgically closed with sutures or staples. The system is applied to the incision site immediately after surgery for a minimum of 2 days up to a maximum of 7 days depending on the surgeon's preference. The Prevena Plus Incision Management System consists of: A Prevena Dressing (Prevena Plus Peel & Place Dressing or Prevena Plus Customizable Dressing) and One of the following KCI Negative Pressure Wound Therapy Units: Prevena Plus 125 Therapy Unit*, ActiV.A.C. Therapy Unit, V.A.C. Freedom Therapy Unit, InfoV.A.C. Therapy Unit, V.A.C. ATS Therapy Unit, V.A.C. Ulta Therapy Unit. * The Prevena Plus 125 Therapy Unit is a slightly modified V.A.C.Via Therapy Unit, previously cleared under K132741, that provides continuous negative pressure at -125mmHg only. The V.A.C.Via Therapy Unit serves as a reference device for 510(k) K153199.

This document describes a 510(k) premarket notification for the Prevena Plus Incision Management System. It's a submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission relies on showing that the new device is as safe and effective as a previously approved device, often through a comparison of technological characteristics and performance data, rather than extensive clinical trials for new medical devices.

Therefore, the typical acceptance criteria and study design elements you'd find for an AI/ML device (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies) are not directly applicable in the same way here. This is a conventional medical device submission focused on physical and functional equivalence to an existing device.

Here's an interpretation based on the provided text, addressing your points where possible within the context of a 510(k) submission for a non-AI device:

1. A table of acceptance criteria and the reported device performance

For this 510(k) submission, the "acceptance criteria" revolve around demonstrating the new device performs equivalently to the predicate device in key functional areas. The "reported device performance" is the result of non-clinical bench testing.

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

• Sample Size: The document does not specify a "sample size" in the context of a patient-based test set, as this was a non-clinical bench study. The "test set" consisted of simulated wound beds and the components of the device (Prevena Plus Customizable Dressing, Prevena Plus 125 Therapy Unit, tubing set).
• Data Provenance: The studies were non-clinical tests (bench testing/simulations) conducted to support the substantial equivalence determination. The country of origin is not explicitly stated, but the submission is from KCI USA, Inc. in San Antonio, TX, suggesting the testing was likely conducted in the US or by KCI-affiliated entities. It is prospective in the sense that the testing was performed to support this specific submission.

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. As a non-clinical bench study, ground truth in terms of expert clinical assessment is not established in the same way as an AI/ML diagnostic or prognostic device. The "ground truth" for the bench tests would be the established engineering specifications and validation methods for negative pressure delivery and alarm functionality.

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

• Not applicable. This was a non-clinical bench study testing physical and functional specifications. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of data (e.g., radiology images) by multiple experts.

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/ML diagnostic or interpretive device that would involve human readers. Therefore, an MRMC study is not relevant.

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

• Not applicable directly in the AI/ML sense. However, the performance data presented is essentially "standalone" device performance, as it evaluates the device's ability to meet its technical specifications (-125 mmHg pressure, alarm function) without human patient interaction as part of the primary measurement.

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

• For the non-clinical tests, the "ground truth" would be the engineering specifications and established validation protocols for negative pressure wound therapy systems. This includes:
  • Target negative pressure level (-125 mmHg).
  • Duration of therapy (7 days).
  • Conditions for testing (simulated wound bed, wet conditions, maximum air leak).
  • Functional requirements for alarms (leak, blockage, full canister).

8. The sample size for the training set

• Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a training set.

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

• Not applicable, as there is no training set for this type of device.

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