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The Avance® NPWT system, with associated products are indicated for patients who would benefit from a suction device (negative pressure wound therapy), as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudates and infectious materials. Examples of appropriate wound types include: chronic, acute, traumatic, sub-acute and dehisced, ulcers (such as pressure or diabetic), partial-thickness burns, flaps and grafts.

Mölnlycke Health Care has developed a Negative Pressure Wound Therapy System in conjunction with Medela AG, which consists of the Avance® NPWT Pump (which is the Medela INVIA Liberty pump cleared under K080357) and the Avance® Foam Dressing Kits (subject of this submission). The Invia Liberty pump will be private labeled with the Avance® NPWT Pump This pump is compatible with the Avance® Foam Dressing Kits described in the branding. below Table. The Avance Foam Dressing Kit is a negative pressure wound therapy device intended to provide negative pressure to the wound bed and thereby transport exudates from the wound. The Avance® Foam Dressing Kit is a combination of different components developed and arranged to meet the needs of the clinical for specific size and types of wounds.

This device is not an AI/ML powered device. It is a Negative Pressure Wound Therapy (NPWT) system. The document does not contain information about acceptance criteria and device performance in the context of AI/ML, human readers, or ground truth establishment.

A table of acceptance criteria and reported device performance cannot be generated in the requested format because the provided document does not specify quantitative acceptance criteria for the Avance® Foam Dressing Kits as they would be for an AI/ML device. Instead, the performance is described qualitatively based on non-clinical tests.

However, based on the provided text, here's a summary of the performance data:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified for each test. The document refers to "the wound model" and "the system" in singular, implying specific setups or instances rather than a large dataset.
• Data Provenance: Not specified, but based on the context, these are likely laboratory or in-vitro tests conducted internally by the manufacturer or a third-party testing facility.

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

• Not applicable as this is not an AI/ML device and ground truth in the context of expert review is not relevant for the described performance tests. The performance is based on physical measurements and observation of the device's function.

4. Adjudication method for the test set:

• Not applicable. The performance tests are objective measurements of the device's physical functions, not subject to expert adjudication.

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 is not an AI/ML device, and no MRMC studies are mentioned.

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

• Not applicable. This is not an AI/ML device. The "standalone" performance here refers to the device itself operating as intended.

7. The type of ground truth used:

• The "ground truth" for the performance tests described would be based on physical standards and objective measurements of vacuum levels, fluid transport efficiency, and sustained operation, rather than expert consensus, pathology, or outcomes data typically associated with clinical or AI performance.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device, so there is no training set in that context.

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

• Not applicable. No training set for an AI/ML algorithm is involved.

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