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The Avance® Foam Abdominal Dressing Kit is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries may be required. Its intended use is with patients who have open abdominal wounds with exposed viscera and organs, and including but not limited to patients with abdominal compartment syndrome. It is intended for use in acute hospital settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre. The dressing kit is intended for use together with the Avance NPWT pump and its accessories.

The Avance® Foam Abdominal 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 Abdominal 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.

The Avance® Foam Abdominal Dressing Kit is together with the Avance® Pump and it's accessories is a complete negative pressure system for managing open abdomens. This dressing kit is intended for use in acute hospital settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre.

The Avance® Foam Abdominal Dressing Kit consists of the following components:

Avance® Organ·Contact Layer (OCL) is based on an oval polyurethane film with fenestrations and is placed in the open abdomen to protect and contain intestines.

Avance® Abdominal Foam is placed over the OCL with the intention to distribute the pressure across the wound surface and allow passage of fluids and exudates through to the negative pressure system.

Avance® Film with Safetac® Technology 20x40 cm in size, is a flexible, transparent film dressing consisting of a thin polyurethane film coated with a soft silicone adhesive. The soft silicone layer adheres gently to dry peri-wound skin, but not to a moist wound surface. The soft silicone layer is covered with a polvethylene release film. It is applied over the wound filler and surrounding skin with the intension to fixate the wound filler and create an airtight seal.

A vance® Transfer Pad is intended to transport exudates from the abdominal cavity to the canister. A hole is cut in the sealant before attaching the Transfer Pad.

The provided document describes the Avance® Foam Abdominal Dressing Kit, a negative pressure wound therapy device, and its acceptance criteria and performance data.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes used for the functional and material property tests (e.g., how many kits were tested for vacuum level, drapability, etc.). It refers to "all test articles," implying a defined, but unquantified, test set.

For biocompatibility testing, the sample size or number of biological units tested for each component is not specified.

The data provenance is not explicitly mentioned as retrospective or prospective, nor are country of origin details provided. However, the tests are laboratory-based performance and biocompatibility assessments, not human clinical trials.

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

This question is not applicable to the presented data. The acceptance criteria for this medical device are based on objective, quantifiable engineering and biological tests (e.g., vacuum levels, fluid transport rates, material strength, biocompatibility assays) and not on expert interpretation of observational data. Therefore, there's no "ground truth" established by experts in the context of diagnostic accuracy.

4. Adjudication method for the test set

This question is not applicable to the presented data. Adjudication methods (like 2+1, 3+1) are typically used in studies where human readers or evaluators make subjective assessments that require consensus, such as interpreting medical images or clinical outcomes. The tests described are objective, laboratory-based physical and chemical assessments.

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

This question is not applicable. The device in question is a negative pressure wound therapy dressing kit, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or evaluation of AI's effect on human reader performance is not relevant.

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

This question is not applicable. The device is a physical medical device, not a software algorithm. Therefore, "standalone algorithm performance" is not relevant to its evaluation.

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

For the functional and material performance tests, the "ground truth" is established by the defined specifications and engineering standards for the device's operation. For example, a specific vacuum level range or a minimum tear strength might be the "ground truth" against which the device's performance is measured.

For biocompatibility, the "ground truth" is established by ISO 10993 standards and the biological responses observed in the in vitro and in vivo tests.

8. The sample size for the training set

This question is not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

This question is not applicable, as there is no training set for this device.

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