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The RENASYS™ - F/-AB Abdominal Wound Dressing Kit is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are necessary. It is intended to be used in open abdominal wounds with exposed viscera, including but not limited to abdominal compartment syndrome.

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 RENASYS™ -FIAB Abdominal Dressing Kit consists of two large hydrophobic reticulated polyurethane foam dressings that incorporate several cuts to facilitate custom sizing if needed. Also included in the kit are a polvurethane organ protection layer, six transparent film drapes and a suction port assembly with tubing that attaches to the exudate canister. The kit is designed specifically for abdominal wounds and is supplied sterile, single use.

The RENASYS- FIAB Abdominal Dressing Kit is used in conjunction with Smith & Nephew RENASYS EZ and EZ PLUS negative pressure wound therapy pumps and canister kits, which have been previously cleared under 510(k) numbers K082426, K091470 and K102001.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific performance criteria in the way a diagnostic or AI-powered device would.

The document is a 510(k) summary for a medical device called the RENASYS™ -F/AB Abdominal Dressing Kit. It primarily focuses on demonstrating substantial equivalence to a predicate device and includes details about:

• Biocompatibility testing: This confirms the materials used are safe for contact with the body. The table lists various tests (Cytotoxicity, Irritation, Sensitization, Implantation, Sub-acute Toxicity, Genotoxicity) completed for each kit component. These are safety standards, not performance criteria in the sense of accuracy, sensitivity, or specificity.
• Design verification testing: The document states this was conducted "to demonstrate the device meets the performance specifications, delivers negative pressure wound therapy to the wound and removes exudates." However, it does not provide:
  • A table of actual "performance specifications" or acceptance criteria.
  • Specific results from this design verification testing.
  • Details on the sample size, data provenance, ground truth establishment, or expert involvement for this testing.
  • Any information about a comparative effectiveness study (MRMC) or a standalone (algorithm only) study.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, device performance, sample sizes, ground truth, or study types as they are typically described for devices with measurable diagnostic or analytical performance claims.

The document concludes that the device "has successfully undergone testing to demonstrate that the device is substantially equivalent to the predicate device and effective for the intended use." This is the general statement required for a 510(k) clearance, indicating that it meets the regulatory bar for market entry, but not detailing specific performance metrics.

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