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RENASYS-F Foam dressing kits with Soft Port and RENASYS Films are intended to be used in conjunction with Smith & Nephew RENASYS Negative Pressure Wound Therapy (NPWT) Systems.

The Smith & Nephew RENASYS system is indicated for patients who would benefit from a suction pump (Negative Pressure Wound Therapy), as it may promote wound healing via removal of fluids, including irrigation and body fluids, wound exudates and infectious materials. Appropriate wound types include:

• Chronic
• Acute
• · Traumatic
• Sub-Acute and dehisced wounds
• · Ulcers (such as pressure or diabetic)
• · Partial-thickness burns
• Flaps
• · Grafts

The RENASYS-F XL Negative Pressure Wound Therapy (NPWT) Foam Dressing Kit with Soft Port is a sterile, single use device containing one extra-large polyurethane foam wound filler sheet (18.9in x 16.1in x 0.6in / 48cm x 41cm x 1.5cm), one soft port and six transparent films (12in x 8in / 30cm x 20cm).

The RENASYS XL Transparent Film Dressing is a sterile, single use device provided in a pack containing five transparent films (15in x 24in / 38cm x 60cm). The RENASYS XL Transparent Film Dressing are provided where additional film dressings may be needed to supplement other RENASYS dressing kits.

The RENASYS-F XL Negative Pressure Wound Therapy Foam Dressing Kit with Soft Port and RENASYS XL Transparent Film Dressing are intended to be used in conjunction with Smith & Nephew RENASYS Negative Pressure Wound Therapy (NPWT) systems and dressing kits.

These devices are compatible with the RENASYS TOUCH NPWT pump (cleared in K181822) and RENASYS GO NPWT pump (cleared in K152163).

The devices for which clearance is being sought are:

RENASYS-F XL Negative Pressure Wound Therapy Foam Dressing Kit with Soft Port Containing cleared components (soft-port and transparent film) and a larger sized foam sheet consisting of identical material to the foam sheets in the predicate device RENASYS XL Transparent Film Dressing

a larger sized transparent film of identical material to the film sheets in the predicate device

The provided document is a 510(k) Premarket Notification for the RENASYS-F XL Negative Pressure Wound Therapy Foam Dressing Kit with Soft Port and RENASYS XL Transparent Film Dressing. It states the device's indications for use and compares its technological characteristics to a predicate device. However, it does not contain detailed information regarding the acceptance criteria for a study, the specific performance of the device against those criteria, sample sizes for test or training sets, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC study results.

The document focuses on demonstrating substantial equivalence to a predicate device (K142979) by highlighting similar indications for use, technological characteristics, and principles of operation, and by presenting a summary of non-clinical tests.

Therefore, much of the requested information cannot be extracted from this document.

Here's a summary of what can be extracted and what is explicitly missing:

1. Table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as a table with numerical thresholds. The testing described focuses on demonstrating that performance is not negatively impacted by the larger size or minor changes in the soft port compared to the predicate device.
• Reported Device Performance:
  • Wound model tests demonstrated performance when used with RENASYS GO and RENASYS TOUCH NPWT pumps at various pressures, minimum/maximum leak rates, and in combination with cleared RENASYS consumables.
  • Wound model testing demonstrated no change in performance between large and extra-large wound sizes.
  • Wound model tests demonstrated that RENASYS GO and RENASYS TOUCH NPWT leak and blockage alarms are not impacted.
  • Physical testing on XL Foam: Tensile strength, elongation at break, loss on drying data were collected but specific results or acceptance criteria are not provided.
  • Physical testing on XL Transparent Film Dressing: Moisture Vapor permeability, Waterproofness, Adhesion to Steel, Tensile strength, Weight of Adhesive (g/m2), Weight of Base Film (g/m2), Extensibility, Permanent Set data were collected but specific results or acceptance criteria are not provided.
  • Biocompatibility requirements were met for Cytotoxicity, Sensitization, Irritation, Material mediated pyrogenicity, Systemic toxicity (acute, sub-acute and sub-chronic), and Implantation, based on ISO 10993 and FDA Blue Book Memorandum #G95-1.
  • Bacterial endotoxin contamination met requirements of ANSI/AAMI ST72:2019.

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

• Sample Size for Test Set: Not specified. The document mentions "wound model tests" and "physical testing" but does not quantify the number of tests performed or the sample sizes involved for each test type.
• Data Provenance (country of origin, retrospective/prospective): Not specified. These appear to be laboratory-based non-clinical tests, likely conducted at the manufacturer's facility or a contracted lab. The document does not indicate if any clinical data (prospective or retrospective) was used.

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

• Not applicable / Not specified. The tests described are non-clinical, involving physical and performance characteristics of the dressing kit and film. There is no mention of expert-established ground truth for a diagnostic or interpretative task.

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

• Not applicable / Not specified. As the studies are non-clinical hardware performance tests, adjudication by human experts as described (e.g., for image interpretation) is not relevant.

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. This device is a wound dressing kit and film, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.

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

• No. This device is hardware (dressing kit and film), not an algorithm or AI.

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

• Not applicable as typically defined for diagnostic devices. The "ground truth" for the non-clinical tests would be the established scientific and engineering principles, specifications, and test methods for material properties (e.g., tensile strength, permeability), pump performance (e.g., leak detection, pressure maintenance), and biocompatibility.

8. The sample size for the training set

• Not applicable / Not specified. There is no mention of a "training set" as this is not an AI/machine learning device.

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

• Not applicable. There is no training set for this type of device.

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