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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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RENASYS TOUCH is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy), as it may promote wound healing via removal of fluids, including irrigation fluids 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 and grafts

When used with the RENASYS AB Abdominal Kit with Soft Port, RENASYS TOUCH 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. The use of RENASYS Abdominal Kit with Soft Port is intended for use in acute hospital care settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre.

The RENASYS Y-Connector can only be used with the RENASYS TOUCH system. RENASYS TOUCH is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of fluids, including irrigation and body fluids, wound exudates and infectious materials.

The following wound types may be used with a RENASYS system that is utilizing a RENASYS Y-connector:

• Flaps and grafts (only in one wound configuration)
• Open abdomen (only in one wound configuration & only with RENASYS TOUCH and RENASYS AB Abdominal Kit)
• Chronic
• Acute
• Traumatic
• Sub-Acute and dehisced wounds
• Ulcers (such as pressure or diabetic)
• Partial-thickness burns

When the RENASYS Y-Connector is used with the RENASYS AB Abdominal Kit with Soft Port (only in one wound configuration), it 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. The use of RENASYS Abdominal Kit with Soft Port is intended for use in acute hospital care settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre.

RENASYS TOUCH device is a software controlled suction device consisting of an electric motor driven, diaphragm, vacuum pump. The device is designed to provide Negative Pressure Wound Therapy at a range of pressure settings between 25-200mmHg to a closed environment over one or two wounds. The device removes exudate from the wound site(s) to a disposable container, which may promote wound healing via removal of fluids, including irrigation of body fluids, wound exudates and infectious materials.

RENASYS TOUCH device can be operated by either a mains power supply or internal battery.

RENASYS TOUCH device contains integrated global cellular technology that allows device location, billing and maintenance data to be sent wirelessly to a secure Internet website providing Health Care Professionals access to device information.

The RENASYS TOUCH device is compatible with Smith & Nephew RENASYS Foam, RENASYS Gauze and RENASYS Abdominal dressing kits previously cleared under K152163, K153209 and K143133.

RENASYS TOUCH has also demonstrated compatibility with RENASYS Y-Connector. The RENASYS Y-connector is only intended to be used in conjunction with RENASYS Negative Pressure Wound Therapy (NPWT) systems. The RENASYS Y-Connector can be used to connect one or two wounds through two RENASYS Soft Ports to a single RENASYS TOUCH device. The Y-Connector is constructed of PVC tubing and is compatible with Smith & Nephew RENASYS Foam, RENASYS Gauze and RENASYS Abdominal dressing kits with Soft Port.

Here's an analysis of the acceptance criteria and supporting study for the RENASYS TOUCH and RENASYS Y-Connector, based on the provided FDA 510(k) summary:

This device is not an AI/ML device. The provided document does not describe the acceptance criteria and study proving an AI/ML device meets them. The document is for a Negative Pressure Wound Therapy (NPWT) device, the RENASYS TOUCH, and its accessory, the RENASYS Y-Connector. It describes non-clinical performance testing rather than an AI/ML study.

Therefore, many sections of your requested output, particularly those related to AI/ML specific criteria (like sample size for test set, data provenance, ground truth establishment, MRMC studies, standalone performance), cannot be answered from the provided text.

However, I can extract information related to the device's performance testing and general regulatory details.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in a formal table format, nor does it provide specific numerical performance results. Instead, it summarises the types of performance testing conducted to verify the device meets design specifications and demonstrates substantial equivalence to the predicate. The "reported device performance" is generally stated as having "successfully completed" the tests.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The document states that performance testing was "performed in triplicate" for the RENASYS TOUCH device (implying 3 devices were tested) and that this was done for "simulated wound model testing." It doesn't specify how many simulated wound models or test scenarios were run for each triplicate.
• Data Provenance: The testing was non-clinical performance testing conducted by the manufacturer, Smith & Nephew Medical Limited. The country of origin for the data generation would likely be the UK (where Smith & Nephew Medical Limited is located) or another internal testing facility. The data is prospective as it was generated specifically for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable as the study involved non-clinical performance testing using simulated wound models and engineering measurements, not expert-adjudicated clinical data or ground truth from human experts.

4. Adjudication Method for the Test Set

Not applicable, as there was no human adjudication of results in this non-clinical performance testing.

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 a medical device (NPWT pump) and not an AI/ML diagnostic tool. No MRMC study was conducted.

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

Not applicable. This is not an AI/ML algorithm. The device's "standalone" performance refers to its ability to perform its intended function of negative pressure wound therapy, which was assessed through the non-clinical performance testing described.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance testing consists of:

• Engineering specifications and design requirements: The device's ability to maintain specific pressure ranges, battery life, and proper function of its components (e.g., SIM card, software GUI).
• Predicate device performance: The new device was tested to verify it performs comparably to its legally marketed predicate device (K153209 RENASYS TOUCH System).
• Relevant standards: Compliance with standards like IEC 60601-1-11 for home healthcare environments.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no "training set," there is no ground truth to establish for one.

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