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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 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

The RENASYS TOUCH is intended for use in acute care settings and other professional healthcare environments where product use is conducted by or under the supervision of a qualified healthcare professional.

The RENASYS TOUCH NPWT device is a lightweight suction pump device intended for wound management via application of continuous or intermittent negative pressure wound therapy to the wound for removal of fluids, including wound exudates, irrigation fluids, and infectious materials. The RENASYS TOUCH NPWT device is designed to deliver negative pressure wound therapy to a closed environment over a wound in order to drain exudates from the wound site to help promote wound healing.

The closed environment over the wound is created by applying a RENASYS sterile foam or gauze wound dressing to the wound site and connecting the sealed wound to the suction pump via a tube that connects to the disposable canister. The suction pump delivers negative pressure wound therapy and removes the exudates from the wound site to the disposable canister.

The device provides negative pressure wound therapy to the wound at a range of pressure settings between 25-200mmHg. The device can operate either by a mains power supply or internal battery.

The RENASYS TOUCH device is compatible with RENASYS Foam and Gauze dressing kits with Soft Port which were cleared under 510(k) K142979.

The RENASYS TOUCH device is also compatible with RENASYS AB Abdominal Dressing Kit with Soft Port cleared under 510(k) K143133.

RENASYS TOUCH is suitable for use in acute care settings and other professional healthcare environments where product use is conducted by or under the supervision of a qualified healthcare professional.

The provided document is a 510(k) summary for the RENASYS TOUCH Negative Pressure Wound Therapy (NPWT) device. It details the device's comparison to a predicate device and the non-clinical tests performed to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a quantitative, pass/fail manner. Instead, it describes performance testing aimed at demonstrating "substantial equivalence" to the predicate device (RENASYS EZ MAX NPWT). The "reported device performance" is largely qualitative, affirming that the device "meets design specifications" and functions "as intended" under various conditions.

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

The document describes "bench testing" which implies in-vitro or simulated environments.

• Sample Size: Not explicitly stated for any of the tests. The descriptions "full range of RENASYS Foam and Gauze NPWT Dressing Kits," "range of wound model sizes and pressure settings," and "various combinations of challenge conditions" suggest multiple test scenarios were run, but specific numbers are not provided.
• Data Provenance: The tests are "Non-Clinical Tests (Bench)," indicating they were conducted in a laboratory setting. There is no information about country of origin, retrospective or prospective data.

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

This type of information is not applicable to the provided document. The tests performed are bench tests (engineering verification) against design specifications and recognized standards, not clinical studies requiring human expert adjudication for ground truth. The "ground truth" here is the expected performance based on engineering principles and regulatory standards.

4. Adjudication Method for the Test Set

This is not applicable as the tests are non-clinical bench tests. The concept of adjudication (e.g., 2+1, 3+1) is typically relevant for clinical studies where human interpretation of data is being evaluated against a consensus of experts.

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

There is no mention of an MRMC comparative effectiveness study, nor any AI component in this device. This document describes a traditional medical device (negative pressure wound therapy pump) and its regulatory submission based on substantial equivalence to a predicate, not an AI-powered diagnostic or therapeutic device.

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

This is not applicable. The RENASYS TOUCH NPWT device is a hardware product with embedded software for control (as noted, it's software-controlled compared to the predicate's analog control). It is not an "algorithm only" device, but a system that requires human interaction and supervision. The software documentation focused on meeting FDA guidance for software in medical devices, not on standalone algorithm performance for diagnosis or treatment.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the non-clinical bench tests, the "ground truth" is implied to be:

• Design Specifications: The device's performance was verified against its established design requirements.
• Engineering Principles: The tests confirm the physical and mechanical operation aligns with expected engineering outcomes.
• Regulatory Standards: Compliance with various ISO, IEC, and AAMI/ANSI standards acts as a form of "ground truth" for safety and performance in a regulated environment.
• Predicate Device Performance: The primary goal is to demonstrate "substantial equivalence" to the predicate device, meaning its performance falls within acceptable parameters similar to the legally marketed predicate.

8. The Sample Size for the Training Set

There is no mention of a training set. This is a traditional medical device, not a machine learning or AI device that typically involves training data.

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

As there is no mention of a training set, this question is not applicable.

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