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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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The RENASYS Y-Connector can only be used with RENASYS TOUCH and RENASYS GO systems.

RENASYS TOUCH and RENASYS GO are 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 RENAS YS 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

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.

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 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 is an accessory device to the previously cleared RENASYS TOUCH (K153209) pump for use on one wound only. It is only intended to be used in conjunction with RENASYS Negative Pressure Wound Therapy (NPWT) system which 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.

The RENASYS Y-Connector can be used to connect one or two wounds of the same etiologies through two RENASYS Soft Ports to a single pump. 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 (it can only be used on one wound with the RENASYS Abdominal dressing kits and only with RENASYS TOUCH).

The provided text describes a 510(k) summary for the RENASYS Y-Connector, demonstrating substantial equivalence to a predicate device, rather than an AI/ML powered medical device. Therefore, many of the typical acceptance criteria and study components usually associated with AI/ML devices (such as MRMC studies, training/test sets, expert adjudication for ground truth, and specific performance metrics like sensitivity/specificity/AUC) are not applicable or detailed in this submission.

However, I can extract the acceptance criteria and study information related to the performance of the negative pressure wound therapy (NPWT) system with the new Y-Connector, which are based on non-clinical bench testing.

Here's the information parsed from the document:

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance:

• Sample Size for Test Set: The document does not specify the exact sample size (number of units/tests) for each bench test. It uses phrases like "for all test configurations," "all units tested," and "none of the RENASYS Y-Connector units."
• Data Provenance: The studies were non-clinical bench tests conducted to support regulatory submission. The country of origin for the data is not explicitly stated, but the submitter's address is "Smith & Nephew Medical Limited, Hull, United Kingdom," suggesting the tests were likely conducted or overseen by them. The studies are by nature prospective, as they were specifically designed and executed for this submission.

3. Number of Experts and Qualifications for Ground Truth:

• This section is not applicable for this type of device and study. The "ground truth" for these bench tests is defined by mechanical measurements and engineering standards (e.g., maintaining negative pressure, alarm functionality, tensile strength according to ISO standards), not by human expert interpretation or consensus as would be the case for image-based AI/ML diagnostic devices.

4. Adjudication Method:

• Not applicable for these bench tests. Adjudication is relevant for subjective assessments, typically found in clinical studies involving multiple human readers or interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, an MRMC comparative effectiveness study was not performed. This type of study is typically done for diagnostic AI devices where human reader performance (e.g., radiologists, pathologists) with and without AI assistance is compared. The RENASYS Y-Connector is a physical accessory to an NPWT system, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only) Performance:

• Not applicable. There is no "algorithm" in the sense of an AI model being evaluated. The performance evaluated is that of the physical device and its interaction with the NPWT system.

7. Type of Ground Truth Used:

• The ground truth metrics are based on pre-defined engineering and performance specifications and international standards (e.g., ISO 8536-4 for tensile strength). For example, "maintaining negative pressure within the test requirements" and "alarms functioned as intended." This is a form of objective, quantitative ground truth.

8. Sample Size for Training Set:

• Not applicable. This submission does not describe an AI/ML device that requires a training set. The device is a physical component, and its design and manufacturing are informed by engineering principles, not machine learning training data.

9. How Ground Truth for Training Set was Established:

• Not applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it does not apply.

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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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