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RENASYS EZ MAX 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

RENASYS EZ MAX professional healthcare facility model (REF 66801309) 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.

RENASYS AB Abdominal Kit with Soft Port 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 EZ MAX Negative Pressure Wound Therapy (NPWT) device is a lightweight, suction device intended for wound management via application of continuous or intermittent neqative pressure wound therapy to the wound for removal of fluids, including wound exudates, irrigation fluids, and infectious materials. The pump is connected to the wound dressing via a tube connected to a disposable canister. The device provides negative pressure wound therapy to the wound at a range of pressure settings and removes exudates from the wound site to the disposable canister. The device can operate either by a mains power supply or internal battery. The technological characteristics of the new device have not changed.

The 800ml and 250ml canisters are non-sterile, single use devices with a lid that is ultrasonically welded on. The canister kits contain a combination of solidifier gel pack, bacterial overflow guard that attaches to the pump and canister tubing that attaches to the Soft Port assembly.

The 800ml canister without solidifier is a non-sterile, single use device with a lid that is ultrasonically welded on. The canister kit contains a bacterial overflow quard that attaches to the pump and canister tubing that attaches to the Soft Port assembly.

RENASYS AB Abdominal Dressing Kit with Soft Port consists of the following components:

• Two large hydrophobic, reticulated polyurethane foam dressings that incorporate several ● cuts to facilitate custom sizing, if needed.
• One organ protection layer made of non-adherent clear polyurethane film perforated with slits. The slits in the organ protection layer facilitate fluid removal under negative pressure wound therapy.
• . Six 12" x 8" polyurethane transparent film drapes with acrylic adhesive backing. The drapes are placed over the foam and surrounding intact skin to create an airtight seal for the application of negative pressure wound therapy.
• . One Soft Port suction assembly with tubing that attaches to the exudate collection canister. The Soft Port assembly is placed over a hole cut in the drape to facilitate application of negative pressure wound therapy to the wound.

The abdominal kit is designed specifically for use with the RENASYS EZ MAX negative pressure wound therapy devices and canisters.

Here's a breakdown of the acceptance criteria and study information for the RENASYS™ EZ MAX Negative Pressure Wound Therapy Device and RENASYS™ AB Abdominal Dressing Kit with Soft Port, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria for improved performance. The acceptance criteria are implicitly defined by the predicate device's performance and the successful completion of various verification tests to show that modifications do not negatively impact device function and usability, and that the new device performs identically or equivalently to the predicate.

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

The document does not explicitly state the sample sizes used for the "test set" in terms of number of devices or number of tests performed. It refers to "testing" and "verification" but doesn't provide specific quantitative sample sizes for each test.

The data provenance is implied to be bench testing conducted by the manufacturer, Smith & Nephew, Inc. There is no mention of clinical data, human subjects, or country of origin for any experimental data.

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

Not applicable. This was a bench testing study for substantial equivalence, not a study involving expert-established ground truth for clinical diagnosis or outcome. The "ground truth" for the tests described would be the physical properties and performance characteristics being measured by the testing equipment and protocols.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable. There was no adjudication method described as this was not a human reader or diagnostic accuracy study.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission is for a medical device (Negative Pressure Wound Therapy Device and Dressing Kit) and focuses on engineering and performance characteristics, not diagnostic interpretation by human readers.

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

Not applicable. This device is a physical medical device (pump and dressing kit), not an AI algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth used for these tests was engineering and performance specifications based on the predicate devices and relevant industry standards (e.g., ISO, IEC). For instance, pumping capacity was compared to the predicate, and alarm functionality was verified against expected operational parameters using simulated wound fluid.

8. The Sample Size for the Training Set

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

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

Not applicable. See point 8.

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RENASYS EZ MAX 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.

Examples of 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 EZ MAX Professional Healthcare Facility model (66801309) 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 EZ MAX Negative Pressure Wound Therapy NPWT device is a lightweight, suction 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 pump is connected to the wound dressing via a tube connected to a disposable canister. The device provides negative pressure wound therapy to the wound at a range of pressure settings and removes exudates from the wound site to the disposable canister. The device can operate either by a mains power supply or internal battery. The technological characteristics of the new device have not changed. The primary changes made are in relation to compliance with the IEC 60601-1 electrical safety standards. The predicate device complies with the IEC 60601-1 200 edition series while the RENASYS EZ MAX NPWT complies with the IEC 60601-1 3rd Edition series of electrical safety standards

RENASYS EZ MAX NPWT is compatible with existing Smith & Nephew wound dressing kits currently on the market.

The provided document describes the K132466 submission for the RENASYS™ EZ MAX Negative Pressure Wound Therapy Device. This submission is for a 510(k) premarket notification, which aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This type of submission primarily relies on non-clinical (bench) testing to show equivalence in performance, safety, and technological characteristics rather than extensive clinical studies on human subjects.

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document details non-clinical bench testing. Therefore, there isn't a "test set" in the sense of patient data. The testing involved physical devices and components to verify performance and compliance with standards. The data provenance is derived from these bench tests, conducted by the manufacturer (Smith & Nephew, Inc.). No specific country of origin for patient data is relevant here, nor is it retrospective or prospective in the clinical study context.

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

Not applicable. For bench testing of a medical device's physical and electrical performance, "ground truth" is established by engineering specifications, validated test protocols, and compliance with recognized standards. It does not involve human experts in the way clinical studies often do for image interpretation or diagnosis.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic imaging, to resolve discrepancies among expert readers. Bench testing directly measures device performance against predefined engineering criteria.

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 submission concerns a physical medical device (Negative Pressure Wound Therapy pump), not an AI-powered diagnostic tool requiring MRMC studies.

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

Not applicable. This device is not an algorithm or AI system. Its performance is measured directly through bench tests as a standalone physical product.

7. The type of ground truth used

The ground truth used for these bench tests is engineering specifications, established performance parameters of the predicate device, and recognized international and national electrical safety and medical device standards. The goal was to prove the RENASYS EZ MAX performs identically to the predicate and complies with updated safety standards.

8. The sample size for the training set

Not applicable. This is not an AI/Machine Learning 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.

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