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The RENASYS GO 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 GO NPWT device is a modification to predicate device K088375. It 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 GO 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 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 40-200mmHg. The device can operate either by a mains power supply or internal battery.

RENASYS GO uses an integral waste canister that is supplied non-sterile, single-use with a volume capacity of 300ml or 750ml. The waste canister is attached to the pump device by two clips on either side of the canister. The canister is permanently sealed to minimize the potential of users coming into contact with exudates. Safety features include a 1.0 micron filter in the top of the canister to resist fluid penetration into the device, as well as a 0.2 micron bacterial filter to prevent the passage of airborne bacteria. Each sealed canister contains a solidifier which acts as a gelling agent to the exudate.

A tube is permanently attached to the bottom of the waste canister through an inlet port. A connector attached to the distal end of the canister tube attaches to the corresponding tubing included in each Smith & Nephew NPWT dressing kit.

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

The provided text describes modifications to an existing negative pressure wound therapy (NPWT) device, the RENASYS GO, and the testing conducted to demonstrate its substantial equivalence to a predicate device (K083375). As this is a 510(k) submission, the focus is on substantial equivalence rather than establishing novel acceptance criteria for a new device. Therefore, the "acceptance criteria" here largely refer to demonstrating that the modified device performs comparably to the predicate and meets relevant safety and performance standards.

Here's an analysis based on your request, understanding that "acceptance criteria" are implied by the scope of a 510(k) modification rather than explicitly listed as performance targets in the same way a new device might have:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes bench testing ("Non-Clinical Tests (Bench)") and verification testing. It does not specify sample sizes (e.g., number of devices tested for each condition). The testing appears to be conducted by the manufacturer, Smith & Nephew, Inc., and therefore the "data provenance" would be internal company testing. There is no mention of external data sources or clinical data.

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

N/A. This document pertains to bench and verification testing for a device modification, demonstrating substantial equivalence. The "ground truth" for these tests relates to engineering specifications and performance against known standards or the predicate device, not expert interpretation of medical images or patient outcomes.

4. Adjudication Method for the Test Set

N/A. As the testing mentioned is bench and verification testing against engineering specifications and standards, there is no mention or need for a medical expert adjudication method like 2+1 or 3+1.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states that "Non-Clinical Tests (Bench)" were performed. It does not describe any human reader studies or MRMC comparative effectiveness studies.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

N/A. This device is a negative pressure wound therapy pump, not an AI/algorithm-based diagnostic or therapeutic device. The "performance" described is the functioning of the pump and its alarm systems, which is inherently standalone in its operation (i.e., the pump operates without continuous human "in-the-loop" interaction for its core function, though it is used by a human).

7. The Type of Ground Truth Used

The "ground truth" for the tests described is primarily:

• Engineering specifications and design requirements: For aspects like pumping capacity, negative pressure range, O-ring durability, and performance in various conditions.
• Predicate device performance: To demonstrate equivalence in core functionalities.
• Regulatory and consensus standards: Such as IEC 60601 series for electrical safety, usability, and alarm systems, and ISO standards for risk management.
• Simulated wound fluid chemistry: For testing alarm functionality.

8. The Sample Size for the Training Set

N/A. This document describes a medical device (a pump) and its modifications, not a machine learning or AI algorithm that requires a training set. The "software modifications" mentioned relate to alarm functionality and compliance with standards, implying traditional software engineering and testing, not AI model training.

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

N/A. See point 8.

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Renasys™ GO is indicated for patients who would benefit from a suction device (negative pressure) to help promote wound healing by removing 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 GO NPWT device is a lightweight, portable suction device intended to deliver negative pressure to a wound at a range of pressure settings via a tube set connected to a wound dressing. The suction pump creates negative pressure and removes exudates from the wound site to a disposable canister. The device can operate either by a mains power supply or internal battery. Renasys GO is suitable for use in both a hospital and homecare setting and includes a shoulder strap and carry case for portability.

Renasys GO is compatible with existing Smith & Nephew wound dressing kits currently on the market.

The provided text describes the Renasys™ GO Negative Pressure Wound Therapy device and its substantial equivalence to predicate devices. However, it does not include detailed information regarding specific acceptance criteria, a standalone study proving the device meets those criteria, sample sizes for test/training sets, expert qualifications, or multi-reader multi-case studies.

The document states that "Performance testing and electrical safety testing has been successfully completed to demonstrate that tooling and enounced and ally equivalent to the marketed devices and is safe and effective for the intended use." This indicates that some form of testing was performed, but the specifics requested in your prompt are not present.

Therefore, many of the sections below will state "Not provided in the document."

Acceptance Criteria and Device Performance

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

• Sample Size for Test Set: Not provided in the document.
• Data Provenance: Not provided in the document. The filing is from the USA (Smith & Nephew, Inc., St. Petersburg, FL and Largo, FL). It is a premarket notification for a medical device seeking substantial equivalence, which typically relies on laboratory testing and comparison to predicate devices rather than clinical trials with patient data for this product type. The text mentions "performance testing," which strongly suggests laboratory-based testing rather than clinical data.

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

Not provided in the document. Given the description of "performance testing and electrical safety testing," it is unlikely that "ground truth" in the clinical sense (e.g., expert consensus on medical images or pathology) was established for a test set, as this likely refers to engineering and functional performance.

4. Adjudication method for the test set

Not provided in the document.

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, an MRMC comparative effectiveness study was not done, nor would it be relevant for this type of device (a negative pressure wound therapy pump). The device is a physical pump, not an AI diagnostic tool that human readers would use.

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

Yes, implicit in the statement "Performance testing and electrical safety testing has been successfully completed." This refers to the device's functional performance in isolation. The testing would assess parameters like pressure delivery, suction efficacy, battery life, alarm functions, and electrical safety standards without human interaction to "improve" the device's basic function.

7. The type of ground truth used

The "ground truth" for this type of device would likely be engineering specifications, performance standards (e.g., specific pressure levels, flow rates, alarm triggers), and electrical safety standards (e.g., IEC standards). The document implies these were used by stating "Performance testing and electrical safety testing has been successfully completed."

8. The sample size for the training set

Not applicable/Not provided in the document. This device is a hardware product, not a software algorithm that would typically have a "training set" in the machine learning sense. The "training" for such a device would be its iterative design and engineering testing.

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

Not applicable/Not provided in the document.

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