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

The RENASYS™ AB Abdominal Dressing Kit with Soft Port consists of two large hydrophobic reticulated polyurethane foam dressings that incorporate several cuts to facilitate custom sizing if needed. Also included in the kit are a polyurethane organ protection layer, six transparent film drapes and a Soft Port suction port assembly with tubing that attaches to the exudate canister. The kit is designed specifically for abdominal wounds and is supplied sterile, single use.

The modification to this kit is the inclusion of a Soft Port suction port, to replace the existing suction port.

The RENASYS AB Abdominal Dressing Kit is used in conjunction with Smith & Nephew RENASYS EZ and RENSASYS EZ PLUS negative pressure wound therapy pumps and canister kits, which have been cleared under 510(k) numbers K082426 and K091470.

The provided text describes a 510(k) summary for the RENASYS™ AB Abdominal Dressing Kit with Soft Port. It focuses on demonstrating substantial equivalence to predicate devices through non-clinical bench testing. Therefore, the requested information regarding acceptance criteria and studies largely pertains to these bench tests, not clinical performance or AI algorithm validation.

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

1. A table of acceptance criteria and the reported device performance

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: The document does not specify exact sample sizes (e.g., number of tests per criterion). It states "Laboratory testing was completed" and "Testing to verify".
• Data Provenance: The tests are described as "Laboratory testing" or "Bench" tests, implying they were conducted in a controlled lab environment. No information on country of origin or whether it was retrospective/prospective in a clinical sense is provided as these are non-clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable to the provided document. The ground truth for the non-clinical bench tests would be the measured physical performance against predefined engineering specifications, not expert interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable to the provided document. Adjudication methods like 2+1 or 3+1 are used for expert consensus on clinical data. For bench tests, performance is typically measured directly against specifications.

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

This question is not applicable to the provided document. The device is a medical dressing kit, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant.

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

This question is not applicable to the provided document. The device is a medical dressing kit, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical bench tests, the "ground truth" is the predefined engineering specifications and measurable performance characteristics of the device components (e.g., flow rate, connection security, performance under stress, biocompatibility).

8. The sample size for the training set

This question is not applicable to the provided document. The device is a medical dressing kit, not an AI algorithm that requires a training set.

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

This question is not applicable to the provided document. The device is a medical dressing kit, not an AI algorithm that requires a training set.

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The RENASYS™ Foam and Gauze NPWT Wound Dressing Kits with Softport are intended to be used in conjunction with Smith & Nephew NPWT systems. Smith & Nephew NPWT systems are indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via the 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.

With the exception of the Softport™ assembly, there are no changes to the components in the currently marketed foam and gauze wound dressing kits. The RENASYS™ Foam and Gauze Wound Dressing Kits with Softport consist of the following components:

Foam Kits: Polyurethane foam wound filler, a Softport assembly and transparent film drape. The foam kits are supplied sterile, single use and are offered in three sizes; small, medium and large.

Gauze Kits: Antimicrobial qauze wound filler, a Softport assembly, non-adherent wound contact layer, transparent film drape, saline bullet, No Sting Skin Prep and wound ruler. The Gauze kits are offered in four sizes: small, medium, large and extra-large. The individual components of the kit are packed sterile and kitted in a non-sterile kit package. The kit is single use.

The Softport assembly attaches to an exudate canister to carry exudate from the wound. The kits are designed specifically for use with the RENASYS EZ / EZ Plus and RENASYS GO negative pressure wound therapy devices and canisters which have been cleared under 510(k) numbers K091470, K102001 and K083375.

This submission describes the RENASYS™ Foam and Gauze NPWT Wound Dressing Kits with Softport™, which adds a Softport assembly to existing Negative Pressure Wound Therapy (NPWT) dressing kits. The evaluation focuses on demonstrating that the new Softport assembly maintains the safety and effectiveness of the previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on functional performance and biocompatibility of the new Softport component, ensuring it performs comparably to the predicate device and does not introduce new risks.

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

The document does not explicitly state the sample sizes for the "verification and validation tests" conducted for the Softport. It mentions that these tests were performed to ensure performance requirements were met.

The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. Given the nature of the tests (functional and biocompatibility), they are typically conducted in a controlled laboratory or testing environment.

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

No information is provided regarding the use of "experts" to establish ground truth for this device's testing. The ground truth for functional performance is established by engineering specifications and objective measurements against those specifications. For biocompatibility, the ground truth is established by adherence to recognized international standards (ISO 10993) and the results of laboratory tests.

4. Adjudication Method for the Test Set

No adjudication method for a "test set" is mentioned, as the testing described is primarily objective performance and safety testing, not human-read evaluation.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human interpretation is a critical component. This submission is for wound dressing kits, and the testing focuses on the functional performance and biocompatibility of the device itself.

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

Yes, the described testing is akin to standalone performance. The verification and validation tests evaluate the physical device's ability to meet its functional specifications and biocompatibility requirements independently, without human interaction as part of the evaluated performance metric.

7. The Type of Ground Truth Used

The ground truth used for this submission is based on:

• Engineering Specifications and Performance Standards: For functional aspects (negative pressure transmission, exudate collection, leak path control, 72-hour functionality, and performance under compression).
• International Biocompatibility Standards: Specifically, ISO 10993 for Cytotoxicity, Skin Irritation, and Skin Sensitization.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this device, as it is a physical medical device (wound dressing kit) undergoing traditional engineering and biological compatibility testing, not an artificial intelligence/machine learning algorithm that requires training data.

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

As noted above, there is no training set for this type of medical device submission.

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The RENASYS™ - F/-AB Abdominal Wound Dressing Kit 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.

This dressing kit is intended for use in acute hospital settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre.

The RENASYS™ -FIAB Abdominal Dressing Kit consists of two large hydrophobic reticulated polyurethane foam dressings that incorporate several cuts to facilitate custom sizing if needed. Also included in the kit are a polvurethane organ protection layer, six transparent film drapes and a suction port assembly with tubing that attaches to the exudate canister. The kit is designed specifically for abdominal wounds and is supplied sterile, single use.

The RENASYS- FIAB Abdominal Dressing Kit is used in conjunction with Smith & Nephew RENASYS EZ and EZ PLUS negative pressure wound therapy pumps and canister kits, which have been previously cleared under 510(k) numbers K082426, K091470 and K102001.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific performance criteria in the way a diagnostic or AI-powered device would.

The document is a 510(k) summary for a medical device called the RENASYS™ -F/AB Abdominal Dressing Kit. It primarily focuses on demonstrating substantial equivalence to a predicate device and includes details about:

• Biocompatibility testing: This confirms the materials used are safe for contact with the body. The table lists various tests (Cytotoxicity, Irritation, Sensitization, Implantation, Sub-acute Toxicity, Genotoxicity) completed for each kit component. These are safety standards, not performance criteria in the sense of accuracy, sensitivity, or specificity.
• Design verification testing: The document states this was conducted "to demonstrate the device meets the performance specifications, delivers negative pressure wound therapy to the wound and removes exudates." However, it does not provide:
  • A table of actual "performance specifications" or acceptance criteria.
  • Specific results from this design verification testing.
  • Details on the sample size, data provenance, ground truth establishment, or expert involvement for this testing.
  • Any information about a comparative effectiveness study (MRMC) or a standalone (algorithm only) study.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, device performance, sample sizes, ground truth, or study types as they are typically described for devices with measurable diagnostic or analytical performance claims.

The document concludes that the device "has successfully undergone testing to demonstrate that the device is substantially equivalent to the predicate device and effective for the intended use." This is the general statement required for a 510(k) clearance, indicating that it meets the regulatory bar for market entry, but not detailing specific performance metrics.

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