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The RENASYS Foam and Gauze Wound Dressing Kits with AIRLOCK Technology and Soft Port are intended to be used in conjunction with Smith + Nephew traditional Negative Pressure Wound Therapy (tNPWT) RENASYS system.

The Smith + Nephew RENASYS NPWT system is indicated for patients who would benefit from a suction pump (Negative Pressure Wound Therapy), as it allows for wound management 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
• Grafts

RENASYS Foam and Gauze Wound Dressing Kits with AIRLOCK Technology and Soft Port are accessories intended for use in conjunction with RENASYS TOUCH, RENASYS GO and RENASYS EDGE Negative Pressure Wound Therapy systems.

Based on the provided text, the document is a 510(k) summary from the FDA for a medical device called "RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port." This document does not describe an AI/ML device or its performance criteria. It pertains to a physical medical device used for negative pressure wound therapy.

Therefore, I cannot provide the requested information as the document does not contain details regarding acceptance criteria for an AI/ML device, nor does it describe a study proving such a device meets those criteria. The original text only mentions non-clinical tests (simulated wound model tests, human factors validation, biological evaluation) and explicitly states "No clinical performance data was necessary" for this particular device.

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The RENASYS™ EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing via removal of fluids, including irrigation fluids, wound exudate 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
• Grafts

The RENASYS™ EDGE pump is compatible with the following accessory dressing kits:

• RENASYS™ Foam Dressing Kits
• · RENASYS™ Foam Dressing Kit XL
• · RENASYS™ Gauze Dressing Kits
• · RENASYSTM Abdominal Dressing Kit
• · RENASYS™ Y Connector Kit
• · RENASYSTM White Foam Wound Dressing

When used with the RENASYS™ AB Abdominal Kit with Soft Port, the RENASYS EDGE™ pump 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™ AB 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™ EDGE 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™ EDGE can be operated by either a mains power supply or internal battery. The RENASYS™ EDGE device is compatible with Smith & Nephew RENASYS™ Dressing Kits.

The provided text is a 510(k) summary for the RENASYS™ EDGE device. This document focuses on demonstrating substantial equivalence to a previously cleared device, not an AI/ML powered device, and thus does not contain the information requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9 of the prompt, which are typically associated with performance studies for AI/ML medical devices.

The submission is specifically for adding "RENASYS™ White Foam dressing kits" as compatible accessories to the existing RENASYS™ EDGE negative pressure wound therapy system. It explicitly states: "No clinical data was provided to support the demonstration of substantial equivalence."

Instead, the document details non-clinical tests performed to demonstrate that the overall system performance of the RENASYS™ EDGE device is not impacted by the use of the new dressing. These tests are:

• Simulated wound model tests: To ensure satisfactory performance, including fluid management and Negative Pressure Wound Therapy (NPWT) delivery.
• EMC Testing: In accordance with IEC 60601-1-2 and RTCA DO-160G.
• Cybersecurity testing: In accordance with FDA guidance "Content of Premarket Submissions for Device Software Functions Guidance for Industry and Food and Drug Administration Staff".
• Software design and testing: In accordance with the framework set out in IEC 62304:2006.
• Low air pressure environment testing: EMC testing (RTCA DO-160G) and NPWT wound model testing were carried out to support the new environment for use (aircraft).

Therefore, I cannot provide a response for the requested information regarding acceptance criteria, device performance tables, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details, as this information is not present in the provided document.

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The RENASYS White Foam NPWT Dressing is a moist, sterile, polyvinyl alcohol (PVA) foam intended to be used in conjunction with Smith & Nephew RENASYS TOUCH and RENASYS GO Negative Pressure Wound Therapy (NPWT) Systems.

The Smith & Nephew RENASYS system is indicated for patients who would benefit from a suction pump (Negative Pressure Wound Therapy) as it may promote wound healing via the removal of wound fluids, including irrigation of 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
• · Grafts

RENASYS™-WF White Foam NPWT Dressing for use as a wound filler in conjunction with the RENASYS Touch or GO Negative Pressure Wound Therapy System and compatible components.

The provided FDA 510(k) Premarket Notification is for a medical device (RENASYS™-WF White Foam NPWT Dressing) and primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to meet explicit quantitative performance acceptance criteria as might be seen for an AI/ML device.

Here's an analysis based on the provided document, addressing the requested points where applicable:

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

The document does not specify quantitative acceptance criteria in terms of performance metrics (like sensitivity, specificity, or accuracy) that an AI/ML device would typically have, because this is not an AI/ML device. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to a predicate device. The performance is assessed through non-clinical testing comparing the subject device to the predicate device in terms of physical characteristics, intended use, indications, contraindications, materials, sterility, and packaging.

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

This information is not provided in the document. The document refers to "wound model testing in challenge conditions" and "comparative wound model testing," which suggests non-clinical bench testing rather than human subject data. Therefore, concepts like sample size for a test set (in the context of patient data) and data provenance (country of origin, retrospective/prospective) are not applicable or detailed here.

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 is not applicable as the study involved non-clinical wound model testing, not expert-adjudicated patient data.

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

This is not applicable for the same reason as point 3.

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 is not applicable as the device is a medical dressing, not an AI/ML diagnostic tool involving human readers.

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

This is not applicable as the device is a medical dressing, not an algorithm.

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

For the non-clinical testing, the "ground truth" would be established by the defined parameters and expected outcomes of the wound models, adherence to ISO standards (e.g., ISO 10993 for biocompatibility), and direct comparison of physical and functional properties against the predicate device. This is more akin to engineering and material performance standards than clinical ground truth obtained from patients.

8. The sample size for the training set

This is not applicable as the device is not an AI/ML algorithm requiring a training set.

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

This is not applicable as the device is not an AI/ML algorithm requiring a training set.

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The RENASYS EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing via removal of fluids, including irrigation fluids, wound exudate 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
• · Grafts

When used with the RENASYS AB Abdominal Kit with Soft Port, the RENASYS EDGE pump 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 AB 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 EDGE 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 EDGE can be operated by either a mains power supply or internal battery. The RENASYS EDGE device is compatible with Smith & Nephew RENASYS Dressing Kits.

The provided document is a 510(k) Premarket Notification for the RENASYS EDGE device, a negative pressure wound therapy (NPWT) system. Based on the document, here's an analysis of the acceptance criteria and the study performed:

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

The document does not explicitly present a table of acceptance criteria with reported device performance in a quantitative manner as typically seen for diagnostic devices. Instead, it lists various verification activities conducted to demonstrate the overall system performance and substantial equivalence to a predicate device.

The "acceptance criteria" here are implicitly linked to compliance with relevant medical device standards and the successful completion of specific types of testing to ensure the device performs as intended and is safe and effective when compared to the predicate device.

• Exudate Management: Ability to remove fluids, wound exudate, and infectious materials.
• Therapeutic Pressure Setting: Ability to maintain negative pressure within the 25-200mmHg range.
• Alarm Functionality: Proper functioning of alarms to notify users of therapy loss.
• Auto-restart Function: Effective re-initiation of therapy after pause. |
  | Software Verification | Successful completion of software verification testing. |
  | Substantial Equivalence | Demonstrated through evaluation of indications for use, principle of operation, materials, technology, product specifications, and energy requirements, alongside performance testing, software verification, EMC, and electrical safety testing. |

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

The document explicitly states: "No clinical data were provided to support the demonstration of substantial equivalence."
Therefore, there is no sample size for a test set of patients, nor is there any provenance information such as country of origin or retrospective/prospective nature, as no human clinical studies were performed. The testing conducted was entirely non-clinical.

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)

Not applicable. Since no clinical data was provided and no human test set was used, there were no experts establishing ground truth for a clinical test set. The validation was based on engineering and performance criteria against standards.

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

Not applicable, as no clinical test set requiring adjudication was used.

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. The RENASYS EDGE device is a physical medical device (NPWT pump), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant to its evaluation.

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

Not applicable. This is not an algorithm-only device. The evaluation focused on the physical device's performance characteristics.

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

The "ground truth" for the non-clinical tests would have been the engineering specifications and established performance parameters defined by the manufacturer and relevant international medical device standards (e.g., specific negative pressure range, exudate removal rates, alarm trigger conditions, electrical safety limits, EMC limits). Compliance with these predefined technical criteria constituted the "ground truth."

8. The sample size for the training set

Not applicable. This is a medical device, not an AI model that requires a training set.

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

Not applicable, as there was no training set for an AI model.

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RENASYS-F Foam dressing kits with Soft Port and RENASYS Films are intended to be used in conjunction with Smith & Nephew RENASYS Negative Pressure Wound Therapy (NPWT) Systems.

The Smith & Nephew RENASYS system 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. Appropriate wound types include:

• Chronic
• Acute
• · Traumatic
• Sub-Acute and dehisced wounds
• · Ulcers (such as pressure or diabetic)
• · Partial-thickness burns
• Flaps
• · Grafts

The RENASYS-F XL Negative Pressure Wound Therapy (NPWT) Foam Dressing Kit with Soft Port is a sterile, single use device containing one extra-large polyurethane foam wound filler sheet (18.9in x 16.1in x 0.6in / 48cm x 41cm x 1.5cm), one soft port and six transparent films (12in x 8in / 30cm x 20cm).

The RENASYS XL Transparent Film Dressing is a sterile, single use device provided in a pack containing five transparent films (15in x 24in / 38cm x 60cm). The RENASYS XL Transparent Film Dressing are provided where additional film dressings may be needed to supplement other RENASYS dressing kits.

The RENASYS-F XL Negative Pressure Wound Therapy Foam Dressing Kit with Soft Port and RENASYS XL Transparent Film Dressing are intended to be used in conjunction with Smith & Nephew RENASYS Negative Pressure Wound Therapy (NPWT) systems and dressing kits.

These devices are compatible with the RENASYS TOUCH NPWT pump (cleared in K181822) and RENASYS GO NPWT pump (cleared in K152163).

The devices for which clearance is being sought are:

RENASYS-F XL Negative Pressure Wound Therapy Foam Dressing Kit with Soft Port Containing cleared components (soft-port and transparent film) and a larger sized foam sheet consisting of identical material to the foam sheets in the predicate device RENASYS XL Transparent Film Dressing

a larger sized transparent film of identical material to the film sheets in the predicate device

The provided document is a 510(k) Premarket Notification for the RENASYS-F XL Negative Pressure Wound Therapy Foam Dressing Kit with Soft Port and RENASYS XL Transparent Film Dressing. It states the device's indications for use and compares its technological characteristics to a predicate device. However, it does not contain detailed information regarding the acceptance criteria for a study, the specific performance of the device against those criteria, sample sizes for test or training sets, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC study results.

The document focuses on demonstrating substantial equivalence to a predicate device (K142979) by highlighting similar indications for use, technological characteristics, and principles of operation, and by presenting a summary of non-clinical tests.

Therefore, much of the requested information cannot be extracted from this document.

Here's a summary of what can be extracted and what is explicitly missing:

1. Table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as a table with numerical thresholds. The testing described focuses on demonstrating that performance is not negatively impacted by the larger size or minor changes in the soft port compared to the predicate device.
• Reported Device Performance:
  • Wound model tests demonstrated performance when used with RENASYS GO and RENASYS TOUCH NPWT pumps at various pressures, minimum/maximum leak rates, and in combination with cleared RENASYS consumables.
  • Wound model testing demonstrated no change in performance between large and extra-large wound sizes.
  • Wound model tests demonstrated that RENASYS GO and RENASYS TOUCH NPWT leak and blockage alarms are not impacted.
  • Physical testing on XL Foam: Tensile strength, elongation at break, loss on drying data were collected but specific results or acceptance criteria are not provided.
  • Physical testing on XL Transparent Film Dressing: Moisture Vapor permeability, Waterproofness, Adhesion to Steel, Tensile strength, Weight of Adhesive (g/m2), Weight of Base Film (g/m2), Extensibility, Permanent Set data were collected but specific results or acceptance criteria are not provided.
  • Biocompatibility requirements were met for Cytotoxicity, Sensitization, Irritation, Material mediated pyrogenicity, Systemic toxicity (acute, sub-acute and sub-chronic), and Implantation, based on ISO 10993 and FDA Blue Book Memorandum #G95-1.
  • Bacterial endotoxin contamination met requirements of ANSI/AAMI ST72:2019.

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

• Sample Size for Test Set: Not specified. The document mentions "wound model tests" and "physical testing" but does not quantify the number of tests performed or the sample sizes involved for each test type.
• Data Provenance (country of origin, retrospective/prospective): Not specified. These appear to be laboratory-based non-clinical tests, likely conducted at the manufacturer's facility or a contracted lab. The document does not indicate if any clinical data (prospective or retrospective) was used.

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

• Not applicable / Not specified. The tests described are non-clinical, involving physical and performance characteristics of the dressing kit and film. There is no mention of expert-established ground truth for a diagnostic or interpretative task.

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

• Not applicable / Not specified. As the studies are non-clinical hardware performance tests, adjudication by human experts as described (e.g., for image interpretation) is not relevant.

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. This device is a wound dressing kit and film, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.

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

• No. This device is hardware (dressing kit and film), not an algorithm or AI.

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

• Not applicable as typically defined for diagnostic devices. The "ground truth" for the non-clinical tests would be the established scientific and engineering principles, specifications, and test methods for material properties (e.g., tensile strength, permeability), pump performance (e.g., leak detection, pressure maintenance), and biocompatibility.

8. The sample size for the training set

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

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

• Not applicable. There is no training set for this type of device.

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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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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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The RENASYS-G Gauze Dressing Kits with Soft Port 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.

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 Gauze Wound Dressing Kit with Soft Port consists of the following components:

• . Antimicrobial gauze wound filler
• Soft Port assembly
• Non-adherent wound contact layer ●
• RENASYS Transparent film ●
• . Saline bullet
• . No Sting Skin Prep
• . Wound ruler

The RENASYS-G Gauze kits are offered in four sizes: small, medium, large and extralarge. The components of the kit are individually packaged and sterilized and kitted in a non-sterile kit package. The kit is single use.

The Soft Port assembly attaches to an exudate canister to deliver negative pressure wound therapy to the wound. The qauze kits are designed specifically for use with the RENASYS negative pressure wound therapy devices and canisters.

This document is a 510(k) summary for the RENASYS-G Gauze Dressing Kits with Soft Port. It describes the device, compares it to a predicate device, and outlines the non-clinical tests performed to demonstrate substantial equivalence.

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

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

The document does not explicitly state quantitative acceptance criteria for the device's performance in terms of wound healing efficacy or similar outcomes. Instead, the study focuses on verifying the substantial equivalence of the modified device to its predicate. The "acceptance criteria" are implied by the successful completion of the verification tests, ensuring the modifications do not compromise the device's performance or safety.

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

The document does not explicitly state the sample sizes for the "transit testing" or "stability testing" or provide details on the data provenance (country of origin, retrospective/prospective). These are non-clinical (bench) tests, not typically subject to the same patient data collection requirements.

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 information is not applicable. The tests performed are non-clinical bench tests (transit testing, stability testing), which do not involve expert interpretation or ground truth establishment in the way clinical studies with expert reviewers would.

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

This information is not applicable as there are no expert adjudications in these non-clinical bench tests.

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 was no MRMC comparative effectiveness study. This document describes the substantial equivalence of a medical device (wound dressing kit), not an AI-powered diagnostic tool.

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

This information is not applicable. The device is a physical wound dressing kit, not an algorithm or AI system.

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

For the non-clinical tests described:

• Transit testing: The "ground truth" for package seal integrity would be based on validated physical testing methods and established criteria for package integrity.
• Stability testing: The "ground truth" for shelf life and performance specifications would be based on validated laboratory testing methods to assess material degradation, sterilization maintenance, and functional performance over time.

8. The sample size for the training set

This information is not applicable. The tests performed are non-clinical bench tests for device modifications, not a machine learning model requiring a training set.

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

This information is not applicable as there is no training set for an algorithm in this context.

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