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BIOBRANE Dressings are indicated for:

• Covering clean partial thickness burn wounds
• Split thickness donor sites

BIOBRANE Glove is indicated for:

• Covering clean partial thickness burn wounds of the hand.

BIOBRANE Dressing and BIOBRANE Glove are wound dressings made from an ultrathin, semipermeable, perforated silicone membrane that is mechanically bonded to a flexible knitted tri-filament nylon fabric. Denatured porcine dermal collagen is bonded to the silicone-nylon membrane to provide a flexible and conformable dressing with adherence properties and a hydrophilic surface.

This document is a 510(k) K242146 premarket notification for the BIOBRANE Dressing and BIOBRANE Glove. It asserts substantial equivalence to the predicate device BIOBRANE II (K901369).

Here's an analysis of the provided information relating to acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide a table of acceptance criteria with specific performance metrics such as sensitivity, specificity, accuracy, or any quantitative measures for the device's diagnostic or predictive capabilities. This is likely because the device is a wound dressing, not a diagnostic AI/ML device.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device through shared characteristics and verification tests. The "acceptance criteria" can be inferred as successful completion of these tests and demonstration that the device's characteristics are similar to the predicate.

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

The document explicitly states: "No clinical data is relied upon in this submission to determine substantial equivalence."

Therefore:

• Sample size for the test set: Not applicable, as no clinical test set was used for substantial equivalence determination.
• Data provenance: Not applicable. The evaluation was based on non-clinical (bench) testing and comparison of technological characteristics.

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

Not applicable, as no clinical test set with a ground truth established by experts was used. The substantial equivalence was based on non-clinical data and direct comparison to a predicate device.

4. Adjudication Method for the Test Set

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

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 performed or relied upon. This is a wound dressing, not an AI/ML diagnostic device where such studies are typical.

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

Not applicable. This device is a wound dressing, not an algorithm or software-only device.

7. The Type of Ground Truth Used

Not applicable, as no clinical data or ground truth in the context of diagnostic performance was used. The "ground truth" for this submission is implicitly the established safety and efficacy profile of the legally marketed predicate device (BIOBRANE II, K901369) and the physical/chemical properties assessed through bench testing.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set or ground truth for training.

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ALLEVYN Ag+ dressing is indicated for the management of exuding wounds such as leg and foot ulcers, traumatic and surgical wounds, superficial and partial thickness burns.

ALLEVYN Ag+ dressing can also be used under compression bandaging.

Silver sulfate present in the dressing helps reduce microbial colonization on the dressing.

ALLEVYN Ag+ dressing should be used under the supervision of a qualified healthcare professional.

The ALLEVYN Ag+ dressing is a: sterile, single-use, composite, absorbent, antimicrobial wound dressing containing silver sulfate within an absorbent pad.

The primary function of the ALLEVYN Ag+ dressing is to absorb exudate and provide a moist woundhealing environment that is optimal for low to highly exuding wounds. As a secondary function the silver in the polyurethane absorbent foam layer of the ALLEVYN Ag+ dressing helps to reduce or inhibit microbial colonization of the device based on in-vitro testing. The antimicrobial agent (silver), is derived from silver sulfate added to the subject device (ALLEVYN Ag+ dressing).

The ALLEVYN Ag+ dressing range includes the following variants which all have the same intended use / indications for use and technological characteristics, and which differ in dimensions, shape and top film colour only):

• ALLEVYN Ag+ Border (including Sacrum) ● Dressings available in square and sacrum sizes with a printed ('Ag+') pink transparent top film.
• ALLEVYN Ag+ Surgical ● Dressings available in rectangles with a printed ('Ag+') clear transparent top film.

The ALLEVYN Ag+ dressing is a composite antimicrobial dressing consisting of:

• . Top Film: Breathable transparent polyurethane top film (clear or with pink depending on dressing size), printed with 'Ag+'
• Superabsorbent Pad: Non-woven superabsorbent particulate pad with cut pattern of slits for ● flexibility and conformability
• Absorbent polyurethane foam layer containing silver sulfate: Absorbent polyurethane foam ● pad impregnated with a powder mix including silver sulfate
• . Wound Contact Layer (WCL): A perforated WCL made of polyurethane film coated with silicone gel adhesive on wound facing side
• . Release Handles: Plain and perforated transparent films

The ALLEVYN Ag+ dressing is provided individually packed in a sealed pouches made from grid-lacquer paper and polyester film laminate; the sealed pouch forms the sterile barrier for each dressing. Multiple pouched dressings are provided in a carton along with a user manual.

The ALLEVYN Ag+ dressing is provided terminally sterilized via Ethylene Oxide Sterilization to a 100 sterility assurance level.

This document is a 510(k) Premarket Notification for the ALLEVYN Ag+ dressing, seeking substantial equivalence to a predicate device. It primarily relies on non-clinical performance testing rather than clinical studies. Therefore, many of the requested points regarding acceptance criteria and clinical study details will not be applicable.

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 present a table of "acceptance criteria" with numerical targets and direct "reported device performance" against those targets in the format typically seen with quantitative clinical endpoints. Instead, it lists types of performance bench tests conducted to demonstrate equivalence to the predicate device. The conclusion states that the subject device is "as safe and effective as the predicate device" based on these tests, implying the performance met the standard set by the predicate.

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

The document primarily refers to "in-vitro testing" and "bench testing." It does not specify sample sizes for these tests, nor does it provide information on data provenance in terms of country of origin or whether it was retrospective or prospective, as these are typically considerations for human clinical trials.

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 to the non-clinical bench testing described in this document. Experts are typically involved in establishing ground truth for clinical studies or evaluating images/data from human subjects.

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

This information is not applicable to the non-clinical bench testing described in this document. Adjudication methods are typically used in clinical studies when multiple readers/experts are interpreting results from human subjects.

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 MRMC comparative effectiveness study was done. The submission explicitly states: "No clinical data is relied upon in this submission to determine substantial equivalence." The device is a wound dressing, not an AI-assisted diagnostic tool.

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

This question is not applicable as the device is a wound dressing, not an AI algorithm.

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

For the non-clinical bench testing, the "ground truth" would be established by the validated methodologies and reference standards of the respective in-vitro and laboratory tests (e.g., AATCC TM100-2019 for antimicrobial effectiveness, ISO 10993 for biocompatibility). These standards define what constitutes an acceptable performance or outcome for that specific test.

8. The sample size for the training set

This is not applicable. There is no mention of a "training set" as this device is a physical wound dressing and not an AI/machine learning model.

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

This is not applicable as no training set was used.

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The VERSAJET III Hydrosurgery System cuts, ablates and foreign matter from wounds via pressurized saline. The system is intended for applications that in the physician's judgment, require sharp debridement:

• wound debridement (acute and chronic wounds, burns),
• soft tissue debridement and cleansing of surgical sites.

The VERSAJET III Hydrosurgery System consists of a reusable console, foot pedal and single-use, sterile hand pieces.
The VERSAJET III Hydrosurgery System can be used to cut, ablate and remove tissue and foreign matter from wounds and to resect and remove material in a variety of surgical applications. This is a debridement system intended for wound and soft tissue debridement, and cleansing of the surgical site. This is achieved yia the delivery of a pressurized stream of sterile saline fluid acts to tangentially ablate the surface of the tissue and propel excised tissue and debris out of the wound. The debris and fluid are directed into the handpiece into a flexible tube, which carries the effluent to the drain or collection canister.
The pressure can be adjusted using either the foot switch or on the touchscreen front panel of the console. Pressure settings range from 1-10 in factory pre-set increments, with the pressure increasing with each higher setting number, depending on the needs of a particular application.

The provided text describes a 510(k) premarket notification for the VERSAJET III Hydrosurgery System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a comprehensive clinical study with quantitative performance metrics for AI applications. The device described (a hydrosurgery system) is a physical medical device, not an AI or software-as-a-medical-device (SaMD) that typically relies on algorithms and data for its function.

Therefore, many of the requested categories in your prompt related to AI/algorithm performance (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this traditional medical device submission.

However, I can extract information related to the device's "performance" in the context of a 510(k) (which means demonstrating safety and effectiveness compared to a predicate) and non-clinical testing.

Here's a summary based on the provided text, addressing the applicable points and indicating when information is not present or relevant to this type of device:

Device: VERSAJET III Hydrosurgery System

Predicate Device: VERSAJET II Hydrosurgery System (K143115)

Regulation Number: 21 CFR 880.5475 (Jet lavage)

Regulatory Class: Class II

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance results in the way one would for an AI diagnostic algorithm (e.g., sensitivity, specificity thresholds). Instead, "performance" in this context refers to the device's functional integrity, safety, and equivalence to the predicate device through non-clinical testing.

The overall conclusion for all tests is that they were completed to prove safety and effectiveness and to demonstrate substantial equivalence in performance to the predicate device. The submission states, "Performance testing, software verification testing, electromagnetic compatibility testing and electrical safety testing has been completed to demonstrate that the VERSAJET III Hydrosurgery System is substantially equivalent to the predicate device for the intended use."

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

• Not Applicable. This is a physical device, and the testing described is non-clinical bench testing, electrical safety, EMC, and human factors. There is no "test set" of patient data in the context of an AI algorithm evaluation.

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

• Not Applicable. As above, no patient data test set requiring expert ground truth for an algorithm. Human factors testing would involve user interaction, but this is different from establishing ground truth for diagnostic imaging.

4. Adjudication method for the test set

• Not Applicable. No test set of patient data requiring adjudication.

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 is not an AI-powered diagnostic device. No MRMC study was conducted.

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

• No. This is a physical, manually operated medical device tool; it does not have an algorithm that performs a standalone function for diagnosis or intervention without human control.

7. The type of ground truth used

• Not Applicable. Ground truth, in the context of AI, refers to the verified correct output for a given input. For this device, "ground truth" would relate to engineering specifications, safety standards, and functional performance benchmarks (e.g., a handpiece reliably delivers X pressure, a safety cutoff activates at Y point, components withstand Z cycles). The document does not detail specific "ground truth" methods beyond adherence to standards and demonstrating equivalence to predicate performance.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not an AI model that requires a training set of data.

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

• Not Applicable. As above, no training set for an AI model.

In summary, the provided document details a 510(k) submission for a conventional medical device (hydrosurgery system). The "acceptance criteria" and "study" refer to non-clinical engineering and performance testing aimed at demonstrating the device's safety, effectiveness, and substantial equivalence to a predicate device, rather than the performance metrics and ground truth methodologies typically associated with AI/SaMD products.

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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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PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System and PICO Fluid Management Packs are indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of low to moderate levels of exudate and infectious materials. Appropriate wound types include:

• Chronic
• Acute
• Traumatic
• Subacute and dehisced wounds
• Partial-thickness burns
• Ulcers (such as diabetic or pressure)
• Venous Leg Ulcers - PICO can be used in combination with Graduated Compression Therapy in the management of Venous Leg Ulcers
• Flaps and grafts
• Closed surgical incisions

PICO 7 Single Use Negative Pressure Wound Therapy Systems, PICO 14 Single Use Negative Pressure Wound Therapy Systems and PICO Fluid Management Packs are suitable for use in both a hospital and homecare setting.

The PICO 7 and PICO 14 Single Use Negative Pressure Wound Therapy Systems consist of:
• PICO Pump
• Batteries
• PICO Dressing (s)
• Instructions for Use
• Fixation Strips

PICO Fluid Management Packs consist of 5 individually packaged PICO dressings designed for use with PICO devices.

PICO 7 and PICO 14 are canister-free single use Negative Pressure Wound Therapy Systems and use an absorbent dressing connected to the PICO pump via a tubing and port.

Wound exudate is managed by PICO dressing using a combination of absorption and evaporation. The PICO pump provides the additional benefit of -80mmHg nominal pressure under the dressing, applying Negative Pressure Wound Therapy to the wound.

The provided text does not contain information about acceptance criteria for a device's performance, nor does it detail a study designed to prove the device meets specific performance criteria.

The document is an FDA 510(k) clearance letter and an accompanying 510(k) summary for the PICO 7 and PICO 14 Single Use Negative Pressure Wound Therapy Systems. The primary purpose of this submission is to demonstrate substantial equivalence to a previously cleared predicate device (K202157) for an expanded Indication for Use: the use of PICO in combination with Graduated Compression Therapy in the management of Venous Leg Ulcers.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning the performance of the device itself (e.g., accuracy, sensitivity, specificity for an AI/algorithm-based device), cannot be extracted from this document.

The document does include:

• Clinical information (Page 6-7): References a Randomized Controlled Trial (RCT) by Kirsner et al. (2019) and a Cochrane Review by O'Meara et al. (2012) to demonstrate the safety of PICO when used with compression therapy for Venous Leg Ulcers, especially regarding adverse events (AEs). This is a safety comparison, not a performance study against acceptance criteria.
  • Study Design: Randomized, multi-centre, open-label, controlled trial.
  • Sample Size: 164 patients for safety analysis. 101 subjects with venous leg ulcers (VLU) and 60 subjects with diabetic foot ulcers were in the ITT population (n=161 total). 80 received PICO treatment, of which 51 (63.8%) had a VLU.
  • Data Provenance: Not specified, but likely multi-center, implying various locations. Retrospective or prospective is not explicitly stated, but RCTs are typically prospective.
  • Ground Truth: The study evaluated adverse events and their frequency, comparing them to historical controls. The "ground truth" here is the occurrence and classification of adverse events by clinical observation as per the study protocol.
  • Acceptance Criteria (Safety): The conclusion drawn is that "PICO used in conjunction with compression therapy does not generate any increased frequency in the number or severity of AEs in patients compared to compression therapy alone." This acts as a comparative safety criterion rather than a performance metric.
  • Reported Device Performance (Safety): Percentage of subjects reporting a device-related AE was 13.7% for PICO + 4-Layer Bandage (4LB) group, compared to 31.9% for historical 4LB control.
  • Experts, Adjudication, MRMC studies, Standalone Performance, Training Set: These are not relevant to the safety study presented in the document, which focuses on device-related adverse events in patients, not on an algorithmic or AI performance.

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PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System. PICO 14 Single Use Negative Pressure Wound Therapy System. and the PICO Fluid Management Pack are indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of low to moderate levels of exudate and infectious materials.

Appropriate wound types include:

• Chronic
• · Acute
• · Traumatic
• Subacute and dehisced wounds
• · Partial-thickness burns
• · Ulcers (such as diabetic or pressure)
• · Flaps and grafts
• Closed surgical incisions

PICO 7, PICO 7 Y and PICO 14 Single Use Negative Pressure Wound Therapy Systems are suitable for use in both a hospital and homecare setting.

All of the PICO devices (PICO 7 (K180698), PICO 7Y (K182323), and PICO 14 (K191760) are canister-free single-use Negative Pressure Wound Therapy (NPWT) Systems and use an absorbent dressing connected to a small NPWT pump by a tubing and port. The dressing manages wound exudate by a combination of absorption and evaporation. The pump provides for a -80mmHg nominal pressure under the dressing, applying Negative Pressure Wound Therapy (NPWT) to the wound. PICO Fluid Management Pack are packs of 5 individually packaged PICO Dressings designed for use with PICO devices.

The provided text is a 510(k) premarket notification for a medical device, specifically the PICO Single Use Negative Pressure Wound Therapy System. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific acceptance criteria through a standalone clinical study on its performance in treating wounds.

Therefore, the information typically found in a clinical study report proving device performance against acceptance criteria (such as sample size, expert adjudication, MRMC studies, ground truth establishment for training, etc.) is not present in this type of regulatory submission. The document explicitly states:

"Performance data provided in previously cleared 510(k)s for PICO 7, PICO 7Y and PICO 14 Single Use Negative Pressure Wound Therapy Systems (including PICO Fluid Management Pack) continue to support substantial equivalence."

Instead of a new clinical performance study, the document focuses on:

• Comparison of Technological Characteristics: Demonstrating that the subject device's features, indications for use, environment of use, patient population, materials, sterilization methods, biocompatibility, pump type, and electrical safety testing methods are the same as the predicate device.
• Minor Changes and Supporting Data: Addressing specific minor changes in the device (updated magnet warning text, removal of pump warning label) and providing additional data to support these changes. This additional data includes:
  • Bench testing: For magnetic field strength.
  • Analysis of postmarket surveillance: Including a systematic literature review on IMDs and magnetic interference, and a review of MAUDE database and company complaint data.
  • Risk analysis: Updating the risk assessment based on the above.

Based on the provided text, here's what can be extracted and what information is not available:

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

The document does not present a table of acceptance criteria in the traditional sense of a clinical trial (e.g., Sensitivity X%, Specificity Y%). Instead, the "acceptance" for this 510(k) is based on demonstrating substantial equivalence to the predicate device for various technical and clinical characteristics. The "performance" is primarily demonstrated by showing that the characteristics are identical or that any changes do not raise new questions of safety or effectiveness.

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

• Test Set (for the current K202157 submission):
  • Magnetic Field Testing: This was bench testing, not involving human subjects. The sample size for devices tested is not specified, but it implies a measurement on the PICO Family pumps.
  • Post Market and Risk Analysis: Reviewed over 60,000 records from the MAUDE database (USA, retrospective) and Smith +Nephew PICO devices complaint data (provenance not specified, but likely global, retrospective).
• Provenance: MAUDE data is from the United States. The literature review is not geographically specified but typically covers international publications. Smith +Nephew complaint data is likely global. All are retrospective analyses.
• The document states that clinical performance data was provided in previously cleared 510(k)s. This suggests the initial clinical data was obtained for those initial clearances, not for this specific submission which focuses on minor labelling changes and supporting evidence for those changes through non-clinical data.

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 to this 510(k) submission. This is not a study assessing diagnostic or clinical performance against expert ground truth. The "ground truth" for the current changes is based on:
  • Bench testing results (magnetic field strength)
  • Regulatory requirements (for labeling updates)
  • Analysis of real-world adverse event data (MAUDE database, company complaints) and scientific literature review. This analysis would have been performed by internal regulatory/safety/scientific experts, but the specifics of their number or qualifications are not provided as it's not a reader study.

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

• Not applicable. This document describes a substantial equivalence claim for a physical medical device, not an AI/imaging algorithm requiring adjudication of interpretations. The analysis of post-market data and literature would involve methods of synthesizing evidence and risk assessment, but not "adjudication" in the context of clinical interpretation.

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 device is a Negative Pressure Wound Therapy System, not an AI-powered diagnostic tool, so an MRMC study is not relevant to its clearance.

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

• Not applicable. This is a physical medical device, not software or an algorithm with standalone performance metrics.

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

• For the magnetic field testing, the "ground truth" is measured physical properties based on calibrated equipment.
• For the post-market surveillance and risk analysis, the "ground truth" is derived from:
  • Reported adverse events/complaints (MAUDE database, company data). These are real-world reported events, which serve as evidence of actual outcomes (or lack thereof).
  • Published scientific literature on magnetic interference with implantable medical devices. This represents the established scientific understanding and reported cases in medical literature.

8. The sample size for the training set

• Not applicable. This device does not use machine learning where a "training set" would be relevant.

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

• Not applicable.

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PICO 14 is indicated for patients who would benefit from a suction device (NPWT) as it may promote would healing via removal of low to moderate levels of exudate and infectious materials.

Appropriate wound types include:

• Chronic
• Acute
• Traumatic
• Subacute and dehisced wounds
• Partial-thickness burns
• Ulcers (such as diabetic or pressure)
• Flaps and grafts
• Closed Surgical incisions

PICO 14 Single Use Negative Pressure Wound Therapy System is suitable for use both in a hospital and homecare setting.

PICO 14 Single Use Negative Pressure Wound Therapy System is a small, lightweight, portable, electro-mechanical pump system connected through a flexible tube to a super-absorbent, gentle adhesive dressing. Secondary fixation strips are also provided to ensure an adequate seal is achieved. The pump, the dressing and fixation strips are supplied sterile and for single use.

The provided text describes the PICO 14 Single Use Negative Pressure Wound Therapy System and its substantial equivalence to the predicate device, PICO 7. However, the information presented primarily focuses on demonstrating equivalence through bench testing and a clinical study on patient outcomes rather than a traditional setup of acceptance criteria and a study dedicated to proving the device meets those specific criteria in a formal, AI-centric evaluation.

The device itself is a powered suction pump for wound therapy, not an AI/ML-driven diagnostic or treatment device, which explains the absence of some of the requested AI-specific information.

Here's an attempt to extract and present the information as requested, aligning it as closely as possible to the nature of the provided text:

Acceptance Criteria and Device Performance Study for PICO 14 Single Use Negative Pressure Wound Therapy System

The PICO 14 device is an electro-mechanical pump system and does not appear to involve AI/ML. Therefore, typical AI-specific acceptance criteria (like sensitivity, specificity, AUC) and an AI-specific study structure are not applicable to the information provided. Instead, "acceptance criteria" here refers to the demonstrated performance aspects that allow the device to be considered substantially equivalent and safe/effective for its intended use. The "study" refers to the non-clinical bench tests and the clinical evidence presented for the device.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a medical device clearance and not an AI/ML product, the "acceptance criteria" are derived from the demonstrated functionalities and safety profiles required for its intended use and comparison to the predicate device.

2. Sample Size and Data Provenance for the Test Set (Clinical Evidence)

• Sample Size for Clinical Evidence:
  • Total patients followed: 3,159
  • Patients using PICO device: 917
  • PICO patients with wound depths > 2 cm: 409 (comprising 233 DFUs, 18 PUs, 147 dehisced surgical wounds, and 11 VLUs).
  • Patients discontinuing PICO: 32 out of 917 (2.8%).
• Data Provenance: Retrospective, from two community care access centers.
• Country of Origin: Not explicitly stated but "community care access centers" suggests a real-world setting. Assuming within the country where the company operates or where the study was managed, which might be the UK (Smith & Nephew Medical Limited is in Hull, UK) or another location.

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

The clinical evidence provided appears to be an observational study of patient outcomes rather than a ground truth establishment by experts for a specific test set in the context of an AI device.

• Number of Experts: Not specified. The study involved patient care in community care access centers, suggesting healthcare professionals (e.g., nurses, doctors) were involved in patient admission, care, and data recording including wound depth and healing.
• Qualifications of Experts: Not specified, but implied to be healthcare professionals involved in wound care. Clinicians decided if exudate rate increased beyond indicated levels.

4. Adjudication Method for the Test Set

Not applicable. The clinical study was an observational study of patient outcomes, not an evaluation where expert adjudication of individual cases was performed to establish a definitive ground truth for device performance.

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

No, an MRMC comparative effectiveness study was not done. The device is a physical therapy system, not an imaging or diagnostic AI tool that would typically involve human readers interpreting cases with and without AI assistance. The clinical evidence compared patient outcomes with PICO vs. non-PICO treatment.

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

Yes, in a sense, the functionality of the device itself (the PICO 14 system delivering negative pressure) was evaluated in "standalone" bench tests, demonstrating its mechanical and software performance over 14 days and for deep wounds. This is not "algorithm only" in the AI sense, but rather the device's inherent function.

7. The Type of Ground Truth Used (Clinical Evidence)

The "ground truth" for the clinical evidence was based on patient outcomes data (time to healing, number and duration of dressing changes, and adverse events) and clinically observed wound parameters (wound depth, exudate levels, and clinicians' decisions).

8. Sample Size for the Training Set

Not applicable. The PICO 14 is an electro-mechanical device. There is no mention of an AI/ML algorithm that requires a "training set" in the context of machine learning. The "training" for the device's development would be engineering and design iterations.

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

Not applicable, as there is no AI/ML component or "training set" described for this medical device in the provided text.

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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.

Ask a specific question about this device

PICO 7Y is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) as it may promote wound healing via removal of low to moderate levels of exudate and infectious materials. Appropriate wound types include:

• Chronic
• Acute
• Traumatic
• Subacute and dehisced wounds
• Partial-thickness burns
• Ulcers (such as diabetic or pressure)
• Flaps and grafts
• Closed Surgical incisions
  PICO Systems are suitable for use both in a hospital and homecare setting.

PICO 7Y Single Use Negative Pressure Wound Therapy System is a small, lightweight, portable, electro-mechanical pump system connected through a Yshaped tube known as the "Y-Connector" to two super-absorbent, gentle adhesive dressings. Secondary fixation strips are also provided to ensure an adequate seal is achieved. The pump, the dressings and fixation strips are supplied sterile and for single use. PICO 7Y was designed to deliver negative pressure wound therapy to low and moderate exudate levels of acute and chronic wound types. PICO 7Y Single Use Negative Pressure Wound Therapy System is suitable for use in both a hospital and homecare setting.

The provided text describes the PICO 7Y Single Use Negative Pressure Wound Therapy System, focusing on performance testing and regulatory clearance. It is important to note that this device is a physical medical device (a powered suction pump) and not an AI device or software. Therefore, the typical acceptance criteria and study designs associated with AI/software devices (e.g., MRMC studies, expert consensus on image interpretation, training/test set ground truth establishment for algorithms) are not applicable here.

However, I can extract the acceptance criteria and study details relevant to this physical medical device based on the information provided in the K182323 submission.

Acceptance Criteria and Device Performance for PICO 7Y Single Use Negative Pressure Wound Therapy System

Given that this is a physical medical device (a Negative Pressure Wound Therapy system) and not an AI or software product, the acceptance criteria and study focus on mechanical and performance-based metrics, rather than diagnostic accuracy or human reader improvement with AI assistance.

1. Table of Acceptance Criteria and Reported Device Performance

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