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The PREVENT™ Kit is intended to be used as an alternative to foam and other negative pressure wound therapy dressings when used in conjunction with the CCT1 and CCT Mini Negative Pressure Wound Drainage Pumps (K082311) for the application of negative pressure wound therapy to the wound. When used in conjunction with the CCT1 or CCT Mini Negative Pressure Wound Drainage Pumps, the PREVENT™ Kit is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of excess exudate, infectious material and tissue debris.

The PREVENT™ Kit is appropriate for use on the following wounds:

• Pressure Ulcers
• Diabetic/Neuropathic Ulcers
• Venous Insufficiency Ulcers
• Traumatic Wounds
• Post-Operative and Dehisced Surgical Wounds
• Skin Flaps and Grafts

The system is for prescription use only.

The PREVENT™ Kits are composed of sterile, single-use, disposable components that are designed to be used with a pump to deliver NPWT to a wound surface as part of a negative pressure wound therapy (NPWT) system.
The dressing kit includes 1) a thermoplastic elastomer (TPE) dressing (Prevent™ barrier) used to contact the wound bed and allow the application of NPWT to the wound and to provide flow pathways for the removal of exudate, 2) occlusive drape(s) to create a seal around the wound, and 3) a dome assembly with drainage tubing that is connected to the suction tubing of the disposable canister of the negative pressure pump to create a closed system.
The negative pressure pump creates a vacuum that provides the suction needed to remove wound exudate from the wound surface to the collection canister.
The wound contact layer is provided in a single size and thickness, so the kits are provided in a single size.

This FDA 510(k) summary describes the PREVENT™ Kit, a negative pressure wound therapy (NPWT) dressing. The primary focus of the provided text is on demonstrating substantial equivalence to a predicate device, rather than providing a detailed report of a diagnostic study for an AI/ML powered device. As such, information regarding AI/ML specific aspects like acceptance criteria for algorithmic performance, independent test sets, expert ground truth establishment, MRMC studies, or training set details for AI are not present in this document.

The document discusses various performance and safety tests for the PREVENT™ Kit, which is a physical medical device, not an AI/ML algorithm.

Here's an attempt to answer the questions based on the provided text, highlighting what is not applicable or not provided for an AI/ML context:

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

The document states acceptance criteria were "pre-determined" and that the device "met the pre-determined acceptance criteria" for various tests. However, it does not provide specific numerical acceptance criteria for most tests, nor does it provide the exact numerical performance results beyond general statements of success.

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

• Bench Testing: Sample sizes are not explicitly stated for individual bench tests.
• Shelf-Life: Not specified.
• Biocompatibility Testing: Not specified.
• GLP Animal Testing: Sample size is not explicitly stated. The study involved swine.
• Usability Testing: 15 participants. Data provenance is implied to be from a controlled, prospective validation study conducted to ISO/IEC 62366-1:2015 standards.

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

This is not applicable as the document describes a physical medical device approval, not an AI/ML diagnostic algorithm. The "ground truth" equivalent here would be the physical and biological test results, which are objectively measured/observed, not established by expert consensus. For usability testing, the "truth" is the observed performance of the participants.

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

This is not applicable as there is no diagnostic image interpretation or similar expert-driven assessment described.

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. This document details the clearance of a negative pressure wound therapy kit, not an AI-powered diagnostic device.

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

This is not applicable, as it is not an algorithm. The device's performance is inherently "standalone" in mechanical/biological terms (e.g., flow rate, seal integrity, biocompatibility, wound healing in animals).

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

• Bench Testing: Mechanical measurements, physical properties, alarm function validation.
• Shelf-Life: Stability data (e.g., material degradation, sterility maintenance).
• Biocompatibility Testing: Lab results from standardized tests (e.g., cytotoxicity assays, irritation tests, analytical chemistry for residuals, LAL test for endotoxins).
• GLP Animal Testing: Direct observation of animal health, gross and histological evaluation of wound healing and tissue response (e.g., pathology findings). This is a form of outcomes data in a controlled animal model.
• Usability Testing: Observed user performance against pre-defined task success criteria and identification of use errors.

8. The sample size for the training set

This is not applicable as this is not an AI/ML device.

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

This is not applicable as this is not an AI/ML device.

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The Theia NPWT Foam Wound Dressing Kit is intended to be used in conjunction with the CCT Mini or CCT1 Negative Pressure Wound Drainage Pumps for the application of negative pressure wound therapy to the wound. When used in conjunction with the CCT Mini or CCT1 Negative Pressure Wound Drainage Pumps, the Theia NPWT Foam Wound Dressing Kit is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of excess exudates, infectious material and tissue debris.

The Theia NPWT Foam Wound Dressing Kit is appropriate for use on the following wounds:

• Pressure Ulcers
• · Diabetic/Neuropathic Ulcers
• · Venous Insufficiency Ulcers
• · Traumatic Wounds
• · Post-Operative and Dehisced Surgical Wounds
• · Skin Flap and Grafts

The Theia NPWT Foam Wound Dressing Kits are sterile, single use, disposable dressings for use with the CCT Mini or CCT1 Negative Pressure Wound Drainage pumps for the application of negative pressure wound therapy (NPWT) to the wound. The kits include a foam dressing made of black reticular polyether based polyurethane hydrophobic foam material, occlusive drape(s), and a dome assembly consisting of a single lumen dome, dome skirt, and drainage tubing with clamp and female luer lock connector. The foam dressing covers the wound and the transparent occlusive drape covers the foam dressing and creates a seal around the wound. The drainage tubing connects to the exudate canister of the negative pressure pump. The powered negative pressure pump delivers negative pressure to the dressing to suction wound exudate into the exudate canister of the pump. The dressing kits are available in three sizes (small, medium, large) based on foam dressing size (length x width) and in two foam dressing thicknesses (1.5 and 3.0 cm), for a total of six dressing kits.

The provided text describes a 510(k) premarket notification for a medical device called "Theia NPWT Foam Wound Dressing Kit." This notification aims to demonstrate the device's substantial equivalence to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The core of the submission is to demonstrate substantial equivalence to a predicate device. This means showing that the new device is as safe and effective as a legally marketed device that does not require premarket approval. The acceptance criteria are implicitly met by comparing the subject device's features and performance to those of the predicate device and demonstrating that any differences do not raise new questions of safety or effectiveness.

The document directly compares the subject device (K211277) to its predicate (K161570) in Table 1: Subject vs. Predicate Theia NPWT Foam Wound Dressing Kit Comparison (pages 5-6).

Here's a summary of the key comparison points relevant to "acceptance criteria" for substantial equivalence:

Note: The primary differences are the foam thickness and the specified compatible NPWT pumps. The manufacturer's rationale for substantial equivalence (page 7) states: "The subject and predicate Theia NPWT Foam Wound Dressing Kits have the same Intended Use. The technological characteristics comparison and results of the verification testing provide evidence that the subject Theia NPWT Foam Wound Dressing Kits are substantially equivalent to the predicate Theia NPWT Foam Wound Dressing Kits (K161570), and the performance of these dressing kits when used in conjunction with CCT pumps (K082311) is substantially equivalent to the performance of the predicate dressing kits used in conjunction with SIMEX pumps (K113291)." This implies that despite the differences in foam thickness and compatible pump, the performance in terms of suction and fluid removal is deemed equivalent.

Study Information

The document describes the performance data provided to support the substantial equivalence claim.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated as a number of specific "samples" or "cases" for what one might typically refer to as a clinical "test set" in an AI context. The testing described is bench testing, which likely involves multiple repetitions or configurations, but a specific "sample size" is not provided in numerical terms.
   • Data Provenance: The studies are bench performance testing. This means the data was generated in a lab setting, not from human or animal subjects. Therefore, there is no country of origin for clinical data. The studies are not retrospective or prospective in the clinical sense, as they are non-clinical bench tests.

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

   • Not applicable. The "ground truth" here is based on engineering specifications and physical measurements in a bench test environment (e.g., demonstrating uniform pressure delivery, effective fluid removal). There is no mention of human experts establishing a "ground truth" in the way one would for diagnostic imaging.

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

   • Not applicable. This concept typically applies to clinical studies where experts review cases for ground truth establishment. For bench testing, results are typically determined by measurement against predefined engineering or performance criteria.

4. 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 passive foam wound dressing kit used in conjunction with a negative pressure pump, and is not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is not relevant or reported.

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

   • Yes, in the context of bench testing. The "Bench Performance Testing" evaluates the device's physical performance (e.g., fluid removal, pressure maintenance) in a controlled, simulated environment, without direct human intervention as part of the performance measurement. The "algorithm" here is the physical design and function of the device.

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

   • Engineering specifications and physical measurements. For example, the "ground truth" for "effectively removing wound fluids" would be a measurable volume of fluid removed over time, and for "pressure is delivered uniformly," it would involve pressure mapping and measurement against specified pressure ranges.

7. The sample size for the training set:

   • Not applicable. This device does not involve an AI algorithm that requires a "training set" in the computational learning sense. The design and manufacturing processes are likely informed by engineering principles and possibly prior iterations, but not a data training set for an AI model.

8. How the ground truth for the training set was established:

   • Not applicable. As there is no AI algorithm training set, there is no ground truth establishment for it.

In summary:

The submission focuses on demonstrating substantial equivalence through a comparison of technological characteristics and bench performance testing. No clinical studies, animal studies, or AI-related performance studies (such as MRMC or standalone AI performance) were conducted or are relevant for this type of medical device as presented in this document. The "acceptance criteria" are implicitly met by showing the subject device's equivalence to the predicate in terms of intended use, indications for use, and physical performance under simulated conditions, despite minor differences in foam thickness and compatible pumps.

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TheraBond Antimicrobial Barrier Systems are indicated for use in light to moderately exuding partial and full thickness wounds including traumatic wounds, surgical wounds, donor sites, 1st and 2nd degree burns, as well as decubitus ulcers, diabetic ulcers and vascular ulcers. TheraBond may be used over debrided and partial thickness wounds.

The TheraBond Antimicrobial Barrier Systems consist of a knitted, flexible, silver-plated nylon-based fabric. The device is available in several sizes and configurations including wound contact dressings, island dressings and wraps.

The provided text describes a 510(k) premarket notification for the TheraBond Antimicrobial Barrier System, a wound dressing. This is a medical device submission, not an AI/ML device, therefore, much of the requested information (like sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance) is not applicable or not detailed in this type of submission.

However, I can extract the acceptance criteria and the general nature of the studies performed.

Here's the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This is a physical medical device (wound dressing), not a software/AI device that uses test sets for algorithmic evaluation. The "tests" here refer to laboratory and bench testing of the physical properties and biological interactions of the device.

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

• Not Applicable. Ground truth, in the context of AI/ML, refers to annotated data. For this device, "ground truth" would be established by standardized laboratory methods and measurements against pre-defined specifications. The "experts" would be the scientists and technicians conducting the tests according to established protocols.

4. Adjudication method for the test set

• Not Applicable. Adjudication methods are typically for evaluating subjective interpretations, such as image analysis. For objective laboratory tests, results are typically compared directly against pre-defined specifications. Any discrepancies would involve re-testing or investigation into methodology, not expert adjudication in the AI/ML sense.

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/ML diagnostic or assistive device. MRMC studies are not relevant.

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

• Not Applicable. This is a physical medical device. There is no "algorithm only" performance to evaluate.

7. The type of ground truth used

• For antimicrobial effectiveness, silver ion release, and silver plating integrity: Standardized laboratory measurements and assays against pre-defined specifications.
• For biocompatibility: Results from standard biocompatibility tests (e.g., cytotoxicity, sensitization, irritation) in accordance with ISO 10993, compared against acceptable limits.

8. The sample size for the training set

• Not Applicable. This is a physical medical device. There is no "training set" in the AI/ML sense.

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

• Not Applicable.

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