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Sterile, single-use dressings for management of pressure ulcers, 1st and 2nd degree bums, skin tears, abrasions, or irritated skin and surgical incisions and graft donor sites.

The AbsoClear product family is a series of single-use, sterile transparent synthetic wound dressings made of absorbent acrylic polymers. The dressings maintain a moist wound environment, which has been shown to be conducive to wound healing, but that also can also absorb wound exudate. Full transparency allows monitoring wound healing stages without removal of the dressing. The sterile dressings are supplied singly in sealed trilaminate pouches and are sterilized by gamma irradiation.

The provided text describes the AbsoClear® wound dressing. The acceptance criteria and the study that proves the device meets the acceptance criteria are outlined as follows:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a "test set" in the context of clinical data for the AbsoClear device. Instead, the performance evaluations are based on:

• Bench Testing: Performed on "each lot" of AbsoClear product. The exact sample size per lot is not specified.
• Sterilization Validation: No specific sample size for a "test set" is mentioned, rather the process was validated per ISO 11137.
• Shelf-life Testing: No specific sample size for a "test set" is mentioned. Testing was done on product and packaging after specific storage conditions.
• Biocompatibility Testing: No specific sample size of devices is mentioned, but tests were performed on "the finished packaged, sterilized product."

The data provenance is not described as being from a specific country or retrospective/prospective in a clinical sense, as the studies are primarily lab-based (bench, sterilization, shelf-life, biocompatibility).

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

Not applicable. The studies described are not clinical studies that would involve experts establishing ground truth for a test set. The acceptance criteria are based on pre-defined technical specifications and international standards (e.g., ISO 11137, ISO 10993).

4. Adjudication Method for the Test Set

Not applicable. There is no clinical test set described that would require an adjudication method.

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 done. The document explicitly states: "Additional clinical testing was not required."

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

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

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by:

• Technical Specifications: Pre-defined performance parameters for the wound dressing (e.g., absorption capacity, seal strength, MVTR).
• International Standards: Compliance with standards such as ISO 11137 for sterilization and ISO 10993 for biocompatibility. These standards define the methods and acceptance limits for various tests.
• Comparison to Predicate Device: The claim of substantial equivalence is based on the new device having "similar technological characteristics and materials as a previously cleared device." This implies the predicate device's established safety and effectiveness serve as the benchmark.

8. The Sample Size for the Training Set

Not applicable. The device is a physical wound dressing and does not involve a training set as would be found in machine learning algorithms.

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

Not applicable. As there is no training set for an algorithm, there is no ground truth to be established for it.

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EpiVIEW Thin Film Dressing is indicated as a securement device and dressing for peripheral and central IV catheters. It may be used as a wound dressing on minor abrasions, superficial pressure ulcers, over eschar to facilitate debridement, skin graft donor sites, closed clean surgical wounds and first and second degree burns. EpiVIEW may also be used to prevent skin breakdown from chafing or from exposure to continuous moisture and friction .

EpiVIEW Thin Film Dressing is similar in construction and design to Tegaderm; both dressings consist of a thin polyurethane film coated with an acrylic adhesive wound contact layer.

EpiVIEW™ Thin Film Dressing

The provided text describes a 510(k) Premarket Notification for the EpiVIEW Thin Film Dressing. This notification aims to demonstrate substantial equivalence to a predicate device, 3M's Tegaderm Transparent Dressing (K811291). The acceptance criteria and the study proving the device meets these criteria are primarily based on comparative performance to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not explicitly state the sample sizes used for the various tests (peel adhesion, MVTR, elasticity, COF, and biocompatibility). It only mentions that "both dressings have been tested."

The data provenance is not specified. It is likely retrospective as these are laboratory tests performed on fabricated samples of the dressings, not clinical data from patients.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This type of device ($510(k)$ for a thin film dressing) and the tests described (physical and biocompatibility) do not typically involve "experts" in the sense of clinical specialists establishing a "ground truth" for a test set. The ground truth for these tests is established by standardized laboratory methods and measurements.

For biocompatibility testing, the "ground truth" would be the scientific interpretation of the ISO 10993 results by experts in toxicology and material science, but the number and qualifications of these individuals are not specified here. The FDA guidance for biocompatibility (ISO 10993 Part I "Biological Evaluation of Medical Devices" with FDA modified matrix) is the standard followed.

4. Adjudication Method

An adjudication method is not applicable to the types of tests described (peel adhesion, MVTR, elasticity, COF, biocompatibility). These are objective laboratory measurements, not subjective evaluations requiring expert consensus.

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 done. This type of study is relevant for diagnostic imaging or screening devices where human readers interpret results, and the AI's impact on their performance is assessed. This is not applicable to a thin film dressing.

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

No, a standalone "algorithm only" performance study was not done. This is also not applicable to a physical medical device like a thin film dressing. The "performance" here refers to the physical and biological characteristics of the dressing itself.

7. The Type of Ground Truth Used

The ground truth used for the performance evaluations is based on:

• Standardized Laboratory Measurements: For peel adhesion, MVTR, elasticity, and COF, the "ground truth" is the objective measurement obtained through established engineering and materials testing protocols.
• Biocompatibility Standards: For biocompatibility, the "ground truth" is determined by adherence to ISO 10993 Part I "Biological Evaluation of Medical Devices" with FDA modified matrix, and the results are interpreted against established criteria for non-toxicity, non-cytotoxicity, etc.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of this 510(k) for a physical medical device. Training sets are used in machine learning or AI algorithm development.

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

Not applicable. As there is no training set, there is no ground truth for it to be established.

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