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TIELLE* Hydropolymer Dressing is an exudate handling system intended for low to moderately exuding wounds. The island dressing maintains a moist wound environment. A moist wound environment supports the wound healing process by encouraging autolytic debridement thus enabling granulation to proceed under optimum conditions. During use the absorbent island gently expands as it takes up exudate.

TIELLE* Hydropolymer Dressing is indicated for the management of chronic and acute, low to moderately exuding, partial and full thickness wounds including:

• Superficial wounds .
  • 1. Minor abrasions
  • 2. Skin Tears
  • Second Degree Burns 3.

TIELLE* Hydropolymer Dressing should be used under health care professional direction for the following indications:

• . Pressure ulcers
• . Lower extremity ulcers
  • 1. Venous
  • 2. Arterial
  • 3. Mixed etiology
• . Diabetic ulcers
• . Donor sites

TIELLE* Hydropolymer Dressing is suitable for use under compression bandaging.

TIELLE* Hydropolymer Dressing is an exudate handling system for low to moderately exuding wounds. The island dressing maintains a moist environment that supports the wound healing process and allows granulation to proceed under optimum conditions. During use the absorbent island gently expands as it takes up exudate. It allows the wound to remain moist which causes autolytic debridement to occur. This may initially increase lesion size, which is normal and to be expected prior to wound granulation.

The document provided is a 510(k) summary for a medical device called TIELLE* Hydropolymer Dressing. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical study data with detailed acceptance criteria and performance metrics typically found in a Premarket Approval (PMA) application or a de novo submission for novel devices.

Therefore, the document does not contain information about:

• A table of acceptance criteria and reported device performance related to a clinical study.
• Sample sizes used for a test set or its data provenance.
• Number of experts, their qualifications, or adjudication methods for ground truth.
• A multi-reader multi-case (MRMC) comparative effectiveness study.
• A standalone (algorithm-only) performance study.
• Specific details about the ground truth used (beyond general "biocompatibility" or "safety").
• Sample size for a training set.
• How ground truth for a training set was established.

Instead, the document focuses on biocompatibility testing to demonstrate the safety of the materials used in the device. The "acceptance criteria" here are implied by the "preclinical testing results" showing that the materials are "non-irritant," "non-sensitizer," "non-cytotoxic," and "non-hazardous."

Here's the information that can be extracted based on the provided text:

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

The document doesn't define explicit numerical acceptance criteria for performance in the context of a clinical study measuring efficacy on wound healing, but rather for safety (biocompatibility) of the materials. The "performance" column indicates the successful outcome of these safety tests.

2. Sample sizes used for the test set and the data provenance:

• Sample Sizes: Not explicitly stated numerically for each test, but standard animal models (Guinea-Pig, Rabbit, Rat, Mice, Cat) and in vitro tests (L929 mammalian cells, L5178Y TK+/- Mouse Lymphoma, Rabbit RBCs) were used. For the Human Repeat Insult Patch Test, the number of human subjects is not specified.
• Data Provenance: Preclinical (laboratory/animal) testing, including in vitro and in vivo studies. No country of origin is mentioned for the data itself, but the submission is to the FDA in the USA for a device manufactured by a division of an American company (Johnson & Johnson Medical, a Division of Ethicon Inc.). The studies are retrospective from the perspective of the 510(k) submission, meaning they were conducted prior to the submission.

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

• This information is not provided. Biocompatibility testing results are typically derived from standardized protocols and measurements, rather than expert consensus on a "ground truth" in the clinical sense.

4. Adjudication method for the test set:

• Not applicable as this is not a study requiring adjudication of clinical outcomes or interpretations.

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 a medical device for wound dressing, not an AI/imaging diagnostic device.

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

• No. This applies to AI/software devices.

7. The type of ground truth used:

• For biocompatibility tests, the "ground truth" is defined by the objective outcomes of the standardized tests (e.g., presence/absence of irritation, cytotoxicity, hemolysis, mutagenicity, and toxicity levels). These are typically quantitative or categorical assessments based on established biological responses.

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI device.

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

• Not applicable.

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