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Algoplaque Film Extra Thin Hydrocolloid Dressing is a topical wound dressing that is intended for the local management of superficial, dry to lightly-exudating wounds, including pressure sores, dermal ulcers, post-operative wounds or suture sites, and abrasions and lacerations.

Algoplaque Film Extra Thin Hydrocolloid Dressings are also suitable for use as protective skin coverings.

Algoplaque Film Extra Thin Hydrocolloid Dressings are not intended for use on third degree burns.

ALGOPLAQUE FILM is a flexible, semiocclusive, topical wound dressing that consists of a polyurethane backing sheet and a hydrocolloid layer. The hydrocolloid layer interacts with wound exudate - liquifying into a soft gel. This gel enables the dressing to be removed with minimal trauma to the underlying tissues.

The provided text describes a 510(k) summary for a medical device called "ALGOPLAQUE FILM Extra Thin Hydrocolloid Dressing." This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

The 510(k) summary does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way one might expect for a novel AI/software medical device. Instead, it focuses on demonstrating safety, effectiveness, and substantial equivalence to existing hydrocolloid dressings already on the market.

Therefore, many of the requested sections about specific types of studies (MRMC, standalone algorithm performance, training/test set details, expert ground truth) are not applicable to this type of traditional medical device submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide specific quantitative acceptance criteria or detailed performance metrics as you would see for a diagnostic device. Instead, the "acceptance criteria" are implied by compliance with safety tests and equivalence to predicate devices.

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

• Sample Size: Not explicitly stated for specific in-vivo animal tests (e.g., number of mice, rabbits, guinea pigs).
• Data Provenance: The studies are described as "in vitro tests and animal safety studies." Given the submitter (Laboratoires URGO) is in France, it's reasonable to infer these studies were conducted by or for them, likely in Europe, though specific country details are not provided. The studies are retrospective in the sense that they were completed before submission.

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

• Not applicable. For these types of safety tests (cytotoxicity, hemolysis, irritation, sensitization), the "ground truth" is established by standard biological assays and the observed physiological responses in animal models, not by human expert consensus or interpretation of complex medical images.

4. Adjudication Method for the Test Set:

• Not applicable. The safety tests described involve objective measurements and observations in laboratory and animal settings, not a review of cases by multiple human readers requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

• No, an MRMC study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. This device is a wound dressing.

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

• No, a standalone algorithm performance study was not done. This device is a physical wound dressing and does not involve AI algorithms.

7. The Type of Ground Truth Used:

• For the safety studies, the ground truth was based on:
  • Biological assay results: Compliance with USP standards for cytotoxicity, non-hemolytic status.
  • In-vivo physiological responses: Observation of lack of primary irritation, corrosivity, systemic toxicity, and sensitization in animal models (mice, rabbits, guinea pigs).

8. The Sample Size for the Training Set:

• Not applicable. There is no "training set" in the context of this device. It is not an AI/ML algorithm that learns from data. Its performance is based on its physical and chemical properties and biological interactions, as demonstrated by the safety tests.

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

• Not applicable. As there is no training set for an AI/ML algorithm, no ground truth needed to be established in this manner.

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