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PerioPatch is intended for the management of all types of oral wounds, injuries and ulcerations of the gingival and oral mucosa, including stomatitis, minor chaffing and traumatic ulcers, abrasions caused by braces and ill fitting dentures, and lesions associated with oral surgery. PerioPatch operates to relieve pain by adhering to and protecting affected tissues from further irritation, thereby allowing healing.

PerioPatch is a hydrogel wound dressing for use in the oral cavity. It is a hydrogel with an occlusive ethyl cellulose backing to support and help the hydrogel conform to the wound, thereby providing protection and coverage to the wound. The dressing is made entirely of GRAS natural ingredients, commonly used in ingested products, which absorb moisture and become a hydrogel. These materials adhere to the wound for up to 5-6 hours. The patch is self-adhesive after contact with moist tissue and provides an absorptive and flexible barrier over the affected area and as such protects the inflamed areas and lesions in the mouth from contact with the rest of the oral environment, thereby preventing irritation and painful aggravation of the affected area.

The provided 510(k) summary for the PerioPatch does not contain information regarding objective acceptance criteria or a study designed to demonstrate device performance against such criteria.

The document primarily focuses on establishing "substantial equivalence" to a predicate device, which is a common pathway for 510(k) clearances. Substantial equivalence is determined by comparing the new device to a legally marketed predicate device based on intended use, technological characteristics, and performance. In this case, the performance aspect is described in general terms, highlighting the similar hydrophilic characteristics and self-adhesive nature upon contact with moisture.

Therefore, I cannot extract the requested information as it is not present in the provided text.

Specifically, the following information is not available in the document:

• A table of acceptance criteria and the reported device performance: No specific performance metrics or thresholds are mentioned.
• Sample size used for the test set and the data provenance: There is no mention of a test set, clinical trial, or any quantitative testing.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not relevant in an application focused on substantial equivalence through comparison of characteristics rather than a new performance study.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no test set or clinical study is described.
• 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 concept is entirely irrelevant to a wound dressing device described here.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth is described as no performance study was conducted.
• The sample size for the training set: Not applicable as this is not an AI/ML device, and no training data for a model is mentioned.
• How the ground truth for the training set was established: Not applicable.

The conclusion states: "The evaluation of PerioPatch does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to its predicate device." This indicates that the regulatory decision was made based on the comparison of the device's characteristics and intended use to an existing, cleared device, rather than on new performance studies with objective acceptance criteria.

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PerioPatch is intended for the management of all types of oral wounds, injuries and ulcerations of the gingiva and oral mucosa, including stomatitis, minor chaffins and traumatic ulcers, abrasions caused by braces and ill fitting dentures, and lesions associated with oral surgery. PerioPatch operates to relieve pain by adharing to and protecting affected tissues from further irritation, thereby allowing healing.

Not Found

This is a 510(k) premarket notification and not a study on device performance. It focuses on regulatory approval rather than clinical study data and acceptance criteria for a medical device. Therefore, a table of acceptance criteria and device performance cannot be generated from the provided text.

Here's why and what's missing:

• Type of Document: This is a letter from the FDA regarding a 510(k) premarket notification. A 510(k) is a submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device (predicate device). It is not a clinical study report or a summary of a study's findings directly proving efficacy against acceptance criteria.
• Focus: The letter confirms that the FDA has reviewed the submission and determined that the device, PerioPatch, is "substantially equivalent" to predicate devices for its stated indications for use. It outlines regulatory requirements that the manufacturer must follow.
• Lack of Performance Data: The provided text does not contain any information about:
  • Specific acceptance criteria (e.g., pain reduction percentage, healing time)
  • Reported device performance metrics (e.g., actual pain reduction observed, healing rates)
  • Details of a study design (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods).
  • Any mention of MRMC comparative effectiveness studies or standalone algorithm performance.

Conclusion: The provided document does not contain the information required to populate the table or answer the questions related to acceptance criteria and a study proving device performance. This information would typically be found in a separate clinical study report or a detailed summary of a clinical trial that was submitted as part of the 510(k), but it is not present in this specific FDA letter.

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