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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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