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For Prescription Use Indication:
Under the supervision of a healthcare professional, Curasite is intended for the management of the following:

• Diabetic foot ulcers
• Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology)
• Pressure ulcers/sores (partial and full thickness)
• 1st and 2nd degree partial thickness burns

For Over-the-Counter Use Indication:
For Over-the-Counter (OTC) use, Curasite may be used for the management of:

• Minor abrasions
• Minor lacerations
• Minor cuts
• Minor scalds and minor burns

Not Found

The provided document (K161991) is a 510(k) "Substantial Equivalence" determination for the device "Curasite." This type of document primarily confirms that a new device is as safe and effective as existing legally marketed devices.

Critical Information Missing for an AI/ML Device Study Description:

The document DOES NOT describe a study for an AI/ML (Artificial Intelligence/Machine Learning) device. Instead, it seems to be for a medical product (likely a wound care product given the "Indications for Use"). Therefore, most of the requested fields regarding acceptance criteria, study performance, ground truth, and expert involvement for an AI/ML device are not applicable and cannot be extracted from this document.

Based on the provided document, here's what can be extracted:

• Device Name: Curasite
• Product Code: FRO (Note: This code, according to FDA, typically refers to "Wound dressing, hydrogel" or similar. It is not an AI/ML product code.)
• Indications for Use:
  • Prescription Use: Management of diabetic foot ulcers, leg ulcers (venous stasis ulcers, arterial ulcers, mixed etiology), pressure ulcers/sores (partial and full thickness), and 1st and 2nd degree partial thickness burns.
  • Over-the-Counter Use: Management of minor abrasions, minor lacerations, minor cuts, minor scalds, and minor burns.

Therefore, I cannot provide the requested information regarding AI/ML device acceptance criteria and study details because the document is not about an AI/ML device.

The questions you've asked (about acceptance criteria, sample size, ground truth, expert adjudication, MRMC studies, standalone performance, training sets, etc.) are highly relevant for the regulatory review of AI/ML-driven medical devices. However, this specific 510(k) clearance letter does not contain the data from such a study.

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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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