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Ulceloocin™ Oral Ulcer Patch is intended for use as an oral wound dressing to protect ulcer tissue by forming a physical barrier on the wound tissue to avoid further irritation and thus to relieve pain. It is indicated for use with all types of ulcers and small wounds of the oral mucosa including canker sores, aphthous ulcers, and injuries such as traumatic ulcers caused by self-biting, braces, and ill-fitting dentures.

Ulceloocin™ Oral Ulcer Patch is a vacuum-dried gel that contains hydrogel with calcium and phosphorus. It does not contain any biological additives or drugs. It is a round, white to off-white thin patch. Ulcelocin™ Oral Ulcer patch is packaged in blister cards of two patches per card, three blister cards per carton, for a total of 6 patches per carton. Each patch is approximately 1 cm in diameter and 0.3 mm thick.

Here's a breakdown of the acceptance criteria and the study that demonstrates the Ulceloocin™ Oral Ulcer Patch meets these criteria, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device. These summaries typically describe the studies done to demonstrate substantial equivalence to a predicate device, rather than strictly defining acceptance criteria and proving all aspects against them in the same way a new drug trial might. The "acceptance criteria" here are inferred from the demonstrated performance in the clinical trials, specifically regarding pain relief. There is no mention of a standalone AI algorithm, MRMC study, or detailed expert ground truth establishment in this context, as it's a physical medical device, not an AI diagnostic tool.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: A total of 95 patients across two multi-centered clinical trials.
  • Trial 1: 45 patients
  • Trial 2: 50 patients
  • Within these 95 patients: 50 patients were treated with the Ulceloocin™ Oral Ulcer Patch (study group), and 45 patients received no treatment (control group).
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the submission is to the U.S. FDA, suggesting the clinical trials were either conducted in the U.S. or followed international standards acceptable to the FDA.
  • Retrospective or Prospective: The studies were described as "Multi-centered clinical trials... conducted... according to the current good clinical practice procedures and IRB approval." This strongly indicates a prospective study design.

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

• Applicability: This section is not applicable as the device is a physical patch for wound dressing and pain relief, not an diagnostic algorithm requiring expert "ground truth" for interpretations of images or complex data.
• Ground Truth: The "ground truth" for the clinical efficacy was the patients' reported pain index and potentially clinical observation of ulcer healing (though pain relief was the primary metric reported in detail). The studies were conducted by medical professionals, implicitly implying their expertise in assessing patient conditions and administering the trials.

4. Adjudication Method for the Test Set

• Applicability: This section is not applicable for the reasons stated above. Pain index was self-reported or clinically assessed, not adjudicated by multiple experts in a consensus manner for diagnostic accuracy.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• Applicability: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, with and without AI assistance. The Ulceloocin™ patch is a treatment device, not a diagnostic one.

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

• Applicability: No, a standalone algorithm performance study was not done. This device is a physical product, not an algorithm or AI.

7. The Type of Ground Truth Used

• Clinical Efficacy (for pain relief): Patient-reported pain index at the time of eating food, measured quantitatively (likely on a standardized scale).
• Safety/Biocompatibility:
  • In vitro cytotoxicity tests: Laboratory findings.
  • Animal biocompatibility studies: Observation of irritation and hypersensitivity in animal models.

8. The Sample Size for the Training Set

• Applicability: Not applicable. The Ulceloocin™ Oral Ulcer Patch is a physical medical device, not an AI/ML algorithm that requires a "training set." The clinical trials described are for demonstrating efficacy and safety in human subjects, not for training a model.

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

• Applicability: Not applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it does not apply here.

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