(72 days)
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
| Acceptance Criteria (Inferred from study outcomes) | Reported Device Performance (Ulceloocin™ Oral Ulcer Patch) |
|---|---|
| Pain Relief: Significant reduction in pain index from baseline during eating compared to a control group within 7 days. | Trial 1: Pain index reduced from 7.33 to 0.20 (vs. 1.53 for control) by day 7. |
| Trial 2: Pain index reduced from 7.30 to 0.80 (vs. 2.31 for control) by day 7. | |
| Statistical Significance: P |
N/A