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.

Device Description

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.

AI/ML Overview

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 < 0.01 in both trials compared to control.
Safety: No cytotoxic effect on human cells, no irritation or hypersensitivity in animal models.	In vitro: No cytotoxic effect on human cells. Animal Biocompatibility: No irritation or hypersensitivity in animals tested.
Biocompatibility: Confirmation of safety and biocompatibility.	Confirmed by both in vitro and animal biocompatibility studies.

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.

Summary

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510(k) Summary (amended)

The Ulceloocin™ Oral Ulcer Patch

The following represents the summary for premarket notification of the Ulceloocin™ Oral Ulcer Patch, a product to be marketed by Sunshine International Group, Inc., located at 1333 Broadway, Suite 1222, New York, NY 10018, (212)268-7771.

CONTACT PERSON:

Liping He Vice President (212) 268-7771

DATE OF SUMMRY:

February 24, 2007

DEVICE NAME:

Proprietary Name: Ulceloocin™ Oral Ulcer Patch

Oral Wound Dressing Common Name:

Unclassified. Classification Name:

The SaliCept™ Oral Patch K012126 (Carrington PREDICATE DEVICE: Laboratories, Inc.)

DEVICE DESCRIPTION:

INTENDED USE:

CLAIMS:

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Ulceloocin™ Oral Ulcer Patch relieves pain by adhering to and protecting affected tissues from further irritation. It is safe if swallowed.

TECHNOLOGICAL CHARACTERISTICS:

Ulceloocin™ Ora! Ulcer Patch is a vacuum-dried hydrogel that adheres to oral mucosa. It is slowly reverts to a soft and gel-type thin sheet in the oral environment while it adheres to and protects affected tissue as a physical barrier to reduce irritation and pain.

NON-CLINICAL DATA:

In vitro study was conducted for cytotoxicity test of Ulceloocin™ Oral Ulcer Patch. Animal biocompatibility studies were conducted for skin irritation test and hypersensitivity test of Ulceloocin™ Oral Ulcer Patch. The studies indicated that Ulceloocin™ Oral Ulcer Patch does not have cytotoxic effect on human cells, and does not cause any irritation or hypersensitivity to the animals tested. The safety and biocompatibiltiy Ulceloocin™ Oral Ulcer Patch are confirmed by both in vitro and animal biocompatibility studies.

CLINICAL DATA:

Multi-centered clinical trials of Ulceloocin™ Oral Ulcer Patch were conducted in two hospitals as Trial 1 and Trial 2 on a total of 95 patients with oral mucosal ulcers according to the current good clinical practice procedures and IRB approval. Forty-five patients were studied in Trial 1 and fifty patients were studied in Trial 2. In these two trials, a total of fifty patients were treated with Ulceloocin™ Oral Ulcer Patch four times a day, before the meals and bedtime, as the study group; and a total of forty-five patients with the same lesions were not treated as the control group.

Effect on pain relief was mainly determined by measuring the pain index at the time of eating food during the time course of trial. Patients in both study and control groups had a starting pain index of 7.33 - 7.37 (Trial 1) and 7.30 - 7.40 (Trial 2) at the time of being enrolled into the study. At the 4th day of study, study group showed a significant reduction to 2.26 ± 2.20 (Trial 1) and 2.24 ± 2.40 (Trial 2) compared to a pain index of 5.31 ± 2.42 (Trial 1) and 6.10±2.33 (Trial 2) in control group. At 7th day, study group showed a pain index of 0.20 ± 0.72 (Trial 1) and 0.80 ± 1.80 (Trial 2) compared to a pain index of 1.53 ± 1.72 (Trial 1) and 2.31 ± 1.82 (Trial 2) in control group. Ulceloocin™ Oral Ulcer Patch demonstrated a significant effect on reducing the pain caused by oral mucosal ulcers (P < 0.01) in both trials.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services, USA. The seal features a stylized eagle with outstretched wings, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 7 2007

Mr. Liping He Vice President Sunshine International Group, Incorporated 1333 Broadway, Suite 1222 New York, New York 10018

Re: K070842

Trade/Device Name: Ulceloocin™ Oral Ulcer Patch Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: MGQ Dated: May 16, 2007 Received: May 22, 2007

Dear Mr. Fisher:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Ameralso outs, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. He

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Clare

Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K070842

Statement of Indication for Use

510(k) Number (if known):

Device Name: Ulceloocin™ Oral Ulcer Patch

Indications for Use:

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 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.

Prescription Use

Over-The-Counter-Use X

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Roeser

sion Sign-Off)
Division of Anesthesiology, General Hospital,
ision Central, Dental Devices

Field Number: K670842

Regulation Number and Section

N/A