(281 days)
OraCure® 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.
OraCure® is an oral wound dressing comprising a mucous-adhesive side on a protection side, wherein the adhesive side has a strong adhesion when it is applied and hydrated on mucus. Adhesive side is water-soluble polymer that reacts with moisture (water and saliva) in the mouth within a short time and changes into a gel state. The protection side for protection of the mucous-adhesive side consists of water-insoluble polymer on the protection side is insoluble in the water and covers the wound to protect the applicable area from the environment (bacteria, saliva, food, etc.) in the mouth. OraCure® does not contain any biological additives or drugs with respect to wound treatment, but it is simple non-sterile bandage to protect ulcer tissue.
The provided text describes the OraCure® oral wound dressing and its substantial equivalence to a predicate device, Ulceloocin™ Oral Ulcer Patch. The document focuses on non-clinical data to support this claim, rather than a clinical study involving human patients. Therefore, information regarding acceptance criteria, device performance in terms of clinical outcomes, sample sizes for test and training sets, number of experts for ground truth, adjudication methods, or MRMC comparative effectiveness studies are not present.
However, the document does list the acceptance criteria in terms of safety and performance tests performed and indicates that the device meets these criteria through the successful completion of these tests.
Here's a summary of the available information:
1. Table of Acceptance Criteria and the Reported Device Performance
The device performance is reported as meeting the standards for each test listed. The document concludes that "the safety and performance test reports are supported to the safety and effectiveness of the subject device."
| Test Item | Standards Used | Reported Device Performance |
|---|---|---|
| Biocompatibility Tests | Passed, demonstrating no undue risks from biological hazards. | |
| Cytotoxicity | ISO 10993-5:2009 | Passed |
| Sensitization | ISO 10993-10:2010 | Passed |
| Intracutaneous Reactivity Test | ISO 10993-10:2010 | Passed |
| Acute Systemic Toxicity Test | ISO 10993-11:2016 | Passed |
| Material-Mediated Pyrogen Test | ISO 10993-11:2016 | Passed |
| Subacute/Subchronic Toxicity Test | ISO 10993-11:2016 | Passed |
| Genetoxicity | ISO 10993-3:2014 | Passed |
| Implantation | ISO 10993-6:2016 | Passed |
| Microbial Limit Test (MLT) | Passed, indicating acceptable levels of microorganisms in the non-sterile product. | |
| Microbial Limit Test | USP 40NF35 , , | Passed |
| Shelf-life Test | Passed, establishing the expiration date and stability of physical properties. | |
| Accelerated Aging Test | ASTM F 1980 | Passed |
| Performance Test | Demonstrated effectiveness of product performance. | |
| Absorbency | EN 13726-1:2002 | Passed |
| Moisture Vapour Transmission Rate | EN 13726-2:2002 | Passed |
| Conformability | EN 13726-4:2003 | Passed |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The study described is a series of laboratory-based non-clinical tests rather than a clinical trial with human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the document describes non-clinical laboratory testing, not a study requiring expert interpretation of results for ground truth establishment. The "ground truth" here would be defined by the Pass/Fail criteria of the respective international standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as there were no subjective assessments requiring adjudication described in the non-clinical tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. The document describes a medical device (wound dressing), not an AI-powered diagnostic or assistive technology. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical wound dressing, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests is based on the objective criteria and analytical methods defined by the international standards listed (e.g., ISO, USP, ASTM, EN standards). These standards outline specific methodologies and acceptance ranges for each test item.
8. The sample size for the training set
This information is not provided and is not applicable as the document refers to non-clinical testing of a physical medical device, not a machine learning model that would require a training set.
9. How the ground truth for the training set was established
This information is not applicable as no training set was used.
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