(210 days)
Intra-oral Wound Dressing is intended for the management of all types of oral wounds, injuries and ulcerations of the gingival and oral mucosa, including stomatitis, minor chafing and traumatic ulcers, abrasions caused by braces and illfitting dentures, and lesions associated with oral surgery.
Intra-oral Wound Dressing operates to relieve pain by adhering to and protecting affected tissues from further irritation, thereby allowing healing.
Intra-oral Wound Dressing is a device comprised of an oral mucosa adhesive side and a protection side. The oral mucosa adhesive side is composed of a water soluble polymer that when exposed to moisture in the oral cavity changes into a gel state to achieve adhesion to the wound area. The protection side consists of a waterinsoluble polymer which covers the wound to protect the applicable area from the environment in the oral cavity. Intra-oral Wound Dressing is simply a non-sterile bandage to protect oral wounds.
This FDA 510(k) summary does not contain information about a clinical study with acceptance criteria and device performance. Instead, it describes a non-clinical evaluation of the "Ora-Aid Intra-oral Wound Dressing" (subject device) for substantial equivalence to a predicate device, "PerioPatch."
The document concludes that the subject device is substantially equivalent to the predicate device based on non-clinical safety and performance tests, not a clinical study demonstrating performance against acceptance criteria in human subjects.
Here's a breakdown of the requested information based on the provided text, highlighting what is not present as well:
1. A table of acceptance criteria and the reported device performance
This information is not available from the provided text for device performance against specific clinical acceptance criteria. The document focuses on demonstrating substantial equivalence through non-clinical testing against standards.
| Acceptance Criteria (Not Explicitly Stated for Clinical Performance) | Reported Device Performance (Non-Clinical) |
|---|---|
| Biocompatibility requirements | Met ISO 10993-5:2009 (Cytotoxicity), ISO 10993-10:2010 (Sensitization, Intracutaneous Reactivity Test), ISO 10993-11:2016 (Acute Systemic Toxicity Test, Material-Mediated Pyrogen Test) |
| Microbial limits | Met KP11th standard (same test method as USP 40NF35 and USP 40NF35 ); no growth observed. |
| Shelf-life stability | Met ASTM F 1980 (Accelerated Aging Test) |
| Absorbency (functional performance) | Met EN 13726-1:2002 |
| Adhesion time (functional performance) | Subject device: 4 hours; Predicate device: 30-45 minutes. (Subject device's longer adhesion time did not raise concerns regarding safety and effectiveness) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: This information is not specified as a clinical test set was not described. The non-clinical tests would have their own sample sizes (e.g., for biological materials, microbial samples, physical property tests), but these are not detailed in the summary.
- Data provenance: The submission is from TBM Corporation in Gwangju, Korea, and the consultant KMC, Inc. is in Seoul, Republic of Korea. The standards used for non-clinical testing are international (ISO, EN, ASTM) and US Pharmacopeia (USP).
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 is not applicable as there was no clinical study described that required expert-established ground truth. The evaluation was based on non-clinical laboratory testing against established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there was no clinical study described that required adjudication.
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 is not applicable. The device is an "Intra-oral Wound Dressing" and not an AI-powered diagnostic or assistive device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical wound dressing and not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable as no clinical ground truth was established for a performance study. The evaluation relied on adherence to international standards and pharmacopeia for non-clinical safety and performance.
8. The sample size for the training set
This is not applicable as this is a physical medical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
This is not applicable as this is a physical medical device, not an AI/ML algorithm requiring a training set or ground truth for training.
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