(16 days)
CARAPASTE® Oral Wound Dressing forms a protective layer over the oral mucosa by adhering to the mucosal surface which allows it to protect against further irritation and relieve pain. The paste may be used in the management of mouth lesions of all types including aphthous ulcer, stomatitis, mucositis, minor lesions, chafing and traumatic ulcers, abrasions caused by braces and ill fitting dentures, and lessions associated with oral surgery.
CARAPASTE ® Oral Wound Dressing, Sucralfate HCl Topical Paste, is an amorphous hydrogel paste formed by the controlled reaction of sucralfate with a limited quantity of hydrochloric acid. The amorphous hydrogel paste formed by this reaction binds reversibly to wounds and is intended to form a protective film that covers lesions where gastric acid or local wound bed acidity is not available or is inconsistently present. CARAPASTE ® Oral Wound Dressing may be administered directly to an accessible oral wound to provide an adherent physical covering of the wound bed. Although prepared by reaction of sucralfate with strong acid, the polymerized sucralfate self-buffers to a pH of approximately 3.5.
The provided document is a 510(k) summary for the CARAPASTE® Oral Wound Dressing, K082856. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring the submission of new clinical or performance data to establish safety and effectiveness.
Therefore, the document does not contain information regarding a study that proves the device meets specific acceptance criteria based on its own performance. Instead, it asserts substantial equivalence based on technological characteristics and intended use.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the 510(k) summary. For a 510(k) submission, the "acceptance criteria" are generally that the new device has substantially equivalent technological characteristics and intended use to a predicate device, and does not raise new questions of safety or effectiveness. Direct performance metrics are typically not required unless there are significant technological differences or new indications for use.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified directly in the document, as this is a 510(k) submission based on substantial equivalence. The primary "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, safety, and effectiveness. | CARAPASTE® Oral Wound Dressing forms a protective layer over the oral mucosa, adheres to the mucosal surface, and relieves pain and promotes wound healing of mouth lesions. (This is a description of its mechanism and intended effects, not quantitative performance data against specific criteria.) |
2. Sample size used for the test set and the data provenance
This information is not applicable/not provided as this 510(k) submission does not include primary clinical studies with a test set. The submission relies on demonstrating substantial equivalence to a predicate device (Sucralfate HCl Topical Paste K043587) rather than presenting new performance data from a specific test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable/not provided. There is no mention of a test set with ground truth established by experts in this 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. There is no mention of a test set requiring adjudication in this 510(k) summary.
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/not provided. The device is an oral wound dressing and does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable/not provided. The device is a physical wound dressing and does not involve algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/not provided. The 510(k) summary does not describe a study that established a "ground truth" for the device's performance, as it relies on substantial equivalence.
8. The sample size for the training set
This information is not applicable/not provided. There is no mention of a training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This information is not applicable/not provided. There is no mention of a training set or ground truth establishment in this 510(k) summary.
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