(89 days)
For the management of, and temporary relief of pain associated with, all types of mouth sores, ulcers of the oral mucosa including canker sores, aphthous ulcers, and injuries such as traumatic ulcers caused by braces and ill-fitting dentures.
OraMagic™ Plus Oral Wound Rinse is a wound dressing containing 10% w/w benzocaine as a topical anesthetic intended for use in the local management of painful oral mucositis/stomatitis. The device is supplied non-sterile in plastic bottles containing 7.1 g or 25g of dry powder for reconstitution with water prior to use.
The provided text is a 510(k) summary for the OraMagic™ Plus Oral Wound Rinse, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with acceptance criteria for a new, novel technology. Therefore, much of the requested information regarding acceptance criteria and performance studies is not typically present in a 510(k) summary for a device like this.
Here’s an analysis of the provided text in relation to your questions:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety | "OraMagic™ Plus Oral Wound Rinse is similar in composition, function and intended use to MPM Medical's OraMagicRx™ Oral Wound Rinse and other legally marketed hydrogel wound dressing products." "the addition of 10% benzocaine to the original formulation does not raise any new biocompatibility issues," as the safety of topical benzocaine (up to 20%) is "well established through a long history of over-the-counter use." |
| Effectiveness | "OraMagic™ Plus Oral Wound Rinse is similar in composition, function and intended use to MPM Medical's OraMagicRx™ Oral Wound Rinse and other legally marketed hydrogel wound dressing products." "MPM Medical, Inc. concluded that OraMagic™Plus Oral Wound Rinse is safe and effective for its intended use and performs as least as well as legally marketed predicate devices, such as MPM Medical's OraMagicRx™ Oral Wound Rinse." |
Explanation: The acceptance criteria for this 510(k) revolve around establishing substantial equivalence to a predicate device (OraMagicRx™ Oral Wound Rinse) in terms of safety and effectiveness. The reported performance is an assertion that the new device is "similar" and "performs at least as well as" the predicate, based on its composition, function, intended use, and the known safety profile of its ingredients. No specific numerical thresholds or performance metrics are provided in the document for these criteria, beyond the general statement of equivalence.
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 510(k) summary. The submission relies on a comparison to a predicate device and the known safety of its ingredients, rather than a new clinical study with a test set of patients.
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 provided as there was no explicit clinical study with a test set requiring expert ground truth establishment mentioned in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as there was no explicit clinical study with a test set mentioned in the document.
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
An MRMC comparative effectiveness study was not conducted. This device is a topical rinse, not an AI or imaging device that would typically involve human readers.
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 topical rinse and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not explicitly stated as a ground truth for a new study. The "ground truth" for the device's efficacy is implicitly derived from the established safety and efficacy of its predicate device and the long history of safe use of its active ingredient (benzocaine).
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 device is not an AI or machine learning product.
9. How the ground truth for the training set was established
This information is not applicable/not provided for the same reason as point 8.
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