(86 days)
For the management of mucositis/stomatitis, all types of oral wounds (mouth sores and injuries), aphthous ulcers/canker sores, and traumatic ulcers caused by ill-fitting dentures or braces.
OraMagicRx™ Oral Wound Rinse is a wound dressing designed for the management of oral mucositis/stomatitis. The device is supplied in plastic bottles containing 7.1 g, 25 g or 37.5 g of dry powder for reconstitution with water prior to use.
The provided 510(k) summary for K024180 (OraMagicRx™ Oral Wound Rinse) does not contain the detailed information typically associated with acceptance criteria and studies for device performance as an AI/ML-driven device or diagnostic. This submission is for a medical device (oral wound rinse) and relies on substantial equivalence to a predicate device, rather than a performance study with specific acceptance criteria in the way a diagnostic or AI algorithm would.
Therefore, many of the requested sections about sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment are not applicable or not present in this document.
However, I can extract the relevant information from the provided text, primarily around the basis for acceptance which is substantial equivalence.
Here's a breakdown based on the information available:
Acceptance Criteria and Study for OraMagicRx™ Oral Wound Rinse (K024180)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied by Substantial Equivalence) | Reported Device Performance/Comparison |
|---|---|
| Safety: | |
| - Biocompatibility (absence of unacceptable irritation, | - Established by primary dermal irritation test (rabbits), sensitization test (guinea pigs), and in vitro cytotoxicity test. |
| sensitization, or cytotoxicity) | |
| Effectiveness/Function: | |
| - Similar composition to predicate device | - "OraMagicRx™ Oral Wound Rinse is similar in composition..." |
| - Identical in function to predicate device | - "...and identical in function..." |
| - Identical in intended use to predicate device | - "...and intended use, to Radiacare™ Oral Wound Rinse (Carrington Laboratories, Inc.) and other legally marketed hydrogel wound dressing products." |
| - Performs at least as well as legally marketed predicate devices | - "...performs at least as well as legally marketed predicate devices, such as Carrington's Radiacare™ Oral Wound Rinse." |
| Intended Use: | |
| - For the management of mucositis/stomatitis, all types of oral | - "For the management of mucositis/stomatitis, all types of oral wounds (mouth sores and injuries), aphthous ulcers/canker sores, and traumatic ulcers caused by ill-fitting dentures or braces." |
| wounds, aphthous ulcers/canker sores, and traumatic ulcers. |
Study Proving Acceptance Criteria:
The "study" proving the device meets the acceptance criteria is primarily based on demonstrating substantial equivalence to a legally marketed predicate device (Radiacare™ Oral Wound Rinse, K964852) and biocompatibility testing. The submission does not describe a clinical performance study in the way a diagnostic product would.
2. Sample Size Used for the Test Set and Data Provenance
- Not applicable / Not provided for clinical performance. The submission relies on substantial equivalence rather than a clinical performance study with a test set of patient data.
- Biocompatibility Testing: The sample sizes used for the biocompatibility tests (primary dermal irritation, sensitization, in vitro cytotoxicity) are not specified in the 510(k) summary (e.g., number of rabbits, guinea pigs, or specific cell lines). The data provenance for these specific tests is not stated regarding country of origin or whether they were retrospective/prospective, but these are typically prospective laboratory studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. No clinical test set requiring expert ground truth establishment for diagnostic performance is described. The relevant "experts" would be those who conducted and interpreted the biocompatibility tests according to standard protocols.
4. Adjudication Method for the Test Set
- Not applicable. No test set requiring expert adjudication for diagnostic performance is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC comparative effectiveness study was not performed or described in this 510(k) summary. This type of study is relevant for diagnostic devices, particularly AI-assisted ones, to assess the impact of the AI on human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an oral wound rinse, not an algorithm. Therefore, "standalone" algorithm performance is not relevant.
7. The Type of Ground Truth Used
- For biocompatibility: The ground truth would be established by the observed biological responses according to standardized testing protocols (e.g., absence of irritation, sensitization, cytotoxicity).
- For substantial equivalence: The "ground truth" is the established safety and effectiveness profile of the predicate device (Radiacare™ Oral Wound Rinse) as determined by its prior regulatory clearance.
8. The Sample Size for the Training Set
- Not applicable. This device is a medical product (oral rinse), not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, no training set for an AI/ML algorithm is involved.
N/A