(70 days)
SINCLAIR ALOCLAIR™ ORAL GEL is indicated for pain relief in all types of mouth lesions, aphthous stomatitis, aphthous ulcers, minor lesions, chafing and traumatic ulcers and abrasions caused by braces and ill fitting dentures and diffused aphthous ulcers. Aloclair Gel forms a protective film that covers lesions to provide rapid pain relief, and avoid further irritation.
ALOCLAIR™ ORAL GEL is a viscous gel formulation, which is presented for over-the-counter use premixed in various sizes. This combination of substances, when rinsed around the mouth, forms a protective layer over the oral mucosa.
The provided text does not contain detailed information about specific acceptance criteria or an in-depth study proving the device meets those criteria, as one might find for a more complex medical device with quantifiable performance metrics (e.g., diagnostic accuracy, sensitivity, specificity).
The document is a 510(k) summary for Sinclair Aloclair™ Oral Gel, which is a wound and burn dressing (hydrogel with drug or biologic) for oral use. The approval for this device is based on substantial equivalence to predicate devices already on the market, rather than a novel claim requiring extensive new clinical trials with detailed performance metrics.
Based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance |
|---|---|
| Intended Use: Pain relief in various mouth lesions (aphthous stomatitis, ulcers, minor lesions, chafing, traumatic ulcers, abrasions from braces/dentures, diffused aphthous ulcers). | Indication: "SINCLAIR ALOCLAIR™ ORAL GEL is indicated for pain relief in all types of mouth lesions, aphthous stomatitis, aphthous ulcers, minor lesions, chafing and traumatic ulcers and abrasions caused by braces and ill fitting dentures and diffused aphthous ulcers. Aloclair Gel forms a protective film that covers lesions to provide rapid pain relief, and avoid further irritation." (This is essentially the stated intended use). |
| Technological Characteristics: Similar method of use, number of applications per day, claim (pain management/relief, non-irritating, non-stinging, safe if swallowed), area of use (oral mucosa), disease state (aphthous ulcers, stomatitis, oral lesions), product type (oral gel/rinse/mouthwash), presentation (non-sterile). | The device's characteristics are presented as "the same" as predicate devices (Aloclair Rinse cleared in K023155, Gelclair Concentrated Oral Gel cleared in K013056, and AloeCeuticals OraRinse™). The table provided lists these characteristics and shows how Aloclair Gel aligns with its predicates. |
| Safety and Effectiveness: Demonstrate safety and effectiveness comparable to predicate devices for the stated intended use. | "Extensive functional and performance testing were conducted to assess the safety and effectiveness of Aloclair® ORAL GEL. All results are satisfactory." (This is a general statement without specific data or metrics). |
| Regulatory Classification: Unclassified. | The FDA letter confirms the device is unclassified and can be legally marketed subject to general controls. |
2. Sample size used for the test set and the data provenance:
- The document does not specify a sample size for a test set in the context of a clinical performance study.
- The review is based on substantial equivalence to predicate devices, implying that the safety and effectiveness were primarily supported by the established history and regulatory status of those predicates, combined with functional and performance testing (likely bench or in-vitro, but not specified as a human clinical test set).
- The provenance of data for any "functional and performance testing" is not detailed (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The document does not describe a clinical study that required expert consensus for ground truth establishment.
4. Adjudication method for the test set:
- Not applicable. There is no described clinical test set requiring 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:
- Not applicable. This device is a topical oral gel, not an AI-powered diagnostic or treatment device, so MRMC studies are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a topical oral gel, not an algorithm.
7. The type of ground truth used:
- The "ground truth" for the substantial equivalence claim is largely established by the regulatory history and accepted safety and effectiveness of the predicate devices for their indications. For the functional and performance testing mentioned, the "ground truth" would be objective measures of the gel's properties (e.g., pH, viscosity, stability, barrier formation ability), but these are not detailed in the summary.
8. The sample size for the training set:
- Not applicable. This device is a medical product, not an AI model, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable.
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