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510(k) Data Aggregation
(364 days)
Aftamed® Mouthwash provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologics, including: aphthous ulcers caused by disease; traumatic ulcers caused by braces, ill-fitting dentures or oral surgery.
Aftamed™ Gel provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologics, including: aphthous ulcers caused by disease; traumatic ulcers caused by braces, ill-fitting dentures or oral surgery.
Aftamed® Spray provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations for relief of tallering to the ordination of the many film ulcers caused by braces, ill-litting dentures or oral surgery
Aftamed® Shield provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: aphthous ulcers caused by disease; traumatic ulcers caused by braces, ill-fitting dentures or oral surgery.
Aftamed® Junior Gel provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various ctiologics, including: aphthous ulcers caused by disease; traumatic ulcers caused by braces, or oral surgery.
Aftamed® Mouthwash adheres to oral mucosa and forms a protective film over lesions and irritations due to various etiologies, including: aphthous ulcers caused by disease; traumatic ulcers caused by braces, illfitting dentures or oral surgery. The viscosity and adherence properties of the constituents of the device allow the device to form the protective film which protects the lesions for external insult.
Aftamed® Gel adheres to oral mucosa and forms a protective film over lesions and irritations due to various etiologies, including: aphthous ulcers caused by disease; traumatic ulcers caused by braces, illfitting dentures or oral surgery. The viscosity and adherence properties of the constituents of the device allow the device to form the protective film which protects the lesions for external insult.
Aftamed® Spray adheres to oral mucosa and forms a protective film over lesions and irritations due to various etiologies, including: aphthous ulcers caused by disease; traumatic ulcers caused by braces, illfitting dentures or oral surgery. The viscosity and adherence properties of the constituents of the device allow the device to form the protective film which protects the lesions for external insult.
Aftamed® Shield adheres to oral mucosa and forms a protective film over lesions and irritations due to various etiologies, including: aphthous ulcers caused by disease; traumatic ulcers caused by braces, illfitting dentures or oral surgery. The viscosity and adherence properties of the constituents of the device allow the device to form the protective film which protects the lesions for external insult.
A flamed® Junior Gel adheres to oral mucosa and forms a protective film over lesions and irritations due to various etiologies, including: aphthous ulcers caused by disease; traumatic ulcers caused by braces, illfitting dentures or oral surgery. The viscosity and adherence properties of the constituents of the device allow the device to form the protective film which protects the lesions for external insult.
The provided document is a 510(k) summary for several Aftamed® products (Mouthwash, Gel, Spray, Shield, and Junior Gel). The purpose of this document is to demonstrate "substantial equivalence" to predicate devices, not to establish performance criteria for a novel device. Therefore, it does not contain the acceptance criteria or a study proving device performance in the manner typically expected for AI/ML devices or diagnostic tools.
Instead, the document focuses on demonstrating that the Aftamed® products are as safe and effective as their respective predicate devices (Gengigel products) by showing identical indications for use, similar ingredients and specifications, and comparable biocompatibility and physical testing results.
Here's an analysis based on the information provided, specifically addressing your points where data is available or noting its absence:
1. A table of acceptance criteria and the reported device performance
The document does not specify "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity, accuracy) like one would see for a diagnostic device. Instead, the acceptance criteria are implicitly that the Aftamed products perform comparably to their predicate devices in terms of safety (biocompatibility) and physical characteristics relevant to their function (adhesion, protective film formation).
The "reported device performance" is presented as the results of non-clinical (biocompatibility) and physical testing.
| Test Category | Acceptance Criteria (Implicit) | Reported Device Performance (Aftamed® Mouthwash, Gel, Spray, Junior Gel) | Reported Device Performance (Aftamed® Shield) |
|---|---|---|---|
| Biocompatibility | Should not be significantly irritating, cytotoxic, or sensitizing. Comparable to predicate device. | - Irritation: Minimal irritant (Mouthwash, Gel); Non-irritant (Spray); Minimal irritant reaction (Junior Gel) | - Irritation (In Vitro EpiGingival™ Tissue Model): Mild/non-irritant |
| - Cytotoxicity: Wholly devoid of cytotoxic/irritant effects on primary human fibroblasts (Mouthwash, Gel); Did not cause cytotoxic effects at all tested concentrations on fibroblasts (Spray); Did not show significant cytotoxic effects on fibroblasts (Junior Gel) | - Cytotoxicity (ISO 10993-5): Did not show significant cytotoxic effects on fibroblasts | ||
| - Sensitization: Does not show significant cytotoxic effects on fibroblasts as a whole (Mouthwash - note: described as cytotoxicity result); Not sensitizing (Gel, Spray, Junior Gel) | - Sensitization (In Vitro THP-1 cell line): Is not considered as a suspect allergen | ||
| - Protective Effect (In vitro, on oral epithelium): Shows epithelium barrier protective and repairing activity following surfactant-induced irritating stress | |||
| Physical Testing | Maintain consistent physical characteristics (organoleptic, viscosity, pH, density, weight, microbe count). Comparable to predicate device. | - Organoleptic characteristics inspected | - Organoleptic characteristics inspected |
| - Viscosity measured | - Viscosity measured | ||
| - pH measured | - pH measured | ||
| - Density measured | - Density measured | ||
| - Mean weight of package contents measured | - Mean weight of package contents measured | ||
| - Microbe count performed | - Microbe count performed |
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: The document does not specify the sample size for the non-clinical or physical tests. For example, it doesn't state how many human subjects were involved in the Human Skin Irritation Test or how many biological samples were used for cytotoxicity evaluations.
- Data Provenance: The document does not explicitly state the country of origin or whether the studies were retrospective or prospective. The applicant, BIOPLAX Limited, is based in London, UK, but the tests themselves could have been conducted elsewhere.
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 type of information is not applicable to this submission. The "ground truth" here is objective scientific measurement for biocompatibility and physical properties, not expert consensus on medical image interpretation or clinical diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This type of information is not applicable to this submission as it pertains to expert review in clinical studies or image interpretation, not laboratory testing for material properties.
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 type of information is not applicable because the device is a medical product for temporary pain relief from oral lesions, not a diagnostic imaging device or an AI/ML-assisted tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This type of information is not applicable for the same reason as point 5.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests (biocompatibility) would be defined by the standardized methodologies of the ISO 10993 series, which outline acceptable levels of biological response (e.g., cell viability for cytotoxicity, skin reaction for irritation). For physical testing, the ground truth is based on engineering and chemical standards for measuring properties like viscosity, pH, and density.
8. The sample size for the training set
This type of information is not applicable. This submission is for a traditional medical device (hydrogel products), not an AI/ML device that requires training data.
9. How the ground truth for the training set was established
This type of information is not applicable for the same reason as point 8.
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