(58 days)
Temporary fillings for inlay and onlay preparations .
Temporary fillings of cavities ●
Temporary filling of implant sites ●
Relining of prefabricated temporary crowns and bridges .
light-curing temporary filling material, tradenamed Cavit®-LC
The provided text describes a 510(k) premarket notification for a dental material, Cavit®-LC, and references comparative testing. However, it does not include detailed information regarding acceptance criteria or the specific study that proves the device meets those criteria in a format that would allow me to fill out all the requested fields for a typical AI/software device evaluation.
The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices (Fermit-N and Clip®) by comparing physical and technical characteristics, and reporting on biocompatibility tests (cytotoxicity, Ames, skin irritation, eye irritation, acute oral toxicity, and sensitization).
Here's an attempt to extract the relevant information based on the provided text, with many fields being marked as "Not Applicable" or "Not Provided" due to the nature of the submission (a dental material, not an AI/software device):
Acceptance Criteria and Device Performance
This section is difficult to fully populate with numerical acceptance criteria and reported performance from the provided text, as the submission focuses on substantial equivalence to predicate devices rather than specific performance metrics against predefined thresholds. The "tests undertaken" are primarily biocompatibility tests.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Material Composition | Similar principal ingredient composition to predicate device (Fermit-N) | Cavit®-LC and Fermit-N have similar principal ingredient composition. |
| Intended Use | Similar intended uses as predicate devices (Fermit-N, Clip®) | Cavit®-LC has similar intended uses to Fermit-N and Clip®. |
| Physical/Technical Characteristics | Comparative characteristics to predicate devices | Physical and technical characteristics of Cavit™-LC have been compared to those of Fermit-N and Clip. (Specific results not detailed) |
| Biocompatibility | Acceptable results for standard biocompatibility tests | Cytotoxicity, Ames, skin irritation, eye irritation, acute oral toxicity, and sensitization tests undertaken on Cavit®-LC. (Specific results not detailed, but implied to be acceptable for 510(k) clearance) |
Notes on Acceptance Criteria: For a 510(k) submission for a material, the "acceptance criteria" are generally that the new device is "substantially equivalent" to legally marketed predicate devices, meaning it has the same intended use, is as safe and effective, and has similar technological characteristics. The comparison of physical and technical characteristics and biocompatibility tests serve to demonstrate this equivalence, rather than meeting specific numerical performance thresholds for an AI algorithm.
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified in terms of number of cases or patients. The tests mentioned (biocompatibility, physical/technical characteristics) would involve material samples or in vitro/animal models.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The tests were "undertaken on the final Cavit®-LC product."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This type of information is relevant for AI/software devices requiring expert review for ground truth establishment. For a dental filling material, ground truth would be established through material testing standards and biocompatibility guidelines.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As above, this pertains to expert review of diagnostic findings for AI/software, not material science or biocompatibility testing.
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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:
- No. This is a material science product, not an AI-assisted diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a material science product. The performance of the material is assessed directly, not via an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For biocompatibility: Standardized in vitro tests (e.g., cytotoxicity, Ames) and in vivo animal studies (skin irritation, eye irritation, acute oral toxicity, sensitization) with defined endpoints and acceptance criteria from regulatory guidelines.
- For physical/technical characteristics: Material science testing methods and standards.
- For substantial equivalence: Comparison to the established characteristics and performance of predicate devices.
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The sample size for the training set:
- Not Applicable. There is no "training set" in the context of a dental material submission demonstrating substantial equivalence through physical and biocompatibility testing.
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How the ground truth for the training set was established:
- Not Applicable. See above.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.