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510(k) Data Aggregation
(253 days)
Protective Cap is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdenture, and can be used for a minimum of 1 day to maximum of 10 days.
The Protective Cap is a dental implant superstructure made of PC(Polycarbonate) according to ASTM F997. It is used temporarily, such as less than 10 days before the final restoration is connected. The Protective Cap is supplied nonsterile and intended for single use. It is to be sterilized by end users before use.
This FDA 510(k) premarket notification for the "Protective Cap" device does not involve an AI/ML algorithm. Therefore, the requested information about acceptance criteria, study details, ground truth, and sample sizes for AI/ML performance evaluation is not applicable to this document.
The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. Here's a breakdown of the non-clinical testing data provided, which serves as the "study" to meet the "acceptance criteria" for safety and effectiveness in this context:
Non-Clinical Testing Data (Acceptance Criteria & Device Performance):
| Acceptance Criteria Category | Specific Test/Standard | Reported Device Performance/Conclusion |
|---|---|---|
| Sterilization Validation | End User Sterilization Validation (according to ANSI/AAMI ST79, ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1) | Recommended sterilization validated according to standards. Worst-case construct tested. |
| Biocompatibility | ISO 10993-1:2018 (including ISO 10993-5, ISO 10993-23, ISO 10993-10, ISO 10993-11) | Demonstrates substantial equivalence with the predicate device regarding biological safety. |
| - Cytotoxicity Test | Passed | |
| - Irritation Test (Oral mucosa) | Passed | |
| - Sensitization Test | Passed | |
| - Systemic Toxicity Test | Passed | |
| Cleaning Process Validation | ISO 11737-1:2018, ISO/TS 17665-2: 2009 | Confirmed effective in terms of cleaning effect (Physicochemical tests, cleaning agent residual test, residual on evaporation test, microbial test, drying validation tests performed). Worst-case sample evaluated. |
Explanation for Missing AI/ML-Specific Information:
Since this submission is for a physical medical device (a protective cap for dental implants) and not an AI/ML software device, the following points are not discussed in the document:
- Sample size for test set and data provenance: No test sets of data were used in the AI/ML sense. Physical samples of the device were used for sterilization, biocompatibility, and cleaning validation.
- Number of experts and their qualifications for ground truth: No ground truth establishment by experts for AI/ML performance was required.
- Adjudication method: Not applicable.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. There is no human reader component that would be "augmented" by an AI.
- Standalone (algorithm-only) performance: Not applicable, as there is no algorithm.
- Type of ground truth used: For physical device testing, the "ground truth" is adherence to established engineering and medical standards (e.g., successful sterilization, non-toxic, effectively cleaned).
- Sample size for training set: Not applicable, as there is no AI model to train.
- How ground truth for training set was established: Not applicable.
The document concludes that the Protective Cap is substantially equivalent to its predicate device based on these non-clinical tests, sharing the same intended use, material, functions, principle of operation, sterilization method, and similar designs and dimensions, with differences not affecting fundamental function.
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