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510(k) Data Aggregation
(42 days)
Ormco Enlight is a single component sealant and single component paste, visible light cured orthodontic bonding adhesive indicated for the attachment of orthodontic appliances to teeth.
Ormco's Enlight is designed to fulfill all of the requirements of a successful orthodontic adhesive. These requirements are itemized below: 1. Ease of placement: optimized resin blend that exhibits supert handling characteristics. 2. Convenience: Both syringe and Unidse delivery systems are available. 3. Enlight provides flouride release for caries protection during the orthodontic treatment period.
The provided text describes a 510(k) submission for the "Ormco Enlight Orthodontic Adhesive" and its claimed substantial equivalence to predicate devices. However, the document does not contain a typical acceptance criteria table with specific performance metrics (e.g., sensitivity, specificity, accuracy) or the detailed results of a study designed to prove the device meets such criteria in a quantitative, statistical manner as typically expected for modern medical device clearances.
Instead, the submission focuses on biocompatibility and efficacy in a more general sense, claiming the device "performs as well or better than the predicate devices currently on the market" based on "in-house testing and side by side test comparisons."
Given the limitations of the provided text, I will extract and present the information as best as possible, acknowledging where specific requested details are not available.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion Type | Acceptance Criteria (Specific Metrics) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Safety as recommended by ISO 10993 guidance standard | - Cytotoxicity Study (Agarose Overlay): Passed (tested by independent lab) |
| - Mucosal Irritation (Rabbit Vagina): Passed (tested by independent lab) | ||
| - Dermal Contact Sensitization (Guinea Pig): Passed (tested by independent lab) | ||
| Efficacy (General) | Performs as well or better than predicate devices | Results of "bench testing" indicate the device "performs as well or better than the predicate devices currently on the market." (No specific metrics or quantitative comparison results provided). |
| Handling Characteristics | Optimized resin blend exhibiting superb handling characteristics | Claimed to have an optimized resin blend with "superb handling characteristics." (Qualitative claim, no specific metric given). |
| Convenience | Availability of delivery systems | Both syringe and Unidose delivery systems are available. (Refers to feature availability). |
| Fluoride Release | Provides fluoride release | Claims to provide fluoride release for caries protection. (Qualitative claim, no specific release rate or duration provided). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified for any of the efficacy (bench testing) or biocompatibility tests. The document only mentions "cured samples" for biocompatibility and "in-house testing and side by side test comparisons" for efficacy.
- Data Provenance:
- Efficacy: "in-house testing" (presumably conducted by the submitter, Ormco)
- Biocompatibility: "independent laboratory which specializes in safety and toxicity evaluation"
- Geographic Origin: Not specified but given the submitter's location (Orange, CA) and FDA submission, it implies a US regulatory context.
- Retrospective/Prospective: Not specified, but bench testing and independent lab biocompatibility tests are typically prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- This information is not provided in the document. For biocompatibility, the ground truth is established by the test results themselves based on recognized standards (ISO 10993). For efficacy, the "ground truth" seems to be the performance of predicate devices, but the method of comparison and expert involvement is not detailed.
4. Adjudication Method for the Test Set
- This information is not provided. Given the nature of bench testing and biocompatibility tests, formal adjudication rounds as seen in clinical image analysis studies are generally not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. The efficacy section mentions "side by side test comparisons to predicate devices" and "bench testing," which are not MRMC studies. The document does not describe human readers, AI assistance, or an effect size for human improvement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable as the device is an orthodontic adhesive, not an AI algorithm.
7. The Type of Ground Truth Used
- Biocompatibility: Ground truth is based on the results of standardized biological tests (Cytotoxicity, Mucosal Irritation, Dermal Contact Sensitization) conforming to ISO 10993 guidance.
- Efficacy: The ground truth for comparison is the performance of "predicate devices currently on the market" (specifically Unitek Transbond and Light-Bond). The specific metrics constituting this performance ground truth are not detailed.
8. The Sample Size for the Training Set
- This question is not applicable as the device is an orthodontic adhesive, not an AI algorithm requiring a training set in the machine learning sense. The formulation would have undergone R&D and optimization, but this isn't a "training set" in the context of AI.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable for the same reason as point 8. The "ground truth" during development would be the desired performance characteristics (e.g., bond strength, cure time, handling properties) established through internal research and development criteria based on industry standards and market needs.
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