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510(k) Data Aggregation
(29 days)
Fixtemp® C&B 4:1 is a resin-based material used to fabricate temporary crowns and bridges.
Fixtemp® C&B 4:1 is an automatically mixable self-curing composite, used for the direct and indirect fabrication of temporary crowns and bridges. Fixtemp C&B 4:1 is a Type 1 – polymer-based material, per ISO 10477:2020. It is available in the tooth colors A1, A2, A3, A3.5, B1 and Bleach X.
1. A table of acceptance criteria and the reported device performance
| Attribute | Acceptance Criteria (from predicate Fixtemp® C&B) | Reported Device Performance (Fixtemp® C&B 4:1) |
|---|---|---|
| Processing/Working Time | ≥ 45 sec | ≥ 45 sec |
| Curing Time in the mouth | ≥ 2 - 3 min | ≈ 2 - 3 min |
| Setting Time | ≥ 6 min | ≥ 6 min |
| Flexural Strength | > 60 MPa | > 60 MPa |
| Water Sorption | ≤ 40 µg/mm³ | ≤ 40 µg/mm³ |
| Duration | Short term < 30 days | Short term < 30 days |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size used for the test set or the data provenance for the non-clinical performance testing. It only states that "Bench test results allowed us to conclude that Fixtemp® C&B 4:1 meets its intended use."
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)
Not applicable. The ground truth for the performance criteria was established against recognized consensus standards (ISO 10477:2020) and compared to a predicate device, not through expert consensus on a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The performance testing was based on compliance with a recognized standard and comparison to a predicate device, not on human interpretation or 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 dental material (temporary crown and bridge resin) and does not involve AI or human readers. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a dental material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the non-clinical performance testing was based on:
- Recognized Consensus Standard: ISO 10477:2020 – Dentistry – Polymer-based crown and veneering materials.
- Predicate Device Performance: Comparison to the established performance characteristics of the legally marketed predicate device, Fixtemp® C&B (K171729).
8. The sample size for the training set
Not applicable. This device is a dental material, not a machine learning algorithm, so there is no training set in the typical sense.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an algorithm, there is no ground truth established for a training set.
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