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510(k) Data Aggregation
(67 days)
Xantasil is a medium flow, addition-curing, elastomer dental impression material that can be used to cover all impression needs where a traditional alginate material would be used, such as impressions for temporaries, crown and bridges, removable dentures, orthodontic models, opposing jaw models, splints, mouth guards and bleaching trays. It is used to get a negative copy of the patients' dental situation.
Xantasil is an addition-curing polyvinyl-siloxane impression material. Xantasil is delivered in 50 ml and 380 ml cartridges. Xantasil is an optimized A-silicone impression material with medium consistency meant as a replacement for alginates. The mouth removal time for the product is 1.5 minutes Xantasil is for use in the Dynamix automatic dispensing and mixing system and the 1:1 Cartridge dispenser.
The provided text describes a 510(k) submission for a dental impression material named Xantasil. The submission focuses on demonstrating substantial equivalence to predicate devices based on physical properties, not on a study with AI in a diagnostic context. Therefore, many of the requested fields are not applicable to this document.
Here's the relevant information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Attribute | Acceptance Criteria (Predicate Devices based on ISO 4823) | Reported Device Performance (Xantasil) |
|---|---|---|
| Working Time | ≥2:30 min | ≥2:30 min |
| Detail Reproduction | ≤20 µm | ≤20 µm |
| Linear Dimensional Change | ≤1.5% | ≤1.5% |
| Compatibility to Gypsum | ≤20 µm | ≤20 µm |
| Strain in Compression | ≤20% | ≤20% |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This is a dental impression material, and the "test set" here refers to the physical properties measured against ISO 4823 standards for dental materials, not a patient-based test set for an AI device. The document does not specify sample sizes for these physical property tests or data provenance beyond "in compliance with ISO 4823."
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. Ground truth as typically understood for AI/diagnostic devices doesn't apply here. The "experts" mentioned in the document are involved in judging the benefit/risk ratio, not establishing ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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 is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the physical properties, the "ground truth" is defined by the technical specifications and test methods outlined in ISO 4823 for dental impression materials.
- For the biological compatibility, "bridging data from predicates in accordance with the international standard ISO 10993-1" was used.
8. The sample size for the training set
- Not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
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