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510(k) Data Aggregation
(34 days)
LUCITONE FRS FLEXIBEL DENTAL RESIN
Used for fabrication of partial or full removable dentures, as well as occlusal splints and night guards.
LUCITONE® FRS™ FLEXIBLE DENTAL RESIN is an injection moldable, flexible thermoplastic resin designed for fabricating removable dental appliances.
The subject device is LUCITONE® FRS™ FLEXIBLE DENTAL RESIN, a dental material. The supporting document is a 510(k) summary (K992956) for this device.
Acceptance Criteria and Device Performance Study for K992956
This 510(k) summary provides information on the substantial equivalence of LUCITONE® FRS™ FLEXIBLE DENTAL RESIN to a predicate device, rather than detailed acceptance criteria and a study demonstrating the device meets those criteria in the context of AI/software performance. The device is a dental material, not an AI or software-driven medical device. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of submission.
The "acceptance criteria" for a dental material are typically defined by a set of physical, chemical, and biocompatibility properties that demonstrate it is safe and effective for its intended use and performs at least as well as a legally marketed predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Property | Predicate Device Information (Implicit Standard: "equal to or better than") | Reported Device Performance (LUCITONE® FRS™ FLEXIBLE DENTAL RESIN) |
|---|---|---|---|
| Physical Properties | (Not specified in detail, but implied as critical for dental resins) | Performance of Valplast® Resin Material (Pre-1976 device) | "performs equal to or better than the predicate device." |
| Biocompatibility | MEM Elution Test | Non-cytotoxic (expected for safe dental materials) | Non-cytotoxic |
| Biocompatibility | Ames Mutagenicity Test | Non-mutagenic (expected for safe dental materials) | Non-mutagenic |
| Biocompatibility | Mucous Membrane Irritation Test | Non-irritant (expected for safe dental materials) | Non-irritant |
| Biocompatibility | Hamster Cheek Pouch Irritation Test, Repeated Dose | Non-irritant (expected for safe dental materials) | Non-irritant |
| Biocompatibility | Kligman Maximization Study (NaCl) | Non-sensitizer (expected for safe dental materials) | Non-sensitizer |
| Biocompatibility | Kligman Maximization Study (Cottonseed oil) | Non-sensitizer (expected for safe dental materials) | Non-sensitizer |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. For physical property testing and biocompatibility, sample sizes are typically determined by relevant ISO or ASTM standards for materials testing.
- Data Provenance: Not specified, but generally refers to laboratory testing results conducted by or for DENTSPLY International. Given the nature of materials testing, it would be laboratory-controlled (neither prospective nor retrospective in the clinical sense).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth, in the context of device performance for a dental material, is established through standardized laboratory testing and accepted chemical/biological assays, not by expert interpretation in the way it is for imaging or diagnostic AI. The tests themselves are the "ground truth."
4. Adjudication method for the test set
- Not applicable. See point 3. Testing results are objective measurements from laboratory instruments and assays.
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 a dental material, not an AI-assisted diagnostic or therapeutic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a dental material.
7. The type of ground truth used
- Laboratory Testing Results: The ground truth for this device is based on the objective results of standardized physical property tests and biocompatibility assays (e.g., cytotoxicity, mutagenicity, irritation, sensitization).
- Predicate Device Performance: Implicitly, the performance and safety profile of the legally marketed predicate device (Valplast® Resin Material) serves as a benchmark for substantial equivalence.
8. The sample size for the training set
- Not applicable. This is a dental material, not a machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
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