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510(k) Data Aggregation
(86 days)
Spee-Dee Patch is a visible light cured, glass-filled resin that is intended as a vital tooth build-up material where restorations were removed and must be built up for crown preparation; as a non-vital tooth post and core; as a build up material; and as a repair material to repair fractured cusps, lost partial or whole fillings, chipped crowns, broken teeth, crowns, or bridges.
Spee-Dee Patch is a visible light cured, glass-filled resin that is intended as a vital tooth build-up material where restorations were removed and must be built up for crown preparation; as a non-vital tooth post and core; as a build up material; and as a repair material to repair fractured cusps, lost partial or whole fillings, chipped crowns, broken teeth, crowns, or bridges.
The provided submission describes a dental material, Spee-Dee Patch, and outlines its performance characteristics based on bench testing. The information does not pertain to an AI/ML powered device, therefore many of the requested fields are not applicable.
Here's an analysis of the provided text against your criteria:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Light Cure Setting Time | < 20 seconds |
| Working time in ambient light | > 5 minutes |
| Clinical depth of cure | > 4 mm |
| Compressive Strength | 45,240 ± 3480 p.s.i. / 312.0 ± 24.0 MPa |
| Specific gravity | 1.520 |
| Flexural Strength | 13,775 ± 1450 p.s.i. / 95.0 ± 10.0 MPa |
| Diametral Tensile Strength | 7540 ± 290 p.s.i. / 52.0 ± 2.0 MPa |
| Shelf-life | Two years |
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 sizes used for each of the performance tests. The data provenance (country of origin, retrospective/prospective) is also not specified. These are "bench" tests, implying laboratory-based evaluations.
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. This is a material science characterization, not an diagnostic/AI device requiring expert ground truth for interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a material science characterization.
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-powered device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI-powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance tests appears to be established through standardized physical and chemical testing methods appropriate for dental materials. This would be based on direct measurement against established material science standards, not expert consensus or clinical outcomes in the traditional sense of diagnostic devices.
8. The sample size for the training set
Not applicable. This device is a material, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is a material, not an AI/ML model that requires a training set.
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