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510(k) Data Aggregation
(51 days)
EXTORAL/TESCERA GLAZING RESIN, MODEL T-1804
This product is used as a surface sealant for indirect composites.
A single bottle glaze for use on indirect resin composite restorations.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the EXTORAL/TESCERA GLAZING RESIN device:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided text focuses on demonstrating substantial equivalence to a predicate device rather than presenting explicit acceptance criteria with numerical targets. The "Significant Performance Characteristics" table highlights shared features between the applicant device and the predicate.
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (EXTORAL / TESCERA GLAZING RESIN) |
|---|---|---|
| Intended Use | Must be a resin sealant. | Resin sealant. |
| Product Description | Must be a clear solution. | Clear solution. |
| Delivery System | Must be a brush. | Brush. |
| Biocompatibility | Must be non-toxic. | Ingredients were tested and found to be non-toxic. |
| Overall Safety and Efficacy | Must be safe and efficacious, demonstrating substantial equivalence to the predicate. | Concluded that information supplied proved safety and efficacy. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly mention a "test set" in the context of the device's performance. Instead, it refers to "side by side comparisons" and "biocompatibility testing."
- Sample Size: Not specified for the comparison or biocompatibility testing. No explicit "test set" is described with a specific number of instances.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document states "ingredients... were tested," implying a laboratory setting, but provides no further details.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. The study described focuses on direct comparison of product characteristics and biocompatibility testing, not on expert-adjudicated "ground truth" labels.
4. Adjudication Method for the Test Set:
Not applicable. There is no mention of a "test set" requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. The document focuses on comparing the applicant device's intrinsic properties and intended use to a predicate device, not on how human readers' performance with or without AI assistance is affected.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This device is a physical product (glazing resin), not an algorithm or AI system.
7. Type of Ground Truth Used:
The "ground truth" in this context is based on:
- Direct comparison of product characteristics: Intended use, product description, and delivery system are directly observed and compared.
- Biocompatibility testing results: Laboratory findings on the toxicity of the ingredients.
- Predicate device characteristics: The legally marketed predicate device (Jet Seal/Ortho-Jet Acrylic Resin K941925) serves as the benchmark for "substantial equivalence."
8. Sample Size for the Training Set:
Not applicable. This device is a physical product, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable. As there is no training set, there is no ground truth establishment for it.
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