(68 days)
The E-1 ESTHETIC COMPOSITE SYSTEM tooth shade resin material is a light-cured, radiopaque, submicron-filled composite resin system for use in dental procedures such as anterior and posterior restorations including occlusal surfaces, direct bonded composite veneers, diastema closures, and the repair of porcelain/composites.
The E-1 ESTHETIC COMPOSITE SYSTEM is for use as a tooth shade resin material in dental procedures.
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The provided text describes a 510(k) summary for a dental device, the E-1 ESTHETIC COMPOSITE SYSTEM. This type of submission relies on demonstrating substantial equivalence to pre-existing devices, rather than conducting new clinical studies with defined acceptance criteria and extensive performance evaluations for standalone or human-in-the-loop performance. Therefore, many of the requested categories are not directly applicable or explicitly stated in this document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical study with outcome measures. Instead, it relies on demonstrating substantial equivalence to predicate devices based on certain performance characteristics.
| Performance Characteristic | Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|---|
| Flexural Strength | Comparable to predicate devices (K#980051 and K#051808) | "slightly different performance characteristics" but not raising new safety/effectiveness questions |
| Water Sorption | Comparable to predicate devices (K#980051 and K#051808) | "slightly different performance characteristics" but not raising new safety/effectiveness questions |
| Solubility | Comparable to predicate devices (K#980051 and K#051808) | "slightly different performance characteristics" but not raising new safety/effectiveness questions |
| Depth of Cure | Comparable to predicate devices (K#980051 and K#051808) | "slightly different performance characteristics" but not raising new safety/effectiveness questions |
| Biocompatibility | Demonstrated by common use of ingredients in similar devices | "All ingredients used in the E-1 ESTHETIC COMPOSITE SYSTEM are biocompatible, as demonstrated by their common use in similar dental devices" |
Study Information:
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. This document refers to the characteristics of the device itself and its materials, rather than a "test set" of patients or data in a clinical trial. The evaluation is based on comparison to existing device specifications and material properties.
- Data Provenance: Not applicable in the context of clinical trial data. The data pertains to the physical and chemical properties of the E-1 ESTHETIC COMPOSITE SYSTEM and its components, compared against documented properties of predicate devices.
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 this context refers to established material science and biocompatibility standards, not expert consensus on patient data.
4. Adjudication method for the test set:
- Not applicable. There was no "test set" in the context of patient data requiring 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, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a dental material.
7. The type of ground truth used:
- The "ground truth" for this submission is based on established material science standards, biocompatibility principles, and the documented performance characteristics of legally marketed predicate devices. The claim is that the E-1 ESTHETIC COMPOSITE SYSTEM's properties (flexural strength, water sorption, solubility, depth of cure, biocompatibility) are sufficiently similar to allow for a determination of substantial equivalence, meaning it raises no new questions of safety or effectiveness.
8. The sample size for the training set:
- Not applicable. There is no concept of a "training set" for this type of device submission.
9. How the ground truth for the training set was established:
- Not applicable.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.