(66 days)
Esthetica is a composite resin-based block intended for the preparation of inlays, onlays, veneers, full crowns, bridges and crowns for implant restorations.
Esthetica is a durable, composite resin-based mill block for chairside and laboratory milling applications. Esthetica is milled as a restoration that is subsequently cemented in place. Esthetica is a highly esthetic, single material, next generation composite block that can be used as an alternative to Porcelain and Porcelain/Zirconia blocks. Esthetica offers Biomimetic features that will wear, age, look, feel, and function like a natural tooth.
The provided text describes the regulatory clearance of a dental material called "Esthetica," a composite resin-based mill block. It is a 510(k) submission, meaning it claims substantial equivalence to a predicate device, not necessarily a new device with novel performance characteristics that require extensive clinical studies with specific acceptance criteria as you've outlined.
Therefore, the document does not contain the kind of information typically found in studies for AI/software-as-a-medical-device (SaMD) or other diagnostic devices. It does not describe:
- Acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, AUC).
- A "study that proves the device meets the acceptance criteria" in terms of clinical diagnostic performance.
- Sample sizes for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a diagnostic algorithm.
Instead, the provided text focuses on the material characteristics and biocompatibility of the dental block. Here's a breakdown of what is available in relation to your request, and where information is missing:
Acceptance Criteria and Reported Device Performance
The "acceptance criteria" here are implicitly that Esthetica's material characteristics are comparable to the predicate device (3M ESPE Adult Crown/Paradigm MZ100 Blocks). The study performed was bench testing and biocompatibility testing.
Table (reconstructed based on the text):
| Characteristic Evaluated | Acceptance Criteria (Implicit: Comparable to Predicate) | Reported Device Performance (Esthetica) |
|---|---|---|
| Flexural Strength | Comparable to 3M ESPE Adult Crown | Implied to meet, as found substantially equivalent |
| Compressive Strength | Comparable to 3M ESPE Adult Crown | Implied to meet, as found substantially equivalent |
| Diametral Strength | Comparable to 3M ESPE Adult Crown | Implied to meet, as found substantially equivalent |
| Flexural Modulus | Comparable to 3M ESPE Adult Crown | Implied to meet, as found substantially equivalent |
| Fracture Toughness | Comparable to 3M ESPE Adult Crown | Implied to meet, as found substantially equivalent |
| Opacity | Comparable to 3M ESPE Adult Crown | Implied to meet, as found substantially equivalent |
| Biocompatibility | Safe for intended use | Demonstrated to be safe |
Study Proving Device Meets Acceptance Criteria:
The study referenced is "bench testing used to evaluate the performance characteristics of Esthetica compared to the predicate device, 3M ESPE Adult Crown," and a "biocompatibility study." The conclusion is that "the clinical performance of Esthetica is substantially equivalent to restorations produced using the predicate device" based on these tests.
Missing Information (as per your request, because this is not a diagnostic device study):
- Sample size used for the test set and the data provenance: Not applicable. This was material testing, not a diagnostic test on a human population. The sample size would refer to the number of material specimens tested, which is not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not a study requiring expert readers to establish ground truth for diagnostic imaging or patient data.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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-powered diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for material characteristics would be the established scientific methods for measuring those properties (e.g., ASTM standards for mechanical properties). For biocompatibility, it would be in vitro or in vivo toxicity testing, with acceptance criteria defined by relevant standards (e.g., ISO 10993). The specific standards or methodologies are not detailed in this summary.
- The sample size for the training set: Not applicable. This device does not use a training set as it is not an AI/ML algorithm.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) summary for a dental material, not a document describing a clinical study or performance evaluation of an AI-driven diagnostic device. Therefore, most of the specific questions about acceptance criteria, study design, and ground truth for a diagnostic device are not relevant to this content.
§ 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.