(78 days)
Denture base material for: Completion of metal frameworks Partial and total denture rebasing Extension of partial dentures Repairs Fabrication of partial and total dentures
VITRON® M is classified as a denture relining, repairing, or rebasing resin (21 C.F.R. § 872.3760) because it is a device composed of methylmethacrylate intended to be used in the fabrication, repair, rebasing of complete or partial removable dentures and other removal dental appliances. VITRON® M is a pourable, cold cured denture base material
Here's a breakdown of the acceptance criteria and study information based on the provided text, but it's important to note that the document is a 510(k) summary for a dental material (denture base material), not an AI or software-as-a-medical-device (SaMD) product. Therefore, many of the typical questions for SaMD studies (like sample sizes for test/training sets, expert ground truth, MRMC studies) are not applicable.
The "study" in this context is a claim of substantial equivalence to existing, legally marketed predicate devices, rather than a clinical trial demonstrating new performance metrics for a novel diagnostic device.
Here's the closest interpretation of your requests given the nature of the document:
Acceptance Criteria and Study for VITRON® M
This submission is for a denture base material, VITRON® M, and focuses on establishing substantial equivalence to existing predicate devices rather than demonstrating novel performance via a clinical study with acceptance criteria. The "acceptance criteria" here are implicitly tied to the safety and effectiveness profile of the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (based on predicate devices) | Reported Device Performance (VITRON® M) |
|---|---|
| Intended Use: Fabrication, repair, rebasing of complete or partial removable dentures and other removable dental appliances. | Intended Use: Denture base material for completion of metal frameworks, partial and total denture rebasing, extension of partial dentures, repairs, fabrication of partial and total dentures. (Matches predicate devices like PALAPRESS® VARIO and LIQCRYLIC®). |
| Classification: Denture relining, repairing, or rebasing resin (21 C.F.R. § 872.3760). | Classification: Same as predicate devices. |
| Material Composition: Methylmethacrylate-based with barbituric acid based initiator system. | Material Composition: Consists of the "same monomers and prepolymerized oligomers" and is cured by the "same well-known barbituric acid based initiator system" as the predicate devices. (Claimed to be chemically equivalent at a high level). |
| Safety and Effectiveness: Demonstrated through long marketing history and clinical experience of predicate devices. | Safety and Effectiveness: "In our opinion biocompatibility studies are therefore not necessary to prove the safety and efficacy of VITRON® M’s formulation." "In our opinion the substantial equivalence of VITRON® M to the predicate devices... with long marketing history and clinical experience, and the performance data support the safety and effectiveness of VITRON® M for the intended use." This assumes VITRON® M will have a comparable safety and effectiveness profile given its compositional and functional similarity to the established predicates. |
2. Sample size used for the test set and the data provenance
- Not Applicable. This is a 510(k) for a dental material, not a diagnostic or AI device that would typically involve a "test set" of patient data for performance evaluation. The "test" is the comparison to predicate devices. The data provenance refers to the clinical history and market presence of the predicate devices (PALAPRESS® VARIO since 1992, LIQCRYLIC® and similar products for over 25 years in Europe/South America).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. No ground truth in the traditional sense of a diagnostic agreement was established for VITRON® M in this submission. The "ground truth" for the predicate devices' safety and effectiveness is their longstanding clinical use and market history, implicitly validated by the dental community over decades.
4. Adjudication method for the test set
- Not Applicable. No "test set" or adjudication process for diagnostic performance was conducted.
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 or diagnostic device, so MRMC studies are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical dental material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the claims of safety and effectiveness for VITRON® M is derived from the long-term clinical history and established market acceptance ("outcomes data" in a very broad sense) of its predicate devices, PALAPRESS® VARIO and LIQCRYLIC®. The assumption is that because VITRON® M is chemically and functionally identical/similar to these products, it will perform similarly in clinical use.
8. The sample size for the training set
- Not Applicable. This is a physical dental material; there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not Applicable. (See #8)
In summary, the 510(k) for VITRON® M sought to demonstrate substantial equivalence by arguing that it shares the same intended use, fundamental technological characteristics (composition and curing mechanism), and therefore the same safety and effectiveness profile as its long-established predicate devices. The "study" supporting this is essentially a comparative analysis of the product's attributes against the known attributes and history of the predicate devices.
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.