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510(k) Data Aggregation
(157 days)
WRIGHT HEALTH GROUP LTD.
These dental plastic teeth are parts used for denture fabrication. PMMA is mixed with monomer in a polymenzation process. The plastic teeth are part of dentures made to fit a patient's mouth which are removable or may be attached to dental implant devices.
The synthetic plastic teeth are used in the production of dentures. They are produced from a I he synuletic process. Polymethylmethacrylate or PMMA is mixed with methylmethacrylate monomer, a cross linking agent and non-toxic pigments under heat and pressure. Once the monomer, a cross iniking agoit and non teen are checked for flash and polished according to the relevant model characteristics.
The provided text is a 510(k) summary for "Denture Preformed Plastic Teeth Proprietary Models: Dentavit, Monarch, Acrotone, Senator, Dentorium". This document is a premarket notification to the FDA for medical devices.
Crucially, this document describes a device that is a physical product (plastic teeth for dentures), not an AI/ML powered device, a diagnostic device, or a software device that would require performance criteria in the way your request outlines.
Therefore, the requested information about acceptance criteria, study details, sample sizes, experts, MRMC studies, standalone performance, and ground truth types is not applicable to this document.
The 510(k) summary focuses on demonstrating Substantial Equivalence to legally marketed predicate devices, meaning it argues that the new device is as safe and effective as existing, approved devices.
Here's a breakdown of what the document does provide, related to its safety and effectiveness, in the context of substantial equivalence:
1. Acceptance Criteria and Reported Device Performance (as applied to Substantial Equivalence):
Instead of performance metrics like sensitivity, specificity, or AUC for an AI device, this document demonstrates equivalence through material composition, manufacturing process, and adherence to established standards.
| Acceptance Criterion | Reported Device Conformance/Evidence |
|---|---|
| Chemical Composition (material) | "The plastic teeth have comparable chemical composition as the predicate devices." (Utilizes Polymethylmethacrylate or PMMA, methylmethacrylate monomer, cross-linking agent, non-toxic pigments.) |
| Physical Characteristics (size, shape, color) | "The models are similar in size, shape, color, and usage to the predicate devices." |
| Manufacturing Process | "The added models use the same materials and controls established for over 20 years." and "PMMA is mixed with monomer in a polymerization process." |
| Intended Use | "The intended use for these plastic teeth is to make partial or full dentures." (Matches predicate devices). "These dentures are made to fit the patient's mouth as a removable device, not implanted. These plastic tech may also be attached to dental implants." |
| Conformity to Standards | - CE Medical Directive 93/42/EEC 2007/47/EC |
- ISO9001/GMP/ISO13485: Quality System Certification
- ADA specification No. 15:2008 Artificial Teeth
- BS EN ISO22112:2006
- Biocompatibility Standards ISO10993-1, ISO7405:2008 |
| Lack of New Safety/Effectiveness Questions | "This control activity shows that there are no new questions of safety and effectiveness for the plastic teeth models made by Wright." "The minor differences raise no new issues of safety or effectiveness." |
| Company History/Experience | "Wright has been a manufacturer for about 100 years and has been in the market for over 40 years and has met preamendment rules. There are no significant health incidents in that time." |
The following points cannot be answered from the provided text as they relate to AI/ML or diagnostic device studies, which is not what this document describes:
- Sample sizes used for the test set and the data provenance: Not applicable. There is no "test set" in the context of an AI/ML algorithm evaluation. The "testing" referred to is physical materials reliability and safety testing.
- 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 AI/ML sense.
- 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 not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical product, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable. There is no AI/ML model with a training set.
- How the ground truth for the training set was established: Not applicable.
In summary: This 510(k) pertains to denture teeth, a traditional medical device, not a software or AI-powered one. Therefore, the typical performance criteria and study design elements for AI/ML devices or diagnostics as requested are not present in this submission. The "study" proving acceptance criteria is a compilation of material testing, adherence to manufacturing quality standards, and comparison to predicate devices, all aimed at demonstrating substantial equivalence.
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