(112 days)
Preformed denture teeth used for total and partial dentures and implant-supported removable prostheses.
Preformed denture teeth used for total and partial dentures and implant-supported removable prostheses.
The provided 510(k) summary describes a device, SR Vivodent S, SR Orthotyp S, SR Ortholingual S, which are preformed denture teeth. This notification is for a dental device, not an AI/ML powered medical device. Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC comparative effectiveness study, standalone performance, training set size) are not applicable to this type of device submission.
The submission focuses on demonstrating substantial equivalence to predicate devices (SR Vivodent PE, SR Orthotyp PE, and Phonares II) through material composition, performance data, and indications for use.
Here's the information that can be extracted from the provided text according to your request:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Artificial denture teeth performance | Meets requirements defined in ISO 22112:2005 (Artificial denture teeth) | The device has been tested and meets these requirements. |
| Flexural Strength | Meets requirements defined in ISO 10477:2004 (Polymer based crown & bridge materials) | The device has been tested and meets these requirements. |
| Water Sorption | Meets requirements defined in ISO 10477:2004 (Polymer based crown & bridge materials) | The device has been tested and meets these requirements. |
| Solubility | Meets requirements defined in ISO 10477:2004 (Polymer based crown & bridge materials) | The device has been tested and meets these requirements. |
| Ball Indentation Test | Meets requirements defined in DIN EN ISO 2039-1 | The device has been tested and meets these requirements. |
| Biocompatibility | Meets requirements defined in ISO 10993 (Biological evaluation of medical devices) | Biocompatibility testing and evaluation was carried out according to ISO 10993. The device's composition (PMMA) is well known and accepted as biocompatible. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable for this type of device. The submission references compliance with international standards for material properties and performance rather than clinical test sets with specified sample sizes or data provenance. The testing would have been conducted in a laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. Ground truth in the context of AI/ML or diagnostic devices is not relevant here. The "ground truth" for this device is its adherence to established material and performance standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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 a physical dental device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is compliance with international standards (ISO 22112:2005, ISO 10477:2004, DIN EN ISO 2039-1, ISO 10993) for material properties and physical performance.
8. The sample size for the training set
- Not applicable. This device does not involve machine learning or a "training set."
9. How the ground truth for the training set was established
- Not applicable.
§ 872.3590 Preformed plastic denture tooth.
(a)
Identification. A preformed plastic denture tooth is a prefabricated device, composed of materials such as methyl methacrylate, that is intended for use as a tooth in a denture.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.