(59 days)
3MTM M.G. Material is designed for making impressions that record the occlusal relationship of the upper and lower dental arches. It is also intended to be used as a matrix when fabricating temporary crowns and bridges.
3MTM M.G. Material is designed to make fast, accurate, and rigid interocclusal records. The material has a consistency which resists slumping and offers minimal resistance to closure to ensure proper occlusion. 3M™ M.G. Material may also be used as a matrix material when fabricating custom temporary crowns and bridges. It is a two-part vinyl polysiloxane paste with an addition-cure reaction. The base and catalyst pastes are extruded from dual-barrel cartridges through a mixing tip onto the occlusal surfaces of the teeth. The material quickly cures into a rigid impression.
The provided documentation (K981325) is a 510(k) summary for a dental product, 3M™ M.G. Material. It focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and bench test results.
Crucially, this document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML-based device with performance metrics like sensitivity, specificity, or AUC.
The product described is a physical dental material (bite registration material), not a software or AI/ML device that would typically involve a test set, ground truth, experts, or MRMC studies. The "performance" discussed relates to material properties through bench tests.
Therefore, many of the requested categories are not applicable to the provided document. I will fill in what information is available and indicate when requested information is not present.
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Bench Test: Strain in Compression | Not explicitly stated as numerical criteria, but implied to be comparable to or better than predicates. | Compared to predicate devices. |
| Bench Test: Detail Reproduction | Not explicitly stated as numerical criteria, but implied to be comparable to or better than predicates. | Compared to predicate devices. |
| Bench Test: Mixed Consistency | Not explicitly stated as numerical criteria, but implied to be comparable to or better than predicates. | Compared to predicate devices. |
| Bench Test: Linear Dimensional Change | Not explicitly stated as numerical criteria, but implied to be comparable to or better than predicates. | Compared to predicate devices. |
| Overall Safety & Effectiveness | "safe, effective, and performs as well or better than the predicate devices." | "Based on the safety analysis and the bench tests, 3M™ M.G. Material is safe, effective, and performs as well or better than the predicate devices." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This document describes the testing of a physical dental material, not an AI/ML device. Bench tests were performed, but no "test set" in the context of data for an algorithm is mentioned.
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. No ground truth established by experts is mentioned, as this is a physical material tested via bench methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No adjudication method for a "test set" (in the context of AI/ML data) is described.
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
- No. An MRMC study was not done. This product is a dental impression material, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This product is a physical dental material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable / Bench Test Standards. The "ground truth" for the bench tests would be the established scientific and engineering standards and methods used to measure material properties. There's no clinical "ground truth" (like pathology or expert consensus) relevant here.
8. The sample size for the training set
- Not Applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not Applicable. There is no "training set" or "ground truth" in this context.
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).