(60 days)
This device is indicated for:
- Base/liner under direct restorations .
- Pit and fissure sealant .
- Veneer Cementation .
- Undercut blockout ●
- Restoration of minimal, shallow, Class V preparations ●
- Restoration of minimally invasive cavity preparations, including air abrasion and tunnel . preparations
- . Repair of small defects in composite and ceramic indirect restorations including veneers, inlays, onlays, crowns and bridges
- . Repair of small marginal defects in direct restorations
- Repair of acrylic temporary marginal defects .
3M™ LVR System is a single part, light curing restorative composite. This device, as well as the predicate devices, are based on methacrylate resin chemistry incorporating an inorganic filler.
The provided text describes the 3M™ LVR System, a light-curing restorative composite, and its 510(k) submission for market clearance. However, it does not include the detailed information needed to fill out all sections of your request regarding acceptance criteria and a study proving the device meets those criteria, especially in the context of an AI/human-in-the-loop system.
The submission is for a dental material, not an AI-powered diagnostic or assistive device. Therefore, many of your requested fields, such as "multi reader multi case (MRMC) comparative effectiveness study," "human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the-loop performance)," and specifics about training and test sets common in AI studies, are not applicable to this type of device.
The "study" mentioned for this device is a series of bench tests comparing its physical and chemical properties to predicate devices and adherence to an ISO standard.
Here's an attempt to extract and present the relevant information based on the provided text, acknowledging the limitations for an AI-focused analysis:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the 3M™ LVR System "meets ISO 4049-1988 'Dentistry - Resin-based filling materials'" and that bench tests were conducted. The acceptance criteria are implicitly those defined by the ISO standard and the performance of the predicate devices. The reported device performance is that it met these criteria.
| Acceptance Criteria Category | Specific Criteria (Implicitly from ISO 4049-1988 and Predicate Device Performance) | Reported Device Performance |
|---|---|---|
| Physical/Chemical Properties | Watts shrinkage (comparable or better than predicates) | Met (comparable results to predicate devices) |
| Wear resistance (comparable or better than predicates) | Met (comparable results to predicate devices) | |
| Compressive strength (comparable or better than predicates) | Met (comparable results to predicate devices) | |
| Diametral tensile strength (comparable or better than predicates) | Met (comparable results to predicate devices) | |
| Film thickness (comparable or better than predicates) | Met (comparable results to predicate devices) | |
| Thermal Expansion Coefficient (comparable or better than predicates) | Met (comparable results to predicate devices) | |
| Flow (comparable or better than predicates) | Met (comparable results to predicate devices) | |
| Water sorption (comparable or better than predicates) | Met (comparable results to predicate devices) | |
| International Standard | Compliance with ISO 4049-1988 "Dentistry - Resin-based filling materials" | Device "meets ISO 4049-1988" |
| Safety and Effectiveness | Safe, effective, and performs as well or better than predicate devices | Concluded to be "safe, effective and performs as well or better than the predicate devices" |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified for each individual bench test. Bench tests typically involve a defined number of samples per test, but the exact count is not provided in this summary.
- Data Provenance: The text does not specify the country of origin for the data. The tests were presumably conducted internally by 3M Dental Products Laboratory. The data is retrospective in the sense that the tests were completed before the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For a dental material, "ground truth" is established by laboratory measurement equipment and adherence to defined physical and chemical standards (e.g., ISO methods) rather than expert consensus on diagnostic images.
4. Adjudication method for the test set
Not applicable. Adjudication methods (like 2+1, 3+1) are relevant for human-interpreted data, such as medical image diagnostics, not for laboratory bench tests of material properties.
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 dental restorative 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 is a physical product, not an algorithm.
7. The type of ground truth used
The ground truth used for the "study" (bench tests) is based on objective measurements of material properties (e.g., shrinkage, strength, wear) according to established laboratory protocols and adherence to an international standard (ISO 4049-1988). The performance of predicate devices also serves as a comparative "ground truth" for demonstrating substantial equivalence.
8. The sample size for the training set
Not applicable. This device is not an AI algorithm that requires a "training set." The materials themselves are developed through R&D, not trained on data in the AI sense.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 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.