(77 days)
CONFORM™ is a light cured (free radical polymerization), flowable composite material, designed for use as a filling material for small restorations, a sealant material for occlusal surfaces, or a lining material in the base of large restorations.
CONFORM™ is a versatile composite material which, when utilized properly, provides a strong, wear resistant material for dental restorations. CONFORM™ can also be used as the initial filled layer or liner of a cavity restoration. When used as a liner, the material provides a strong base that assures the mechanical interface between the bonded tooth substrate and a highly filled composite are optimal. CONFORM™ is compatible with all other methacrylate based dental materials.
CONFORM™ is a light activate (photo initiated, free radical polymerization), flowable hybrid composite material designed to act as a filling material in small restorations or as a liner material for larger restorations. CONFORM™ has been designed to provide a flowable material with a high level of thixotropic behavior. The material also contains fillers to optimize the cured strength and radiopacity properties.
CONFORM™ is a methacrylate (BisGMA) based material that has been designed to work effectively with methacrylate based adhesives and composites currently sold into the dental market.
The provided text is a 510(k) summary for a dental material called CONFORM™ and a letter from the FDA regarding its clearance. It describes the device, its intended uses, and claims substantial equivalence to predicate devices based on "physical testing observations and analysis, including diametric tensile strength and compressive strength." However, it does not contain the detailed information required to answer your specific questions about acceptance criteria and the study that proves the device meets them, as these would typically involve specific metric thresholds, detailed study designs, and human reader performance data, none of which are present here.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, or clinical study methods like MRMC or standalone performance.
The submission focuses on chemical composition similarities and basic physical properties to establish substantial equivalence, not on clinical performance metrics typically associated with AI/device acceptance criteria regarding diagnostic accuracy.
Here's what can be extracted based on the provided document, addressing the structure of your request where possible, but highlighting the missing information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a formal table of acceptance criteria with specific quantitative thresholds. The "Performance Characteristics and Concepts" section states: "CONFORM™ has similar handling to the AELITEFLO® (510K number K955292, Bisco, Inc.) composite. From the physical testing observations and analysis, including diametric tensile strength and compressive strength, we suggest that CONFORM™ is substantially equivalent to AELITEFLO® (510K number K955292, Bisco, Inc.)."
This narrative indicates that the acceptance criteria revolved around demonstrating similar physical properties (handling, diametric tensile strength, and compressive strength) to the predicate device, AELITEFLO®. However, specific numeric ranges or targets for these properties are not disclosed in this summary.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Similar handling to AELITEFLO® | Similar handling |
| Similar diametric tensile strength to AELITEFLO® | Similar diametric tensile strength |
| Similar compressive strength to AELITEFLO® | Similar compressive strength |
| Substantially equivalent to AELITEFLO® | Substantially equivalent |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not reported in this document. The submission references "physical testing observations and analysis" but does not specify the number of samples or specimens tested.
- Data provenance: Not specified. It can be inferred that the testing was conducted by Apex Dental Materials, Inc. (the manufacturer) as part of their submission process. The country of origin and whether it was retrospective or prospective is not stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not reported. This type of information is typically relevant for diagnostic devices where human experts establish ground truth for clinical cases. For a dental material, the "ground truth" would be established through standardized physical property testing, not expert consensus on diagnostic images.
4. Adjudication method for the test set:
- Not applicable/Not reported. As this pertains to physical properties, not clinical adjudication of cases.
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-powered diagnostic device; it is a dental filling material. Therefore, MRMC studies are not relevant in this context.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used:
- For physical property testing (diametric tensile strength, compressive strength), the "ground truth" is typically established by standardized laboratory measurement protocols using calibrated equipment.
8. The sample size for the training set:
- Not applicable. The concept of "training set" is for machine learning models. For a physical material, there isn't a training set in the same sense. The material formulation itself is developed based on chemical and material science principles, not machine learning.
9. How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the context of this traditional medical device. The "ground truth" for the material's properties would be established through the initial R&D and quality control processes based on established material science standards.
§ 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.