(59 days)
TopCEM-Veneer Light Cure Veneer Cement is used for permanent cementation of veneer made from materials of porcelain/ceramic and composites.
TopCEM-Veneer Light Cure Veneer Cement is a visible light curing cementation system that is designed for use with porcelain/ceramic and composite veneer restorations. The simple and versatile shade selections allow this material to be used with a wide range of veneer cases. The principal organic components are mixtures of dental methacrylate resins (TEGDMA, EBP ADMA and UDMA). The inorganic filler loading is about 40% by volume having particle size range of about 0.01 to 5 microns. Light Cure Veneer Cement is radiopaque, allowing for easy identification on radiographs. It is classified as Type 2 Class 2 Group 1 in accordance with ISO 4049:2019, which belongs to materials whose use requires the energy to be applied intro-orally.
The provided text is an FDA 510(k) summary for a dental cement (TopCEM-Veneer Light Cure Veneer Cement). It describes the device, its intended use, and bench testing performed to demonstrate substantial equivalence to predicate devices.
However, the request asks for information about acceptance criteria and a study proving a device meets these criteria, specifically in the context of an AI/ML-enabled medical device performance study. The document supplied does not describe an AI/ML-enabled device or any studies involving human readers, AI assistance, or ground truth establishment by experts. Instead, it describes a conventional material science device (dental cement) and its testing against physical and chemical properties standards (ISO 4049, ISO 29022).
Therefore, I cannot extract the requested information (such as AI/ML specific acceptance criteria, sample size for test/training sets in an AI context, expert qualifications, MRMC studies, standalone algorithm performance, or ground truth establishment for AI models) from the provided text. The document refers only to "bench testings" of physical and chemical properties.
Response based on the provided document:
The provided document describes the acceptance criteria and study for a dental cement, not an AI/ML-enabled medical device. Therefore, many of the requested categories related to AI/ML device performance studies (e.g., number of experts, adjudication methods, MRMC studies, standalone AI performance, training/test set details for AI) are not applicable and are not present in the text.
Here's an attempt to answer the relevant parts based only on the provided text, while explicitly stating when information is not applicable or not provided for an AI/ML context.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard / Parameter) | Reported Device Performance (Conclusion) |
|---|---|
| ISO 4049 (5.2.2) Film thickness, luting materials: ≤ 50 µm | Satisfactory |
| ISO 4049 (5.2.7) Sensitivity to ambient light: Remain physically homogeneous | Satisfactory |
| ISO 4049 (5.2.8) Depth of cure: ≥ 1 mm (opaque) or ≥ 1.5 mm (other) | Satisfactory |
| ISO 4049 (5.2.9) Flexural strength: ≥ 50 MPa | Satisfactory |
| ISO 4049 (5.2.10) Water sorption: ≤ 40 µg/mm³ | Satisfactory |
| ISO 4049 (5.2.10) Solubility: ≤ 7.5 µg/mm³ | Satisfactory |
| ISO 4049 (5.5) Radio-opacity: ≥ same thickness of aluminium (1 mm of material) | Satisfactory |
| Shear bond strength (ISO 29022) | Meet internal standards |
| Bonding durability (ISO 29022) | Meet internal standards |
| Compressive strength | Meet internal standards |
| Elastic modulus | Meet internal standards |
| Surface hardness | Meet internal standards |
| Filler particle size distribution | Meet internal standards |
| Curing time | Meet internal standards |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated in terms of specific number of samples tested for each criterion. The document states "Bench testings were performed on the subject device and the predicate devices."
- Data Provenance: Not specified in terms of country of origin for the testing data. The submitter is Rizhao HuGe Biomaterials Company, Ltd., China. The tests refer to international standards (ISO).
- Retrospective or Prospective: Not applicable for this type of material bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as the study is not based on expert interpretation of medical images or data requiring "ground truth" establishment by human experts in the context of an AI/ML device. The "ground truth" here is determined by compliance with material properties standards (e.g., a film thickness measurement must be ≤ 50 µm).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This concept typically applies to human reader studies or expert consensus for AI/ML ground truth, which is not described here.
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, this was not done. The device is a dental cement, not an AI/ML diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" or reference for the physical and chemical properties tests is established by international standards (ISO 4049, ISO 29022) and FDA guidance for dental composite resin devices. The "ground truth" is adherence to predefined physical/chemical limits.
8. The sample size for the training set
- Not applicable. This device is a physical material, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As stated above, this is a physical material tested against standards, not an AI/ML model with a training set.
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.