(113 days)
TopCEM-Try in Veneer Try-in Gel is used to evaluate the shade and the matching of the restoration prior to permanent cementation.
TopCEM-Try in Veneer Try-in Gel is primarily made of polyethylene glycol, inorganic fillers and pigments. It is used to indicate the color of the Light Cure Veneer Cement before use, so as to select the right color to achieve the best aesthetic effect. The polyethylene glycol and inorganic filler in the Veneer Try-in Gel component are hydrophilic and can be rinsed off with a water gun nozzle after the color test operation. The principal organic components of TopCEM-Try in Veneer Try-in Gel are mixtures of polyethylene glycol, and the inorganic fillers loading is about 50% by volume.
The provided document is a 510(k) premarket notification for a dental product, TopCEM-Try in Veneer Try-in Gel. It concerns the substantial equivalence determination for this device, which means proving it is as safe and effective as a legally marketed predicate device.
The document does not describe an AI medical device or a study involving AI, machine learning, or human readers. Therefore, many of the requested details about acceptance criteria, test sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, and standalone performance are not applicable to this document.
However, I can extract the information that is provided regarding the device's performance based on the general format and content of the filing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Stated as "Pass/fail criteria" or "internal standards") | Reported Device Performance (Conclusion) |
|---|---|
| Meet internal standards for Appearance | Satisfactory |
| Meet internal standards for Shade | Satisfactory |
| Meet internal standards for Liquidity | Satisfactory |
| Meet internal standards for Consistence | Satisfactory |
| Conform to HuGe internal inspection standard for Physical Properties | Substantially equivalent (to predicate) |
| Biological evaluation according to ISO 10993 standards and FDA guidance | Passed Cytotoxicity, Sensitization, and Irritation tests |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to "Bench testing" performed on the subject device and the primary predicate device. It also states that biological evaluation (biocompatibility tests) was performed.
- Sample size: Not specified.
- Data provenance: Not specified, but the tests were performed by Rizhao HuGe Biomaterials Company, Ltd. in China. The nature of these tests (bench testing, biocompatibility) implies they are prospective tests conducted on manufactured samples.
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. The "ground truth" for the physical and chemical properties as well as biocompatibility tests would be the established scientific and regulatory standards (e.g., ISO 10993 for biocompatibility, and the company's internal standards for physical properties). These do not typically involve human expert consensus in the same way an AI diagnostic device's ground truth would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing a consensus ground truth in studies involving human interpretation or subjective assessments, which is not the case for the type of bench testing and biocompatibility reported 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
Not applicable. This is not an AI medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For physical and chemical properties: "HuGe internal inspection standard" for parameters like appearance, shade, liquidity, and consistence.
- For biocompatibility: International Standard ISO 10993-1 and FDA guidance for biological evaluation of medical devices.
8. The sample size for the training set
Not applicable. There is no training set mentioned 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 mentioned as this is not an AI/ML device.
§ 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.