(94 days)
XeraCem is intended for the permanent cementation of
- Porcelain Fused to Metal Crowns and Bridges .
- Metal (gold etc.) crowns and bridges .
- Gold inlays and onlays .
- . Prefabricated metal and cast posts
- . Prefabricated metal provisional crowns
- . All-zirconia or all-alumina ceramic crowns and bridges
XeraCem is a hybrid between glass ionomer cement and ceramic cement based on calcium aluminate. It combines the advantages of glass ionomer cements with those of calcium aluminum based cements. XeraCem is a hand mixed cement and consists of a powder (XeraCem powder) and a liquid (XeraCem liquid).
Here's an analysis of the provided text, focusing on the acceptance criteria and the study used to demonstrate the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Clinically safe | Passed biocompatibility testing of cytotoxicity, genotoxicity, irritation, and sensitization. |
| Clinically effective | Functioned as intended; performance observed was as expected. |
| Substantially Equivalent to Predicate Devices | XeraCem is as safe and effective as the predicate devices (KetacTM Cem Maxicap and DoxaDentTM). It has the same intended uses and similar indications, technological characteristics, and principles of operation. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state a sample size for a test set or the data provenance in terms of country of origin or whether a study was retrospective or prospective.
Instead, the submission relies on:
- Comparison to predicate devices: "Various physical and mechanical studies were conducted to compare XeraCem the predical realidas [sic]."
- Biocompatibility testing: "XeraCem has been evaluated and passed biocompatibility testing of cytotoxicity, genotoxicity, irritation, and sensitization."
These are general descriptions of tests, not specific clinical study outlines with sample sizes for a 'test set.'
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The text does not mention the use of experts to establish ground truth for a test set. The evaluation focuses on physical/mechanical properties and biocompatibility.
4. Adjudication Method for the Test Set
The text does not describe an adjudication method as typically found in studies with human interpretation or subjective endpoints.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a dental cement, and its evaluation does not involve human readers interpreting images or data for diagnostic purposes that would necessitate an MRMC study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
N/A. This question is applicable to AI/algorithm-driven devices. XeraCem is a physical dental cement, not an algorithm, so the concept of "standalone performance" in this context does not apply.
7. The Type of Ground Truth Used
The ground truth for XeraCem's evaluation was primarily based on:
- Objective physical and mechanical properties: Comparison to established values or performance of predicate devices.
- Biocompatibility standards: Passing established tests for cytotoxicity, genotoxicity, irritation, and sensitization.
- Performance as intended: Functional performance observed as expected.
8. The Sample Size for the Training Set
The provided text does not mention a training set sample size. This is because XeraCem is a product of materials science and engineering, not a machine learning model that requires training data.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" in the context of this dental cement, the question of how ground truth was established for it is not applicable. The development and validation of the cement would follow materials science and engineering principles, with testing against established specifications and predicate devices.
§ 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.