(71 days)
Self-adhesive Resin Cement is intended for the cementation of indirect restoratives including ceramic, composite and metal-based inlays, onlays, crowns, bridges, and posts.
Self-adhesive Resin Cement consists of a base paste and a catalyst paste, mixed to form a dual-curing cement. The Cement is available in five shades and is delivered in double-barrel syringes and unit dose systems.
The provided 510(k) summary for K073173 describes a Self-adhesive Resin Cement and focuses on its substantial equivalence to predicate devices (Unicem, K020256 and MaxCem, K041474). This type of device (dental cement) does not typically involve the kinds of acceptance criteria and performance studies (e.g., diagnostic accuracy, multi-reader multi-case studies) that are common for AI/ML-enabled devices or diagnostic tools.
Instead, the acceptance criteria for a dental cement would revolve around physical and chemical properties, biocompatibility, and adhesive performance as defined by relevant industry standards and comparison to predicate devices. The study to prove it meets acceptance criteria would be a series of laboratory tests demonstrating these properties.
Based on the provided text, here's an attempt to answer the questions, keeping in mind the nature of the device:
Acceptance Criteria and Device Performance for Self-adhesive Resin Cement (K073173)
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary for K073173 does not provide specific numerical acceptance criteria or detailed performance data in a tabular format. The review focuses on substantial equivalence based on the use of previously approved components and general performance and biocompatibility claims.
However, based on the text, the implicit acceptance criteria and reported performance are as follows:
| Acceptance Criterion (Category) | Reported Device Performance (Summary) |
|---|---|
| Compositional Safety | All components have been used in legally marketed devices and/or were found safe for dental use. |
| Biocompatibility | Evaluated and passed biocompatibility testing for cytotoxicity, genotoxicity, irritation, and sensitization. |
| Intended Use Fulfillment | Performance data supports the safety and effectiveness for cementation of various indirect restoratives (ceramic, composite, metal-based inlays, onlays, crowns, bridges, posts). |
| Technological Characteristics | Similar to predicate devices (Unicem, K020256 and MaxCem, K041474) based on the components and intended use. |
Note: Specific quantitative values for properties like bond strength, film thickness, radiopacity, or water sorption, which would typically be part of a dental cement’s performance evaluation, are not present in this summary document. The substantiation is primarily qualitative and comparative to existing devices.
2. Sample Size for the Test Set and Data Provenance
The document does not specify sample sizes for any tests conducted. The "performance data provided" is mentioned but not detailed. Given the nature of a dental cement, a "test set" in the context of an AI/ML device (e.g., patient data) is not applicable here. Instead, it refers to samples of the cement material itself that underwent laboratory testing.
The data provenance is not explicitly stated (e.g., country of origin of data). Such testing is typically conducted in a laboratory setting by the manufacturer or a contracted lab. There is no indication of retrospective or prospective patient data studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This question is not applicable to this device. Dental cements are evaluated based on physical, chemical, and biological properties, not by expert interpretation of images or clinical outcomes that require a "ground truth" derived from human experts in the way that AI/ML diagnostics do.
4. Adjudication Method for the Test Set
This question is not applicable to this device. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers/experts in diagnostic studies, which is not relevant for a dental cement.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. MRMC studies are used to evaluate the diagnostic performance of human readers, with and without AI assistance, typically in medical imaging. This is not pertinent to a dental cement.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable to this device. There is no algorithm or AI component in this self-adhesive resin cement. It is a physical material.
7. The Type of Ground Truth Used
The term "ground truth" as it applies to diagnostic or prognostic studies is not applicable here. The "truth" for a dental cement is established through standardized laboratory tests that measure its physical, chemical, and biological properties against established benchmarks or predicate device performance. For example:
- Physical Property Tests: ASTM or ISO standards for bond strength, film thickness, setting time, etc.
- Biocompatibility: In vitro and in vivo toxicology tests (e.g., ISO 10993 series).
8. The Sample Size for the Training Set
This question is not applicable to this device. There is no AI model requiring a training set. The "development" of the cement involves formulation and testing, not machine learning.
9. How the Ground Truth for the Training Set was Established
This question is not applicable to this device, as there is no training set or AI model.
§ 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.