(52 days)
- [1] Cementation of crowns, bridges, inlays and onlays made of porcelain, ceramic, composite resin or metal
- [2] Cementation of porcelain, ceramic, composite resin or metal restorations on implant abutments
- [3] Cementation of metal cores, resin cores, metal posts or glass fiber posts
PANAVIA SA CEMENT Automix is a dual-cure (light- and/or self-cure), radiopaque self-adhesive resin cement for porcelain, ceramic, composite resin and metal restorations. It is supplied in an automix delivery system which can mix equal amount of two components.
The provided text describes a 510(k) submission for a dental cement (PANAVIA SA CEMENT Automix) and explicitly states that it complies with ISO 4049: 2009. However, the document does not present specific acceptance criteria in a table format with corresponding device performance data, nor does it detail a study that proves the device meets specific acceptance criteria in the manner requested (e.g., sample size, ground truth, expert adjudication, MRMC studies, standalone performance).
The information available is primarily focused on demonstrating substantial equivalence to predicate devices rather than proving performance against quantitative acceptance criteria through a detailed study.
Here's an analysis of what is provided, and where information is missing based on your request:
1. A table of acceptance criteria and the reported device performance
- Available Information: The document states, "PANAVIA SA CEMENT Automix complies with all requirements of ISO 4049: 2009 as polymer-based restorative materials." It also mentions, "And also, the bond strength of the subject device is equivalent to that of the predicate devices."
- Missing Information/Cannot Create Table: The specific requirements of ISO 4049: 2009 (e.g., flexural strength, water sorption, solubility, film thickness, radiopacity) are not detailed, nor are the actual measured performance values for PANAVIA SA CEMENT Automix presented alongside those specific ISO requirements. The document only provides a high-level statement of compliance. No numerical acceptance criteria or performance data are given for "bond strength."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Missing Information: This information is not provided in the document. The text does not describe a "test set" in the context of clinical or performance evaluation with a specified sample size or data provenance. The assessment is based on compliance with ISO standards and chemical ingredient comparison, not a "test set" in the typical sense for AI/medical device performance evaluation.
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)
- Missing Information: Not applicable to the type of information presented. This document is related to material properties and substantial equivalence, not a diagnostic device requiring expert ground truth for image interpretation or similar tasks.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Missing Information: Not applicable for the reasons stated above.
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
- Missing Information: Not applicable. This is not an AI-assisted diagnostic device, but a dental cement.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Missing Information: Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Available Information (Implicit): The "ground truth" for this device's performance relies on ISO 4049: 2009 standards for physical and mechanical properties, and chemical ingredient equivalence to predicate devices. For bond strength, the "ground truth" appears to be comparative testing against predicate devices.
- Missing Information: Specific details of these "ground truths" (e.g., the specific parameters from ISO 4049: 2009, the methodology for comparing bond strength) are not provided.
8. The sample size for the training set
- Missing Information: Not applicable as this document is not about an AI/ML device with a "training set."
9. How the ground truth for the training set was established
- Missing Information: Not applicable.
Summary of Device Acceptance Criteria and Study Information (Based on provided text):
Acceptance Criteria:
| Criterion Category | Specifics (from text) |
|---|---|
| Material Properties | Compliance with ISO 4049: 2009 for polymer-based restorative materials. The subject device is classified as Class 3: materials that are cured by the application of external energy and also have a self-curing mechanism present. |
| Effectiveness/Performance | Bond strength equivalent to predicate devices. |
| Chemical Ingredients / Safety | All chemical ingredients are the same as predicate device (CLEARFIL SA CEMENT). No reported problems or recalls for predicate device. |
| Biocompatibility | All chemical ingredients are the same as predicate device (CLEARFIL SA CEMENT). No reported problems or recalls for predicate devices. |
| Intended Uses | Indications for use are substantially the same as predicate devices. |
Study and Performance Information:
| Feature | Details (from text) |
|---|---|
| Reported Device Performance | - Complies with all requirements of ISO 4049: 2009. |
- Bond strength is equivalent to that of predicate devices. |
| Sample Size (Test Set) | Not specified (no clinical or performance test set described in detail). |
| Data Provenance (Test Set) | Not specified. |
| Number of Experts (Ground Truth) | Not applicable (device evaluation is based on standards compliance and chemical composition, not expert interpretation). |
| Qualifications of Experts | Not applicable. |
| Adjudication Method (Test Set) | Not applicable. |
| MRMC Comparative Effectiveness Study? | No. |
| Standalone Performance Study? | No (this refers to an algorithm's performance; the device is a material). Its "standalone performance" is compliance with ISO 4049. |
| Type of Ground Truth Used | - ISO 4049: 2009 standards for physical/mechanical properties. - Chemical composition equivalence.
- Comparative bond strength data (details not provided). |
| Sample Size (Training Set) | Not applicable. |
| Ground Truth for Training Set | Not applicable. |
§ 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.