(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 Handmix is a dual-curc (light- and/or self-cure), radiopaque self-adhesive resin cement for porcelain, ceramic, composite resin and metal restorations. It is intended for the following indications:
(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
It is classified into dental cement (21 CFR section 872,3275. Product code: EMA ) according to 21 CFR§872 since it is composed of various materials other than zinc oxide-eugenol.
Physical and mechanical properties of the subject device were evaluated according to ISO 4049: 2009 (Dentistry - Polymer-based restorative and materials). According to ISO 4049: 2009, the subject device is classified into the following:
Class 3: materials that are cured by the application of external energy and also have a self-curing mechanism present
(This product contains the adhesive monomer. ISO 4049:2009 does not cover the polymer-based luting materials that have an adhesive component within the structure of the material. However, we tested referring to this standard.)
Here's a breakdown of the acceptance criteria and study information for the PANAVIA SA CEMENT Handmix device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Set by ISO 4049:2009 for Class 3 Polymer-based Restorative Materials) | Reported Device Performance (PANAVIA SA CEMENT Handmix) |
|---|---|
| Compliance with all requirements of ISO 4049: 2009 for polymer-based restorative and materials. | Complies with all requirements of ISO 4049: 2009. |
| Bond strength equivalent to predicate devices. | Bond strength is equivalent to that of the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific sample size for a "test set" in the context of clinical performance or a separate evaluation. The performance claims are based on compliance with an ISO standard and comparison to predicate devices, which implies lab-based testing. Therefore, we cannot determine a sample size for a test set, its provenance, or whether it was retrospective or prospective from this document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The "ground truth" for the device's performance is established by its compliance with the physical and mechanical property requirements of ISO 4049:2009 and comparison of bond strength to predicate devices. This type of evaluation does not typically involve expert consensus on a test set of clinical cases.
4. Adjudication Method for the Test Set
Not applicable, as there is no mention of a clinical test set or adjudication process in the provided text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or performed for this device. The evaluation focuses on the physical and mechanical properties of the dental cement itself, not on human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done.
Not applicable. This device is a dental cement, not an AI algorithm. Therefore, a standalone performance evaluation of an algorithm is not relevant.
7. The type of ground truth used
The "ground truth" for the device's performance is based on:
- A recognized international standard: ISO 4049:2009 (Dentistry - Polymer-based restorative and materials). This standard defines specific physical and mechanical properties that the material must meet.
- Comparison to predicate devices: The bond strength of the device was compared to that of existing, legally marketed predicate devices.
8. The Sample Size for the Training Set
Not applicable. This device is a physical material (dental cement), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" for this type of device.
§ 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.