(73 days)
ENA TEMP/ ENAMEL PLUS TEMP is a system of liquid and powder resin available in different colours, for aesthetic temporary crown and bridge. It can be used both in laboratory (by indirect method: diagnostic waxing up or vacuum forming matrix) and in dental practice (by direct method in the mouth: silicone impression or preformed crown).
ENA TEMP/ ENAMEL PLUS TEMP is a system of liquid and powder resin available in different colours, for aesthetic temporary crown and bridge. It can be used both in laboratory (by indirect method: diagnostic waxing up or vacuum forming matrix) and in dental practice (by direct method in the mouth: silicone impression or preformed crown). Please note that the resin is absolutely the same, but they will be sold with two different brand names for commercial reasons. So, in order to simplify, from here on they will be denoted as "Temp"
This document describes a 510(k) premarket notification for a dental device, specifically a temporary crown and bridge resin. It focuses on establishing substantial equivalence to a predicate device rather than detailing extensive clinical trials with specific acceptance criteria and outcome measurements usually found in PMAs or clinical studies for novel devices.
Therefore, the requested information about acceptance criteria, study design, sample sizes for test and training sets, ground truth establishment, expert qualifications, and MRMC studies is largely not present in the provided text. The submission focuses on compliance with performance standards and comparison to a predicate device.
Here's a breakdown of what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated/Implied) | Reported Device Performance |
|---|---|
| Compliance with ISO 20795 (Denture Materials) | Listed as complying. |
| Compliance with ISO 10477 (Crowns and Bridges) | Listed as complying. |
| Substantial Equivalence to K000894 (C&B RESIN PLUS POWDER/LIQUID, MODELS RETEMP A2, A3, A3.5, CL, RETEMP B2, B3, C2, D3, WH. RE by DENTAL VENTURES OF AMERICA, INC) | Stated as substantially equivalent. The specific performance metrics used for this equivalence are not detailed. |
| Addressing identified risks: | The document lists risks (Allergic reaction, No or incomplete stability, Gaps at tooth side if not tight, Secondary caries, Irritation of respiratory system and skin) but does not provide specific performance data or tests demonstrating how these risks are mitigated or how performance meets criteria related to them. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not mentioned. No specific "test set" in the context of a clinical performance study is described. The evaluation appears to be based on bench testing (compliance with ISO standards) and comparison to existing products.
- Data Provenance: Not applicable, as detailed patient data or clinical study data is not presented. The submission is from Micerium SpA, Italy.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not mentioned.
- Qualifications: Not mentioned.
This type of information would be relevant for clinical studies where expert review is used to establish ground truth for a diagnostic or AI-driven device. This submission is for a material used in dentistry, and its performance evaluation likely relies on material science testing rather than expert-adjudicated clinical outcomes.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No clinical test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI Assistance
- MRMC Study: No, an MRMC study was not done. This device is a dental material, not an AI-driven diagnostic tool or a system involving human readers interpreting outputs.
- Effect Size of AI: Not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: Not applicable. This is not an algorithmic device.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for this device's performance would primarily be established through material property testing against ISO standards (ISO 20795 for denture materials and ISO 10477 for crowns and bridges) and comparison to the identified predicate device (K000894) based on specifications and intended use. There is no mention of pathology, outcomes data from patients, or expert consensus in the clinical sense for establishing ground truth for this particular submission.
8. The Sample Size for the Training Set
- Sample Size: Not applicable. This is not an AI/ML device that requires a training set. The device is a resin for temporary crowns and bridges.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable, as there is no training set for an AI/ML model.
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.