(275 days)
FixTemp ™ Cement is a dental luting agent indicated for:
- temporary cementation of provisional crowns and bridges,
- cementing of semi-permanent implants.
The Fixtemp Cement is designed as a luting cement for temporary dental applications. This dental cement having the active ingredients of zinc oxide does not include Eugenol. This lack of Eugenol does not reduce structural properties but allows a choice among healthcare professionals where Eugenol can cause objectionable results.
The provided text is for a 510(k) premarket notification for a dental cement called FixTemp Cement. This document primarily focuses on establishing substantial equivalence to a predicate device, not on presenting a detailed clinical study demonstrating the device's performance against specific acceptance criteria in a medical AI context. Therefore, much of the requested information regarding AI device studies (e.g., sample sizes for test/training sets, number of experts for ground truth, MRMC studies) is not applicable to this document.
However, the document does contain "acceptance criteria" in the form of performance characteristics used to demonstrate substantial equivalence to a predicate device.
Here's the information that can be extracted or inferred from the provided text, adapted to the request:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are the performance characteristics of the predicate device, which the FixTemp Cement aims to match or exceed.
| Acceptance Criteria (Predicate Device TempoCem K110759) | Reported Device Performance (FixTemp™ Cement) |
|---|---|
| Physical Properties (ISO 3107) | |
| Film Thickness: Less than 20 µm | Less than 20 µm |
| Setting Time: 4 min | Approx. 4 - 7 min |
| Compressive Strength: 8 MPa | More than 8MPa |
| Working Time: 1 minute | More than 1 min |
| Other Characteristics | |
| Compliance to standard: ISO3107 | ISO3107 |
| Container: double cartridge or syringe | double cartridge or syringe |
| Dispenser: injector / syringe | injector / syringe |
| Paste Ratio: 1:1 ? | 1:1 |
| Appearance: Homogeneous and smoothly consistent | Homogeneous and smoothly consistent |
| Storage: Room temperature, dry (15-25°C) | Room temperature, dry (15-25°C) |
| Indications for Use: Temporary cementation of crowns and bridges or provisional cementation of crowns and bridges on implant abutments | Indicated for luting of temporary dental prosthesis (crowns, inlays, onlays) (Note: The document also states "Same" for the predicate's full indications, indicating broad equivalence) |
| Intended Use: Temporary luting and cementation of temporary crowns and bridges | Temporary luting and cementation of temporary crowns and bridges |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document refers to "a series of factory tests" and "testing has confirmed this device meets its product specification," but does not provide details on sample sizes for these tests.
- Data Provenance: The tests are referred to as "factory tests," implying they were conducted by the manufacturer, Exacta Dental Direct, Inc. No information regarding country of origin of the data or whether it was retrospective/prospective is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This document describes performance testing of a dental cement, not an AI device requiring expert-established ground truth from images or other medical data. The ground truth for physical properties (like film thickness, setting time) would be based on standardized laboratory measurements.
4. Adjudication method for the test set
- Not applicable. See point 3. Performance is based on direct physical measurements against a standard (ISO 3107), not on human adjudication of classification or detection tasks.
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
- Not applicable. This document is for a dental cement, not an AI medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This document is for a dental cement, not an AI medical device.
7. The type of ground truth used
- The ground truth for the performance characteristics (e.g., film thickness, setting time, compressive strength, working time) is established by physical measurements based on recognized international standards (ISO 3107). These are objective, quantitative measurements.
8. The sample size for the training set
- Not applicable. This document does not describe the development of an AI model; 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. See point 8.
§ 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.