(162 days)
EsTemp Implant, EsTemp Clear is a non-eugenol temporary cement for luting implantretained crowns, bridges, inlays, onlay and splints.
Estemp temporary resin cement series consists of EsTemp Implant & EsTemp Clear. Each is designed to be suitable for various applications such as cementing temporary crowns, bridges, inlays and splints. They are available in an automix dual barrel syringe. It is light-curing temporary filling materials
The provided text describes the 510(k) summary for the SPIDENT EsTemp Implant and EsTemp Clear dental cements. The information focuses on establishing substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed device performance metrics in the format requested.
Here's an analysis based on the provided text, while acknowledging that a direct "study" as typically understood for AI-driven devices (with acceptance criteria, test sets, ground truth, etc.) is not present for this type of medical device (dental cement).
The submission relies on demonstrating substantial equivalence to a predicate device (Premier Implant Cement, K033309) through various performance characteristics, primarily mechanical and chemical properties, and biocompatibility.
Absence of Information: The provided text does not include information on:
- A test set size or data provenance in the context of an AI/algorithm study.
- Number of experts for ground truth or their qualifications.
- Adjudication method for a test set.
- MRMC comparative effectiveness study.
- Standalone (algorithm only) performance.
- Sample size for a training set or how ground truth was established for it.
1. Table of Acceptance Criteria and Reported Device Performance
Instead of traditional "acceptance criteria" and "device performance" in the context of an AI study, the document presents performance characteristics and biocompatibility test results, indicating passing relative to established standards or equivalence to the predicate device.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate Equivalence/Standards) | Reported Device Performance (EsTemp Implant, EsTemp Clear) |
|---|---|---|
| Chemistry of setting reaction | Equivalent to predicate | Equivalent to predicate |
| Proportion of powder to liquid | Equivalent to predicate | Equivalent to predicate |
| Maximum solubility | Equivalent to predicate | Equivalent to predicate |
| Disintegration | Equivalent to predicate | Equivalent to predicate |
| Dimensional Change | Equivalent to predicate | Equivalent to predicate |
| Working and setting Time | Equivalent to predicate | Equivalent to predicate |
| Bonding Strength | Equivalent to predicate | Equivalent to predicate |
| Optimum Film thickness | Equivalent to predicate | Equivalent to predicate |
| Conductivity | Equivalent to predicate | Equivalent to predicate |
| Amount of heat generated | Equivalent to predicate | Equivalent to predicate |
| Compressive Strength | Equivalent to predicate | Equivalent to predicate |
| Biocompatibility Testing | Adherence to ISO 10993 and FDA Blue Book Memorandum #95-1 | |
| 1. Cytotoxicity | Pass | Pass |
| 2. Sensitization | Pass | Pass |
| 3. Irritation/Intracutaneous reaction | Pass | Pass |
| 4. Subacute toxicity | Pass | Pass |
| 5. Genotoxicity | Pass | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and not provided in the document, as this is not a study of an AI/algorithm. The performance testing refers to physicochemical and biological evaluations of the material itself.
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)
This information is not applicable and not provided. The "ground truth" for dental cement performance is established through standardized laboratory testing protocols (e.g., ISO, ASTM standards for dental materials) and validated methods, not expert consensus in the medical image interpretation sense. The biocompatibility tests follow ISO 10993 standards, conducted by qualified labs.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Data adjudication methods are typically used in clinical or image-based studies to resolve discrepancies among expert readers, which is not relevant for this type of material performance testing.
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
This information is not applicable and not provided. This device is a dental cement, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. This device is a dental cement, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance evaluation of the dental cement is based on:
- Standardized laboratory tests: Results of tests for properties like solubility, dimensional change, working/setting time, bonding strength, film thickness, conductivity, heat generation, and compressive strength, evaluated against recognized dental material standards or in comparison to the predicate device.
- Biocompatibility standards: Confirmation that the device meets the applicable requirements of the FDA Blue Book Memorandum #95-1 and ISO 10993 Biological Evaluation of Medical Devices Part -1.
8. The sample size for the training set
This information is not applicable and not provided. There is no "training set" in the context of this traditional medical device submission.
9. How the ground truth for the training set was established
This information is not applicable and not provided. 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.