(37 days)
Temp-Bond NE is a non-eugenol temporary cement used for the cementation of temporary restorations.
The device is a non-eugenol temporary cement that is used for the cementation of temporary restorations. Temp-Bond NE 2 is a two-part, base/catalyst - paste/paste system. The product will not inhibit the set of permanent resin cements or soften acrylic temporary restorations. Temp-Bond NE 2 is indicated for patients who are allergic to eugenol.
The provided 510(k) summary for Temp-Bond NE 2 does not contain the information requested regarding acceptance criteria and performance studies in the specific format required.
This document is a premarket notification (510(k)) submission to the FDA. Such submissions primarily focus on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive performance study data against pre-defined acceptance criteria, especially for a Class II device like a temporary dental cement. The focus is on comparing the new device's characteristics (materials, intended use, and performance) to the predicate.
Therefore, I cannot populate the table or answer most of the questions based on the provided text.
Here is what I can extract and the reasons why other information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document |
Reasoning: The document states that "The modified formulation of Temp-Bond NE functions in a manner identical to and is intended for the same use as the original Temp-Bond NE formula currently manufactured by Kerr Corporation." This statement serves as the primary basis for demonstrating substantial equivalence. It implies that the performance of Temp-Bond NE 2 is expected to be the same as the predicate, but it does not define specific, quantifiable acceptance criteria or present performance data from a dedicated study.
2. Sample size used for the test set and the data provenance
- Sample size: Not specified.
- Data provenance: Not applicable, as no specific performance study with a test set is described. The comparison is based on the new device's formulation and intended use being identical to the predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not applicable.
- Qualifications of experts: Not applicable.
Reasoning: No test set or ground truth establishment by experts is described for this submission. The "ground truth" for substantial equivalence is based on the established performance and safety of the predicate device.
4. Adjudication method for the test set
- Adjudication method: Not applicable.
Reasoning: No test set requiring adjudication is described.
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
- MRMC study: No.
- Effect size: Not applicable.
Reasoning: This device is a temporary dental cement, not an AI-powered diagnostic device. MRMC studies are not relevant to its type of evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone study: No.
Reasoning: This is not an algorithm-based device.
7. The type of ground truth used
- Type of ground truth: The "ground truth" for this 510(k) is the established safety and effectiveness of the legally marketed predicate device (Kerr Corporation, Temp-Bond NE), to which Temp-Bond NE 2 is claimed to be substantially equivalent. This is not a ground truth derived from expert consensus, pathology, or outcomes data for a specific study of the new device.
8. The sample size for the training set
- Sample size: Not applicable.
Reasoning: This submission does not describe an AI/ML-based device that would require a training set.
9. How the ground truth for the training set was established
- Ground truth establishment: Not applicable.
Reasoning: As above, not an AI/ML-based device.
In summary, the provided 510(k) notification focuses on establishing substantial equivalence to a predicate device, which is a different regulatory pathway than demonstrating performance against specific acceptance criteria through a dedicated clinical or performance study for a novel device or an AI/ML product.
§ 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.