(161 days)
Periacryl™ is indicated for use as a dental cement for bonding dental materials such as crowns, caps, and pins.
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Here's an analysis of the provided text regarding the acceptance criteria and study for PERIACRYL™ dental cement:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary of Equivalence) |
|---|---|
| Material Composition: | N-Butyl 2 Cyanoacrylate |
| - Type of Cyanoacrylate | |
| Intended Use: | Dental cement for bonding dental materials (crowns, caps, pins) |
| - Bonding dental materials | |
| Technological Characteristics: | Similar to predicate device (Indermil™ Dental) |
| - General characteristics | |
| Safety and Effectiveness: | Comparable to Indermil™ Dental cement |
| - Overall safety | |
| - Overall effectiveness |
Explanation of "Acceptance Criteria (Implicit)":
The document provided is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than setting explicit, quantifiable acceptance criteria for a new, de novo device. Therefore, the "acceptance criteria" are inferred from the comparison points used to establish substantial equivalence. The core acceptance criterion for a 510(k) is that the new device is as safe and effective as a legally marketed predicate device and does not raise new questions of safety or effectiveness. The performance parameters of the predicate device (Indermil™ Dental) effectively serve as the target for the new device.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. This submission relies on a comparison to a predicate device and does not present data from a test set in the traditional sense of a clinical trial or performance study on the PERIACRYL™ device itself.
- Data Provenance: Not applicable. The information is a declaration of substantial equivalence based on a comparison to existing, legally marketed devices. It does not refer to new data generated from a study on PERIACRYL™.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. There is no mention of a test set with ground truth established by experts. The determination of substantial equivalence is made by the FDA based on the information provided in the 510(k) submission.
4. Adjudication Method for the Test Set
- Not applicable. No test set requiring expert 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
- Not applicable. This is not an AI-assisted device, and no MRMC study is described. The device is a dental cement, not an imaging or diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm or software device.
7. The Type of Ground Truth Used
- The "ground truth" here is the performance and characteristics of the legally marketed predicate device (Indermil™ Dental cement). Substantial equivalence is demonstrated by showing that PERIACRYL™ shares the same intended use, similar technological characteristics, and comparable safety and effectiveness to this established predicate. The FDA's existing knowledge and acceptance of the predicate device form the basis for evaluating PERIACRYL™.
8. The Sample Size for the Training Set
- Not applicable. There is no mention of a "training set" as this is not an machine learning or AI-based device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. There is no "training set" for this type of device submission.
§ 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.