(42 days)
For calcium hydroxide root canal therapy either prior to or after root career industration for emergency root canal there prior for treatment of root resorptions: and for early still and area root canar preparation; for emergency root canal treat. for treatment of root resorptions; and for early childhood trauma.
The Roeko Calcium Hydroxide Points are deposit preparations which release calcium hydroxide from a gutta percha matrix. The device consists of calcium hydroxide, gutta percha, barium sulfate, stearic acid, and colorants.
The provided text is a 510(k) summary for the Roeko Calcium Hydroxide Points. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies to establish novel performance criteria. Therefore, the details requested in your prompt regarding acceptance criteria and a study proving device performance are largely not present in this document.
Here's an analysis of what can and cannot be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
- Cannot be provided. The document does not specify quantitative acceptance criteria or detailed performance metrics. The demonstration of safety and effectiveness relies on substantial equivalence to a predicate device, not on meeting predefined performance targets through a standalone study.
2. Sample size used for the test set and the data provenance
- Cannot be provided. No new efficacy study or test set is described. The device is deemed substantially equivalent based on its technical characteristics being similar to the predicate and its intended use.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Cannot be provided. No test set requiring expert ground truth establishment is mentioned.
4. Adjudication method for the test set
- Cannot be provided. No test set requiring adjudication is mentioned.
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
- Cannot be provided. This document concerns a dental filling material, not an AI-assisted diagnostic or therapeutic device. Therefore, an MRMC study or AI assistance is not relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. Again, this is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot be provided. Without a study, there's no ground truth data type. The safety and effectiveness are inferred from the predicate device.
8. The sample size for the training set
- Cannot be provided. No training set for an algorithm is mentioned or relevant to this device type.
9. How the ground truth for the training set was established
- Cannot be provided. No training set is involved.
Summary of available information related to performance/equivalence:
- Device Name: Roeko Calcium Hydroxide Points
- Intended Use: Temporary filling and disinfection of root canals between endodontic visits following pulp removal. Also indicated for calcium hydroxide root canal therapy, emergency root canal treatment, treatment of root resorptions, and early childhood trauma.
- Predicate Device: TempCanal™ manufactured by Pulpdent Corporation.
- Basis for Substantial Equivalence: "The technical characteristics are similar to those found with the predicate device where a root canal is temporarily filled with calcium hydroxide. In the Roeko device, calcium hydroxide powder is delivered from a gutta percha matrix inserted into the canal. In the predicate device, calcium hydroxide is delivered as an aqueous suspension by dispensing it into the canal through a syringe."
In essence, the "study" demonstrating the device meets "acceptance criteria" here is the assertion and FDA's agreement that the Roeko Calcium Hydroxide Points are substantially equivalent to the predicate device based on similar technical characteristics and intended use. This type of 510(k) submission does not typically involve new clinical performance studies or specific quantitative acceptance criteria beyond established product standards for the class of device.
§ 872.3250 Calcium hydroxide cavity liner.
(a)
Identification. A calcium hydroxide cavity liner is a device material intended to be applied to the interior of a prepared cavity before insertion of restorative material, such as amalgam, to protect the pulp of a tooth.(b)
Classification. Class II.