(58 days)
MTA ROOT CANAL SEALER is indicated for use for the permanent sealing of root canals of teeth and may be used in combination with root canal obturation materials.
The MTA ROOT CANAL SEALER is a powder and liquid root canal sealer system. The combination of the powder and liquid creates a colloidal gel that solidifies to form a strong impermeable barrier to seal off pathways of communication between the root canal system and external surfaces of the tooth.
The provided text describes a medical device, MTA Root Canal Sealer, and its FDA clearance. However, it does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.
The document is a 510(k) premarket notification, which demonstrates substantial equivalence to a legally marketed predicate device, not necessarily a study proving performance against defined acceptance criteria for a new clinical endpoint.
Therefore, many of the requested sections cannot be filled based on the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
- Cannot be created. The document describes the device's intended use and technological characteristics, and states it passed biocompatibility testing, but it does not provide quantitative acceptance criteria for clinical performance (e.g., success rates, sealing effectiveness metrics) or results from a clinical study demonstrating such performance. The clearance is based on substantial equivalence, not a direct performance study against criteria.
2. Sample size used for the test set and the data provenance
- Not applicable. No clinical "test set" in the context of performance metrics is described. The clearance relies on biocompatibility testing and demonstration of substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No clinical "test set" and ground truth establishment by experts is described.
4. Adjudication method for the test set
- Not applicable. No clinical "test set" and adjudication method 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 device is a root canal sealer, not an AI-powered diagnostic tool. MRMC studies are irrelevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a medical material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No ground truth in the context of clinical performance evaluation against specific criteria is mentioned for the 510(k) submission itself. The "ground truth" for a 510(k) is typically the predicate device's established safety and effectiveness.
8. The sample size for the training set
- Not applicable. No training set for an algorithm described.
9. How the ground truth for the training set was established
- Not applicable. No training set for an algorithm described.
Summary of available information:
- Device Name: MTA ROOT CANAL SEALER
- Intended Use: Permanent sealing of root canals of teeth, possibly with obturation materials.
- Technological Characteristics: All components have been used in legally marketed devices or were deemed safe for dental use.
- Biocompatibility Testing: The device has been evaluated and passed biocompatibility testing for cytotoxicity, mutagenicity, sensitization, and endodontic usage. This is a safety assessment, not a clinical performance assessment against specific criteria.
- Substantial Equivalence: The device is considered substantially equivalent to the MTA Advanced Material (K073218), cleared January 7, 2008. This is the primary basis for its clearance, indicating it does not raise new safety or effectiveness concerns compared to a predicate.
§ 872.3820 Root canal filling resin.
(a)
Identification. A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.