(48 days)
Aqueous ointment material that temporarily fills the root canal for the following indications: Apexification Temporary root filling Root canal filling for primary teeth Vital pulpotomy Temporary pulp capping
Diapaste is a calcium hydroxide paste with barium sulfate, used as a temporary root canal filling material.
The provided document is a 510(k) summary for a medical device called DiaPaste, a root canal filling resin. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical studies with acceptance criteria for device performance in diagnosing or predicting conditions.
Therefore, I cannot extract the information required for a table of acceptance criteria and reported device performance related to diagnostic or predictive capabilities, nor can I provide information on sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth was established for a diagnostic AI.
However, I can provide the non-clinical performance data and acceptance criteria as presented in the document for the physical properties of the device:
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Physical Properties)
| Test | Acceptance Criteria (Requirement) | Reported Device Performance | Result |
|---|---|---|---|
| Flowability | Each disc to have a diameter of not less than 17mm | 18mm (mean value) | Pass |
| Film thickness | No more than 50µm | 23µm (mean value) | Pass |
| Radiopacity | Equivalent to not less than 3mm of Aluminum | Not less than 3mm of Aluminum (approx. 4.1mm) | Pass |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The performance data listed (Table 1) pertains to non-clinical physical and material property tests of the device itself, not to a test set of patient data.
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 physical properties (flowability, film thickness, radiopacity) is established by standardized laboratory measurements rather than expert human interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are typically relevant for human interpretation of medical images or clinical data, not for material property 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 document describes a paste used for root canal filling, not an AI-powered diagnostic device.
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 document describes a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the physical property tests, the "ground truth" is derived from established laboratory measurement standards and protocols (e.g., ISO 6876). For biocompatibility, the ground truth is established through standardized biological evaluation tests (e.g., ISO 10993 series), confirming that the material does not cause adverse biological responses.
8. The sample size for the training set
This information is not applicable and not provided. This document describes a physical medical device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable and not provided. As noted above, this is a physical device, not an algorithm with a training set.
§ 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.