(96 days)
Metapaste Plus is a biocompatible root canal filling used for the temporary filling of root canals after endodontic surgery. Metapaste Plus can be used on its own and for vital pulpotomy in deciduous teeth. Metapaste Plus is intended for use by qualified healthcare personnel trained in its use.
Metapaste Plus is a water-based calcium hydroxide paste material for root canal temporary filling. It is pre-mixed in a syringe for convenient delivery in the root canal. When applied to root canal, it is alkaline by calcium hydroxide. The state of the treatment can be confirmed by the radiopacity of barium sulfate contained. Also, it is water-soluble and easy to remove.
The provided document is a 510(k) premarket notification for a medical device called "Metapaste Plus." This document primarily focuses on demonstrating substantial equivalence to a predicate device based on material composition, performance specifications, and biocompatibility, rather than clinical efficacy studies involving human readers or AI algorithms.
Therefore, the information required to fully answer your request regarding acceptance criteria, human reader studies, AI performance, and expert ground truth establishment is not available in the provided text. The document describes non-clinical testing only.
However, I can extract what is available regarding the device's performance and the standards it meets.
Device: Metapaste Plus (Root Canal Filling Resin)
Study Focus: Non-clinical (performance testing, biocompatibility, shelf life) to demonstrate substantial equivalence to a predicate device (Metapaste). The study does not involve AI, human readers, or a test set with expert ground truth in the context of diagnostic performance.
1. Table of Acceptance Criteria (from ISO 6876:2012) and Reported Device Performance
| Parameter | Acceptance Criteria (from ISO 6876:2012) | Reported Device Performance (Metapaste Plus) |
|---|---|---|
| Flowability | Shall be more than 17 mm | 21 mm |
| Radio-opacity | Equivalent to not less than 3 mm of aluminum | 3.1 mm |
(Note: The document states these are the acceptance criteria from ISO 6876:2012, to which the device conformed.)
2. Sample Size Used for the Test Set and Data Provenance
Given this is non-clinical testing of a material, "test set" here refers to samples of the material itself subjected to physical and chemical tests. The document does not specify the sample sizes of Metapaste Plus used for these non-clinical tests (e.g., how many samples were tested for flowability or radio-opacity).
Data Provenance: The tests were conducted by the manufacturer, Meta Biomed Co., Ltd., based in South Korea. The data is from non-clinical testing on the device material. It is not applicable in terms of retrospective/prospective human data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not Applicable. The ground truth for this device's performance is established by international standards (ISO 6876:2012) for material properties and biocompatibility standards (EN ISO 10993 series). No human experts were involved in defining "ground truth" for diagnostic accuracy or image interpretation, as this is not a diagnostic device and no such study was performed.
4. Adjudication Method for the Test Set
Not Applicable. As no human experts were establishing diagnostic ground truth, there was no need for an adjudication method. The testing involved standardized laboratory procedures.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC study was not conducted as this is a non-clinical evaluation of a material, not a diagnostic imaging device involving interpretation by human readers, with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This is not an AI-based diagnostic device. Therefore, no standalone algorithm performance study was relevant or conducted.
7. The Type of Ground Truth Used
The "ground truth" for the device's acceptance is based on:
- International standards for dental root canal filling materials: ISO 6876:2012 (for flowability and radio-opacity).
- International standards for biocompatibility: EN ISO 10993-1:2009, EN ISO 10993-3:2014, EN ISO 10993-5:2009, EN ISO 10993-6:2009, EN ISO 10993-10:2013, EN ISO 10993-11:2017.
- Manufacturer's internal standards for appearance, weight, and packaging.
8. The Sample Size for the Training Set
Not Applicable. This is not an AI device, so there is no training set in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. (See point 8)
§ 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.