(89 days)
GuttaSil is a material for permanent obturation of root canals after treatment of pulpal gangrene and temporary filling of the canal.
GuttaSil, a product in the form of a paste which combines gutta-percha with a sealer. The gutta-percha powder is mixed in a matrix of polyvinylsiloxane. It is convenient since sealing and obturation are simultaneously possible without heating and the root canal can be filled in a quick manner. This device contains a syringe, auto-mix& Endo tips, spatula, and mixing pads.
This document describes the acceptance criteria and study proving the device meets those criteria for the GuttaSil, a root canal filling material.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Standard/Test) | Device Performance |
|---|---|---|
| Mechanical/Physical | Appearance (ISO 6876:2012) | Conformed to standard |
| Weight (ISO 6876:2012) | Conformed to standard | |
| Packaging (ISO 6876:2012) | Conformed to standard | |
| Flow (ISO 6876:2012) | Conformed to standard | |
| Working Time (ISO 6876:2012) | Conformed to standard | |
| Setting Time (ISO 6876:2012) | Conformed to standard | |
| Film Thickness (ISO 6876:2012) | Conformed to standard | |
| Solubility (ISO 6876:2012) | Conformed to standard | |
| Radio-opacity (ISO 6876:2012) | Conformed to standard | |
| Biocompatibility | Cytotoxicity (ISO 10993-5:2009) | Biocompatible |
| Sensitization (ISO 10993-10:2010) | Biocompatible | |
| Irritation (ISO 10993-10:2010) | Biocompatible | |
| Systemic Toxicity (ISO 10993-11:2006) | Biocompatible | |
| Overview (ISO 10993-1:2009) | Biocompatible | |
| Shelf Life | ISO 6876 tests (Appearance, Package, Flow, Setting Time, Solubility) after aging | Conformed to standard for 2 years |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for each specific test within the non-clinical testing. It only generally refers to "the following testing was conducted." The provenance of the data is not specified (e.g., country of origin, retrospective or prospective), but it is implied to be laboratory testing conducted by or for Meta Biomed Co., Ltd.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The tests conducted are non-clinical, primarily physical, chemical, and biocompatibility tests based on ISO standards. These types of tests typically do not involve human expert adjudication of results in the way clinical performance studies do.
4. Adjudication Method for the Test Set
This information is not applicable as the tests are non-clinical performance and biocompatibility tests against quantitative ISO standards, not evaluations requiring human rater adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes non-clinical performance and biocompatibility testing. The device is a material for root canal filling, not an AI-assisted diagnostic or treatment planning tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Not Applicable. This device is a material (gutta-percha with a sealer) used in a medical procedure, not an algorithm or software. Therefore, the concept of "standalone algorithm performance" is not relevant.
7. The Type of Ground Truth Used
For the non-clinical performance tests, the "ground truth" is defined by the specifications and acceptable ranges outlined in the ISO 6876:2012 standard for root canal sealing materials.
For the biocompatibility tests, the "ground truth" is adherence to the biocompatibility criteria specified in the relevant ISO 10993 series standards.
8. The Sample Size for the Training Set
Not Applicable. This device is a physical material, not an AI algorithm or model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not Applicable, as there is no training set for this type of device.
§ 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.