(28 days)
Permanent root canal obturation
White ENDOSEAL MTA is a root canal sealer conforming to ISO 6876, in a pre-loaded syringe that does not require any pre-mixing and is set by absorbing moisture from the root canal environment. The sealer can be used either alone or in combination with gutta-percha obturating cones, injected gutta-percha material or core-carriers, master cones.
The provided text is a 510(k) summary for a medical device (White ENDOSEAL MTA), which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This document does NOT contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of an AI/ML medical device.
The document discusses:
- Device Description: A root canal sealer for permanent root canal obturation.
- Performance Testing (Non-Clinical): This section outlines physical and chemical tests (e.g., setting time, flow, radiopacity, solubility, cytotoxicity) conducted according to ISO standards.
- Substantial Equivalence: The primary purpose of a 510(k) is to show that a new device is as safe and effective as a legally marketed predicate device. This is done by comparing technological characteristics and performance data.
The document does NOT contain the information requested in your prompt regarding acceptance criteria and a study proving a device meets acceptance criteria using human readers, ground truth, or AI performance metrics.
Specifically, the following information is NOT present in the provided text:
- Acceptance Criteria Table and Device Performance for specific clinical or AI metrics: The "performance testing" section refers to ISO standards for material properties, not clinical or AI performance.
- Sample size for a test set (clinical or AI): No clinical study with a test set is described.
- Data provenance (country of origin, retrospective/prospective): Not mentioned.
- Number of experts and their qualifications for ground truth: No expert review for ground truth is described.
- Adjudication method for a test set: Not mentioned.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not conducted or reported.
- Effect size of human reader improvement with AI assistance: Not applicable as it's not an AI device.
- Standalone (algorithm only) performance: Not applicable as it's not an AI device.
- Type of ground truth (expert consensus, pathology, outcomes data): No ground truth for clinical or AI performance is described.
- Sample size for the training set: Not applicable as it's not an AI device.
- How ground truth for the training set was established: Not applicable.
The document focuses on the physical and chemical properties of a dental material and its biocompatibility to demonstrate substantial equivalence to a predicate device, not on diagnostic performance or capabilities involving AI or human interpretation of images.
§ 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.