(152 days)
Permanent obturation of the root canal following vital pulp-extirpation.
Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings.
Vista BC Sealer is a convenient premixed ready-to-use injectable white hydraulic cement paste developed for permanent root canal filling and sealing applications. Vista BC Sealer is an insoluble, radiopaque material based on a calcium phosphosilicate and calcium aluminate cement composition, which requires the presence of water to set and harden. Vista BC Sealer does not appreciably shrink during setting and demonstrates excellent physical properties. Vista BC Sealer is packaged in a preloaded syringe and supplied with disposable single use application tips.
The provided text describes the 510(k) submission for the Vista BC Sealer, a root canal filling material. It details non-clinical performance testing but does not include information about acceptance criteria or a study proving that the device meets those criteria in the context of an AI/ML algorithm or a typical clinical study with a test set, ground truth, or expert involvement. The submission focuses on demonstrating substantial equivalence to predicate devices through physical, chemical, and biocompatibility testing.
Therefore, many of the requested fields regarding acceptance criteria, study design for AI/ML, sample sizes for test/training sets, ground truth establishment, expert involvement, and MRMC studies cannot be answered from the provided document as they are not relevant to this type of device clearance.
However, I can extract the information related to the performance demonstrated by the non-clinical tests.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria for many of the tests in a table format, but it does state compliance with ISO standards and favorable comparison to the predicate device. Where specific values or qualitative outcomes are mentioned, they are included below.
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Shelf-Life Testing | Not explicitly stated; implied to meet typical storage conditions. | Through accelerated shelf life testing, Vista BC Sealer was found to have a shelf-life of two years. Real-time aging is being performed to support this. |
| ISO 6876 Testing | Compliance with ISO 6876 (standards for flow, set time, film thickness, solubility/degradation, radiopacity). | Performed very similarly to the predicate device, ENDOSEAL MTA, thereby confirming substantial equivalence for: * Flow testing * Set time testing (Vista BC Sealer: |
§ 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.