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510(k) Data Aggregation
(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: < 90 minutes; Predicate ENDOSEAL MTA: 12.31 minutes) * Film thickness testing * Solubility and degradation testing * Radiopacity testing |
| Transit Testing | Packaging should withstand simulated transit conditions, and products should perform satisfactorily post-transit. | Packaging configurations are sufficient and withstand simulated transit conditions. Products performed satisfactorily post-transit, confirming transit did not have a negative effect. |
| Microbiological Testing | Not explicitly stated; implied to mitigate contamination risks and exhibit bactericidal properties. | Exhibits bactericidal properties. Results support shelf stability and multiple use of non-patient contacting materials (syringes) as introduced microbes will not remain viable. |
| Cytotoxicity Testing | Not explicitly stated; implied to be acceptable or superior to predicate. | Yielded equivalent, or better, cytotoxicity results compared to the predicate device, ENDOSEAL MTA. |
| Sensitization Testing | No evidence of causing delayed dermal contact sensitization. | Showed no evidence of causing delayed dermal contact sensitization in guinea pigs. Not considered a sensitizer. |
| Intracutaneous Irritation Testing | Does not cause intracutaneous irritation. | Does not cause intracutaneous irritation and is not considered an irritant. |
| Acute Systemic Toxicity Testing | No mortality or evidence of systemic toxicity. | No mortality or evidence of systemic toxicity from systemic exposure. All animals displayed normal behaviors and positive weight gain. Not systemically toxic. |
| Genotoxicity Testing | No signs of mutagenicity. | Showed no signs of mutagenicity during tests. Confirmed as non-mutagenic. |
2. Sample size 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 tests performed are non-clinical (laboratory and animal studies), not studies on human subjects with test sets in the context of AI/ML or diagnostic performance.
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 these non-clinical tests is based on standardized laboratory measurements and observations in animal models, not expert human assessment of a medical condition.
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 used in studies involving human interpretation or clinical endpoints, not in the non-clinical laboratory and animal studies described.
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
No MRMC study was done, and this device is not an AI/ML diagnostic or assistive device for human readers. It is a root canal filling material.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests involved standardized laboratory measurements, physical property testing (e.g., set time, flow, solubility), and biological responses observed in in vitro cultures and in vivo animal models for biocompatibility.
8. The sample size for the training set
This information is not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not applicable as this is not an AI/ML device.
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