(77 days)
Snowpost & Snowlight posts are indicated for use wherever root canal posts are required Showpost & Showingin posts are mellor and/or where known metal allergies are of concern.
Not Found
The provided 510(k) summary (K012354) for the Snowpost & Snowlight devices describes acceptance criteria and a study to demonstrate substantial equivalence to predicate devices, but does not describe an AI/ML device or its performance criteria. The device in question is a physical dental product (glass fiber composite root canal post).
Therefore, I cannot fulfill the request to describe the acceptance criteria and study that proves an AI device meets acceptance criteria based on this document. The information requested regarding AI/ML device performance, sample sizes for training/test sets, ground truth establishment, expert adjudication, MRMC studies, and standalone performance is not applicable to this 510(k) submission.
However, I can extract the information relevant to the actual device described in the 510(k):
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No evidence of cytotoxic response (per ISO 10993-5 "Biological evaluation of medical devices - Tests for Cytotoxicity: in vitro methods") | "ISO 10993-5 ... was conducted and shows no evidence of a cytotoxic response." |
| Material suitable for root canal posts (per ISO 3597-2-94 Three-point Bending Standard mechanical tests) | "Mechanical tests were conducted in conformance with ISO 3597-2-94 Three-point Bending Standard results showed the material to be suitable for root canal posts." The specific bending strength values or acceptance thresholds are not provided in this summary, only that "results showed the material to be suitable". |
| Substantial equivalence to predicate devices for intended use and technological characteristics | The primary purpose of this 510(k) is to demonstrate substantial equivalence. The FDA concurred with this determination, allowing the device to be marketed. The equivalence is based on similar intended use (retention for reconstruction of non-vital teeth) and technological characteristics, with minor material and dimensional changes from the predicate. |
Regarding the other points requested (which are for AI/ML devices):
- 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, this is a physical medical device.
- 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): Not applicable.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" here is the performance against ISO standards.
- 8. The sample size for the training set: Not applicable. There is no AI model.
- 9. How the ground truth for the training set was established: Not applicable.
§ 872.3810 Root canal post.
(a)
Identification. A root canal post is a device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be cemented into the root canal of a tooth to stabilize and support a restoration.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.