(184 days)
Use for: Primosplint System should be used for producing functional therapy and bite splints.
Primosplint is a light composite developed for functional therapy bite splints and other applications. It is fabricated outside of the mouth from stone models. It may be polished mechanically or by the use of a glaze.
This document is a 510(k) clearance letter from the FDA for the Primosplint System. It does not contain information about acceptance criteria or a study proving device performance as typically expected for medical device evaluations. The letter primarily establishes substantial equivalence to a legally marketed predicate device.
Therefore, most of the requested information cannot be extracted from this document.
Here's a breakdown of what can be inferred or stated based on the provided text, and what is missing:
1. A table of acceptance criteria and the reported device performance
- Information not provided. The document does not describe specific performance characteristics, acceptance criteria, or a study that measures and reports these.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Information not provided. There is no mention of a test set, sample size, or data provenance.
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)
- Information not provided. There is no mention of a test set or experts for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Information not provided. No test set is 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
- Information not provided. This device is a "light composite developed for functional therapy bite splints," indicating it's a dental material, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Information not provided and not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Information not provided. No ground truth is discussed as no study is detailed.
8. The sample size for the training set
- Information not provided. No training set is discussed.
9. How the ground truth for the training set was established
- Information not provided. No training set or ground truth is discussed.
Summary from the provided document:
The document is a 510(k) clearance letter confirming that the Primosplint System is substantially equivalent to a legally marketed predicate device. The basis for clearance is not through a detailed performance study with acceptance criteria, but rather through demonstrating equivalence to existing devices. The key information provided about the device is:
- Trade/Device Name: Primosplint System
- Regulation Number: Unclassified
- Regulation Name: None
- Regulatory Class: None
- Product Code: MQC
- Indications for Use: Producing functional therapy and bite splints.
- Description of Device: A light composite developed for functional therapy bite splints and other applications. Fabricated outside of the mouth from stone models. May be polished mechanically or by the use of a glaze.
- Review Type: Section 510(k) premarket notification.
- Basis for Clearance: Substantial equivalence to legally marketed predicate devices.
- Confidential Chemical Analysis: Mentioned in "Rein Maly SachSR Appendix B," but the details are not included in this letter.
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