(73 days)
Precision VPS Impression Material is intended for use with all crowns, bridges, occlusal and dental impression techniques to reproduce the structure of a patient's teeth and gums.
Precision VPS Impression Material is an addition-reaction base/catalyst polyvinylsiloxane dental impression material available in three different viscosities intended for use with all crowns, bridges, occlusal and dental implant impression procedures.
This document is a 510(k) premarket notification for a dental impression material, which typically involves demonstrating substantial equivalence to a predicate device rather than presenting a full clinical study with acceptance criteria and a test set and experts in the way machine learning algorithms are evaluated. Therefore, most of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment is not applicable or not provided in the context of this type of regulatory submission.
However, based on the information provided, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
This document does not specify formal "acceptance criteria" or provide "reported device performance" in the quantitative manner typically associated with clinical trials for new medical devices or software. The submission focuses on demonstrating substantial equivalence to legally marketed predicate devices based on the same intended use and basic technological characteristics of a dental impression material.
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 510(k) submission for a dental impression material, not a study involving a test set of data in the context of a machine learning or diagnostic device study. The "test set" in this context would implicitly be the physical testing of the material's properties (e.g., set time, accuracy, tear strength), which are not detailed in this summary.
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. There is no mention of experts establishing a ground truth for a test set in the provided summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method is mentioned as there is no "test set" in the context of human interpretation.
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. This device is a dental impression material, not an AI-assisted diagnostic tool or system that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for a dental impression material would likely refer to its physical and chemical properties meeting established standards for accuracy, stability, etc., which are usually validated through bench testing rather than clinical "ground truth" as in diagnostic studies. This summary does not provide details on such testing.
8. The sample size for the training set
Not applicable. The concept of a "training set" is not relevant for a physical dental impression material.
9. How the ground truth for the training set was established
Not applicable. The concept of a "training set" and its "ground truth" is not relevant for a physical dental impression material.
Summary of Device and Regulatory Context (Based on provided text):
- Device Name: Precision VPS Impression Material
- Applicant: Discus Dental, Inc.
- Application Type: 510(k) Premarket Notification
- Date of Summary: January 8, 2004
- Intended Use: For use with all crowns, bridges, occlusal, and dental implant impression procedures to reproduce the structure of a patient's teeth and gums.
- Device Description: An addition-reaction base/catalyst polyvinylsiloxane dental impression material available in three viscosities.
- Regulatory Classification: Class II, Product Code ELW, Regulation Number 872.3660 (Impression Material)
- Basis for Substantial Equivalence: Precision VPS Impression Material is claimed to be substantially equivalent to:
The FDA's letter (dated March 25, 2004) confirms that they reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use, allowing it to be marketed. This determination implies that the device has met the necessary regulatory requirements for substantial equivalence, which for this type of device typically involves demonstrating similar technological characteristics and performance (e.g., mechanical properties, biocompatibility) to the predicate devices, rather than a clinical study with primary endpoints and statistical analysis of a test set.
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).