(37 days)
Kerr VPS Impression Material is suitable for impressions in preparation of case study models, orthodontic models, opposing models, simple removable dentures, removable retainers and splints, provisional crown and bridge, and dental impressions.
Kerr VPS impression material is an outstanding A-silicone impression material intended as an alternative to traditional alginate materials. Quick set time, excellent detail reproduction, compatibility with disinfection products, dimensional accuracy and stability make the best alternative. Available in 1:1 cartridges suitable for the Kerr Extruder and in Volume™ 5:1 362 mL foil packs for use in commercially available mixing machines.
This document is a 510(k) premarket notification for a dental impression material named "Kerr VPS Impression Material." The purpose of a 510(k) submission is to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This type of submission does not typically include detailed performance studies with acceptance criteria in the same way a PMA (Premarket Approval) would for novel, high-risk devices.
Therefore, the specific information requested in the prompt related to acceptance criteria, detailed study designs, sample sizes, ground truth establishment, expert adjudication, and MRMC studies is not present in this 510(k) summary.
Here's an analysis based on the provided text, explaining why the requested information is absent and what can be inferred:
1. A table of acceptance criteria and the reported device performance
- Absent. This document does not provide a table of acceptance criteria or specific quantitative performance metrics for the Kerr VPS Impression Material.
- Reason: For a 510(k) substantial equivalence submission, the primary focus is to show that the new device is as safe and effective as a predicate device. This is often done by demonstrating similar technological characteristics, materials, and intended use, rather than extensive de novo performance testing against pre-defined acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Absent. There is no mention of a "test set" or any specific study that would utilize a test set with a defined sample size.
- Reason: The document focuses on demonstrating similarity to predicate devices rather than presenting novel clinical or performance study data that would typically involve a test set.
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)
- Absent. Since no test set or related performance study is described, there's no mention of experts establishing ground truth.
- Reason: Not applicable to a 510(k) summary of this nature.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Absent. No adjudication method is mentioned as there is no specific performance study outlined.
- Reason: 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
- Absent. No MRMC study is mentioned.
- Reason: This device is a dental impression material, not an AI-powered diagnostic tool. MRMC studies are relevant for evaluating AI systems where human reader performance is a key metric.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Absent. "Standalone" performance is relevant for AI algorithms. This device is a physical material.
- Reason: This question is not applicable to the device type.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Absent. No ground truth is discussed as no formal performance study against a definitive standard is presented.
- Reason: Information not typically included in this type of 510(k) submission for a dental material.
8. The sample size for the training set
- Absent. There is no mention of a "training set."
- Reason: Training sets are relevant for machine learning algorithms. This device is a physical material.
9. How the ground truth for the training set was established
- Absent.
- Reason: Not applicable for a physical dental impression material.
Summary of what is present and relevant to "proving" the device meets criteria for regulatory clearance:
- Acceptance Criteria (Implied for 510(k)): The acceptance criterion for a 510(k) is substantial equivalence to predicate devices. This means the device must be shown to be as safe and effective as a legally marketed device and not raise different questions of safety and effectiveness.
- Study Proving Acceptance: The "study" is the 510(k) submission itself, where Sybron Dental Specialties conducted a comparison of the Kerr VPS Impression Material to two predicate devices:
- 3M ESPE, Position Penta Quick
- DMG. Status Blue Mixstar
- Mechanism of Proof: The submission aims to prove substantial equivalence by demonstrating that the Kerr VPS Impression Material:
- Has the same intended use: "impressions in preparation of case study models, orthodontic models, opposing models, simple removable dentures, removable retainers and splints, provisional crown and bridge, and dental impressions."
- Functions in a similar manner and has similar technological characteristics (A-silicone impression material, quick set time, excellent detail reproduction, compatibility with disinfection products, dimensional accuracy and stability).
- The FDA's letter states they "have determined the device is substantially equivalent... to legally marketed predicate devices."
In essence, for this 510(k), the "acceptance criteria" is a regulatory determination of substantial equivalence, and the "study" is the comparative analysis presented in the submission to satisfy that requirement, rather than a detailed performance study with explicit outcome measures and statistical analyses.
§ 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).