(86 days)
Take 1 Advanced Rigid Tray is an addition-cure vinyl polysiloxane dental impression material that is used for all crown and bridge, edentulous, orthodontic and implant impression techniques.
The device is an addition-cure vinyl polysiloxane dental impression material that is used for all crowns and bridges, edentulous, orthodontic and implant impression techniques. Take 1 Advanced Rigid Tray is a two-part, base/catalyst – paste/paste system. The product is available in a heavy body viscosity, offered in cartridge 1:1 delivery and Volume 5:1 delivery, and in 3 setting speeds: regular set, fast set and super fast set.
The provided text describes a 510(k) submission for a dental impression material, Take 1 Advanced Rigid Tray. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of a device's performance against specific acceptance criteria in the way an AI/ML device study would. Therefore, most of the requested information regarding acceptance criteria, sample sizes for test/training sets, expert qualifications, and adjudication methods is not directly applicable or available in the provided text for a device like this.
However, I can extract the information that is present and indicate where it's not applicable.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
For this specific device, the "acceptance criteria" are implied by demonstrating substantial equivalence to its predicate for certain material properties, rather than explicit numerical thresholds the device must achieve independently. The reported performance is comparative.
| Acceptance Criteria (Implied for Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|
| Performance characteristics of Take 1 Advanced Rigid Tray are comparable to the predicate device (Take 1 Advanced Rigid Tray, K092176). | Evaluated characteristics included, but were not limited to: Working Time, Setting Time, Compressive Strength, Diametral Strength, Flexural Strength, and Shore D Hardness. The submission implies these were found to be comparable to the predicate, leading to a substantial equivalence conclusion. |
| Device is safe for its intended use (biocompatibility). | A biocompatibility study according to ISO 10993 was completed, demonstrating the device is safe for its intended use. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated for specific tests (e.g., how many samples for compressive strength were tested). The text mentions "data from bench testing," implying multiple tests were performed.
- Data Provenance: Bench testing data. No geographic origin is specified, but it was performed by Sybron Dental Specialties, Inc. (USA-based company). Retrospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a dental impression material. The "ground truth" for its performance is derived from physical and chemical measurements rather than expert human interpretation.
4. Adjudication method for the test set
- Not Applicable. As per point 3, no human adjudication was involved in establishing performance metrics for this material.
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. This is not an AI/ML device, nor does it involve human readers. Clinical testing was explicitly stated as not conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical dental material; there's no algorithm.
7. The type of ground truth used
- For physical/chemical properties (Working Time, Setting Time, Compressive Strength, etc.): Objective physical and chemical measurements governed by established testing standards (e.g., those specified in ISO standards for dental materials, though specific standard numbers for each test are not listed other than ISO 10993 for biocompatibility).
- For biocompatibility: Adherence to ISO 10993 standards for biological evaluation of medical devices.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device; there is no training set in the machine learning sense. The "training" in manufacturing would relate to process control and quality assurance, not data-driven model training.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 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).