(191 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 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.
This submission pertains to a dental impression material, which is a low-risk device. As a result, the provided documentation focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and performance data in the context of AI/software. There is no mention of a study involving artificial intelligence, human readers, or specific quantitative performance metrics beyond the general characteristics expected of dental impression materials.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts, MRMC study, standalone performance) are not applicable to the provided information.
However, based on the context of a 510(k) submission for a non-AI device, we can infer some general "acceptance criteria" through the lens of substantial equivalence and device characteristics for dental impression materials.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a non-AI device, the "acceptance criteria" are implicitly derived from the characteristics of the predicate device and the general intended use of dental impression materials. Performance is reported through the substantial equivalence claim.
| Acceptance Criteria (Inferred from Predicate/General Device Type) | Reported Device Performance (from 510(k) Summary) |
|---|---|
| Material Type: Addition-cure vinyl polysiloxane | Addition-cure vinyl polysiloxane |
| Usage: All crown and bridge, edentulous, orthodontic, and implant impression techniques | Used for all crown and bridge, edentulous, orthodontic, and implant impression techniques |
| Viscosity: Heavy body | Heavy body |
| Delivery System: Cartridge 1:1 and Volume 5:1 | Cartridge 1:1 delivery and Volume 5:1 delivery |
| Setting Speeds: Regular, Fast, Super Fast | 3 setting speeds: regular set, fast set, and super fast set |
| Substantial Equivalence: Similar function and intended use to predicate device | Substantially equivalent to Kerr Corporation, Take 1 (marketed as Take 1 Advanced) |
Notes on "Acceptance Criteria" for this device:
- No quantitative statistical thresholds are explicitly stated because this is a Class II dental impression material cleared via substantial equivalence, not a high-risk device with specific performance endpoints like sensitivity/specificity for disease detection.
- The "acceptance criteria" here refer to matching the material composition, physical properties (viscosity, setting times), and intended use to a legally marketed predicate device.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The document does not describe a "test set" in the context of evaluating a software algorithm or diagnostic device. The evaluation for substantial equivalence typically involves material characterization and comparison to the predicate, not a clinical study with a specified test set of patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not a study requiring expert-established ground truth for a test set of medical cases.
4. Adjudication Method for the Test Set
Not applicable. No test set requiring adjudication is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically conducted for diagnostic imaging devices or AI-powered interpretation systems to evaluate the impact of the AI on human reader performance, which is not relevant for a dental impression material.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical dental impression material, not an algorithm, so the concept of "standalone performance" for an algorithm is not relevant.
7. The Type of Ground Truth Used
Not applicable in the conventional sense of expert consensus, pathology, or outcomes data for diagnostic accuracy. For this type of device, the "ground truth" for demonstrating equivalence would be based on established dental material standards and performance data for the predicate device, as well as the physical and chemical properties of the new device confirming it performs as intended.
8. The Sample Size for the Training Set
No training set is mentioned or applicable. This is a physical product, not a machine learning model.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for a machine learning model.
§ 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).