(62 days)
Take 1 Advanced is a complete system of vinylpolysiloxane impression materials suitable for all crown and bridge, edentulous and implant impressions.
Toke 1 Advonced is a complete system of vinylpolysiloxane impression materials composed of addition silicone chemistry where reaction between vinyl-terminated polydimethyl siloxane and poly-hydrogen siloxane catalyzed by platinum complex catalyst generates an optimum elastomeric material suitable for all crown and bridge, edentulous and implant impressions. The Take 1 Advanced system of materials is available in five viscosities, four delivery options, and in a range of set times. Take 1 Advanced has high elongation for easy mouth removal while its elastic recovery and tear strength provide accurate, detailed impressions time after time. The Wash viscosities are available in both Cartridge and Unidose syringe, a single use delivery system. The Tray viscosity is available in both Cartridge and Volume 5:1 delivery, for use in automated dynamic mixing machines. Take 1 Advonced offers three setting speeds: Regular Set, Fast Set, and Super Fast Set. Take 1 Advanced Putty is also available for Putty/Wash technique.
The provided text describes a 510(k) submission for a dental impression material named "Take 1 Advanced." This submission focuses on demonstrating substantial equivalence to a predicate device ("Take 1") based on non-clinical performance data (biocompatibility and bench testing) rather than clinical testing or an AI algorithm. Therefore, many of the requested elements for an AI-based device, such as sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, are not applicable.
However, I can extract the acceptance criteria related to the device's technical characteristics and summarize the reported performance based on the non-clinical data.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly based on demonstrating comparable performance to the predicate device, "Take 1 (K091613)", across various physical and chemical properties. The study concluded that "Take 1 Advanced" is substantially equivalent to the predicate device based on these comparisons.
| Acceptance Criteria (Comparison to Predicate Device "Take 1") | Reported Device Performance ("Take 1 Advanced") |
|---|---|
| Biocompatibility: Safe for intended use | Demonstrated safe through: Agar Diffusion Test- ISO Direct Contact, ISO Kligman Maximization Test, and ISO Oral Irritation Test. |
| Method of Manipulation: Comparable to predicate | Evaluated and found comparable to predicate. |
| Work Time: Comparable to predicate | Evaluated and found comparable to predicate. |
| Set Time: Comparable to predicate | Evaluated and found comparable to predicate. |
| Strain in Compression: Comparable to predicate | Evaluated and found comparable to predicate. |
| Deformation Recovery: Comparable to predicate | Evaluated and found comparable to predicate. |
| Mixed Paste Consistency: Comparable to predicate | Evaluated and found comparable to predicate. |
| Dimensional change: Comparable to predicate | Evaluated and found comparable to predicate. |
| Hardness (Shore A): Comparable to predicate | Evaluated and found comparable to predicate. |
| Compatibility with Die/Cast Material: Comparable to predicate | Evaluated and found comparable to predicate. |
| Tensile Strength: Comparable to predicate | Evaluated and found comparable to predicate. |
| Tensile Elongation: Comparable to predicate | Evaluated and found comparable to predicate. |
| Tear Strength: Comparable to predicate | Evaluated and found comparable to predicate. |
| Contact Angle: Comparable to predicate | Evaluated and found comparable to predicate. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of an AI device. The testing conducted was non-clinical (biocompatibility and bench testing) to compare "Take 1 Advanced" against a predicate device. The sample sizes for these specific bench tests are not provided in the summary, nor is the country of origin explicitly stated, though the submitting company is based in Orange, California, USA. The data is retrospective in the sense that it relies on existing established test methods and comparisons to an already-marketed device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There was no "ground truth" to establish in the context of an AI device's performance. The evaluation was based on objective, quantifiable physical and chemical properties measured, and biocompatibility testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No clinical or human-reader-based adjudication was involved.
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 is not an AI device, and no MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a dental impression material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth was established through objective measurements of physical and chemical properties (e.g., work time, set time, strain in compression, hardness) and standardized biocompatibility tests as per ISO guidelines (Agar Diffusion Test, Kligman Maximization Test, Oral Irritation Test). The "truth" was whether these measurements for "Take 1 Advanced" were comparable to those of the predicate device, "Take 1."
8. The sample size for the training set
Not applicable. This is not an AI device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI device.
§ 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).