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Splash!® Dental Impression Material is intended for use with all crowns, bridges, occlusal and dental implant impression techniques to reproduce the structure of a patient's teeth and gums.
Splash!® Dental Impression Material is an addition-reaction base/catalyst polyvinylsiloxane dental impression material. It is available in Regular set or fast-setting Half-time varieties. Both are available in a heavy viscosity and in wild berry flavor, as well as unflavored.
Here's an analysis of the provided information regarding the Splash!® Dental Impression Material, focusing on acceptance criteria and the supporting study details:
Device: Splash!® Dental Impression Material
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Splash!® Dental Impression Material are primarily based on demonstrating substantial equivalence to predicate devices across various physical and chemical properties relevant to dental impression materials. The "acceptance criteria" are implied by the ranges and values observed in the predicate devices which the new device aims to meet or perform comparably to.
| Property | Acceptance Criteria (Implied from Predicates) | Splash!® Dental Impression Material Performance |
|---|---|---|
| Material Type (ISO 4823) | Type 0-3 (Consistent with Precision) or Type 1-3 (Aquasil, P2 Polyether) | Type 0-3 |
| Recovery from Deformation | >98.0% (Aquasil) or 97.5% - 99.6% (P2, Precision) | 99.2% - 99.5% |
| Shrinkage | <0.50% (Aquasil) or 0.40 - 0.50% (P2 Polyether) or <0.10% (Precision) | Max. <0.10% |
| Working Time | 45 - 120 seconds (Range of Predicates) | 55 - 65 seconds |
| Hardness (Shore A) | 44 - 69 (Range of Predicates) | 62 - 67 |
| Strain in Compression | 1 - 10% (Range of Predicates) | 2.3 - 2.5% |
| Storage Conditions | 59° - 80° F (15° - 25° C) (Range of Predicates) | 59° - 78° F (15° - 25° C) |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not explicitly state the sample sizes for the "in-house testing" conducted on the Splash!® Dental Impression Material. It only mentions "Evaluations and in-house testing."
- Sample Size: Not specified.
- Data Provenance: The testing was "in-house testing" by Discus Dental, Inc. This typically means the data was generated internally by the manufacturer. The country of origin is not explicitly stated for the testing, but Discus Dental, Inc. is a US-based company, suggesting the testing likely occurred in the US. The data is retrospective in the sense that it's presented to support an existing product, but the tests themselves would have been conducted prospectively on samples of the material.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The testing described focuses on physical and chemical properties of the material, not on interpretations or diagnoses that would require expert consensus for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable/provided. The testing is for physical properties, not for diagnostic outcomes requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable/provided. The device is a dental impression material, not an AI-assisted diagnostic tool or system that would involve human readers interpreting images or data with and without AI assistance.
6. Standalone Performance Study (Algorithm Only)
This information is not applicable/provided. The device is a physical material, not an algorithm. Therefore, "standalone algorithm performance" is not relevant.
7. Type of Ground Truth Used
The "ground truth" for the performance evaluation of the Splash!® Dental Impression Material is based on standardized test methods for physical and chemical properties of dental impression materials. These methods define objective measurements for properties like recovery from deformation, shrinkage, working time, hardness, and strain in compression. The "truth" is established by the results of these standardized tests.
8. Sample Size for the Training Set
This information is not applicable/provided. As a physical material, there isn't a "training set" in the sense of machine learning algorithms. The material's formulation and manufacturing processes are likely developed through research and development, but this is distinct from an algorithmic training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided for the reasons stated above (not an AI/algorithmic device). The development of the material's properties would be guided by material science principles and performance targets, often benchmarked against existing successful products (like the predicates mentioned).
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