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510(k) Data Aggregation
(38 days)
- A-SILICONE is a dental impression material intended to be placed on an impression . tray and used to reproduce the structures of a patient's teeth and gums.
- A-SILICONE is also intended to be used as a bite registration or occlusal registration . material.
A-SILICONE is vinyl polymethyl siloxane dental impression material composed of four viscosities or bodies including: putty, heavy body, medium body, and light body. The material is suitable for use in traditional double mix technique, monophase technique, and putty-wash technique as well as unique combinations of techniques.
Here's an analysis of the provided information regarding the A-SILICONE device, focusing on acceptance criteria and the study proving it:
The provided document is a 510(k) summary for a dental impression material named A-SILICONE. A 510(k) submission primarily demonstrates substantial equivalence to a previously legally marketed device (predicate device), rather than directly proving acceptance against a set of performance criteria through a traditional clinical study with defined ground truth and expert adjudication in the same way a diagnostic AI might be evaluated.
Therefore, the answers below will reflect this context, explaining that the "acceptance criteria" here are essentially the properties and performance parameters that need to be comparable to predicate devices for a favorable substantial equivalence determination. The "study" for this type of device is the testing conducted to measure these properties against established standards or predicate device performance.
Acceptance Criteria and Study for A-SILICONE
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission of a dental impression material, the "acceptance criteria" are the physical and chemical properties that demonstrate it is as safe and effective as predicate devices. The reported device performance is measured against these properties.
| Property | Acceptance Criteria (Implied by Predicate & ISO Standards) | Reported Device Performance (A-SILICONE) |
|---|---|---|
| Consistency, ISO 4823 | Type-specific (e.g., heavy body type 0, light body type 3) | Matches ISO 4823 types for each viscosity |
| Color | Distinct colors for different viscosities | Putty: light green, Heavy: turquoise, Medium: lilac, Light: pink |
| Working time including mixing | Clinically acceptable range | 45 seconds to one minute |
| Time in the mouth | Clinically acceptable range | two minutes |
| Total setting time, minimum | Clinically acceptable range | 2 minutes - 45 seconds |
| Strain in compression, % | Typically low (< 5-6%) for impression materials | Putty: <2, Heavy: <4, Medium: <5, Light: <5 |
| Recovery from deformation, % | High (>99%) to ensure impression accuracy | Putty: >99.4, Heavy: >99.4, Medium: >99.6, Light: >99.6 |
| Linear dimensional change, %, max | Low (<0.2%) for dimensional stability | Putty: 0.2, Heavy: 0.15, Medium: 0.15, Light: 0.15 |
| Hardness Shore A | Appropriate range for impression material type | Putty: 70, Heavy: 50, Medium: 45, Light: 40 |
| Intended Use | Reproduction of teeth/gums, bite registration | Matches predicate devices |
| Composition | Addition reaction, silica filled polydimethyl siloxane | Matches predicate devices |
| Clinical properties | Multiple viscosities allowing various techniques | Matches predicate devices |
| Viscosities or grades available | Putty, heavy, medium, light body | Matches predicate devices |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a "test set" in the context of patient data or a clinical trial. For material properties, testing is typically done on a sufficient number of material samples (batches or specimens) to ensure statistical validity and reproducibility of the measurements. This is in vitro testing, not in vivo (patient) testing.
- Sample Size: Not explicitly stated, but for physical/chemical property testing of materials, this would typically be multiple samples per batch, and multiple batches to demonstrate consistency.
- Data Provenance: The data would be derived from laboratory testing of the A-SILICONE material itself, likely performed by the manufacturer (Cosmedent, Inc.) or a contract testing lab. It is in vitro (laboratory) data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information (experts establishing ground truth for a test set) is not applicable to a 510(k) submission for a dental impression material demonstrating substantial equivalence through physical property testing. "Ground truth" in this context refers to the measured physical and chemical properties of the material itself, determined by standardized laboratory methods (e.g., ISO 4823 for consistency). These are objective measurements, not subjective evaluations requiring expert consensus.
4. Adjudication Method for the Test Set
Not applicable. There is no "adjudication method" in the sense of reconciling differences in expert opinion for material property testing. Measurements are objective and follow standard protocols.
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/diagnostic device. It is a dental impression material. MRMC studies are used for evaluating diagnostic performance, often with AI assistance, which is irrelevant for this product.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is based on standardized physical and chemical property measurements (e.g., consistency by ISO 4823, strain in compression, recovery from deformation, linear dimensional change, hardness) as well as a demonstration that its intended use and composition are comparable to legally marketed predicate devices. This is a form of empirical measurement against established material science standards.
8. The Sample Size for the Training Set
Not applicable. This is a physical material, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no "training set" for a physical material, there is no ground truth to establish for one. The "ground truth" for material properties is established through standardized laboratory testing and measurement protocols.
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