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A-Silicone for Bite Registration is indicated for making occlusal registrations.

A-Silicone for Bite Registration is a vinylpolysiloxane (addition silicone), also known as A-Silicones, polyvinyl siloxanes (PVS), or vinyl polysiloxanes (VPS), especially made for bite registration work in the surgery and laboratory. It mainly contains polydimethylsiloxane, silica and platinum catalyst.

This document does not describe a study involving a medical device with AI components or an AI/ML algorithm that requires specific performance metrics like sensitivity, specificity, or measures of human reader improvement.

The device in question, "A-Silicone for Bite Registration," is a dental impression material. The information provided relates to its substantial equivalence application to the FDA, focusing on its physical and chemical properties and biocompatibility.

Therefore, many of the requested items (e.g., sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone AI performance, type of ground truth for AI) are not applicable to this kind of medical device submission.

However, I can extract the acceptance criteria and performance data for the physical properties testing that was conducted:

1. Acceptance Criteria and Device Performance (Physical Properties)

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a series of non-clinical, laboratory-based physical properties tests.

2. Sample size used for the test set and the data provenance:

• The document does not specify the sample size for each physical properties test.
• Data provenance: The tests were conducted internally by "Shandong Huge Dental Material Corporation" as per "our company's" pre-test planning approaches and test methods. The country of origin for the data can be inferred as China, where the manufacturer is located. The tests are retrospective to the submission date.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. The ground truth for physical properties (e.g., consistency, dimensional change, detail reproduction) is established by standardized laboratory measurement techniques defined by ISO 4823, not by expert consensus in a clinical sense.

4. Adjudication method for the test set:

• Not applicable. The physical properties tests follow standardized protocols. There is no mention of adjudication, which is common in clinical imaging studies.

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 device is a material, not an AI diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable. This device is a material, not an AI algorithm.

7. The type of ground truth used:

• For physical properties: The ground truth is defined by the objective, measurable standards set forth in ISO 4823 Fourth edition 2015-08-01 Dentistry - Elastometric impression materials.
• For biocompatibility: The ground truth is established by the results of tests performed fully following the ISO 10993 standards (Cytotoxicity, Sensitization, and Irritation).

8. The sample size for the training set:

• Not applicable. This device is a material, not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established:

• Not applicable, as there is no training set for this type of device.

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