(79 days)
GC BLUE SILICONE is a silicone impression material for fit check by detecting the high spots and pressure points of ceramic crowns, ceramic bridges, ceramic inlays and the occlusal surface.
GC BLUE SILICONE is available in a 2-part cartridge device in which part 1 is a base silicone paste and part 2 is a catalyst silicone.
The provided text is a 510(k) summary for a dental impression material named "GC BLUE SILICONE." It outlines the device description, indications for use, predicate devices, and performance testing based on ISO standards. However, it does not describe:
- An AI/Software as a Medical Device (SaMD) device.
- Any study involving a test set, training set, or concepts like ground truth, expert readers, or multi-reader multi-case (MRMC) studies.
- Acceptance criteria related to AI model performance metrics (e.g., sensitivity, specificity, AUC).
Instead, the acceptance criteria and performance data are related to physical properties of the dental impression material, measured according to ISO standards.
Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to the content of this 510(k) summary for a physical medical device.
Here's the information that can be extracted from the document, tailored to the testing of a physical material:
The device, GC BLUE SILICONE, is a silicone impression material. Its performance was evaluated against specific physical properties as outlined by ISO 4823:2000(E) standards for dental impression materials.
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides the acceptance criteria (requirements) for three key properties based on ISO 4823:2000(E) for "Light-bodied consistency." It does not explicitly state the reported device performance results in this summary, only the requirements it must meet.
| Property | Standards | Acceptance Criteria (Requirements) | Reported Device Performance |
|---|---|---|---|
| Detail reproduction (µm) | ISO 4823: 2000(E) Classification: Light bodied consistency | 20µm | Not explicitly reported |
| Elastic Recovery (%) | ISO 4823: 2000(E) Classification: Light bodied consistency | ≥96.5 | Not explicitly reported |
| Strain in compression (%) | ISO 4823: 2000(E) Classification: Light bodied consistency | 2.0-20 | Not explicitly reported |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in this 510(k) summary. Testing for physical properties like these typically involves a specific number of samples for each test, as defined by the ISO standard.
- Data Provenance: The tests were conducted according to international standards (ISO 4823:2000(E)). The document implies the tests were performed by GC America Inc. or a contracted lab. There is no mention of country of origin of data or retrospective/prospective study design as these concepts apply more to clinical or AI data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for physical material properties is established by adherence to measurement protocols specified in recognized international standards (ISO 4823:2000(E)), not by expert consensus or review.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for subjective medical image interpretation or clinical outcomes, not for objective physical property measurements.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- Not applicable. This is a physical material, not an AI or imaging device requiring human-in-the-loop studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical material, not an algorithm.
7. The type of ground truth used:
- The "ground truth" (or reference standard) for these tests is defined by the measurement methodology and acceptance criteria specified in the ISO 4823:2000(E) standard. These are objective, quantitative measurements of material properties.
8. The sample size for the training set:
- Not applicable. This device is a physical material, not a machine learning model; therefore, no "training set" is involved.
9. How the ground truth for the training set was established:
- Not applicable. No training set was used.
§ 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).