(100 days)
MD-flex Heavy Body is used to record the shape of the patient's teeth and alveolar ridges.
MD-flex Heavy body is hydrophilic Polyvinylsiloxane Impression Material with thixotropic property, dimensional accuracy and excellent recovery from deformation. It complies with the requirements of ISO 4823:2000 Type 1 for dental elastomeric impression materials. It is supplied as a two-part base/catalyst formulation preloaded in a dual-barrel cartridge.
The MD Flex Heavy Body package includes two dual-barrel 50 ml cartridges, and six mixing tips that allows for easy mixing of the base and catalyst. The device (cartridge) and accessories (mixing tip) are to be sold non-sterile. Testing demonstrates that MD-Flex has a shelf life 2 years from the manufacturing date.
MD-Flex can be used to make a mold of a patient teeth and alveolar ridges. The mold can be used to generate Gypsum model within 30 minutes of removal of the mold from patient's mouth. The Gypsum model will be effectively reproduced without transformation due to an excellent reproducibility and volume stability of MD Flex.
The provided text is a 510(k) summary for the MD-Flex Heavy Body dental impression material. This type of document focuses on demonstrating substantial equivalence to a predicate device, primarily through physical and chemical properties and intended use, rather than clinical study data involving human subjects or AI performance.
Therefore, many of the requested details related to clinical trials, AI performance, ground truth establishment for AI, and expert adjudication are not applicable to this submission.
Here's a breakdown of the information that can be extracted and how it relates to your request:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for MD-Flex Heavy Body are primarily based on its compliance with ISO 4823:2000 Type 1 for dental elastomeric impression materials. The summary states that the device "complies with the requirements of ISO 4823:2000 Type 1".
| Acceptance Criteria (from ISO 4823:2000 Type 1) | Reported Device Performance |
|---|---|
| Physical properties for dental elastomeric impression materials. Specific values for dimensional accuracy, recovery from deformation, etc., as per ISO 4823:2000 Type 1. | Complies with the requirements of ISO 4823:2000 Type 1. |
| Thixotropic property. | Possesses thixotropic property. |
| Dimensional accuracy. | Possesses dimensional accuracy. |
| Excellent recovery from deformation. | Possesses excellent recovery from deformation. |
| Shelf life of 2 years. | Demonstrates a shelf life of 2 years from the manufacturing date. |
| Biocompatibility (Cytotoxicity, Irritation, Sensitization). | Biocompatible, as demonstrated by tests conducted in compliance with ISO 10993. |
Study Information (Based on Available Text)
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Sample size used for the test set and the data provenance: Not explicitly stated. The performance testing is based on compliance with ISO 4823:2000. It doesn't detail a "test set" in the context of clinical or AI performance. The data provenance is generally from laboratory testing of the material itself.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI or diagnostic studies (e.g., expert consensus on clinical images) is not relevant here. The "ground truth" for material properties is derived from standardized laboratory measurements.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. There is no expert adjudication for material property testing.
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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 dental impression material, not an AI-powered diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For material properties, the "ground truth" is established through standardized laboratory measurement methods as defined by ISO 4823:2000. For biocompatibility, it's based on biocompatibility testing results according to ISO 10993.
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The sample size for the training set: Not applicable. This is not an AI device.
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How the ground truth for the training set was established: Not applicable. This is not an AI device.
Summary of the "Study"
The device meets the acceptance criteria by demonstrating compliance with the ISO 4823:2000 Type 1 standard for dental elastomeric impression materials. This compliance is achieved through performance testing of the material's physical and chemical properties in a laboratory setting. Additionally, biocompatibility tests (Cytotoxicity, Irritation, Sensitization) conducted in compliance with ISO 10993 confirm its biological safety. These tests are the "study" that proves the device meets its acceptance criteria, showing it is substantially equivalent to predicate devices in its properties and intended use.
§ 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).