(63 days)
Kromopan type 1 and 2, Alginor type 1, Alginelle type 1, Alginelle type 2 and Millenium alginates are irreversible hydrocolloids for dental impressions used by the dentist to take the anatomical data of the patient's mouth and subsequently realize a plaster mold useful to diagnose problems, define the required interventions and/or check their effectiveness. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.
Kromopan type 1, Kromopan type 2, Alginor type 1, Alginelle type 1, Alginelle type 2 and Millenium alginates are irreversible hydrocolloids for dental impressions.
The provided text describes dental impression materials (alginates) and their compliance with established standards, not an AI/ML powered medical device. Therefore, the information requested in the prompt, such as acceptance criteria based on performance metrics, sample sizes for test and training sets, expert qualifications, and AI-specific study details, is not applicable to this document. The document focuses on demonstrating substantial equivalence to predicate devices through chemical composition, intended use, and adherence to ISO standards and internal performance criteria for traditional material properties.
However, I can extract and present the relevant information regarding the performance and acceptance criteria for these dental alginate materials based on the provided text, and explain why other requested details are not present.
Acceptance Criteria and Device Performance (for Dental Alginates)
Since this is not an AI/ML device, performance is measured against established material standards and internal specifications, rather than clinical metrics like sensitivity or specificity.
| Acceptance Criteria Category | Specific Criteria (Standard/Internal Spec) | Reported Device Performance |
|---|---|---|
| International Standards | ISO 1563:1990 - 4.1 / 6.2 (Powder) | Complies with ISO 1563:1990 standards |
| ISO 1563:1990 - 4.3 / 6.2 (Mixed material) | Complies with ISO 1563:1990 standards | |
| ISO 1563:1990 - 4.4 (Mixing Time) | Complies with ISO 1563:1990 standards | |
| ISO 1563:1990 - 4.5 / 6.3 (Total working time) | Complies with ISO 1563:1990 standards | |
| ISO 1563:1990 - 4.6 / 6.4 (Reproduction of detail) | Complies with ISO 1563:1990 standards | |
| ISO 1563:1990 - 4.7 / 6.5 (Recovery from deformation) | Complies with ISO 1563:1990 standards | |
| ISO 1563:1990 - 4.8 / 6.6 (Strain in compression) | Complies with ISO 1563:1990 standards | |
| ISO 1563:1990 - 4.9 / 6.7 (Compressive strength) | Complies with ISO 1563:1990 standards | |
| Lascod Internal Criteria | LAVSCOD PVPF001 - 3.8 (setting time) | Complies with LASCOD performance criteria |
| LAVSCOD PVPF001 - 3.3 (first color change & second color change) | Complies with LASCOD performance criteria | |
| LAVSCOD PVPF001 - 3.11 (dimensional stability) | Complies with LASCOD performance criteria | |
| LAVSCOD PVPF001 - 3.5 (Flavor) | Complies with LASCOD performance criteria | |
| LAVSCOD PVPF001 - 3.6 (color after setting time) | Complies with LASCOD performance criteria |
Why other requested details are not applicable or provided in this document:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This document describes the properties of dental impression materials. Performance is evaluated against published international standards (ISO) and the manufacturer's own internal standards for material properties (e.g., mixing time, dimensional stability, elastic recovery). These tests are typically conducted in a laboratory setting on samples of the material, not on a "test set" of patient data or clinical images. Therefore, concepts like data provenance (country, retrospective/prospective) and sample size in the context of clinical data are not relevant here. The ISO standards themselves define the number of specimens required for each test.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- "Ground truth" in the context of material properties is established by objective measurements based on scientific principles and standardized testing procedures (e.g., using calipers for dimensional stability, rheometers for setting time). It does not involve expert clinical interpretation in the way AI/ML models are evaluated.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for material 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 is not an AI-powered device, nor does it involve "human readers" or "cases" in the diagnostic sense.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical dental material, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for material properties is derived from physical and chemical measurements following highly standardized laboratory protocols (e.g., dimensional accuracy measured against a known standard, mechanical properties measured using calibrated instruments).
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The sample size for the training set:
- Not applicable. This is a manufactured product, not a statistical model that requires a training set. The "training" for such a product involves R&D and manufacturing process validation.
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How the ground truth for the training set was established:
- Not applicable.
In summary, the provided document is a 510(k) summary for traditional dental impression materials, focusing on demonstrating substantial equivalence to predicate devices and compliance with established material standards. It does not pertain to AI/ML powered devices, and thus the requested AI/ML specific information is not present.
§ 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).