(134 days)
Identic Alginate Dental Impression Materials 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.
KromaFaze Alginate Dental Impression Materials 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.
Alginate impression materials are elastic, irreversible hydrocolloid impression materials made from seaweed. They are used to take primary or preliminary impressions of a patient's teeth and gums. Alginate impressions are taken to obtain diagnostic study models, which are the positive reproductions of the teeth and surrounding structures. Identic Alginate is cinnamon flavored and comes in three options - Regular Set, Fast Set, and Extra Fast Set. KromaFaze Alginate is mint flavored and comes in two options – Regular Set and Fast Set. KromaFaze Alginate has a color change feature that offers a visual guide for consistent impression making.
The provided text describes the 510(k) premarket notification for "Identic and KromaFaze Alginate Dental Impression Materials." This document focuses on demonstrating substantial equivalence to a predicate device (Kromopan Impression Material, K121824) rather than proving that an AI-driven device meets specific acceptance criteria through a study involving human readers or sophisticated ground truth establishment.
Therefore, many of the requested details about acceptance criteria, study design for AI, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, and training set information are not applicable to this type of medical device submission.
This submission is for a dental impression material, which is a physical material, not an AI/software device. The "performance data" refers to the physical properties of the material itself.
However, I can extract the acceptance criteria and performance related to the physical properties of the dental impression material as presented in the document.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document uses the ISO 1563:1990 standard for Dental Elastic Impression Materials, Part 2 Alginate Dental Impression Material, as the basis for acceptance criteria for most physical properties. The "acceptance criteria" are implied by the standard's requirements, which the devices are stated to "Pass."
| Element (Acceptance Criteria Implicitly from ISO 1563) | Predicate Kromopan Performance (for comparison) | Proposed Identic Alginate Performance | Proposed KromaFaze Alginate Performance | Meets Acceptance Criteria? |
|---|---|---|---|---|
| Mixing time | Type I = 1'45", Type II = 2'45" | Pass 30" | Pass 30" | Yes (Pass) |
| Working time | Type I = 1'45", Type II = 2'45" | Pass 2'20" (Regular Set), Pass 1'45" (Fast Set), Pass 1'15" (Extra Fast Set) | Pass 2'20" (Regular Set), Pass 1'45" (Fast Set) | Yes (Pass) |
| Setting time | 30" | Pass ≤3'30" (Regular Set), Pass ≤2'20" (Fast Set), Pass ≤2'00" (Extra Fast Set) | Pass ≤3'30" (Regular Set), Pass ≤2'20" (Fast Set) | Yes (Pass) |
| Homogeneous Mixed Material | Unknown | Pass | Pass | Yes (Pass) |
| Compatibility with gypsum and reproduction of detail (μm) | Type I = 20, Type II = 20 | Imparts a smooth surface to, and separates cleanly from, a gypsum cast. Impression reproduces 50 µm line. Pass | Imparts a smooth surface to, and separates cleanly from, a gypsum cast. Impression reproduces 50 µm line. Pass | Yes (Pass) |
| Recovery from deformation (%) | 95.5 | ≥95%, Pass | ≥95%, Pass | Yes (Pass) |
| Strain in compression | Unknown | Between 5% and 20%, Pass | Between 5% and 20%, Pass | Yes (Pass) |
| Compressive strength | Unknown | ≥0.35 MPa, Pass | ≥0.35 MPa, Pass | Yes (Pass) |
| Dimensional Changes at 100 hours | 100 hours | Pass ≤ 2% when compared to a mold | Pass ≤ 2% when compared to a mold | Yes (Pass) |
| Biocompatibility | Unknown | Meets requirements | Meets requirements | Yes |
| Shelf Life | 60 months based on real time data | 24 months based on real time data | 24 months based on real time data | Yes (Stated as conforming) |
Notes:
- The term "Acceptance Criteria" is not explicitly defined with numerical thresholds in the table, but implied by compliance with ISO 1563 and the "Pass" status.
- "Unknown" for predicate indicates the specific data point for the predicate was not provided in the comparison table, but the predicate itself was cleared.
- "N/A" (Not Applicable) for certain flow, viscosity, and wettability properties indicates these properties do not apply to alginate impression materials.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the exact sample sizes (e.g., number of impressions or tests performed) for each physical property test. It only states that "Non-clinical performance data included testing for..." various properties.
- Data Provenance: The document states that "Biocompatibility testing was performed at a third party laboratory." No country of origin is specified for the testing data. The data is non-clinical performance data, likely from laboratory testing rather than human subject studies (as indicated by "Clinical performance testing has not been performed"). Therefore, the terms retrospective or prospective do not apply in the context of clinical trial data.
3. 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)
- This is not applicable. This submission is for a physical dental material, not an AI or diagnostic imaging device that requires expert review for ground truth establishment. The "ground truth" for these tests are the objective measurements of the material's physical and chemical properties as defined by ISO standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or for establishing consensus ground truth, typically in the context of diagnostic interpretations (e.g., by radiologists). The testing reported here is for the physical properties of a material, which are measured objectively.
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
- This is not applicable. This is not an AI-assisted diagnostic device, nor does it involve human readers interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable. This is not an algorithm or software device. It is a physical dental impression material.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the non-clinical performance data (physical and chemical properties) is established by conformance to internationally recognized standards (ISO 1563:1990, ISO 10993 series) through validated laboratory test methods. There is no expert consensus on case interpretations, pathology, or outcomes data used for the "ground truth" of material properties.
8. The sample size for the training set
- This is not applicable. This device is a physical material, not an AI or machine learning model that requires a "training set."
9. How the ground truth for the training set was established
- This is not applicable, as there is no training set for this type of device.
§ 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).