(41 days)
The intended use of Kalginate ®, a Dental Alginate Impression Material, is to obtain impressions of the patient's teeth and oral tissues.
Kalginate ® is a powdered material, that is mixed with water and placed in the patients oral cavity. It contains alginate, an essential gel forming material, that reacts with water to form an elastic material suitable for making impressions of the patients teeth and oral tissues.
This 510(k) summary (K970594) describes an Alginate Impression Material named "Kalginate®" and focuses on a change in the color pigment from Valencia Orange to Red Pigment #38. The document does not describe a study that uses acceptance criteria in the way typically expected for an AI/ML medical device submission.
Instead, this submission details an accelerated shelf-life test to demonstrate the stability of the new formulation and a biocompatibility test.
Here's an analysis based on the provided text, recognizing the significant difference in the type of device and study:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Shelf Life/Stability (New vs. Old) | No significant stability difference between old and new formulations after accelerated aging. | "The results show no stability difference between the new and old Kalginate® Impression Material formulations." |
| Biocompatibility | Non-irritating to oral mucosa. | "non-irritating to the cheek pouch mucosa of hamsters." |
Note: The acceptance criteria for the shelf-life test are implied by the statement "no stability difference." For biocompatibility, it's explicitly stated as "non-irritating."
2. Sample Size Used for the Test Set and Data Provenance
- Shelf Life Test: "A batch of the new Kalginate® Impression Material." No specific number of samples (impressions/material specimens) is provided, just "test samples from the batch."
- Data Provenance: Not explicitly stated, but implies materials produced by Teledyne Water Pik for internal testing. Retrospective in the sense that the material was produced, then aged and tested.
- Biocompatibility Test: "hamsters." The exact number of hamsters is not specified.
- Data Provenance: Animal study ("cheek Pouch Mucosal Irritation Histopathology Study").
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Given the nature of the tests:
- Shelf Life Test: No "experts" in the sense of clinical reviewers establishing ground truth for perception or diagnostic accuracy. Material scientists or chemists would interpret the stability test results (e.g., changes in physical properties over time). Their qualifications are not specified.
- Biocompatibility Test: A "Histopathology Study" would be interpreted by a pathologist. Their number and specific qualifications (e.g., "veterinary pathologist with X years of experience") are not provided.
4. Adjudication Method for the Test Set
- Shelf Life & Biocompatibility: Not applicable in the context of typical clinical or AI/ML ground truth adjudication. These are laboratory-based tests with objective measurements or pathological interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This is a material science and biocompatibility study, not an MRMC study comparing human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done
- No. This device is an impression material, not an AI algorithm.
7. The Type of Ground Truth Used
- Shelf Life Test: Objective material property measurements (e.g., physical properties, chemical composition, setting times, consistency – though not explicitly listed, these are typical for impression materials).
- Biocompatibility Test: Histopathological findings (cellular and tissue-level changes) observed by a pathologist.
8. The Sample Size for the Training Set
- Not applicable. This study does not involve a "training set" as it's not an AI/ML algorithm.
9. How the Ground Truth for the Training Set was Established
- Not applicable.
Summary of Discrepancy with Request:
The provided 510(k) summary is for a physical medical device (dental impression material) and its specific tests for a formulation change. The questions in the prompt are heavily geared towards the evaluation of an Artificial Intelligence/Machine Learning (AI/ML) powered medical device. Therefore, many questions related to AI-specific elements like "test set," "ground truth experts," "adjudication," "MRMC," and "training set" are not applicable to this submission. The "acceptance criteria" here refer to material stability and biocompatibility, not diagnostic performance metrics like sensitivity or specificity.
§ 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).