(478 days)
No Stress Impress is intended for use as a rebasing and relining impression material as well as for general impressions including but not limited to dentures, root surfaces, and posts.
No Stress Impress is a thermoplastic impression material available for full or partial impressions that comes as a stick or wafer.
Here's an analysis of the provided text regarding the acceptance criteria and study for the "No Stress Impress" device, broken down as requested.
The document is a 510(k) Summary for a dental impression material. As such, the "acceptance criteria" are mainly focused on product performance standards and biocompatibility, rather than clinical efficacy metrics typical of AI/software devices. The "study" refers to the testing performed to demonstrate compliance with these standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Test) | Reported Device Performance (Results) |
|---|---|
| Material testing per ISO 4823:2015, 7.8 Dentistry Elastomeric Material | Satisfactory results |
| Biocompatibility Testing: | |
| ISO Oral Mucosal Irritation Study in Hamsters - Collar Method - 24 hours | Non-irritating |
| ISO Guinea Pig Maximization Sensitization Test | Non-sensitizing |
| Cytotoxicity Study Using the ISO Elution Method | No lysis, no reactivity, no pH shift |
| Cytotoxicity Study Using the ISO Agarose Overlay Method | No lysis, no reactivity |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for the material testing per ISO 4823:2015.
For biocompatibility testing, the following "sample sizes" are implied by the test names, but precise numerical counts of animals/cells are not given:
- Hamsters (for Oral Mucosal Irritation Study)
- Guinea Pigs (for Sensitization Test)
- Cell cultures (for Cytotoxicity Studies)
The data provenance (e.g., country of origin, retrospective/prospective) for these tests is not specified in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to the "No Stress Impress" device as described in this 510(k) summary. The device is a material, not an AI or diagnostic tool that requires expert interpretation for ground truth establishment. The ground truth for material properties is established by adherence to international standards (e.g., ISO) and laboratory test results.
4. Adjudication Method for the Test Set
This information is not applicable as the device is a material, not a diagnostic or AI device that requires adjudication of expert opinions. The "ground truth" for material properties is determined by the specific outcomes of the standardized tests.
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 information is not applicable to the "No Stress Impress" device. This is a material, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This information is not applicable to the "No Stress Impress" device. It is a material, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on:
- Material properties and performance standards: Compliance with ISO 4823:2015 for dentistry elastomeric material.
- Biocompatibility test results: Specific empirical outcomes from standardized biological assays (irritation, sensitization, cytotoxicity) conducted according to ISO 10993-1.
8. The Sample Size for the Training Set
This information is not applicable to this device. As a dental impression material, there is no "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable to this device for the reasons stated above.
§ 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).