(25 days)
The Panasil® Impression Materials are intended to: be placed on an impression tray (or injected directly into the mouth, depending on the technique and device) and used to reproduce the structure of a patient's teeth and gums; provide models for study and for production of restorative prosthetic devices.
Panasil® initial contact (regular, regular fast, light fast, x-light, x-light fast) is to be used as a syringeable impression material for: Two-step putty-wash impression technique. One-step putty-wash impression technique. One-step impression technique using a foil (plastic putty spacer). One-step impression technique (simultaneous technique) using dual viscosities. Reline impressions. Fabricating full or partial dentures.
Panasil® tray (fast 1:1, soft fast 5:1, soft fast 1:1) is to be used as a heavy-bodied material for: One-step impression technique (simultaneous technique) using single or dual viscosities. Two-step impression technique using dual viscosities. Functional impressions.
Panasil® Impression Materials are addition-curing, elastomeric materials with hydrophilic properties, high tear strength, dimensional accuracy, and resistance to permanent deformation. The Panasil Impression Materials include four different viscosities (heavy-bodied, medium-bodied, light-bodied, x-light-bodied), available in an assortment of delivery systems: traditional 1:1 50 ml automix cartridge and 5:1 362 ml foil bags for use in most automatic dispensing and mixing systems.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ISO 4823 (Dentistry - Elastomeric impression materials):2000/Cor. 1:2004/Amd. 1:2007 | Met applicable requirements. The Panasil® Impression Material subject devices were found suitable for use as dental impression materials. |
| Guidance for Industry and FDA Staff: Dental Impression Materials – Premarket Notification (FOD#2203, 8/17/1998) | Met applicable requirements, demonstrating substantial equivalence to predicate devices. |
2. Sample Size for Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that performance testing was conducted.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. The ground truth for this device is based on compliance with established industrial standards (ISO 4823) and FDA guidance, rather than expert consensus on diagnostic images or similar data.
4. Adjudication Method for the Test Set
Not applicable. The testing appears to be quantitative measurements against technical specifications outlined in the referenced standards, not a qualitative assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with AI/diagnostic imaging devices where human readers' performance with and without AI assistance is evaluated. The Panasil® Impression Materials are dental impression materials, which are physical devices.
6. Standalone Performance Study
Yes, a standalone study (algorithm only without human-in-the-loop performance) was effectively done. The performance data section states that the "Panasil® Impression Material subject devices... have been evaluated in accordance with the applicable criteria established in Guidance for Industry and FDA Staff: Dental Impression Materials – Premarket Notification... and ISO 4823." This indicates that the materials themselves were tested against a set of objective technical benchmarks.
7. Type of Ground Truth Used
The ground truth used is based on established industry standards and regulatory guidance. Specifically, the device's performance was evaluated against the technical requirements outlined in:
- ISO 4823 (Dentistry - Elastomeric impression materials):2000/Cor. 1:2004/Amd. 1:2007
- Guidance for Industry and FDA Staff: Dental Impression Materials – Premarket Notification (FOD#2203, 8/17/1998)
8. Sample Size for the Training Set
Not applicable. This device is a dental impression material, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this is not an AI/machine learning device, there is no training set or associated ground truth establishment process in that context.
§ 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).