(4 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.
Indications for Use:
Panasil putty (putty, putty fast set, putty soft) and Panasil binetics (putty fast, putty soft) are to be used as preliminary materials for:
-Two step putty/wash impression technique.
-One step putty/wash impression technique.
-Two step putty/wash impression technique using a foil (plastic putty spacer)
-One step putty impression technique for forming functional peripheries.
Panasil trav (fast. soft) 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 monophase is to be used as a medium-bodied tray or syringeable impression material for:
-Taking impressions over fixed/removable restorations and implants
(transferring impression posts and bridge components).
-Functional impressions.
-Fabricating crown and bridgework or inlays.
-Fabricating full or partial dentures.
-Reline impressions.
-Use in the simultaneous mixing technique as well as the putty/wash and triple tray techniques.
-Transferring root posts when fabricating posts and cores indirectly.
Panasil contact (two in one, plus) 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® Impression Materials are addition-curing, elastomeric materials with hydrophilic properties, high tear strength, dimensional accuracy, and resistance to permanent deformation. The Panasil Impression Material family consists of five different viscosities (putty, heavy-bodied, medium-bodied, light-bodied, x-lightbodied), available in an assortment of delivery systems: traditional 1:1 50 ml automix cartridge, 5:1 362 ml foil bags for use in most automatic dispensing and mixing systems, and traditional 1:1 putty jars.
The provided document describes Panasil® Impression Materials, a dental impression material, and its substantial equivalence to predicate devices, rather than an AI/ML powered medical device. Therefore, the information requested regarding acceptance criteria, study details, and AI/ML specific metrics (like MRMC studies) is not directly applicable or available in the given text.
However, I can extract the relevant information from the document considering it's a traditional medical device submission (dental impression material) and present it in a modified format that aligns with the spirit of your request, focusing on how its "performance" was assessed against established criteria.
Here's an interpretation based on the provided text, adapted for a non-AI/ML device:
Acceptance Criteria and Device Performance for Panasil® Impression Materials
The primary "acceptance criteria" for this traditional medical device product are based on demonstrating substantial equivalence to legally marketed predicate devices, as per the FDA 510(k) pathway. This equivalence is established through meeting applicable criteria from relevant guidance documents and international standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (Derived from Standards/Guidance) | Referenced Standard/Guidance | Reported Device Performance/Conclusion |
|---|---|---|
| Technological Characteristics Equivalence | FDA Guidance for Industry and FDA Staff: Dental Impression Materials (FOD#2203, 8/17/1998) | Panasil® Impression Materials (Panasil putty, Panasil binetics, Panasil tray, Panasil monophase, Panasil contact) and the predicate devices are addition-curing, elastomeric materials designed and manufactured for use as dental impression materials, demonstrating substantial equivalence in technology. |
| Material Properties (e.g., tear strength, dimensional accuracy, resistance to permanent deformation, hydrophilic properties) | ISO 4823 (Dentistry – Elastomeric impression materials):2000/Cor 1:2004/Amd 1:2007 | The device has hydrophilic properties, high tear strength, dimensional accuracy, and resistance to permanent deformation. Performance testing demonstrated suitability for use as dental impression materials, performing in a manner substantially equivalent to predicate devices. |
| Intended Use & Indications for Use Equivalence | Comparison with predicate devices (K954281, K021413, K021410, K050604) | The intended use for reproducing patient's teeth/gums for study models and prosthetic devices, and the specific indications for each Panasil product variation, are consistent with the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a quantitative sample size for performance testing. It generally refers to "device performance testing." For material characteristics of this type, testing would typically involve a statistically relevant number of samples of the material itself, rather than a "test set" of patient data.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, given that Kettenbach GmbH & Co. KG is a German company, a significant portion of the material testing could have been conducted in Germany or by third-party labs. As this is a premarket notification for a material, the "data" would primarily be laboratory-based material characterization, not patient-derived data in the way an AI/ML diagnostic device uses it.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- This concept is not applicable to this type of device. The "ground truth" for dental impression materials is established by objective physical and chemical measurements against recognized standards (like ISO 4823) and comparison to the properties of predicate devices. There wouldn't be "experts" establishing a clinical ground truth for a test set in the same way as for an image-based diagnostic AI.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication in the context of expert review for diagnostic outcomes is not relevant here. Device performance is determined by objective laboratory measurements and comparison to established specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a traditional dental impression material, not an AI-powered device, so no MRMC studies or human reader improvement with AI assistance were conducted or are relevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a material, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for Panasil® Impression Materials is established by:
- Objective Material Property Measurements: Adherence to physical and chemical parameters defined in international standards like ISO 4823 (e.g., tear strength, dimensional stability, resistance to permanent deformation).
- Predicate Device Comparison: Direct comparison and demonstration of similar or identical properties and performance characteristics to previously cleared dental impression materials.
8. The Sample Size for the Training Set
- Not applicable. This is a traditional medical device (material), not an AI/ML algorithm that requires a "training set." The development of such materials involves chemical formulation and iterative testing, not machine learning model training.
9. How the Ground Truth for the Training Set was Established
- 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).