(15 days)
- Impressions for the production of temporary restorations
- All types of preliminary impressions .
- Impressions of the opposing jaw .
- Impressions for orthodontic models .
Flash AR Penta™ and Flash AR Penta™ Quick are classified as impression materials (21 C.F.R. § 872.3660) because they are devices intended to reproduce the structure of a patient's teeth. Flash AR Penta™ and Flash AR Penta™ Quick are medium-bodied (ISO Type 2) consistency A-silicone impression materials for all kinds of preliminary impressions. Like Position Penta™ & Position Penta™ Quick, Flash AR Penta™ and Flash AR Penta™ Quick are two component (base paste/catalyst) vinyl polysiloxane impression materials designed to automatically be mixed and dispensed in all versions of Pentamix™ devices of 3M Deutschland GmbH. The mixing ratio for both materials is base paste:catalyst, 5:1 (by volume).
The provided 510(k) summary describes a dental impression material (Flash AR Penta™ and Flash AR Penta™ Quick), not an AI-powered medical device. Therefore, much of the requested information regarding acceptance criteria for AI performance, clinical studies with human readers, and ground truth establishment is not applicable to this submission.
However, I can extract the relevant information about the device and its demonstrated equivalence.
Nature of the Device:
The device is described as "medium-bodied (ISO Type 2) consistency A-silicone impression materials for all kinds of preliminary impressions." It is a two-component vinyl polysiloxane impression material.
Equivalence Claim:
The core of this 510(k) submission is to demonstrate substantial equivalence to predicate devices (Position Penta™ & Position Penta™ Quick, and Flash materials by 3M Deutschland GmbH) based on indications for use, physical and mechanical properties, and chemical composition.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a dental impression material, the "acceptance criteria" and "reported device performance" are primarily related to physical and mechanical properties, chemical composition, and biocompatibility rather than diagnostic performance metrics like sensitivity or specificity. The submission states that these properties were compared to predicate devices.
| Acceptance Criteria Category | Reported Device Performance (as demonstrated by comparison to predicate) |
|---|---|
| Indications for Use | Substantially equivalent to predicate devices. |
| Physical Properties | Substantially equivalent to predicate devices. |
| Mechanical Properties | Substantially equivalent to predicate devices. |
| Chemical Composition | Substantially equivalent to predicate devices. |
| Biocompatibility | Materials are biocompatible for intended use, evaluated per FDA & internationally recognized guidelines. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The comparison against predicate devices involved evaluating physical and mechanical properties, chemical composition, and biocompatibility. The specific number of samples tested for each property is not detailed in the summary.
- Data Provenance: The device manufacturer (3M Deutschland GmbH) is located in Germany. Biocompatibility evaluations considered FDA and internationally recognized guidelines, implying data generated adheres to these standards. The comparison studies would have been conducted by the manufacturer as part of the submission package. The data is retrospective in the sense that it evaluates the device's properties against established benchmarks and predicate devices.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable. For a dental impression material, "ground truth" in the context of diagnostic accuracy (like in AI studies) is not relevant. The evaluation relies on standardized material testing (e.g., ISO standards) and chemical analysis.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human reviewers (e.g., radiologists) when establishing ground truth for diagnostic AI. This device does not involve such a process. Material testing results are typically objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is designed for evaluating the impact of AI assistance on human reader performance in diagnostic tasks. This is a material, not a diagnostic AI device.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
- No. This is not an AI algorithm. Its performance is evaluated through material science testing.
7. The Type of Ground Truth Used
- For this device, the "ground truth" refers to accepted standards for material properties, chemical composition, and biocompatibility. This would involve:
- Standardized Material Testing: Adherence to relevant ISO standards (e.g., for impression materials) for properties like tear strength, dimensional stability, working time, setting time, etc.
- Chemical Analysis: Verification of the chemical composition against the formulation and comparison to predicate devices.
- Biocompatibility Standards: Compliance with ISO 10993 series for medical device biocompatibility, which involves tests like cytotoxicity, sensitization, and irritation.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/machine learning device, so there is no "training set." The materials are formulated and manufactured, then tested.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no training set for an AI model, this question does not apply. The development of the material is based on chemical and polymer science principles, with iterative formulation and testing, rather than an AI training paradigm.
§ 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).