(119 days)
- Impressions for the production of temporary restorations .
- . All types of preliminary impressions
- . Impressions of the opposing jaw
- Impressions for orthodontic models .
Flash AR and Flash AR 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. As the predicate devices Flash AR Penta™ and Flash AR Penta™ Quick (K131404), Flash AR and Flash AR Quick are medium-bodied (ISO Type 2) consistency A-silicone impression materials for all kinds of preliminary impressions. Like Flash AR Penta™ and Flash AR Penta™ Quick, Flash AR and Flash AR Quick are two component (base paste/catalyst) vinyl polysiloxane impression materials to be used for impressions, where typically alginates are used. Whereas Flash AR Penta™ and Flash AR Penta™ Quick are designed to automatically be mixed and dispensed in all versions of Pentamix™ devices of 3M Deutschland GmbH and the mixing ratio for both materials is base paste:catalyst, 5:1 (by volume), Flash AR and Flash AR Ouick will be delivered in Garant™ cartridges (50 ml plastic cartridges) and can be mixed and extruded using the Garant™ dispenser manufactured by 3M Deutschland GmbH with the mixing ratio for both materials of base paste:catalyst, 1:1 (by volume).
The provided text describes a 510(k) premarket notification for two dental impression materials, Flash AR and Flash AR Quick. The study presented focuses on demonstrating substantial equivalence to predicate devices rather than the performance of an AI/ML powered device. Therefore, many of the requested categories (such as sample size for test set, number of experts for ground truth, MRMC study, standalone study, and training set details) are not applicable to this submission.
Here's an analysis of the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Measured Property as per ISO 4823) | Flash AR Performance | Flash AR Quick Performance |
|---|---|---|
| Working Time | Same as predicate device Flash AR Penta | Same as predicate device Flash AR Penta Quick |
| Intra-oral Setting Time | Same as predicate device Flash AR Penta | Same as predicate device Flash AR Penta Quick |
| Material Consistency (ISO Type 2) | Medium-bodied A-silicone impression material | Medium-bodied A-silicone impression material |
| Biocompatibility | Biocompatible for intended use | Biocompatible for intended use |
| Indications for Use | Same as predicate device Flash AR Penta | Same as predicate device Flash AR Penta Quick |
| Mixing Ratio (Base:Catalyst) | 1:1 (by volume, in Garant™ cartridges) | 1:1 (by volume, in Garant™ cartridges) |
| Chemical Composition | Substantially equivalent to predicate devices | Substantially equivalent to predicate devices |
| Physical and Mechanical Properties | Substantially equivalent to predicate devices | Substantially equivalent to predicate devices |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided text. The study references "Test results according to ISO 4823" and "Biocompatibility testing," but does not detail the sample sizes for these tests.
- Data Provenance: The tests were conducted to establish substantial equivalence to predicate devices manufactured by 3M Deutschland GmbH, Germany. The actual location of the testing is not explicitly stated, but given the company's location, it is likely that the studies were performed in Germany or under the purview of a German entity. The exact nature (retrospective or prospective) of the physical/mechanical and biocompatibility testing is not specified, but typically these types of studies for product equivalency are laboratory-based and controlled.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This information is not applicable as the submission is for a dental impression material, not an AI/ML powered device requiring interpretation by experts to establish ground truth. Substantial equivalence was based on physical, mechanical, chemical, and biocompatibility testing against ISO standards and predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable as the submission is for a dental impression material. Ground truth in this context is established through objective physical, mechanical, chemical, and biological tests, not through expert consensus requiring adjudication.
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 as the submission is for a dental impression material and does not involve AI or human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable as the submission is for a dental impression material and does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the device's performance was established through:
- Objective physical and mechanical property measurements: Conducted according to ISO 4823, comparing working time, intra-oral setting time, consistency, and other properties.
- Chemical composition analysis: To ensure similarity with predicate devices.
- Biocompatibility evaluations: Performed in consideration of FDA and internationally recognized guidelines.
- The primary "ground truth" for the submission's goal was the established performance and safety of the predicate devices (Flash AR Penta™ and Flash AR Penta™ Quick), against which substantial equivalence was demonstrated.
8. The sample size for the training set
- This information is not applicable as the device is not an AI/ML powered device and therefore does not have a "training set."
9. How the ground truth for the training set was established
- This information is not applicable as the device is not an AI/ML powered device and therefore does not have a "training set" or ground truth for it.
Summary of the Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is a substantial equivalence evaluation comparing the new devices (Flash AR and Flash AR Quick) to their predicate devices (Flash AR Penta™ and Flash AR Penta™ Quick). This evaluation involved:
- Performance testing: According to ISO 4823, focusing on physical and mechanical properties such as working time and intra-oral setting time. The new devices reportedly had the "same" working and intra-oral setting times as their respective predicates.
- Chemical composition comparison: Demonstrating similarity to the predicate devices.
- Biocompatibility evaluations: Performed under FDA and international guidelines, concluding that the materials are biocompatible for their intended use.
- Indications for Use comparison: Establishing that the new devices share the same intended uses as the predicate devices.
The conclusion of the study was that Flash AR and Flash AR Quick are substantially equivalent in safety and effectiveness to the predicate devices, thereby meeting the necessary criteria for regulatory clearance.
§ 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).