(120 days)
Bite registration.
Flash Bite is classified as impression materials (21 C.F.R. § 872.3660) because it is a devices intended to reproduce the structure of a patient's teeth. Flash Bite is a two component (base paste/catalyst) vinyl polysiloxane bite registration material designed to be used in 3M Deutschland GmbH's mixing, dosing and dispensing device, Garant of 3M Deutschland GmbH. The mixing ratio for both materials is base paste:catalyst, 1:1 (by volume).
The provided text describes a 510(k) premarket notification for a dental impression material named "Flash Bite." This submission focuses on demonstrating substantial equivalence to predicate devices, primarily through comparison of indications for use, physical and mechanical properties, and chemical composition, rather than presenting a study with acceptance criteria and device performance in the typical sense of a diagnostic medical device.
Therefore, many of the requested elements for a study establishing acceptance criteria do not apply directly to this type of submission. However, I will extract what can be inferred or directly stated from the document regarding equivalence testing.
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" for quantitative performance metrics in a table. Instead, it relies on demonstrating substantial equivalence to predicate devices in terms of properties. The performance is assessed against the existing, legally marketed predicate devices.
| Property (Implicit Acceptance Criteria) | Reported Device Performance (Flash Bite) |
|---|---|
| Indications for Use | Substantially equivalent to predicate devices (Bite registration) |
| Physical Properties | Compared to predicate devices; deemed substantially equivalent |
| Mechanical Properties | Compared to predicate devices; deemed substantially equivalent |
| Chemical Composition | Compared to predicate devices; deemed substantially equivalent |
| Biocompatibility | Biocompatible for its intended use (as per FDA & internationally recognized guidelines) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for any tests. The data provenance is not mentioned beyond the submitting company being located in Germany. The nature of the comparisons (e.g., laboratory tests) suggests prospective data collection for the new device, but this is not explicitly stated.
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 is not applicable. For material equivalence, ground truth is established through standardized material testing methods and comparison to known properties of predicate materials, not through expert reader consensus on clinical images or data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the submission is for material equivalence based on physical, mechanical, and chemical properties, and biocompatibility, not clinical diagnostic performance requiring adjudication of results.
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 is not applicable. The device is a dental impression material, not an AI-powered diagnostic tool. Therefore, no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is the established performance characteristics and safety profile of the predicate devices, along with adherence to recognized biocompatibility standards. For the physical, mechanical, and chemical properties, the ground truth would be the values obtained from standardized material testing. For biocompatibility, it's compliance with FDA and international guidelines.
8. The sample size for the training set
This is not applicable as the device is a dental material, not a machine learning model, and therefore does not have a "training set."
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
§ 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).