(45 days)
Dental impression material for mixing and dispensing in a GARANT® dispenser:
Impressions for inlay, onlay, crown, and bridge restorations
Functional impressions
Fixation impressions
Implant impressions
IMPREGUM® GARANT® L DUOSOFT is classified as an impression material (21 C.F.R. § 872.3660) because it is a device intended to reproduce the structure of a patient's teeth.
ESPE is submitting this Special 510(k) for modifications to its polyether based impression material PERMADYNE® GARANT®. IMPREGUM® GARANT® L DUOSOFT is intended to be used together with ESPE's new impression material IMPREGUM® PENTA® H DUOSOFT in a one-step and two-step "putty wash" technique.
Like PERMADYNE® GARANT®, IMPREGUM® GARANT® L DUOSOFT is a low viscosity impression material for mixing, dosing and dispensing in the GARANT® dispenser.
This is a 510(k) premarket notification for a dental impression material, not an AI/ML medical device. Therefore, many of the requested criteria, such as "acceptance criteria and reported device performance," "sample sizes for test set," "number of experts for ground truth," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," "sample size for training set," and "how ground truth for training set was established," are not applicable in this context.
A 510(k) submission demonstrates substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for an AI/ML algorithm.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
Not applicable in the context of a 510(k) for an impression material, as there are no specific numerical performance metrics like sensitivity, specificity, accuracy, or AUC that would typically be reported for an AI/ML device.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (PERMADYNE® GARANT®, K953374) by comparing:
- Intended Use: Identical.
- Operating Principle: Identical.
- Basic Chemical Design: Identical.
- Shelf Life: Identical.
- Manufacturing and Packaging: Identical materials and processes.
- Chemical Components: All components of the modified device are either in the predicate device or other 510(k)-cleared impression materials from the same manufacturer.
2. Sample size used for the test set and the data provenance:
Not applicable. The submission does not describe a clinical "test set" in the way an AI/ML device would. The "test" here refers to a comparison of chemical, physical, and mechanical properties, not a clinical trial with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth as typically understood for AI/ML (e.g., expert consensus on medical images) is not relevant for this type of device submission. The comparison is based on scientific and technical properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. There is no expert adjudication process described or required for this type of device submission.
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:
Not applicable. This is not an AI-assisted diagnostic or therapeutic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. For this specific dental impression material, the "truth" is established through engineering and chemical characterization, demonstrating that its properties are comparable to the predicate device.
8. The sample size for the training set:
Not applicable. There is no AI/ML training set.
9. How the ground truth for the training set was established:
Not applicable. There is no AI/ML training set.
Summary of the Study and Findings as per the document:
The submission is a Special 510(k) for modifications to an existing polyether-based impression material, PERMADYNE® GARANT®. The modified device is named IMPREGUM® GARANT® L DUOSOFT.
- Goal of the Study (Submission): To demonstrate substantial equivalence of IMPREGUM® GARANT® L DUOSOFT to the legally marketed predicate device PERMADYNE® GARANT® (K953374).
- Methodology: The submission compares the chemical composition, physical and mechanical properties, and indications for use of the modified device against the unmodified predicate device. It also states that ESPE's design control activities are briefly explained.
- Key Findings for Substantial Equivalence:
- Same intended use.
- Same operating principle.
- Same basic chemical design.
- Same shelf life.
- Same manufacturing and packaging materials and processes.
- All chemical components are already part of the predicate device or other 510(k) cleared impression materials by ESPE, hence no additional biocompatibility testing was deemed necessary.
The FDA reviewed the submission and determined that the device is substantially equivalent to devices marketed prior to May 28, 1976. This determination allows the device to be marketed.
§ 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).