(53 days)
Blugoo HD is used to reproduce the structure of a patient's teeth and gums.
Blugoo HD is a three part product (Part A, Part B, and Part C). Part A and B are a two part resin based impression mix. Blugoo HD Part C Yellow Wash is a two part resin based impression material. It can be used in conjunction with Blugoo HD for high definition impressions.
This 510(k) premarket notification describes a dental impression material named Blugoo HD. The submission focuses on demonstrating substantial equivalence to a predicate device, Extrude, rather than providing a performance study with specific acceptance criteria and reported device performance metrics in the way a diagnostic AI device would.
Therefore, many of the requested sections (e.g., acceptance criteria table, sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, ground truth type, training set size, training set ground truth) are not applicable to this type of submission for a dental impression material. The submission aims to show that the new material performs similarly to an already approved material for its intended use.
Here's an overview based on the provided document:
1. Table of acceptance criteria and the reported device performance
Not applicable. For a dental impression material, acceptance criteria would typically involve physical and chemical properties matching or performing equivalently to a predicate device, as opposed to diagnostic performance metrics like sensitivity or specificity. This document lists attributes for comparison but does not provide specific numerical acceptance criteria or reported performance values.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The submission does not describe a clinical performance study with a 'test set' in the context of diagnostic performance. The comparison is based on technological characteristics and material properties.
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)
Not applicable. Ground truth as typically understood in AI/diagnostic studies is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or adjudication method is described.
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. Blugoo HD is a dental impression material, not an AI or diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. Blugoo HD is a physical material, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. Ground truth in the diagnostic sense is not relevant here. The "ground truth" for this type of submission is the performance of the legally marketed predicate device against which the new device is compared. This comparison is based on established industry standards and material science, not clinical diagnostic outcomes.
8. The sample size for the training set
Not applicable. There is no AI model or training set involved.
9. How the ground truth for the training set was established
Not applicable. There is no AI model or training set involved.
Summary of the Study / Equivalence Claim:
The study described is not a performance study in the diagnostic sense, but rather a substantial equivalence claim based on a comparison of technological characteristics between the new device (Blugoo HD) and a legally marketed predicate device (Extrude, manufactured by Sybron Dental Specialties, Inc., K012405).
The submission asserts that Blugoo HD has similar technological characteristics to the predicate device in the following areas:
- Anatomical sites
- Design
- Formulation
- Type
- Intended use
- Mixing time
- Working time
- Minimum removal time from start of mix
- Linear dimensional change
- Elastic recovery
- Strain in compression
- Impression longevity
- Storage conditions
- Detail reproduction
- Compatibility with gypsum
The evidence presented is this list of comparative characteristics. The regulatory body (FDA) reviewed this claim and determined that the device is substantially equivalent to the predicate device for its stated indications for use: "Blugoo HD is used to reproduce the structure of a patient's teeth and gums."
§ 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).