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DentoEtch: It is intended used for etching tooth enamel and dentine when preparing surfaces for application of composites.
Quickbond: It is intended for: Bonding composite to enamel and/or dentin; Bonding veneers, crowns & bridges, onlays and inlays; Bonding composite core built-up material; Bonding of composite to metal, Intraoral repairs (i.e. composite, fractured crowns & bridges, inlays & onlays and veneers); Treatment of hypersensitive teeth or exposed root surfaces; and Cavity sealing under amalgam restorations
Bond Activator: It is intended for use to enable the practitioner to use self-cure techniques for the indications where dual-cured adhesive may be desired.

DentoEtch: DentoEtch is an etching gel phosphoric acid 37%.
Quickbond: Simple to use, two-bottle, two step self-etching bonding system, with a first bottle containing the primer and a second one containing the bonding agent. This subject device may also be used with a self-curing activator

The provided text is related to a 510(k) summary for dental devices (DentoEtch, Quickbond, and Bond Activator) and does not contain information about a study proving that a device meets specific acceptance criteria in the context of AI/ML performance testing for medical image analysis or similar diagnostic tools. The document describes the devices, their classification, predicate devices, and indications for use, as well as the FDA's clearance of the devices based on substantial equivalence to existing products.

Therefore, for almost all points requested, the information is not present in the provided text, as the context is a traditional medical device clearance, not an AI/ML diagnostic tool.

Here's how the information maps to the provided text:

1. A table of acceptance criteria and the reported device performance: Not present. The 510(k) summary focuses on substantial equivalence based on indications for use and technological characteristics, not on quantifiable performance metrics of an AI/ML system.
2. Sample sizes used for the test set and the data provenance: Not present. This type of detail is not typically included in a 510(k) summary for these types of dental devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. Ground truth establishment for AI/ML models is not relevant to this submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not present.
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 present. This type of study is relevant for AI/ML-assisted diagnostic tools, not for dental bonding agents and etchants.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. Not applicable to these devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not present.
8. The sample size for the training set: Not present.
9. How the ground truth for the training set was established: Not present.

The only "performance" or "test" information mentioned is:

• "cell reactions that have been interpreted as Moderate-severe and none, respectively, validating the test." This is a very brief and high-level statement, likely referring to biocompatibility testing, which is standard for medical devices, but it does not provide acceptance criteria or detailed performance data in the way an AI/ML study would. It serves only to state that a test was performed and validated the product.

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