(121 days)
Restoration primer for treatment of:
metal/silicate ceramics, oxide ceramic and composite surfaces
- · to cement prosthetic restorations
- · to repair fractured restorations with composite materials
Visalys® Restorative Primer with adhesive monomers (10-MDP, silane methacrylate) is for building up adhesive surfaces on restoration materials (metal, composite, as well as silicate and oxide ceramics). Visalys® Restorative Primer is a single component primer. Do not light cure Visalys® Restorative Primer. BPA or BPA precursors are not used in the manufacturing process of this device.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Visalys® Restorative Primer device.
It's important to note that this document is a 510(k) summary for a Class II medical device (Resin Tooth Bonding Agent). For such devices, the FDA often relies on substantial equivalence to a predicate device, which means direct comparative effectiveness studies with human subjects against the predicate might not always be required in the same way as for novel high-risk devices. The information provided is primarily focused on demonstrating this substantial equivalence through bench testing.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly derived from the bond strength values of the predicate device, CLEARFIL™ CERAMIC PRIMER PLUS (K150703). The study aims to show that Visalys® Restorative Primer performs similarly. No explicit "acceptance criteria" are stated as numerical thresholds; rather, the "Similar" conclusion in the table below serves as the acceptance.
| Test Parameter / Material | Predicate Device Performance (CLEARFIL™ CERAMIC PRIMER PLUS) | Visalys® Restorative Primer Performance | Acceptance Criteria (Implicit) | Conclusion |
|---|---|---|---|---|
| Shear Bond Strength (MPa) | Similar performance to predicate | |||
| Lithium disilicate | (8.9 MPa) | (10.2 MPa) | Achieving comparable shear bond strength | Similar |
| Zirconium oxide | (8.4 MPa) | (7.5 MPa) | Achieving comparable shear bond strength | Similar |
| Non-precious metal | (8.3 MPa) | (12.5 MPa) | Achieving comparable shear bond strength | Similar |
2. Sample sized 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: The document does not explicitly state the number of samples or specimens used for the shear bond strength tests. It only lists the resulting bond strength values.
- Data Provenance: The study was conducted by Kettenbach GmbH & Co. KG (located in Eschenburg, Germany). The data is prospective as it involves new bench testing to support the 510(k) submission.
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. This device is a dental primer, and the ground truth for its performance (shear bond strength) is established through in vitro bench testing according to a recognized standard (ISO 16506). This does not involve human expert adjudication of images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as the evaluation is based on objective physical measurements (shear bond strength) from bench tests, not on subjective expert consensus or 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
Not applicable. This device is a dental primer, not an AI-based diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a dental primer, not an algorithm. The performance evaluation presented is strictly standalone in vitro bench testing of the product's physical properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the device's performance is established by objective physical measurements (shear bond strength) obtained through standardized in vitro bench testing adhering to relevant ISO standards (specifically, ISO 16506 Chapter A 2.2.5).
8. The sample size for the training set
Not applicable. This is a physical dental product, not a machine learning model. Therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.