(154 days)
- · A dental adhesive formulated to adhesively bond to hard tissues of the oral cavity, enamel and dentin
- · Dentin-enamel primer/bonding agent for direct composite restorations
- · Indirect composite restorative luting system
- · Porcelain veneer luting system
- · Bonding composite to composite
- · Bonding composite to metal/amalgam
- · Adhesive amalgam restorations
Meta P&Bond is a wet bond adhesive system that is activated by visible light curing. This bonding agent is one-step for priming and bonding. It is formulated to adhesively bond to hard surfaces of the oral cavity, namely enamel and dentin, for use with dental cements. It is useful as a primer for use with other methacrylate cements. It is intended to be painted on the interior of a prepared cavity or surface of a tooth to improve retention of a restoration such as a filling or crown. It also is useful as a prime and bonder for porcelain veneer luting, bonding composite, and composite to metal/amalgam. Meta P&Bond is packaged with Microbrush accessories.
The document provides details about the Meta P&Bond device, a resin tooth bonding agent. However, it does not describe an AI/ML device or a study involving human readers or expert consensus for ground truth establishment. Therefore, most of the requested information regarding AI/ML device performance, ground truth, expert involvement, and MRMC studies cannot be extracted from the provided text.
Based on the information provided, here's what can be extracted:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Meta P&Bond device are based on compliance with ISO 4049:2009 for performance tests and ISO 10993 series for biocompatibility. The reported device performance is compared against a predicate device (K081913, also Meta P&Bond manufactured by Meta Biomed Co., Ltd.). The table below summarizes the comparison:
| Characteristic | Acceptance Criteria (Predicate) | Reported Device Performance (Subject Device) |
|---|---|---|
| Capacity | 2.15% | 1.37% |
| Film thickness | 1 µm | 2 µm |
| Solubility (ISO 4049:2009) | 7.5 µg/mm² | 1.4 µg/mm² |
| Sensitivity to Ambient Light | Material remained physically homogeneous | Material remained physically homogeneous |
| Depth of Cure | 3.53 mm | 2.9 mm |
| Bond Strength, Dentine | 10 MPa | 17 MPa |
| Bond Strength, Enamel | 30.76 MPa | 31 MPa |
| Shelf Life | 2 Years | 2 Years |
The document states that "As the solubility value of the subject device is within the range that ISO 4049:2009, it doesn't affect safety and effectiveness." This implies that the ISO 4049:2009 standard provides the acceptance range for solubility. The document also concludes that the differences between the subject and predicate devices "do not raise different questions of safety and effectiveness than the predicate."
Information Not Found in the Document:
The provided document is a 510(k) summary for a dental adhesive and does not contain the following information relevant to an AI/ML device study:
- Sample size used for the test set and the data provenance: Not applicable as this is not an AI/ML device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI/ML device study. For the physical and chemical tests, the "ground truth" would be the measured values against established scientific standards.
- The sample size for the training set: Not applicable as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
In summary, the document focuses on the non-clinical testing and comparison of physical and chemical properties of a dental bonding agent against a predicate device and relevant international standards (ISO). It is not about an AI/ML-driven medical 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.