(216 days)
The TOKUYAMA UNIVERSAL BOND is indicated for:
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Direct anterior and posterior restorations with light-curing, and self-curing composite materials
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Intraoral repair of composite restorations, porcelain fused to metal, and all-ceramic restorations without an additional primer
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Cementation of indirect restorations and veners when combined with light-cure, and self-curing resin cements
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Bonding of core build-ups made of core build-up materials
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Bonding of denture resin to metal base, clasp or attachment
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Repair of denture with metal base, clasp or attachment
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Bonding of opaque resin to a metal base in the fabrication of resin-faced crowns
The TOKUYAMA UNIVERSAL BOND device is a two-component self-cured dental adhesive system for both direct and indirect restorations that can be used with self-etch, selective-enamel-etch, and total-etch techniques. The TOKUYAMA UNIVERSAL BOND device is fully compatible with light-cured. self-cured, and dual-cured composite materials.
Bond A and Bond B are packaged in separate plastic bottles. A group of polymerization agents is contained in the Bond A and Bond B to avoid reaction during storage, and the polymerization reaction begins upon mixing. When the mixture is applied thinly to adherends and concentrate by air-drying, a cured layer is formed by polymerization of methacrylic monomers. The cured layer functions as an adhesive layer for enhancing adhesiveness of polymerization resin to the adherends.
The device improves the bond strength of polymerizable resin material (adhesive resin cement, acrylic resin, and composite resin) to indirect restorative materials such as glass-ceramics (porcelain), oxide-ceramics (zirconia and alumina), metals (precious and non-precious), and resin materials including inorganic filler.
The provided document is a 510(k) premarket notification for a dental adhesive device, the TOKUYAMA UNIVERSAL BOND. It describes the device, its intended use, technological characteristics, and non-clinical testing performed to demonstrate substantial equivalence to predicate devices.
However, the document does NOT describe an AI/ML-based medical device. Therefore, it does not contain the information required to answer the questions about acceptance criteria, study design for AI models (sample size, data provenance, ground truth, expert adjudication, MRMC studies, standalone performance, training set details).
The Acceptance Criteria and Study Proof for the TOKUYAMA UNIVERSAL BOND device are entirely based on physical property testing as it is a material-based dental product, not an AI diagnostic or assistance tool.
Here's a summary of the acceptance criteria and proof as presented for this specific dental device:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the TOKUYAMA UNIVERSAL BOND device are based on achieving certain tensile bond strengths to various dental materials, as well as satisfactory working time, paintability, and appearance.
| Acceptance Criteria Item | Acceptance Criteria (In-house Specification) | Reported Device Performance (TOKUYAMA UNIVERSAL BOND) |
|---|---|---|
| Tensile bond strength to enamel | > 12 MPa | > 12 MPa |
| Tensile bond strength to dentin | > 10 MPa | > 10 MPa |
| Tensile bond strength to metal | > 12 MPa | > 12 MPa |
| Tensile bond strength to porcelain | ≥ 10 MPa | ≥ 10 MPa |
| Tensile bond strength to zirconia | ≥ 10 MPa | ≥ 10 MPa |
| Tensile bond strength to resin material including inorganic filler | ≥ 10 MPa | ≥ 10 MPa |
| Working time | Cured after 90 seconds (Confirmation) | Confirmed to be cured after 90 seconds |
| Paintability | Even film formed (Evaluation) | Even film formed |
| Appearance | Visual inspection (Normal) | Normal |
(Note: The tables in the original document present the performance of the predicate and reference devices against the same specifications, with all devices meeting these criteria.)
Study that Proves the Device Meets the Acceptance Criteria:
The study conducted is a series of non-clinical, benchtop physical property tests.
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Sample size used for the test set and data provenance:
- The document does not explicitly state the sample size (number of individual samples or replicates tested) for each physical property. It only states that "Non-clinical testing of the following physical properties was conducted."
- Data Provenance: The tests were conducted by Tokuyama Dental Corporation, based in Japan. This implies the data originates from their internal laboratory testing. The data is retrospective in the sense that it was generated prior to the 510(k) submission.
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Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- Not applicable. For physical property testing of a dental material, "ground truth" is established by the direct measurement of physical properties (e.g., bond strength in MPa) using established testing standards (ISO/TS 11405:2015). This does not involve human expert adjudication or consensus in the way an AI diagnostic would require for image interpretation.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. As this is a physical property test, not an interpretive one, there is no adjudication process involving multiple human readers. The measurement results are directly compared against the pre-defined in-house specifications.
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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 material, not an AI or a system that assists human readers. Therefore, an MRMC study is irrelevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device has no algorithm and does not perform any diagnostic or interpretive function. Its performance is intrinsic to its physical and chemical properties.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is the direct, quantitative measurement of physical properties (tensile bond strength) and qualitative assessments (working time, paintability, appearance) against pre-defined, standardized specifications. The testing was conducted pursuant to Section 5.1 of ISO/TS 11405:2015 for tensile bond strength tests.
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The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no "training set."
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How the ground truth for the training set was established:
- Not applicable. There is no training set for this type of device.
In summary, the provided document pertains to a dental bonding agent, and therefore the "acceptance criteria" and "proof" relate to its physical and chemical characteristics and performance as a material, rather than the statistical or clinical performance metrics associated with AI/ML medical devices.
§ 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.