(50 days)
Therma-Cure is a heat cure orthodontic adhesive intended to be used within an orthodontic, dental or pediatric dental office for the indirect bonding of orthodontic brackets and appliances.
Therma-Cure™ is a heat curable orthodontic adhesive used for the indirect bonding of orthodontic brackets and appliances.
The provided text describes the 510(k) summary for the device "Therma-Cure™", a heat-curable orthodontic adhesive, and its comparison to a predicate device, "Light Bond™ Orthodontic Adhesive". The study focused on demonstrating substantial equivalence, primarily through performance testing.
Here's an analysis of the acceptance criteria and study information:
Acceptance Criteria and Reported Device Performance
| Property | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (Therma-Cure) |
|---|---|---|
| Intended Use | Light Cure Adhesive for indirect bonding (as per predicate device, Light Bond) | Heat Cure Adhesive for indirect bonding |
| Mechanical / Physical Properties | Single paste in a hand-held delivery (as per predicate device, Light Bond) | Single paste in a hand-held delivery |
| Chemical Composition | Bisphenol A Diglycidyl Methacrylate / Urethane Dimethacrylate Resin Monomer and Silica Filler Triethyleneglycol Dimethacrylate Diluent 2-3-Di-tert-butyl-4-methylphenol Inhibitor (as per predicate device, Light Bond) | Bisphenol A Diglycidyl Methacrylate resin Monomer and Silica Filler Triethyleneglycol Dimethacrylate Diluent 2-3-Di-tert-butyl-4-methylphenol Inhibitor |
| Shear Bond Strength | Not explicitly stated as a numerical acceptance criterion, but the implied criterion is similar performance to the predicate device, Light Bond, when tested using an in-vivo performance test method. This means the shear bond strength should be within an acceptable range of the predicate, indicating comparable adhesive strength for orthodontic bracket retention. | The study reported "similar performance" to the predicate device for shear bond strength using an in-vivo performance test method. No specific numerical values were provided. |
| Non-toxicity | The device must be non-toxic, conforming to applicable biocompatibility standards. The implied acceptance criterion would be passing the requirements of ISO 10993-5 (tests for in vitro cytotoxicity). | Therma-Cure has been proven to be non-toxic when tested according to ISO 10993-5. |
Study Details
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: "replicates of 5 for both Therma-Cure and Light Bond" were used for the shear bond strength testing. This means 5 samples for the Therma-Cure device and 5 samples for the Light Bond device, for a total of 10 samples in the test.
- Data Provenance: The study states "in-vivo performance test method". While it doesn't explicitly state the country of origin, the FDA submission context implies the data would be relevant to U.S. regulatory standards. It is a prospective study as it involves conducting new tests for regulatory submission.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not provided in the given text. The study describes "in-vivo performance test method" for shear bond strength, which is a laboratory or clinical measurement rather than an expert interpretation task. For the non-toxicity test, reference to ISO 10993-5 implies standard toxicology protocols were followed, not expert consensus on ground truth.
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Adjudication Method for the Test Set:
- Not applicable. The tests described are objective performance measurements (shear bond strength, non-toxicity) rather than subjective assessments requiring adjudication among experts.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This was not an MRMC study. The device is an orthodontic adhesive, not an AI-powered diagnostic tool. Therefore, human reader improvement with or without AI assistance is not relevant to this submission.
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If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a physical product (adhesive), not an algorithm or AI system.
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The Type of Ground Truth Used:
- For Shear Bond Strength: The ground truth was established through a direct, objective measurement using an "in-vivo performance test method." The predicate device's performance served as the comparative "ground truth" for demonstrating substantial equivalence.
- For Non-Toxicity: The ground truth was established by adherence to the objective test standards outlined in ISO 10993-5.
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The Sample Size for the Training Set:
- Not applicable. The device is a physical product, not a machine learning model, so there is no concept of a "training set" in this context.
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How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no training set for a physical adhesive, this question does not apply.
§ 872.3750 Bracket adhesive resin and tooth conditioner.
(a)
Identification. A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.(b)
Classification. Class II.