(120 days)
The CLEAR ALIGNER ADHESIVE is intended for use as an orthodontic bonding adhesive for brackets and appliances to thermoplastic aligner surfaces.
The Clear Aligner Adhesive is a light cure, orthodontic adhesive for metal, composite and porcelain brackets and appliances to bond to a thermoplastic aligner. The Clear Aligner Adhesive is formulated in a viscosity that flows easily from the syringe and bonds chemically to a typically difficult to adhere to surface. a thermoplastic aligner now common in the dental industry. This adhesive, upon polymerization, is clear and virtually indistinguishable from the thermoplastic aligner thereby making it aesthetically pleasing to the patient. The light cure property of the adhesive allows the user to determine the polymerization time required by simply exposing the adhesive to an LED light source until set. The Clear Aligner Adhesive will be marketed in a push syringe for dispensing.
The provided text describes a medical device called "Clear Aligner Adhesive" and its 510(k) submission for premarket notification. The information pertains to the adhesive's composition, intended use, and a comparison to a predicate device. However, the document does not contain information about acceptance criteria or specific studies that would typically be described for a diagnostic AI/ML device approval (e.g., sensitivity, specificity, clinical endpoints, reader studies).
Therefore, I cannot provide a detailed answer to your request in the format specified. The information about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set sizes, and ground truth establishment for a diagnostic AI/ML device is not present in the provided text.
The document primarily focuses on establishing substantial equivalence for a physical medical adhesive based on its technical characteristics and an assessment of shear bond strength and cytotoxicity.
Here's what can be extracted from the provided text about the device:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly list quantitative "acceptance criteria" for regulatory approval in the typical sense for an AI/ML device. Instead, it compares the new device's properties to a predicate device and reports on specific tests.
| Property | Acceptance Criteria (Not explicitly stated as such for regulatory approval, but implied for comparison) | Reported Device Performance |
|---|---|---|
| Intended Use | Orthodontic Bonding Adhesive for Thermoplastic Aligners (similar to predicate) | Orthodontic Bonding Adhesive for brackets and appliances to thermoplastic aligner surfaces. |
| Method of Cure | Light Cure (similar to predicate) | Light Cure |
| Aesthetic Features | Clear when polymerized (improvement over predicate's A1 shade) | Clear when polymerized |
| Physical Properties / Bond | Chemical bond to thermoplastic aligner and metal, composite or porcelain (similar to predicate) | Chemical bond to thermoplastic aligner and metal, composite or porcelain. |
| Shear Bond Strength | (Implicitly: demonstrate adequate or improved bond strength compared to predicate) | Testing resulted in highly increased bond strength values for the Clear Aligner Adhesive when compared to the use of Flowtain with a Plastic conditioner (predicate). (Specific quantitative values are not provided in this summary). |
| Biocompatibility / Cytotoxicity (ISO 10993-5) | No evidence of causing cell lysis or toxicity | Tested via the ISO 10993-5 elution test method and showed no evidence of causing cell lysis or toxicity. |
Regarding the study proving the device meets criteria, the document states:
"Clear Aligner Adhesive was tested and compared to Reliance Orthodontic Products, Inc. Flowtain in conjunction with Plastic Conditioner for Shear Bond Strength. Testing resulted in highly increased bond strength values for the Clear Aligner adhesive when compared to the use of Flowtain with a Plastic conditioner. Clear Aligner Adhesive has been tested for cytotoxicity via the ISO 10993-5 elution test method and showed no evidence of causing cell lysis or toxicity."
The following information cannot be provided from the given text:
- 2. Sample size used for the test set and the data provenance: Not mentioned.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/mentioned for this type of device and submission.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/mentioned.
- 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 is not an AI/ML device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For Shear Bond Strength, the "ground truth" would be the measured force. For cytotoxicity, it would be the cellular response observed in the lab. These are not clinical "ground truths" in the diagnostic sense.
- 8. The sample size for the training set: Not applicable for this type of device.
- 9. How the ground truth for the training set was established: Not applicable.
§ 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.