(2 days)
3MIM Clinpro™ Clear 2.1% Sodium Fluoride Treatment is indicated for the treatment of hypersensitive teeth.
3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment is an aqueous fluoride coating that is applied topically to the tooth surfaces for the treatment of hypersensitive teeth. The product is sweetened with xylitol and sucralose. Clinpro 2.1% Sodium Fluoride Treatment contains 9,500 ppm fluoride and added calcium and phosphate. 3M Clinpro Clear 2.1% Sodium Fluoride Treatment uses the L-Pop™ unit dose dispensing system designed by 3M. Each L-Pop contains 0.5 ml (0.5 grams) of the coating and is offered in mint and melon flavors and a flavorless version.
The provided document is a 510(k) premarket notification for a medical device called "3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than conducting a full clinical trial to prove efficacy and safety through detailed acceptance criteria and studies as one might see for novel high-risk devices.
Therefore, the information typically available for a detailed acceptance criteria and performance study (as requested in the prompt) such as prospective studies, ground truth establishment by multiple experts with adjudication, MRMC studies, or standalone algorithm performance, is not present in this type of FDA submission.
Instead, the document details bench testing to demonstrate that the subject device performs similarly to or better than its predicate devices based on certain physical properties and release characteristics. The acceptance criteria here are mainly "Pass/Fail" based on whether the device meets specific thresholds or shows comparable performance to the predicate devices in these bench tests.
Here's an attempt to extract and present the available information in the requested format, with the understanding that many aspects of your request (e.g., human-in-the-loop studies, multi-reader studies, detailed expert ground truth, training set information) are not applicable or not provided in a 510(k) submission for a dental varnish.
Acceptance Criteria and Device Performance Study for 3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment
Note: This 510(k) submission primarily relies on demonstrating substantial equivalence through bench testing against predicate devices, rather than clinical efficacy studies with human subjects. Therefore, many of the requested details, particularly those related to human reader studies, multi-expert ground truth establishment, and training/test set specifics for AI/ML models, are not applicable or not provided in this type of regulatory document for a tooth varnish. The "acceptance criteria" here refer to the performance thresholds set for the bench tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Physical Properties/Characteristic | Test Method | Acceptance Criteria (Specification) | Reported Device Performance (3M Clinpro Clear 2.1% Sodium Fluoride Treatment) | Predicate Device (3M Vanish Varnish) Performance | Reference Device (Fluor Protector S) Performance |
|---|---|---|---|---|---|
| Dentin tubule occlusion (In-vitro) | SEM | Pass/Fail: Must visually occlude (cover) exposed dentin tubules | Pass | Pass | Pass |
| Dentin fluid flow reduction (In-vitro) | Modified Pashley Test | Pass/Fail: Must demonstrate visual reduction in fluid flow when treated compared to when they were untreated | Pass | Pass | Pass |
| Fluoride Release | ISO 17730-2020 | Pass/Fail: Fluoride release potential is ≥ 14 µg F/mm² after 60 minutes | Pass | Pass | Pass |
| Cumulative fluoride release potential (1 hour) | Internal 3M Test Method | Pass/Fail: Cumulative fluoride release potential at 1 hour is >0 µg/cm²/g | Pass | Pass | Pass |
| Cumulative fluoride release potential (24 hours) | Internal 3M Test Method | Pass/Fail: Cumulative fluoride release potential at 24 hours is >0 µg/cm²/g | Pass | Pass | Pass |
| Calcium Release (1 hour) | ICP-AES | Pass/Fail: Cumulative calcium release potential at 1 hour is >0 µg/cm²/g | Pass | Pass | Not tested - not claimed |
| Calcium Release (24 hours) | ICP-AES | Pass/Fail: Cumulative fluoride release potential at 24 hours is >0 µg/cm2/g | Pass | Pass | Not tested - not claimed |
| Phosphorus (Phosphate) Release (1 hour) | ICP-AES | Pass/Fail: Cumulative phosphorus (phosphate) release potential at 1 hour is >0 µg/cm2/g | Pass | Pass | Pass |
| Phosphorus (Phosphate) Release (24 hours) | ICP-AES | Pass/Fail: Cumulative phosphorus (phosphate) release potential at 24 hours is >0 µg/cm2/g | Pass | Pass | Pass |
| Consistency | Internal 3M Test Method | Pass/Fail: The reading number of 1/32th inch is 32-52. | Pass | Pass | Not applicable (3M requirement) |
| pH | Internal 3M Test Method | Pass/Fail: 6.0-8.0 | Pass | Not applicable | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of patient data or clinical images, as the evaluation is based on in-vitro bench testing of the device material. The sample size for each bench test (e.g., number of replicates, number of specimens) is typically detailed in the internal test reports, but not provided in this summary. The data provenance is from laboratory bench testing conducted by 3M, not from specific patient populations or countries.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. The "ground truth" for this device's performance is established by standardized laboratory testing methods and physical measurements, not by human expert interpretation of clinical data or images.
4. Adjudication Method for the Test Set
Not applicable. As the "test set" is material performance data from laboratory tests, no adjudication method is required.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This type of study (comparing human readers with and without AI assistance) is not applicable to a dental varnish product. This device is not an imaging AI or diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical product (dental varnish), not an algorithm or software. Its performance is evaluated through material science and physical property tests.
7. The Type of Ground Truth Used
The ground truth used is based on physical and chemical measurements and observations from in-vitro laboratory bench tests, conforming to established standards (e.g., ISO 17730-2020) or validated internal methods. For example, "visually occlude exposed dentin tubules" for SEM, or measurable fluoride release values.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product, not a machine learning model, so there is no "training set" in the context of data for model development.
9. How the Ground Truth for the Training Set was Established
Not applicable. See point 8.
§ 872.3260 Cavity varnish.
(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.