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Flowtain™ is a flowable, light-cure orthodontic adhesive intended to be used within an orthodontic, dental or pediatric dental office for the bonding of lingual retainers and splinting materials, creation of archwire stops and indirect bonding of orthodontic brackets. Flowtain™ can also be used for the retention of thermoplastic aligners.

Flowtain™ LV is a lower viscosity, flowable light cure orthodontic adhesive intended to be used for indirect bonding of orthodontic brackets.

Flowtain™ is a light-cure orthodontic adhesive with a low modulus of elasticity that is flowable. This low modulus of elasticity makes it ideal for bonding lingual retainers, splinting materials and for indirect bonding of brackets. Thixotropic design properties of Flowtain™ also make it highly polishable which allows it to be used for comfortable archwire stops and as an aid for retention of a thermoplastic aligner.

Flowtain™ LV is a low viscosity version of the Flowtain™ product used primarily for indirect bonding of brackets.

Both are available in push syringe or tips for preferences in dispensing.

The provided text describes the 510(k) summary for "Flowtain™ and Flowtain™ LV," orthodontic adhesives. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than defining and proving acceptance criteria for a novel AI or software device. As such, many of the requested categories for AI/software device evaluation are not directly applicable or explicitly stated in the document.

However, I can extract and infer information relevant to the device's performance evaluation as presented:

Acceptance Criteria and Study for Flowtain™ and Flowtain™ LV

The acceptance criteria for Flowtain™ and Flowtain™ LV relate to demonstrating comparable performance, specifically in shear bond strength, to the legally marketed predicate device, 3M Unitek Transbond™ Supreme LV. The study aimed to show similar performance between the new devices and the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Sample Size for Test Set: Replicates of 5 for Flowtain™, Flowtain™ LV, and Transbond™ Supreme LV. (Total of 15 samples for shear bond strength testing, assuming 5 replicates for each of the three products).
• Data Provenance: Not explicitly stated, but the testing method ("in-vivo performance test method") suggests biological or simulated biological conditions. The manufacturer is based in Itasca, Illinois, USA, implying the study was likely conducted in the USA. The study design (comparison against a predicate device) is typical for a 510(k) submission. It's a retrospective comparison against a known predicate device's performance data or a prospective comparative study where both were tested simultaneously under the same conditions. Given the phrasing "tested against," it implies a comparative study.

3. Number of Experts and Qualifications for Ground Truth

• Not applicable for this type of device. The assessment of shear bond strength is a quantitative mechanical test, not dependent on expert interpretation or ground truth established by human experts in the way an image analysis or diagnostic AI would require.

4. Adjudication Method

• Not applicable for this type of device. Adjudication methods like 2+1 or 3+1 are used for expert consensus on qualitative assessments (e.g., medical image interpretation). Shear bond strength is a physical measurement.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC study was done. This type of study is relevant for AI systems that assist human readers in tasks like medical image interpretation. Flowtain™ and Flowtain™ LV are orthodontic adhesive materials, not AI systems.

6. Standalone Performance Study (Algorithm Only)

• Not applicable. This relates to AI algorithms. The performance of the adhesive materials was evaluated directly through mechanical testing.

7. Type of Ground Truth Used

• Mechanical Test Results / Physical Property Measurement: The "ground truth" for shear bond strength is the objective measurement obtained from a standardized mechanical test. For toxicity, it's based on toxicology testing.

8. Sample Size for Training Set

• Not applicable. This device is a physical product (orthodontic adhesive), not a machine learning model, so there is no "training set."

9. How Ground Truth for Training Set was Established

• Not applicable. As there is no training set for an AI model, this question is irrelevant to the described device.

Summary of the Study:

The study detailed in the 510(k) summary for Flowtain™ and Flowtain™ LV involved in-vivo performance testing to assess shear bond strength. This testing was conducted using an indirect bonding procedure for replicates of 5 for Flowtain™, Flowtain™ LV, and the predicate device, 3M Unitek Transbond™ Supreme LV. The results indicated that the new adhesives achieved "similar performance" to the predicate device, thereby meeting the implied acceptance criterion for substantial equivalence in this critical mechanical property. Additionally, Flowtain™ was explicitly tested and proven to be non-toxic.

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