(148 days)
This device is intended for bonding brackets to teeth for orthodontic treatment.
Lion Se is a one step orthodontic adhesive. It comprises of two major components, i.e., a viscous polymeric resin paste and a watery component called. Activator. The formulation of Lion Se adhesive is identical to the predicate adhesive, except that the Lion Se paste contains 2% of a Selenium compound . This is a modified acrylic monomer which polymerizes & becomes an integral part of the final cured adhesive. The paste is delivered from a syringe, while the activator is dispensed from a squeeze bottle. Besides the paste & the activator, the product kit contains a preloaded syringe of etchant (35% phosphoric acid solution), brushes to apply the activator on the tooth and a stack of mixing pads for easy transfer of the activator.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study used to prove the device meets them:
Acceptance Criteria and Device Performance
| Test Criterion | Acceptance Criteria (Implicit from Predicate/Clinical Relevance) | Reported Device Performance (Lion Se) |
|---|---|---|
| Physical Characteristics: | ||
| a) Paste | White, translucent thick paste (matches predicate) | White, translucent thick paste |
| b) Activator | Clear liquid, acrylic odor (matches predicate) | Clear liquid, acrylic odor |
| Set-Time | Typically 20-25 seconds (based on general one-step adhesives) | 32 seconds |
| Shear Bond Strength (Clinical Survival) | > 6-8 MPa (based on reported mastication forces, Ref. 1); Pass 24 lb static load (equivalent to 10 MPa) | > 8 MPa (Pass) |
| Ultimate Shear Bond Strength | (Not explicitly defined as a pass/fail criterion, but comparative to predicate) | 9.1 MPa |
Note: The acceptance criteria for "Set-Time" and "Shear Bond Strength" are inferred from the description of typical values for one-step adhesives and the reference to clinical survival standards (Ref. 1). For physical characteristics, substantial equivalence to the predicate device is the implicit criterion.
Study Details
The study presented focuses on demonstrating substantial equivalence to Classone Orthodontics' own predicate device, "Reli-On One Step Adhesive F700," for orthodontic bracket bonding.
2. Sample Size and Data Provenance
- Set Time: 5 different samples were tested for both the Lion Se and Reli-On adhesives.
- Shear Bond Strength: 5 different brackets for both the Lion Se and Reli-On adhesives were tested.
- Data Provenance: The data is prospective and generated in-house by Class One Orthodontics in Lubbock, TX, USA. The experiments were conducted specifically for this submission.
3. Number of Experts and Qualifications
- Not applicable. The ground truth for these performance tests is based on objective, quantifiable physical measurements rather than expert human interpretation.
4. Adjudication Method
- Not applicable. The tests involve direct physical measurements and pass/fail criteria, not subjective human assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging or clinical assessment devices where human interpretation plays a significant role. The device in question is an adhesive.
6. Standalone Performance (Algorithm Only)
- This concept is not applicable as the device is a physical adhesive, not a software algorithm or AI-driven system. The performance presented is the standalone performance of the adhesive itself.
7. Type of Ground Truth Used
- The ground truth used for both Set Time and Shear Bond Strength is objective physical measurement based on established standardized (or internally standardized) experimental procedures.
- Set Time: Measured directly by stop-watch until the bracket becomes difficult to manipulate.
- Shear Bond Strength: Determined by applying a static load equivalent to 10 MPa and observing if the bond withstands this load, referencing published clinical survival standards (6-8 MPa mastication force). Reference 1 (Reynolds I.R.) serves as the basis for the clinical relevance and acceptance criteria for shear bond strength.
8. Sample Size for the Training Set
- Not applicable. This device is an adhesive, not a machine learning model. Therefore, there is no "training set" in the context of AI. The development of the adhesive would involve formulation and testing, but these are not considered "training" in the AI sense.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no training set for this type of device. The formulation and properties of the adhesive were likely established through iterative chemical and materials engineering processes, guided by desired performance characteristics rather than a formal "ground truth" for a training set.
§ 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.