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510(k) Data Aggregation
(82 days)
The indication for use of Ortho-1 is a bracket bonding system in the oral cavity of dental patients.
Ortho-1 is an orthodontic no-mix direct bonding system consisting of Paste, a Primer, and Liquid Etchant. The micromechanical bond to enamel utilizes the acid.etch technique and Bisco's unique composite chemistry. Ortho-1 will bond to brackets (such as metal, plastic, or porcelain) without additional conditioners. Ortho-1 will also bond any type of bracket to properly conditioned dental material restorative materials (such as porcelain, composites, and metal).
The acceptance criteria and study proving the device meets those criteria are described below:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Property | Acceptance Criteria (Predicate) | Reported Device Performance (Ortho-1) |
|---|---|---|
| Chemical Composition | Chemical Cure Present | Chemical Cure Present (X) |
| Solvent-free, unfilled, methacrylate-based primer present | Solvent-free, unfilled, methacrylate-based primer present (X) | |
| Silica filled methacrylate-based paste present | Silica filled methacrylate-based paste present (X) | |
| Phosphoric Acid present (Liquid Etchant) | Phosphoric Acid present (X) | |
| Physical/Mechanical Properties | Low viscosity Primer (Ortho-One K962946) | Low viscosity Primer (X) |
| Tacky Paste (Ortho-One K962946) | Tacky Paste (X) | |
| Medium viscosity paste (Not specified for predicate) | Medium viscosity paste (X) | |
| Low viscosity paste (Not specified for predicate) | Low viscosity paste (X) | |
| High viscosity paste (Ortho-One K962946) | High viscosity paste (X) | |
| Low viscosity, semi-gel (Bisco Etchants K101485) | Low viscosity, semi-gel (X) | |
| Green color (Bisco Etchants K101485) | Green color (X) | |
| Biocompatibility | Safe for intended uses (implied from legally marketed predicate) | Cytotoxicity-agarose diffusion testing conducted; safe for intended uses |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a numerical sample size for the test set. The performance data section states that "The physical/mechanical properties of Ortho-1 and Liquid Etchant were tested in the lab using R&D testing protocols."
The data provenance is retrospective, as the testing was conducted in a lab setting by the manufacturer (BISCO, Inc.) for the purpose of demonstrating substantial equivalence to predicate devices. The country of origin can be inferred as USA, where BISCO, Inc. is located.
3. 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 document. The performance data appears to be based on internal R&D testing protocols rather than expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not provided in the document, as the testing described is primarily laboratory-based physical/mechanical property comparison, not clinical evaluation requiring adjudication.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an orthodontic adhesive, and the evaluation focuses on its chemical and physical properties for bonding, not on interpretation by human readers. Therefore, the concept of improvement with AI assistance is not applicable in this context.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a physical orthodontic adhesive, not a software algorithm or AI.
7. The Type of Ground Truth Used
The ground truth used for performance evaluation is primarily comparison to established chemical and physical characteristics of legally marketed predicate devices. For biocompatibility, "cytotoxicity-agarose diffusion testing" was conducted, indicating a laboratory-based biological assessment.
8. The Sample Size for the Training Set
This information is not applicable as this is not an artificial intelligence or machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as this is not an artificial intelligence or machine learning device that requires a training set.
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