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510(k) Data Aggregation
(296 days)
The proposed OrthoFix Screw is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for a single use only. For use in adolescents greater than age 12 and adults.
The OrthoFix Screw is fabricated from titanium Alloy, which meets the material requirements specified in the ASTM standard ASTM F-136-08. The head on the proximal portion of the screw incorporates a recess, which provides an option for the orthodontist to pass through a wire and tie it in the neck of the OrthoFix Screw in the orthodontic treatment. Distal to the recess is a square indentation that is used as a screw head for screwing the OrthoFix Screw with an instrument, insertion handle tip that is connected to a commercially available insertion handle. The insertion handle tip is manufactured with a medical grade stainless steel 316L. The smooth neck distal to the proximal head employs a hole through which a wire can be passed to fix the mandible and maxilla in orthodontic treatment. Distal to the neck is the collar, which has a tapered design to protect the soft tissue. The distal portion of the proposed OrthoFix Screw is threaded for quick insertion and provides stability and bio mechanic retention once the screw is fully inserted. The distal tip of the screw is machined with high precision manufacturing to aid the orthodontist in self screwing or self drilling.
The application describes the OrthoFix Screw as an endosseous dental implant intended to provide a fixed anchorage point for orthodontic appliances. The study evaluates the device's mechanical properties through non-clinical testing and compares it to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Predicate Device K033767) | Reported Device Performance (OrthoFix Screw) |
|---|---|
| Torque value at fracture of the Dual Top Anchor screw of Jeil Medical Corp. (Implicit: demonstrating similar or better performance). | Torque testing demonstrated that the torque value at fracture for the OrthoFix Screw is substantially equivalent to the predicate Dual Top Anchor screw of Jeil Medical Corp. |
| Ability to withstand loads in typical orthodontic applications (Implicit: exceeding 300 grams max load). | Shear Cut and Tensile Strength (Axial) tests showed that the implant was able to withstand loads close to 80kg without presenting any kind of damage, which is well above the 300grs maximum load present in typical orthodontical applications. |
| Material: Medical Grade Titanium Alloy (ASTM 136-98 or equivalent). | Material: Medical Grade Titanium Alloy (ASTM 136-08). |
| Design (incorporates a recess, through hole, tapered collar, self-drilling/self-tapping thread) | Design (incorporates a recess, through hole, tapered collar, self-drilling/self-tapping thread. |
| Principle of Operation: Provide fixed anchorage for orthodontic movement of teeth. | Principle of Operation: Provide fixed anchorage for orthodontic movement of teeth. |
| Indications for Use: Fixed anchorage for orthodontic appliances, temporary use, single-use only, for adolescents greater than age 12 and adults. | Indications for Use: Fixed anchorage for orthodontic appliances, temporary use, single-use only, for adolescents greater than age 12 and adults. |
| Sterility: Provided as non-sterile (for predicate K033767, another predicate K093299 is also non-sterile). | Sterility: Provided as sterile. (Note: This is a difference from the comparator, but likely deemed acceptable as sterility is generally a positive attribute). |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not explicitly state the sample size for the mechanical tests. It refers to "Torque testing performed on the OrthoFix Screw" and "Shear Cut and Tensile Strength (Axial) tests." It can be inferred that a sufficient number of devices were tested to draw the reported conclusions, but no specific count is provided.
The data provenance is not specified (e.g., country of origin). The testing described is non-clinical laboratory testing, not human study data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not applicable to the provided study. The study focuses on non-clinical mechanical testing, not a clinical assessment requiring human expert ground truth.
4. Adjudication Method for the Test Set:
This information is not applicable as the study involves non-clinical mechanical testing, not clinical diagnosis or interpretation that would require adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The study presented is a non-clinical mechanical performance comparison.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, this is a medical device (screw) and not an AI algorithm. Therefore, "standalone" performance in the context of AI is not applicable. The device's performance is inherently "standalone" in that it performs its mechanical function independently. However, its clinical effectiveness is always in conjunction with a human orthodontist.
7. The Type of Ground Truth Used:
For the mechanical tests, the "ground truth" used was the mechanical properties and performance of the predicate device (Jeil Medical Corp.'s Dual Top Anchor System Screw, K033767) as a benchmark for substantial equivalence, along with established engineering standards and expected forces in orthodontic applications (e.g., 300grs maximum load).
8. The Sample Size for the Training Set:
This information is not applicable. This is not a machine learning or AI-based device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for this type of medical device.
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