Search Results
Found 2 results
510(k) Data Aggregation
(139 days)
BONAFIX SURGICAL AND DENTAL IMPLANTS, LLC
The proposed MiniFix Implant system consists of MiniFix One and MiniFix Ball implants.
The MiniFix One implants are indicated to provide support for single unit dental prostheses in the mandibular central and lateral incisor and maxillary lateral incisor regions of partially edentulous jaws. The MiniFix One implant must be splinted if two or more are used adjacent to each other. The MiniFix One implant may be immediately restored with a temporary prosthesis that is not in functional occlusion.
The MiniFix Ball implants are intended to be placed throughout the maxillary and mandibular arches to provide support for multi-unit restorations on long-term or short term fixation of upper and lower dentures. Immediate loading should only be done in the presence of primary stability and appropriate occlusal loading.
Built in Grade 5 ELI Titanium Alloy and treated with RBM technology, the proposed MiniFix implants are designed for both provisional and permanent implementations of singleunit or multi-unit restorations.
The major component of the MiniFix Implant consists of a one-piece, root-form, self-tapping screw. This implant is offered in two models, each with its own applicability: MiniFix Ball and MiniFix One.
The MiniFix Ball implant provides a spherical head that allows for easy placement and removal of both partial and full dentures. Additionally, this model is available in an option without the RBM treatment for use in transitional applications (temporary dentures).
Minifx One is a single piece implant that provides a flat head for permanent installation of single crowns.
The provided text describes a 510(k) submission for a dental implant device called "MiniFix Implant". It details the device's description, intended use, and a comparison to predicate devices, but does not contain information about acceptance criteria or specific studies proving the device meets those criteria in the context of performance metrics like accuracy, sensitivity, or specificity.
The submission focuses on establishing substantial equivalence to existing predicate devices (MDI MII One-Piece Implant 2.9mm, Inclusive Mini Implant, and Mini Drive-Lock Dental Implant System) based on materials, design, surface treatment, fatigue testing, and risk management. The "Non-Clinical Test Data" section explicitly states: "Minifx Implants do not introduce new issues for materials, design, surface treatment, fatigue testing and risk management that have not been addressed in all other substantially equivalent predicate devices." This indicates that the regulatory approval relies on the similarity to already approved devices rather than new performance studies with acceptance criteria for the device itself.
Therefore, I cannot provide the requested information. The document does not describe:
- A table of acceptance criteria and the reported device performance: No such criteria or performance data is presented in the context of study outcomes.
- Sample size used for the test set and the data provenance: There is no test set described for performance evaluation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there's no performance test set.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document is a regulatory submission for a medical device seeking substantial equivalence, not a report on a performance study with detailed clinical or non-clinical evaluation metrics and acceptance criteria.
Ask a specific question about this device
(296 days)
BONAFIX SURGICAL AND DENTAL IMPLANTS, LLC
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.
Ask a specific question about this device
Page 1 of 1