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The Bonafix TWO Dental Implant System is indicated for delayed loading in surgical and restorative applications placement in the upper or lower jaw and to provide support for prosthetic devices such as artificial teeth with the goal of restoring the patient's chewing function.

Bonafix TWO Implant is a bone level type implant indicated for delayed loading only, built in Grade 5 ELI Titanium Alloy and treated with RBM technology. To prevent unnecessary rotations between the implant and the abutment, the implant has an internal hex connection style. The body of the implant is tapered, the implant neck is straight and has micro-rings; and the apex of the implant has a dome shape. Was designed with a double-thread that has a constant depth and thickness. Has two-spiral channel at the apical end of the implant that provide self-tapping properties to the implant. This system has 3.35, 3.75, 4.20, 5.00, 6.00 diameter distributed in three (3) platform (Narrow, Standard and Wide) and 8, 10, 11.5, 13 and 15 mm lengths. The 3.35 mm diameter excludes the 8 mm length, and the 6.00 mm diameter excludes the 15 mm length. The implants are provided sterile and are ready to be implanted. The system includes various prosthetic device such as, Cover screw, Healing caps, and two (2) abutments, Straight abutments and Angle abutments are connected to implant through the hex and secured by retained screw. The Straight abutment has 2 to 3 emergence profiles depending on platform. The Angle abutments has a single emergence profile by platform. The angle abutment has axis inclined of 20° compared to the implant's axis. The abutments are provided non-sterile and are intended to be sterilized before use. All prosthetic device are made in Grade 5 ELI Titanium Alloy.

This document describes the Bonafix TWO - Dental Implant System. Here's a breakdown of the acceptance criteria and study information provided, focusing on what is present and what is not mentioned in the text.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state a table of "acceptance criteria" against which a direct performance measure is reported in a pass/fail manner. Instead, it details various performance tests and their outcomes, indicating that the device's performance was found to be "comparable" or "demonstrated."

Here's an attempt to extract the relevant information into a table format based on the "Performance Data" section:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "laboratory testing," but does not provide any details regarding sample size, data provenance, or whether the study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided as the studies described are non-clinical (laboratory) tests and do not involve human expert review for establishing ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided as the studies described are non-clinical (laboratory) tests and do not involve human review with 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

There is no mention of an MRMC study, AI assistance, or human reader improvement in this document. The device is a physical dental implant system, not an AI software.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as the device is a physical dental implant system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests, the "ground truth" is established by adherence to recognized international standards for laboratory testing (e.g., ISO 10993-5, USP , ISO 14801, ISO 11137, ISO 17665). The outcomes are objective measurements against these standards. There is no mention of expert consensus, pathology, or outcomes data in the context of these specific performance tests.

8. The sample size for the training set

This is not applicable/not provided. The document describes a physical medical device and non-clinical performance testing, not a machine learning model that would require a training set.

9. How the ground truth for the training set was established

This is not applicable/not provided as there is no training set for a machine learning model.

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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:

1. A table of acceptance criteria and the reported device performance: No such criteria or performance data is presented in the context of study outcomes.
2. Sample size used for the test set and the data provenance: There is no test set described for performance evaluation.
3. 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.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. 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.

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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:

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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