Search Results

The sterile plate and screw kit configurations for use with the Bioplate® Titanium Fixation System are intended for use on non-load bearing fixation, including cranial bone fixation and brow fixation and the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implant

The Bioplate® Titanium Fixation System includes a variety of plate configurations for different anatomical applications. Unalloyed commercially pure Grade 1, Grade 2 and Grade 4 titanium and titanium allov plates, and titanium allov screws of varying diameters and lengths are included for fixation of the plates to the craniomaxillofacial bony tissues. These materials have been implanted safely for many years. The predicate device had been approved under K022033.

The bone plates will be manufactured of unalloyed, commercially pure titanium and titanium 6A1-4V Eli alloy. The materials adhere to the American Society of Testing and Materials (A.S.T.M.) F67 Standards and the American Society of Testing and Materials ( A.S.T.M.) F136 Standard.. The screw will be manufactured of a titanium 6A1-4V Eli alloy that meets the American Society of Testing and Materials (A.S.T.M.) F136 Standard.

The plate and screw fit configurations are sterilized by gamma radiation sterilization, using VD Max dose setting method. Successful completion of sterilization validation and packaging validation studies provides a high level of assurance that sterility of the device has been achieved and can be maintained.

The provided text is a 510(k) summary for a medical device (Modified Sterile Plate & Screw Kit Configurations for use with the Bioplate® Titanium Fixation System) and primarily focuses on establishing substantial equivalence to predicate devices, rather than presenting a performance study with specific acceptance criteria as would typically be seen for a new or novel device.

Therefore, the document does not contain the information requested regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication method for the test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used (e.g., pathology, outcomes).
8. Sample size for the training set.
9. How ground truth for the training set was established.

Instead, the document states:

• Comparison of the device's technological characteristics with those of the predicate devices: "All the technical characteristics of the sterile plate and screw kit configurations for use Bioplate® Titanium Fixation System are substantially equivalent to the corresponding characteristics of the predicate devices, and any minor differences raise no new issues of safety and efficacy."
• The materials used have been implanted safely for many years.
• Sterilization validation and packaging validation studies were successfully completed, providing a high level of assurance of sterility.

The "acceptance criteria" in this context are effectively demonstrating that the device is substantially equivalent to legally marketed predicate devices, meaning it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. The study proving this involves comparing the new device's specifications (materials, sterilization method, intended use) against those of established predicate devices.

Ask a specific question about this device