(25 days)
The Biomet Microfixation Thoracic Fixation System is indicated for use in the stabilization and fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies. The system may be used in normal and poor bone to promote union.
The Biomet Microfixation RibFix Blu Thoracic Fixation System is composed of metallic locking screws that are utilized with previously cleared metallic locking bone plates. These devices provide rigid fixation of fractures and osteotomies of the chest wall and sternum. The locking screws are offered in two diameters, 2.4mm and 2.7mm. The 2.4mm diameter screws are offered with two tip designs, self-drilling and self-tapping, and range in lengths from 7mm to 16mm. The 2.7mm diameter screws are offered with a self-tapping tip design and range in lengths from 7mm to 16mm. The locking screws are manufactured from Titanium Alloy (Ti-6Al-4V).
This document describes a 510(k) premarket notification for the Biomet Microfixation RibFix Blu Thoracic Fixation System. The submission does not provide information about acceptance criteria or a study that specifically proves the device meets acceptance criteria related to its performance in a clinical or AI-assisted context. The document's purpose is to demonstrate substantial equivalence to a legally marketed predicate device, not to report on an AI algorithm's performance.
Therefore, many of the requested categories are not applicable (N/A) based on the provided document.
Here's an assessment based on the available information:
- Table of acceptance criteria and the reported device performance:
Not applicable, as this document focuses on substantial equivalence for a medical device (bone fixation system), not an AI algorithm with specific performance metrics. There are no performance metrics or acceptance criteria for an AI system in this document.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| N/A | N/A |
-
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
Not applicable. The document states "Non-Clinical Performance Data: Non-clinical testing was not necessary for the determination of substantial equivalence." and "Clinical Performance Data: Clinical testing was not necessary for the determination of substantial equivalence." Therefore, no test set was used for this substantial equivalence determination in the context of device performance. -
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):
Not applicable. No test set was used, and thus no ground truth was established by experts for performance evaluation. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. No test set was used. -
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:
Not applicable. This is a medical device submission for a physical fixation system, not an AI diagnostic or assistance tool. Therefore, no MRMC study or AI-related comparative effectiveness was conducted or reported. -
If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
Not applicable. There is no AI algorithm involved with this device. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. No ground truth was established for performance evaluation. The "ground truth" for this 510(k) submission relates to the functional and material characteristics of the device and its predicate, established through engineering design, material specifications, and regulatory guidelines, rather than clinical performance data. -
The sample size for the training set:
Not applicable. There is no AI algorithm to train. -
How the ground truth for the training set was established:
Not applicable. There is no AI algorithm to train, and therefore no training set or associated ground truth.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.