(248 days)
The Biomet Microfixation RibFix Blu Thoracic Fixation System is in the stabilization and fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, rib fractures associated with flail chest, 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 bone plates and locking screws that provide rigid fixation to fractures and osteotomies of the chest wall. These implants are available in multiple sizes and manufactured from Commercially Pure Titanium and Titanium Alloy (Ti-6Al-4V).
This document is a 510(k) Premarket Notification from the FDA regarding the Biomet Microfixation RibFix Blu Thoracic Fixation System. It confirms that the device is substantially equivalent to a legally marketed predicate device.
The document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of comparing device performance metrics like sensitivity, specificity, accuracy, etc.
Instead, the document focuses on demonstrating substantial equivalence through non-clinical performance data and showing that the technological characteristics are similar or do not raise new questions of safety and effectiveness compared to the predicate device.
Here's what can be extracted and what is explicitly stated as not applicable or not provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Non-Clinical Performance Data | ||
| Magnetic Resonance Testing | Per ASTM F2182-11 (Specific criteria for MR compatibility, e.g., acceptable levels of magnetic force, torque, heating, and image artifact. Details not provided in this document but are standard for this ASTM). | "met all established acceptance criteria" (implies the device is safe and performs as expected within specified MR environments according to ASTM F2182-11 standards). |
| Physiologic Loading Thoracic Testing | Established acceptance criteria relevant to the physiological loads experienced in the thoracic region (e.g., strength, stiffness, deformation within physiological limits). Specific criteria not provided. | "met all established acceptance criteria" (implies the device can withstand expected physiological forces in the chest wall without failure or excessive deformation). |
| Thoracic Fatigue Testing | Established acceptance criteria for durability under cyclic loading conditions typical of the thoracic region (e.g., ability to withstand a certain number of load cycles without failure). Specific criteria not provided. | "met all established acceptance criteria" (implies the device can endure repetitive stresses over time without material degradation or failure beyond acceptable limits). |
| Thoracic Failure Testing | Established acceptance criteria for ultimate strength/failure load (e.g., ability to withstand a maximum load before catastrophic failure, exceeding specified safety margins). Specific criteria not provided. | "met all established acceptance criteria" (implies the device's ultimate strength and failure characteristics are within acceptable safety margins). |
| Clinical Performance Data | Not Applicable / Not Performed. Clinical testing was explicitly stated as "not necessary for the determination of substantial equivalence." |
Regarding AI-specific questions (2-9), this document does not refer to an AI/ML device. The Biomet Microfixation RibFix Blu Thoracic Fixation System is a physical metallic bone fixation system (plates and screws). Therefore, the following points are not applicable to this submission.
2. Sample size used for the test set and the data provenance: Not applicable, as this is not an AI/ML device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is not an AI/ML device.
4. Adjudication method for the test set: Not applicable, as this is not an AI/ML device.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance: Not applicable, as this is not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as this is not an AI/ML device. The "ground truth" for this device relates to its material properties and mechanical performance.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.
Summary for this specific medical device (Biomet Microfixation RibFix Blu Thoracic Fixation System):
This document describes the non-clinical testing performed to demonstrate that a physical medical device (bone fixation system) meets established acceptance criteria for mechanical performance and MR compatibility. It does not involve any AI/ML components, clinical trials, or the use of experts for ground truth in the context of diagnostic interpretation. The acceptance criteria are based on recognized standards (like ASTM F2182-11 for MR testing) and mechanical engineering principles.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.