(45 days)
The Biomet Microfixation RibFix Blu 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 bone plates and locking screws that provide rigid fixation to fractures 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 for the Biomet Microfixation RibFix Blu Thoracic Fixation System. It grants substantial equivalence to a previously cleared device. As such, it does not contain the detailed study information typically found when a novel device is being introduced and rigorous performance criteria need to be established and proven.
Here's why the requested information cannot be fully provided:
- No new acceptance criteria or study: The document explicitly states: "Non-clinical testing was not necessary for the determination of substantial equivalence." and "Clinical testing was not necessary for the determination of substantial equivalence." This means there were no new studies conducted to prove the current device meets acceptance criteria distinct from its predicate. The device is considered substantially equivalent because its indications, design, sterilization, and materials are identical to the predicate device (K152253).
- Focus on substantial equivalence: The purpose of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This typically means it has the same intended use and technological characteristics, or if there are differences, they do not raise new questions of safety or effectiveness.
Therefore, the requested information elements (acceptance criteria, study details, sample size, expert ground truth, adjudication, MRMC, standalone performance, training set details) are not present in this 510(k) summary because no new performance studies were required for this specific filing.
However, based on the principle of substantial equivalence, we can infer the acceptance criteria and performance are identical to the predicate device (K152253). Since this document doesn't provide those details, I cannot create the table or answer the specific questions about the study design.
If this were a new device requiring performance demonstration, the information would typically include:
- A table of acceptance criteria and the reported device performance: This would list specific quantitative or qualitative measures (e.g., tensile strength, fatigue life, bending stiffness, biocompatibility results) with their targets and the actual measured performance from testing.
- Sample size used for the test set and the data provenance: Details on how many devices were tested, if it was an in-vitro, ex-vivo, or in-vivo study, and where the data originated.
- Number of experts and qualifications: If human interpretation or evaluation was involved (e.g., in a clinical study or imaging study), details about the physicians or specialists involved in assessments.
- Adjudication method: How disagreements among experts were resolved.
- MRMC comparative effectiveness study: Not typically applicable for hardware like fixation systems, but if comparing diagnostic performance, this would quantify improvements with AI assistance.
- Standalone performance: The performance of the algorithm itself, without human input, if AI was involved.
- Type of ground truth used: What was considered the definitive truth (e.g., histopathology, surgical confirmation, long-term outcomes).
- Sample size for the training set: If machine learning was used, the size of the dataset used to train the algorithm.
- How the ground truth for the training set was established: How accurate labels were assigned to the training data.
In summary, the provided document indicates that the Biomet Microfixation RibFix Blu Thoracic Fixation System is substantially equivalent to a previously cleared device, and thus, no new non-clinical or clinical performance data were deemed necessary for this 510(k) submission.
§ 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.