(86 days)
The MatrixRIB Endo Thoracoscopic Rib Plating System is indicated for the fixation, stabilization, and fusion of rib fractures and osteotomies of normal and osteoporotic bone.
The MatrixRIB Endo Thoracoscopic Rib Plating System consists of a pre-assembled stability plate with threaded locking posts, and locking caps intended for the minimally invasive thoracoscopic fixation and stabilization of ribs. The implants are manufactured from titanium (CPTi4) and titanium alloy (Ti-6Al-7Nb).
The document provided is a 510(k) summary for the MatrixRIB Endo Thoracoscopic Rib Plating System. It discusses the device's indications for use, technological characteristics, and comparison to predicate devices, along with non-clinical performance data.
However, the document states specifically that "Clinical testing was not necessary for the determination of substantial equivalence." This means that there was no study performed to demonstrate the device meets acceptance criteria regarding clinical performance.
Therefore, I cannot provide information on acceptance criteria, a study proving the device meets them, sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC comparative effectiveness studies, or standalone performance, as these pertain to clinical studies which were explicitly stated as not being performed.
The document does mention non-clinical performance data:
- Non-clinical performance data: Biomechanical Cadaveric Testing (Static Compression Bending, Dynamic Compression Bending).
- Conclusion from non-clinical data: "The non-clinical performance data demonstrate that the mechanical performance of the proposed MatrixRIB Endo Thoracoscopic Rib Plating System is comparable to that of the predicates."
This implies that the acceptance criteria for non-clinical performance were based on demonstrating mechanical comparability to predicate devices through these biomechanical tests. However, the specific quantitative acceptance criteria and the detailed results showing how the device met these are not provided in this summary.
In summary, based on the provided document:
- Acceptance Criteria & Device Performance: Not provided for clinical performance as no clinical study was deemed necessary. For non-clinical performance, the acceptance criteria were implicitly based on demonstrating mechanical comparability to predicate devices. The reported device performance for non-clinical testing was that it is "comparable to that of the predicates."
- Sample Size (test set) & Data Provenance: Not applicable as no clinical test set was used.
- Number of Experts & Qualifications: Not applicable.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: No.
- Standalone Performance Study: No clinical standalone study presented.
- Type of Ground Truth: Not applicable for clinical performance.
- Sample Size (training set): Not applicable as no machine learning algorithm or training data is mentioned.
- How Ground Truth for Training Set was Established: Not applicable.
§ 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.