MEDTRONIC ORTHOPAEDIC TRAUMA APPLICATION

• K Number: K050651
• Device Name: MEDTRONIC ORTHOPAEDIC TRAUMA APPLICATION
• Manufacturer: MEDTRONIC NAVIGATION, INC.
• Date Cleared: 2005-07-27 ( 135 days)
• Product Code: HAW
• Regulation Number: 882.4560
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: K021980 , K990214 , K012448
• Predicate For: K093206

Intended Use

The Orthopaedic Trauma Application is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The Orthopaedic Trauma Application is indicated for trauma procedures in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone, pelvis or vertebra can be identified relative to a CT or MR based model, digitized landmarks or fluoroscopy images of the anatomy

• Acetabular, femoral and tibia fractures
• Guide Wire placement
• Implant/Hardware Removal
• Intertrochanteric Fractures
• Intramedullary Nailing
• Long-bone Fracture Fixation
• Long-bone Fracture Reduction
• Pelvic Fracture Fixation
• Pelvic Fracture Reduction
• Screw/Implant Placement
• Tibial, Femoral and Acetabular Osteotomies

Device Description

The Medtronic Orthopaedic Trauma Application software combines existing FluoroNav (K99014) The Meditorile Orthopaedic Tradina Applications used to assist surgeons with the stabilization and repair of orthopaedic fractures.

AI/ML Overview

The provided text does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) premarket notification summary for the Medtronic Orthopaedic Trauma Application, which describes the device, its intended use, and its substantial equivalence to previously marketed devices. It also includes the FDA's letter of approval for the 510(k) submission.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and data provenance
3. Number of experts used to establish ground truth and their qualifications
4. Adjudication method
5. Multi-reader multi-case (MRMC) comparative effectiveness study results
6. Standalone performance information
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).