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Magly 6.5mm Cannulated Screws are generally intended for fracture fixation of large bones and large bone fragments.

Indication(s) for Use:

• Femoral neck fractures
• Metaphyseal fractures of the distal femur and tibia
• Fractures of the tibial plateau
• Fractures of the humerus, olecranon process, scapuls, and os calcis
• Fractures of the sacrum, acetabulum, and pelvic ring
• Fixation of the ileo-sacral joint
• Fusions of the foot and ankle

Magly 6.5mm Cannulated Screws are of a single thread profile with a nominal major diameter of 6.5mm and can be used in conjunction with a guide wire for precise placement.

At the distal tip the screws will incorporate 20mm of thread and will embody five cutting flutes that are used for reaming and tapping the thread profile. Located at the thread runout to the shank, we placed two reverse cutting flutes, located 180° to each other, to assist in the removal of the screw.

The screws will be available in 5mm incremental lengths, from 30mm-150mm.

Magly 6.5mm Cannulated Screws will be manufactured from titanium alloy

This is a 510(k) premarket notification for a medical device (Magly 6.5mm Cannulated Screws), not a study report for a diagnostic AI/ML device. Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating AI/ML diagnostic tools, is not present in this document.

The document describes the device, its intended use, and states that it is "substantially equivalent" to a predicate device (DePuy/ACE 6.5mm Titanium Cannulated Cancellous Screws). This substantial equivalence is based on similarities in design, function, materials used, and indications for use, rather than a performance study with specific metrics and acceptance criteria as would be expected for an AI/ML diagnostic device.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or other details related to a diagnostic performance study from the provided text.

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Magly 4.0 and 5.5mm Locking screws are used for the interlocking of APEX Intramedullary Femoral and Tibial Nails

The screws are fully threaded from the distal tip to approximately 1mm to 2mm under the head. The distal end will embody a spherical shape at the tip and four cutting flutes used for tapping the thread profile.

The locking screws will be available in 2mm incremental lengths, measured from under the head to the distal tip, the 4.0mm from 16mm-80mm and the 5.5mm from 20mm-120mm.

Magly 4.0 and 5.5mm Locking Screws are manufactured from titanium alloy.

The provided text is a 510(k) premarket notification summary for the Magly 4.0 and 5.5mm Locking Screws. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than a clinical study proving the device meets specific acceptance criteria related to performance metrics like sensitivity, specificity, accuracy, or human reader improvement for AI/CAD systems.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC comparative effectiveness studies is not applicable to this type of document because it describes a mechanical medical device (bone screws), not a diagnostic algorithm or an AI/CAD system.

The document states that the Magly 4.0 and 5.5mm Locking Screws are substantially equivalent to the Synthes 4.0 and 5.0mm Locking Screws based on "design, function, materials used, and indications for use." This is the core "acceptance criteria" for a 510(k) submission for this type of device – demonstrating equivalence to a predicate device that is already legally marketed. No formal study in the sense of a clinical trial with statistical endpoints for performance metrics is described because it's a mechanical device for fixation.

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• Low subtrochanteric fractures
• Pseudarthrosis and corrective osteotomies
• Transverse fractures
• Pathologic fractures, impending pathologic fractures, and tumor resections.
• Oblique and spiral fractures
• Supracondylar fractures, including those with intra-articular extension
• Segmental fractures
• Ipsilateral femoral neck fractures
• Comminuted fractures
• Fractures proximal to total knee arthoplasty
• Fractures distal to a hip implant
• Nonunions and malunions.
• Acute bone lengthening and shortening
• Reamed and unreamed applications
• High Supracondylar fractures, including those with intra-articular extension.

The APEX Intramedullary Nail System consists of intramedullary rods for fixation inside the canal of the tibia or femur. All the rods are cannulated and cylindrical in shape. The rods are available in a variety of diameters and lengths and have holes located the proximal and distal ends for fixation to bone by means of locking screws. An end cap is available. It screws into the threaded end of the nails to prevent bone ingrowth, which may hamper attachment of the extraction instrumentation. All components of the APEX Intramedullary Nail System are manufactured from titanium alloy (Ti-6Al-4V).

This document is a 510(k) premarket notification for a medical device called the "APEX Intramedullary Nail System." This type of submission is for establishing substantial equivalence to a predicate device, not for proving a device meets specific performance criteria through a study with acceptance criteria in the way an AI/ML device would.

Therefore, the requested information points (acceptance criteria, device performance table, sample sizes, expert qualifications, adjudication, MRMC, standalone performance, ground truth, training set size) are not applicable in the context of this specific document, as it describes a traditional orthopedic implant (intramedullary nail) and not a device that would necessitate such a performance study.

The core of a 510(k) for a device like this relies on demonstrating that it is "substantially equivalent" to a legally marketed predicate device (or devices). This is typically achieved by comparing design, materials, intended use, and performance characteristics (often mechanical testing for implants) to established standards or to the predicate device(s).

Summary of what can be extracted from the provided text, related to substantial equivalence:

• Device Type: APEX Intramedullary Nail System (intramedullary rods for fixation inside the canal of the tibia or femur).
• Predicate Devices:
  • Stryker Howmedica Osteonics Retrograde/Antegrade Femoral Nail
  • ACE AIM Titanium Nails (DePuy/ACE, a Johnson Company)
  • Smith & Nephew TriGen Knee Nail
• Basis for Substantial Equivalence: "The APEX Intramedullary Nail System is similar to the listed predicate device in design, function, materials used, and indications for use."
• Materials: Titanium alloy (Ti-6Al-4V) for all components.
• Indications for Use: A comprehensive list of femoral fractures and conditions that the device is intended to treat (e.g., low subtrochanteric fractures, transverse fractures, nonunions, malunions, etc.).

In conclusion, this document does not contain the information required to fill out the table and answer the study-related questions because it describes a different type of regulatory submission (510(k) for a traditional device) than one that would involve performance studies with acceptance criteria for tasks like image interpretation or diagnosis.

Ask a specific question about this device