(24 days)
The Opus Magnum® implant is indicated for use for rotator cuff repair in the shoulder.
The purpose of this 510(k) is to notify the FDA of a modification to the Opus Magnum® Implant System wherein a new suture, MagnumWire™, will be added as an option to provide convenience to the user. MagnumWire™ is substantially equivalent to FiberWire® USP braided polyester suture size #2 originally cleared under 510(k) 031083. The intended use and indications for use are the same as the predicate device. The addition of the use of MagnumWire™ with the Opus Magnum® Implant System does not alter the fundamental technology of the Opus Magnum® Implant System.
This document is a 510(k) summary for the Opus Magnum® Anchor with Inserter, focusing on a modification to include a new suture, MagnumWire™. The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The 510(k) is primarily concerned with demonstrating substantial equivalence to a predicate device (the existing Opus Magnum® Implant Set with FiberWire® suture) for the purpose of regulatory clearance, not with presenting performance studies against predefined acceptance criteria for a new AI/software device.
Therefore, I cannot provide the requested information, as it is not present in the provided text.
The document details:
- Manufacturer, contact, and date prepared.
- Device information: Trade Name, Common Name, Classification Name, Classification, and Product Code.
- Substantial Equivalence claim: States the new device (with MagnumWire™) is substantially equivalent to the previously cleared Opus Magnum® Implant Set (with FiberWire®).
- Indications For Use: Rotator cuff repair in the shoulder.
- Reason for 510(k) Notification: To add MagnumWire™ as an option, stating it is substantially equivalent to the previously cleared FiberWire®.
- FDA Clearance Letter: Confirms the device's substantial equivalence and clearance for marketing.
To answer your specific questions, information about acceptance criteria, performance studies, sample sizes, ground truth establishment, expert involvement, or MRMC studies would need to be present in a different section of the 510(k) submission, typically a more detailed performance data section, which is not included in the provided summary.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.