Search Results

The Modified Shoulder Fixation System is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal Humerus.

The Modified Shoulder Fixation System is a set of orthopedic plates and fasteners supplied in a sterilization tray together with several reusable and disposable tools. The set of orthopedic plates and fasteners provided in the sterilization tray consists of the following implantable devices: Shoulder Plates Shoulder Nail Plates Multidirectional and 90° Lock Screws 90° Set Screws Pegs Included in the sterilization tray are the following re-useable instruments: Peg drivers Other standard surgical tools.

The provided text does not contain information about the acceptance criteria or a study proving that the device meets those criteria.

The document is a 510(k) premarket notification summary for a medical device called the "Modified Shoulder Fixation System." It details administrative information such as the device name, predicate device, classification, indications for use, and a general description of the system. It also includes a letter from the FDA confirming substantial equivalence to a predicate device.

Specifically, the document does not include:

1. A table of acceptance criteria or reported device performance.
2. Details about sample sizes, data provenance, or study design for testing.
3. Information on experts, ground truth establishment, or adjudication methods.
4. Any mention of multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
5. Information about training sets or how ground truth for training was established.

Instead, the summary states: "The Modified Shoulder Fixation System is substantially equivalent to the predicate Shoulder Fixation System. The equivalence was confirmed through pre-clinical testing." This implies that the basis for approval was a demonstration of substantial equivalence to an already legally marketed device, often involving comparison of design, materials, and potentially certain mechanical tests, rather than clinical performance studies against specific acceptance criteria.

Ask a specific question about this device