(105 days)
The GFS Ultimate are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
The GFS Ultimate devices are designed for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair. The devices are made from medical grade titanium and UHMWPE suture. The GFS Ultimate devices are provided sterile.
The provided text is a 510(k) Substantial Equivalence Determination for the GFS Ultimate device. This type of document is for medical device regulation and focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device. It does not typically contain information about AI-based CADe/CADx systems or studies with acceptance criteria as commonly understood in that context.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details, as these are not present in the given document.
The document does include "Summary Performance Data" which states:
Summary Performance Data:
- The GFS Ultimate were evaluated and testing was conducted on the worst case configurations.
- Devices were assembled per the DFU and placed in a test fixture.
- Devices were evaluated for strength and elongation under cycle loading and ultimate failure conditions.
- Results were compared with test data for the predicate device and demonstrated substantial equivalency.
However, this summary does not provide specific acceptance criteria or quantitative performance metrics for the GFS Ultimate, nor does it detail the study design, sample sizes, or ground truth establishment that would be relevant for an AI-powered diagnostic/CADe device. Instead, it confirms that mechanical testing was performed and the results supported substantial equivalence to the predicate device.
§ 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.