(44 days)
The MegaFix-T™ Titanium Interference Screw is intended for tibial and femoral fixation (primary anchorage) of tendon grafts in anterior and posterior cruciate ligament reconstruction.
The MegaFix-T™ is composed of titanium, which is commonly used in medical devices for a wide range of application and has a long history of biocompatibility for human use.
The provided documents are a 510(k) summary and FDA clearance letter for a medical device called the "Karl Storz MegaFix-T™ Titanium Interference Screw." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing the detailed performance studies typically associated with AI/software devices.
Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance) is not part of this 510(k) submission.
This document describes a traditional medical device (an interference screw for ACL reconstruction), not an AI/software device. As such, the specific metrics and study designs relevant to AI/software device validation (e.g., AUC, sensitivity, specificity, MRMC studies, ground truth establishment by experts for imaging data) are not applicable and are not found within this 510(k) submission.
The submission focuses on:
- Device Identification: Karl Storz MegaFix-T™ Titanium Interference Screw
- Intended Use: Tibial and femoral fixation of tendon grafts in anterior and posterior cruciate ligament reconstruction.
- Device Description: Composed of titanium, used in medical devices for biocompatibility.
- Substantial Equivalence: Demonstrated to predicate devices due to similar basic features and intended use. Minor differences raise no new issues of safety and effectiveness.
There are no details on acceptance criteria and a study that proves the device meets the acceptance criteria in the context of an AI/software device. The safety and effectiveness for this device are based on its material (titanium) and its substantial equivalence to previously cleared devices.
§ 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.