(84 days)
The AperFix™ Femoral Implant with Inserter is intended for use with soft tissue grafts to provide tendon to bone fixation during arthroscopic or open ACL reconstruction procedures.
The Cayenne Medical AperFix™ Femoral Implant with Inserter is a non-absorbable internal fixation device intended to provide tendon to bone fixation in hamstring tendon arthroscopic or open anterior cruciate ligament (ACL) reconstruction. It includes a body, wedge and two deployable arms with compression pads. AperFix Femoral Implants are available in diameters of 9, 10 and 11 mm with a standard length of 35 mm. Each device is intended for single use and is pre-loaded on a sterile inserter.
The AperFix Femoral Implant with Inserter will be supplied sterile. Sterilization will be accomplished by means of Co60 gamma irradiation at a dose of 25-40 kGy .
Mechanical testing was performed on the AperFix Femoral Implant. It was shown that pull-out strength is significantly higher than that of a predicate interference screw.
The provided text is a 510(k) summary for the AperFix™ Femoral Implant with Inserter, a medical device for ACL reconstruction. It focuses on administrative information, device description, and substantial equivalence to previously marketed devices. This type of documentation typically does not include the detailed information requested in your prompt regarding acceptance criteria and performance study specifics that are common for AI/software devices.
Therefore,Based on the provided 510(k) summary, I cannot provide the requested information for the following reasons:
- This document is for a mechanical medical implant, not a software or AI device. The questions you've posed (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set, ground truth) are highly relevant to the validation of AI/ML algorithms, particularly in medical imaging or diagnostic contexts.
- The 510(k) summary for this device focuses on demonstrating substantial equivalence to predicate mechanical devices. The primary "study" mentioned is "Mechanical testing... shown that pull-out strength is significantly higher than that of a predicate interference screw." This is a mechanical engineering test, not a clinical study involving human readers or AI performance metrics.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details as they pertain to AI/software validation, because this information is not present in the provided document about a mechanical implant.
§ 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.