(28 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 AperFix Femoral Implant with Inserter is a non-absorbable internal fixation device used in arthroscopic or open anterior cruciate ligament (ACL) reconstruction to anchor tendon grafts (such as the hamstring tendon) within a surgically created femoral tunnel to enable tissue ingrowth with the resultant formation of a permanent bony attachment.
The provided text is a 510(k) summary for the AperFix™ Femoral Implant with Inserter. A 510(k) submission is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This process typically relies on comparisons to existing devices and does not usually involve clinical studies to establish novel performance criteria or extensive studies demonstrating device performance against new acceptance criteria.
Based on the provided text:
- No specific acceptance criteria and detailed device performance study are described. The document focuses on establishing substantial equivalence to predicate devices, not on proving performance against a specific set of acceptance criteria through a clinical study.
- The provided text does not contain information about:
- Sample sizes for test sets or data provenance.
- Number or qualifications of experts used to establish ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for training sets.
- How ground truth for training sets was established.
Summary of what is available from the text:
The AperFix™ Femoral Implant with Inserter is seeking 510(k) clearance based on substantial equivalence to predicate devices. The claim of equivalence is based on the device having:
- The same intended use.
- The same operating principle.
- The same basic design.
- The same polymer materials.
- Equivalent metallic materials.
- Same packaging materials and processes.
Therefore, it is not possible to complete the requested table and answer the specific questions about acceptance criteria and performance studies from the provided document. The 510(k) process for this device relies on demonstrating similarity to existing devices, not on a new study proving performance against defined acceptance criteria.
§ 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.