(171 days)
The Biosteon® cross pin is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures. The Biosteon® cross pin is used to provide suspension fixation during femoral fixation in ACL reconstruction using a soft tissue graft (semi-tendonosis gracilis).
The cannulated Cross Pins are 40-60mm long by 6-9mm diameter with a conical tip 10mm long.
This document describes a 510(k) premarket notification for the Biosteon Cross Pin, a medical device. The information provided heavily focuses on the device's substantial equivalence to predicate devices, particularly in materials, manufacturing, function, and indications for use.
Based on the provided text, there is no acceptance criteria or study information related to device performance in the context of AI/ML or diagnostic accuracy. The submission is mechanical and material focused for a physical implantable device.
Therefore, I cannot populate the requested table and answer the questions. The provided text does not contain information about:
- Acceptance criteria (beyond functional equivalence to a predicate device)
- Reported device performance (in terms of sensitivity, specificity, etc.)
- Sample sizes for test sets or data provenance (as it's not a data-driven device)
- Number of experts or their qualifications for ground truth establishment
- Adjudication methods
- MRMC comparative effectiveness studies
- Standalone algorithm performance
- Type of ground truth (as it's not a diagnostic device)
- Sample size for training set
- How ground truth for the training set was established
The document details a traditional medical device submission for a physical implant, not a software-as-a-medical-device (SaMD) or AI-powered diagnostic tool. The "acceptance criteria" for this device would have been related to mechanical strength, biocompatibility, and sterilization, which were likely demonstrated through engineering tests and material characterization, and comparison to predicate devices, rather than clinical study performance metrics or expert consensus on diagnostic accuracy.
§ 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.