(25 days)
This device is intended for use with the Wichita™ Fusion Nail in cases for intramedullary knee arthrodesis is performed to relieve pain and to stabilize a knee joint that has been severely damaged as a result of trauma, infection, or failed previous surgeries (including previous total joint replacement). More specific indications include treatment of the sequelae of septic arthritis in patients who are not candidates for total knee arthroplasty, irretrievably failed total knee arthroplasty (either septic or aseptic), Charot arthropathy, painful degenerative knee in patients who are not candidates for total knee arthroplasty, arthrodesis of the knee for salvage in tumor surgery, delayed or non-union after previous arthrodesis of the knee, and any other condition where arthrodesis is the treatment of choice.
This Special 510(k) submission is intended to address a design modification to the predicate Wichita™ screw. The predicate device is a partially threaded screw manufactured from wrought Vitallium® (CoCr) Alloy which conforms to ASTM standard F1537. This device was found substantially equivalent via the 510(k) process. The subiect device is being modified from a partially threaded screw with course thread design to a fully threaded screw with fine thread design. The screw head length is being reduced by 1mm, and the head profile is changing from the square to the rounded design. Additionally, a 25mm screw will be added to the current product line. The intended use of the Wichita™ Fully Threaded Self-Tapping Screw is identical to the Wichita™ Partially Threaded Self-Tapping Screw.
This document is a 510(k) submission for a device modification, specifically for the Wichita™ Fusion Nail Fully Threaded Self-Tapping Screw. It does not contain information about acceptance criteria or a study proving the device meets performance criteria in the way typically seen for diagnostic or AI-enabled devices.
The information provided describes:
- Device: Wichita™ Fusion Nail Fully Threaded Self-Tapping Screw.
- Modification: From a partially threaded screw with a coarse thread design to a fully threaded screw with a fine thread design. Also, a 1mm reduction in screw head length, changing the head profile from square to rounded, and adding a 25mm screw to the product line.
- Intended Use: Identical to the predicate device, for intramedullary knee arthrodesis in cases of severe knee damage due to trauma, infection, or failed surgeries, and other specific indications like septic arthritis, failed total knee arthroplasty, and Charcot arthropathy.
- Regulatory Outcome: The FDA found the device substantially equivalent to a predicate device, allowing it to be marketed.
Therefore, the questions you've asked, which are relevant to evaluating the performance of a diagnostic device or an AI algorithm, cannot be answered from the provided text.
Here's why and what kind of information would be needed to answer your questions:
- Acceptance Criteria & Reported Performance: This document is about a design modification to a physical implant. The "acceptance criteria" here would relate to manufacturing specifications, material properties, and mechanical strength, not diagnostic performance metrics like sensitivity, specificity, or AUC. A study proving conformance would be mechanical testing (e.g., fatigue strength, pull-out strength).
- Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth (for Test & Training), Training Set Size: These questions are specific to the evaluation of diagnostic algorithms (especially AI/ML). This document describes a surgical implant, not a diagnostic algorithm. There is no AI component, no "performance" in the sense of accuracy, recall, or precision, and no "ground truth" established by experts for classification tasks.
To summarize, based on the provided text, none of the specific questions regarding acceptance criteria, study design for performance evaluation, or AI-related metrics can be answered. This document is a regulatory submission for a physical medical device modification, demonstrating substantial equivalence rather than performance against a set of diagnostic acceptance criteria.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.