(26 days)
The trochanteric nail is intended to treat stable and unstable proximal fractures of the femur including peritrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures. The long trochanteric nail is additionally indicated for subtrochanteric fractures, peritrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fracture, ipsilateral femoral fractures, proximal and distal non-unions and malunions and revisions procedures.
The ES trochanteric nail is intended to treat stable and unstable proximal fractures of the femur including peritrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures.
The Arthrex Anti-Rotation Screw, 5.0 x 115 mm is 5.0 mm in diameter and 15 mm in length. The Arthrex Anti-Rotation Screw, 5.0 x 115 mm is a line extension to the Anti-Rotation Screws cleared within Arthrex Intramedullary Nails (K230257). The Arthrex Anti-Rotation Screw, 5.0 x 115 mm is manufactured from Titanium Alloy conforming to ASTM F136. The Arthrex Anti-Rotation Screw, 5.0 x 115 mm is sold sterile and is single-use.
The provided text is a 510(k) premarket notification for a medical device (Arthrex Intramedullary Nails, specifically an Anti-Rotation Screw line extension). This document describes the device, its indications for use, and a comparison to a predicate device to establish substantial equivalence.
Crucially, this document is not for a device that uses Artificial Intelligence (AI) or machine learning. Therefore, it does not contain the kind of information typically found in an AI/ML device submission regarding acceptance criteria, performance studies with test sets, expert ground truth, MRMC studies, or training set details.
The "Performance Data" section solely refers to mechanical testing (failure torque/insertion torque, torsional yield strength) and MR compatibility testing for a physical implantable screw. It does not involve any algorithm performance or diagnostic accuracy metrics that would require the elements you've asked for.
Therefore, I cannot provide the requested information from the given text.
To illustrate, if this were an AI/ML device, the sections you asked about would typically be found in a "Clinical Study" or "Performance Evaluation" section, detailing:
- Acceptance Criteria Table: Would list quantitative thresholds for metrics like sensitivity, specificity, AUC, or F1-score.
- Sample Size and Data Provenance: Would describe the number of images/cases in the test set, their origin (e.g., U.S. hospitals), and whether they were collected retrospectively or prospectively.
- Experts for Ground Truth: Would specify the number of clinicians (e.g., 3 radiologists) and their qualifications (e.g., 5+ years of experience in musculoskeletal imaging).
- Adjudication Method: Would explain how disagreements among experts were resolved (e.g., 2 out of 3 agreement, or a senior expert for tie-breaking).
- MRMC Study: Would detail if human readers were evaluated with and without AI assistance, and quantify the improvement (e.g., increase in AUC, reduction in reading time).
- Standalone Performance: Would present the algorithm's performance without any human intervention.
- Type of Ground Truth: Would specify if ground truth was from expert consensus, pathology reports, surgical confirmation, or patient outcomes.
- Training Set Sample Size: The number of images/cases used to train the AI model.
- Training Set Ground Truth: How the labels for the training data were established.
Since the provided document is for a physical medical implant and not an AI/ML device, none of this information is present.
§ 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.