(254 days)
Fracture of the proximal extremity of the humerus. Fracture of the diaphysis of the humerus.
The FH Industrie TELEGRAPH® EVOLUTION Humeral Nailing System includes short and long intramedullary cannulated humeral nails with right and left orientations, proximal screws and a washer. The nails, screws, and washer are intended for use in treatment of fracture of the proximal extremity of the humerus or fracture of the diaphysis of the humerus. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI). The nails that are the subject of this submission are cannulated.
I'm sorry, but I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.
The document you provided, K200127, is a 510(k) Premarket Notification from the FDA for a medical device called the "TELEGRAPH® EVOLUTION Humeral Nailing System." This document primarily focuses on demonstrating substantial equivalence to previously cleared devices, rather than laying out specific, quantitative performance acceptance criteria or detailed study results for a new, AI-powered diagnostic device.
Here's why the provided text does not contain the information you are looking for:
- Device Type: The device described is a surgical implant (intramedullary fixation rod for humeral fractures), not an AI-powered diagnostic or imaging device. Therefore, the types of performance metrics and study designs you've asked about (e.g., sensitivity, specificity, MRMC studies, ground truth establishment for AI models) are not relevant to this mechanical device.
- Regulatory Pathway: The 510(k) pathway is for demonstrating a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparisons of indications for use, technological characteristics (materials, design, dimensions), and often mechanical testing to show similar performance to the predicate. It does not generally require the kind of clinical performance studies with specific statistical acceptance criteria that would be needed for novel diagnostic algorithms (like those typically found in a De Novo or PMA submission for AI/ML devices).
- "Performance Testing" Section: The "Performance Testing" section in the document refers to:
- Sterilization (ISO 11137), packaging (ISO 11607), and biocompatibility (ISO 10993-1) validations: These are standard tests for medical device safety and sterility, not clinical performance metrics.
- Mechanical testing per ASTM F1264 and ASTM F543: These are engineering standards for testing the mechanical properties (e.g., strength, fatigue) of orthopedic implants. The conclusion states that "results have shown them to be substantially equivalent to the predicate device," which is a comparative statement rather than a demonstration of meeting predefined absolute performance thresholds.
In summary, the provided document does not discuss:
- A table of acceptance criteria and reported device performance related to diagnostic accuracy.
- Sample sizes for test sets in the context of diagnostic performance.
- Number of experts establishing ground truth or their qualifications.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Types of ground truth like pathology or outcomes data for diagnostic purposes.
- Training set sample sizes or ground truth establishment for training an AI model.
To answer your prompt, you would typically need a regulatory submission document for an AI/ML device, which would include detailed statistical analysis plans, clinical study results, and defined performance metrics.
§ 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.