(29 days)
The AFFIXUS® Natural Nail® System Humeral nails are temporary fixation intramedullary nails designed for fixation and stabilization of fractures or osteotomies of the humerus. They restore the shape of preiniured bone and are available in a variety of lengths and diameters to meet assorted anatomical needs. Nail caps are available to protect the nail threads from tissue ingrowth and extend the nail length if necessary. Each of the intramedullary nails is secured by a series of screws that pass through holes in the nail.
The AFFIXUS Humeral Nails are indicated for use in a variety of fractures, such as:
- · Proximal fractures (proximal short and long nails only)
- · Diaphyseal fractures (proximal long, antegrade/retrograde nails)
- · Open and closed fractures
- · Comminuted fractures
- · Nonunions and malunions
- · Pathologic fractures
The Affixus Natural Nail System Humeral nails are temporary fixation intramedullary nails designed for fixation and stabilization of fractures or osteotomies of the humerus. They restore the shape of preinjured bone and are available in a variety of lengths and diameters to meet assorted anatomical needs.
Nail caps are available to protect the nail threads from tissue ingrowth and extend the nail length if necessary. Each of the intramedullary nails is secured by a series of screws that pass through holes in the nail. Nails and nail caps are made from Tivanium® Ti-6Al-4V alloy. Screws are also made from Tivanium alloy. Package labels indicate the material of each component.
Selected components of the Affixus Natural Nail System are colour coded to aid in identifying which components should be used together. Refer to the colour coding chart and/or surgical technique for more detailed instructions on the use of Affixus Natural Nail System components.
The provided text is an FDA 510(k) clearance letter and a 510(k) Summary for the Affixus® Natural Nail® System Humeral Nail. This device is an intramedullary fixation rod, which is a physical device used for stabilizing fractures.
The requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is typically associated with the evaluation of AI/ML-based medical devices or diagnostic tools, where performance is measured against a ground truth and often involves human reader studies.
For the Affixus® Natural Nail® System Humeral Nail, an intramedullary fixation rod, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as requested is not applicable in the same way it would be for an AI diagnostic device.
Here's why and how to interpret the provided document:
- This is a physical medical device clearance, not an AI/ML device clearance. The FDA document is about a Class II medical device (intramedullary fixation rod) for fixing humeral fractures not a software.
- Substantial Equivalence: The clearance is based on substantial equivalence to a previously cleared predicate device (K181827). This means the FDA determined the new device is as safe and effective as the predicate without raising new questions of safety or effectiveness.
- Performance Data: The 510(k) Summary explicitly states:
- "Non-clinical performance and conclusions were not needed for this device."
- "Clinical data and conclusions were not needed for this device."
- This is because the device is largely identical to its predicate, and any minor modifications did not warrant new performance data.
- Acceptance Criteria for Physical Devices: For physical devices like this, acceptance criteria typically involve engineering specifications, biocompatibility, mechanical testing (e.g., fatigue, torsional strength, bending strength), and sterilization validation, rather than diagnostic performance metrics like sensitivity, specificity, or AUC against a ground truth. These tests ensure the device meets required functional and safety standards. However, the document states "performance testing" was done to address differences, but it doesn't detail these tests or criteria because no new questions of safety/effectiveness were raised.
Therefore, it is not possible to extract the requested information (table of acceptance criteria, study details, sample sizes, expert qualifications, etc.) from this document for the following reasons:
- Nature of the Device: It's a physical implant, not a diagnostic AI.
- Regulatory Pathway: 510(k) clearance based on substantial equivalence, especially for minor modifications, often relies on existing data for the predicate device and does not always require new extensive performance studies for the modified device if no new questions of safety or effectiveness are raised.
- Explicit Statement: The document clearly states that non-clinical and clinical performance data were not needed for this submission.
In summary, the provided document does not contain the specific type of acceptance criteria and study details (especially related to human-in-the-loop, MRMC, or standalone performance against a ground truth) that would be relevant for an AI/ML diagnostic device. The "performance data" mentioned in the document refers to the demonstration that "any differences do not raise new questions of safety and effectiveness as established with performance testing" and that the devices are "at least as safe and effective as the legally marketed predicate devices." This implies that prior engineering and safety testing for the predicate device were sufficient, and no new, extensive clinical or non-clinical performance studies were required for this specific 510(k) submission to prove substantial equivalence.
§ 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.