(97 days)
The Phantom® Hindfoot TTC/TC Nail system is intended for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot. Examples of specific indications include:
- Post-traumatic or degenerative arthritis
- Previously infected arthrosis
- Revision of failed ankle arthrodesis
- Revision of failed total ankle arthroplasty
- Talar deficiency conditions such as avascular necrosis of the talus (requiring tibiocalcaneal arthrodesis)
- Neuromuscular deformity or other neuromuscular disease with severe deformity or instability of the ankle
- Rheumatoid arthritis
- Osteoarthritis
- Nonunions or pseudarthrosis of hindfoot and distal tibia
- Trauma (severe or malunited tibial pilon fracture)
- Charcot foot (neuroarthropathy)
- Severe end-stage degenerative arthritis
- Instability and skeletal defects after tumor resection
- Pantalar arthrodesis
- Severe foot/ankle deformity
The Paragon 28® Phantom® Hindfoot TTC/TC Nail System is comprised of intramedullary nails, screws and accessory components. The Phantom® nails are offered in a variety of sizes lengths, and configurations to accommodate variations in patient anatomy. The Phantom® screws insert through the intramedullary nail to secure the construct. These are offered in varying lengths to accommodate the anatomical fixation required.
This FDA 510(k) summary describes the Paragon 28 Phantom® Hindfoot TTC/TC Nail System, a medical device for tibiotalocalcaneal arthrodesis. It does not present acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/ML device.
The provided text focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance, not on validating the performance of an AI/ML algorithm.
Therefore, I cannot provide the requested information for an AI/ML device based on this document. The document describes a traditional medical device (intramedullary nail system) and its mechanical and biocompatibility testing.
Here's why the provided text does not contain the requested information about AI/ML device performance:
- No mention of AI/ML: The document makes no reference to artificial intelligence, machine learning, algorithms, or any computational component that would require such performance evaluations.
- Focus on mechanical and biological properties: The preclinical testing described (ASTM F1264 for static and dynamic mechanical testing, cadaveric implantation, biocompatibility per ISO 10993-1, bacterial endotoxins, and sterilization) are standard tests for orthopedic implants, not for software or AI/ML components.
- "Substantial Equivalence" claim: The core of the 510(k) submission is to show that the new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and similar technological characteristics, and does not raise new questions of safety or effectiveness. This is a comparison to an existing device, not a performance validation against defined criteria for an AI/ML system.
To answer your request, if this were an AI/ML device, the document would need to include information such as:
- Performance metrics: Sensitivity, specificity, AUC, F1 score, accuracy, precision, etc.
- Ground truth: How the true positive/negative cases were established (e.g., expert consensus, pathology, follow-up data).
- Test set details: Size, characteristics, provenance (e.g., retrospective/prospective, patient demographics).
- Expert qualifications: If human experts were involved in ground truth establishment or reading studies.
- AI vs. human performance: If comparative studies were conducted.
- Training set details: Size, ground truth establishment.
Since the provided text is for a traditional orthopedic implant, none of the requested AI/ML specific 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.