(208 days)
The Precice Ankle Salvage System is intended for tibio-talo-calcaneal fusions. When used for TTC fusion, the Precice Ankle Salvage System may be used for open and closed fracture fixation, pseudarthrosis, mal-unions, or bone transport of long bones adjacent to the fusion site. The device may be used for subsequent limb lengthening once tibio-talo-calcaneal fusion has been achieved.
The Precice Ankle Salvage System is a tibio-talo-calcaneal fusion system that consists of the Precice Ankle Salvage Nail, locking screws, end caps, and associated general instruments. The Precice Ankle Salvage Nail is compatible with an external remote controller (ERC). The Precice Ankle Salvage Nail and endcap are supplied sterile by gamma radiation. The locking screws are offered either sterile or non-sterile. The Precice Ankle Salvage Nail contains an enclosed rare earth magnet, telescoping distraction rod, and planetary gearing which allows the length of the nail to be adjusted non-invasively by the ERC. Retraction of the Precice Ankle Salvage Nail can be utilized to maintain compression across the tibio-talo-calcaneal joints post-operatively. The Precice Ankle Salvage Nail can also be used to correct a limb length discrepancy that may result after the TTC fusion procedure. The subject device is manufactured from medical grade Biodur 108 alloy per ASTM F2229. The Precice Ankle Salvage Nail is available in various nail styles, diameters, and lengths to accommodate a variety of patient anatomies and surgeon preference. The locking screws are available in a variety of diameters, lengths, and thread styles. The ERC is available in several compatible models.
I am sorry, but the provided text does not contain the information necessary to describe the acceptance criteria and the study proving the device meets those criteria, as requested in your prompt.
The document is a 510(k) premarket notification summary from the FDA, which focuses on establishing "substantial equivalence" of a new medical device (Precice® Ankle Salvage System) to already legally marketed predicate devices.
Here's why the requested information is absent:
- No Acceptance Criteria or Performance Data: The document states that "Nonclinical performance verification testing was performed to demonstrate that the subject Precice Ankle Salvage System is substantially equivalent to the predicate devices." It lists types of testing performed (Dynamic Compression, Bending Strength, Axial Pullout Strength, Insertion Torque, Torque Resistance, Distraction and Retraction Force) and applicable ASTM standards. However, it does not provide any specific acceptance criteria (e.g., "must achieve X MPa bending strength") nor does it report the device's actual performance results against any such criteria. It only states that the "results demonstrate that the subject Precice Ankle Salvage System is substantially equivalent to the predicates."
- No Clinical Study Details: The document mentions a "cadaver lab was performed to address creation of osteotomy around the nail," but this is a pre-clinical, non-human study. There is no mention of a human clinical study, MRMC study, or any details about test set size, data provenance, expert ground truth, adjudication methods, or training set details. This type of information is typically found in clinical study reports, which are not part of this 510(k) summary.
- Focus on Substantial Equivalence, Not De Novo Performance: The core purpose of a 510(k) submission is to argue that a new device is "substantially equivalent" to a predicate device. This means demonstrating that it's as safe and effective as a device already on the market, rather than proving its absolute performance against predefined metrics in a clinical setting like a PMA de novo submission often requires.
Therefore, I cannot populate the table or answer the specific questions about the study design, experts, ground truth, or sample sizes because that information is not present in the provided text.
§ 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.