(37 days)
The VALOR® Hindfoot Fusion Nail System is intended to facilitate tibiotalocalcaneal arthrodesis in any of the following indications:
- Severe foot/ankle deformity.
- Osteoarthritis.
- Instability and skeletal defects after tumor resection,
- Neuro-arthropathic deformity or Charcot deformity,
- Avascular necrosis of the talus,
- Revision of a failed joint replacement or failed ankle fusion,
- Distal tibia fracture and non-unions,
- Rheumatoid arthritis and pseudoarthosis
The design features of the subject VALOR® Hindfoot Fusion Nail System are summarized below:
- Nails and screws are manufactured from titanium alloy.
- Nails are available in two diameters and a range of lengths.
- Screws are available in one diameter and a range of lengths.
The subject nail in this Special 510(k) is a line extension of the system to include a 300mm length nail. The design features of the VALOR® Hindfoot Fusion Nail System are substantially equivalent to the design and features of other the devices in this product family previously cleared for market.
This document is a 510(k) premarket notification for the VALOR® Hindfoot Fusion Nail System. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria or a study proving device performance in the context of an AI/algorithm-based medical device.
The document appears to be for a physical medical implant (an intramedullary fixation rod), not an AI/software device. Therefore, the questions regarding acceptance criteria, reported performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable to this submission.
The "Substantial Equivalence- Non-Clinical Evidence" section (Point 7 on page 5) states: "The subject 300mm nails do not provide a new worst case. From testing parameters performed on the predicate device, the 300mm nail will perform the same as the predicate in worst case testing because the working length and diameters have remained unchanged from the 250mm to 300mm nails." This refers to mechanical performance of the implant, not performance of an AI/algorithm.
Therefore, I cannot provide the requested information based on 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.