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The Vilex Redemption Duo Hindfoot Nail System is intended for tibiotalcaneal arthrodesis (fusion)

Specific indications include:

• · Post-traumatic or degenerative arthritis
• · Previously infected arthrosis
• Revision ankle arthrodesis
• Failed total ankle arthroplasty
• · Avascular necrosis of the talus
• · Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease
• Rheumatoid arthritis
• · Osteoarthritis
• Pseudarthrosis
• · Trauma (malunited tibial pilon fracture)
• · Charcot foot
• · Severe endstage degenerative arthritis
• Severe defects after tumor resection
• Pantalar arthrodesis
• · Post-traumatic arthrosis
• · Neuroarthropathy

The Vilex Redemption Duo system consists of implantable intramedullary nails, endcaps, and locking screws manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136 and PEEK per ASTM F2026) that are implanted into the talocrural region to facilitate tibiotalocalcaneal arthrodesis (fusion). A variety of implant sizes are provided to accommodate individual patient anatomy. The Vilex Redemption Duo system includes device specific instrumentation for use in site preparation, implantation, and removal of the implants and instruments are packaged clean and non-sterile in a sterilization tray with instructions for sterilization prior to surgery.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "Vilex Redemption Duo Hindfoot Nail System." This type of document does not typically contain information about AI/ML device performance, acceptance criteria, or a study specifically designed to demonstrate meeting such criteria as it would for an AI/ML diagnostic or prognostic system.

Instead, this clearance letter is for a physical orthopedic implant system (intramedullary nail) that facilitates tibiotalocalcaneal arthrodesis (fusion). The "performance data" referred to in Section VII relates to mechanical testing of the implant's physical properties, not diagnostic accuracy or AI algorithm performance.

Therefore, I cannot provide the requested information about acceptance criteria, AI/ML device performance, sample sizes, ground truth establishment, or expert involvement, as these concepts are not applicable to the type of device described in this FDA clearance.

The document describes the device's technical characteristics and provides references to the following:

Device Name: Vilex Redemption Duo Hindfoot Nail System
Regulation Number: 21 CFR 888.3020
Regulation Name: Intramedullary fixation rod
Regulatory Class: Class II
Product Code: HSB

Performance Data (Mechanical Testing):
The performance data provided supports the mechanical integrity and safety of the implant, not the performance of an AI algorithm. The tests performed are standard for orthopedic implants and include:

• Bending Fatigue per ASTM F1264-16e1
• Static Torsion per ASTM F543-17
• Driving Torque per ASTM F543-17
• Removal Torque per ASTM F543-17
• Axial Pullout Strength per ASTM F543-17
• Static Four-Point Bending per ASTM F1264-16e1
• Static Torsion per ASTM F1264-16e1
• Dynamic Four-Point Bending per ASTM F1264-16e1

The conclusion states that "Although minor differences in the design exist between the subject and predicate devices, the testing supports that these differences do not raise any different questions of safety and effectiveness. Therefore, it is concluded that the Vilex Redemption Duo Hindfoot Nail System is substantially equivalent to the predicate device." This indicates that the mechanical tests demonstrated equivalent performance to predicate devices, satisfying the FDA's requirements for 510(k) clearance for this type of physical implant.

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The antegrade femoral nail is intended for use in intramedullary fixation of fractures of the femur to include the following: Open and closed femoral fractures, Pseudoarthrosis and correction osteotomy, Pathologic fractures, impending pathologic fractures and tumor resections, Supracondylar fractures, including those with severe comminution and intra articular extension, Ipsilateral femur fractures, bone lengthening, fractures proximal to a total knee arthroplasty or prosthesis, fractures distal to a hip joint, nonunions and malunions, and fractures resulting from osteoporosis.

The retrograde femoral nail is intended for use in intramedullary fixation of fractures of the femur to include the following: Open and closed femoral fractures, Pseudoarthrosis and correction osteotomy, Pathologic fractures, impending pathologic fractures and tumor resections. Supracondylar fractures, including those with severe comminution and intra articular extension, Ipsilateral femur fractures, bone lengthening, fractures proximal to a total knee arthroplasty or prosthesis, fractures distal to a hip joint, nonunions, and fractures resulting from osteoporosis.

The tibial nail system is intended to provide temporary stabilization of various types of fractures, malunions, and nonunions of the tibia. The tibial nail system is indicated for long bone fracture fixation of tibial fractures, which may include the following: traverse, oblique, spiral, segmental and comminuted fractures with bone loss and bone transport; open and closed fractures; pathologic fractures; pseudarthrosis of the tibial shaft; nonunions, malunions, metaphyseal and epiphyseal fractures.

The trochanteric nail is intended to treat stable and unstable proximal fractures of the femur including peritrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures. The long trochanteric nail is additionally indicated for subtrochanteric fractures associated with shaft fractures pathologic fractures (including prophylactic use) in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fracture, ipsilateral fractures, proximal and distal non-unions and malunions and revisions procedures.

The ES trochanteric nail is intended to treat stable proximal fractures of the femur including peritrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures.

The Arthrex Intramedullary Nails are comprised of Femoral, Tibial, and Trochanteric Nail Systems.

The proposed Arthrex Femoral Nail System is comprised of femoral nails (antegrade, retrograde, supracondylar retrograde), proximal and distal locking screws, end caps, spacer, and washers. All retrograde nails are threaded on the distal end to accept an end cap. The proximal and distal locking screws are comprised of fully threaded, cancellous or cortical screws and partially threaded cancellous screws. The Arthrex Femoral Nail System is manufactured from Titanium Alloy (Ti-6AL-4V ELI conforming to ASTM F136). The Arthrex Femoral Nail System is sold sterile and is single-use.

The proposed Arthrex Tibial Nail System is comprised of tibial nails, proximal and distal locking screws, end caps, and spacer of varying lengths and diameters. The tibial nail contains slots to accept the locking screws. The proximal and distal locking and blocking screws are comprised of fully threaded, cortical screws and partially threaded cannulated cancellous screws. The end caps are designed to prevent bony in-growth in the distal portion of the nail implant. The spacer is provided for proximal locking. The Arthrex Tibial Nail System is manufactured from Titanium Alloy (Ti-6AL-4V ELI confirming to ASTM F136). The Arthrex Tibial Nail System is sold sterile and single-use.

The proposed Arthrex Trochanteric Nail System is comprised of trochanteric nails (short, ES [Extended Short], and long), proximal and distal locking screws, and end caps. The trochanteric nails have slots to accept distal and proximal screws. The proximal end of the nail is threaded to accept an end cap. The Arthrex Trochanteric Nail System (nails, screws, and end caps) is manufactured from Titanium Alloy (Ti-6AL-4V ELI conforming to ASTM F136) and Stainless Steel (316LVM conforming to ASTM F138).

The provided FDA 510(k) summary (K230257) for the Arthrex Intramedullary Nails does not contain information related to software or AI/ML components. Therefore, it does not include acceptance criteria, study details, or performance metrics typically associated with such devices.

The document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices through:

• Technological Comparison: Highlighting that the intended use, fundamental scientific technology, design, material, sterility, and shelf-life are identical or have minor modifications that do not raise new questions of safety or effectiveness.
• Performance Data for Hardware Components: Detailing tests performed on the physical device components and packaging, such as:
  • Packaging validation and 5-year accelerated aging shelf-life testing (conforming to ISO 11607).
  • MRI safety testing (force, torque, image artifact, radiofrequency induced heating) in accordance with FDA guidance and ASTM standards (ASTM F2052, ASTM F2119, ASTM F2182, ASTM F2213).
  • Bacterial Endotoxins Test (BET) to ensure pyrogen limit specifications are met (in accordance with ANSI/AAMI ST72:2011/(R)2016, USP , USP , EP 2.6.14).

Therefore, I cannot answer questions 1 through 9 as they pertain to the evaluation of AI/ML or software performance. The device described is a physical medical implant (intramedullary nails) and the clearance is based on its similarity to existing, cleared hardware.

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