Search Results

The Ortho Solutions Limited Oxford Ankle Fusion Nail (AFN) System is a tibiotalocalcaneal (TTC) solid fusion system that has been developed for the following indications:

• Failed ankle replacement
• Arthritis of ankle and subtalar joint
• Correcting neuromuscular imbalance of hindfoot, where bone fusion is required
• Revision of failed ankle and/or subtalar fusion
• Revision of failed Tibiotalocalcaneal (TTC) fusion
• Talar Avascular Necrosis (AVN)
• Charcot
• Trauma
• Neuroarthropathy
• Pseudoarthrosis
• Rheumatoid arthritis

The Ortho Solutions Oxford Ankle Fusion Nail (AFN) System is composed of three(3) diameter (10, 11 & 12mm) sizes by two(2) lengths (150 & 180mm) as a straight nail, cannulated, to accept a 3.9mm Guide Pin. The cannulated nail is inserted through a dorsal heel incision over a guide wire using x-ray fluoroscopy within the ankle boney anatomy and distal tibia medullary canal. The guidewire is used to achieve adequate positioning. A Revision Nail in all sizes is also offered where the angled transverse hole is removed. A low-profile head 5.0mm Cortical Transverse Bone Screw (in 26 lengths of 20 - 115mm in 2 & 5mm increments) is used for proximal and distal multiple 'cross-screw' fixation after compression of the ankle joint space. Dynamization Slots(2) are located at the Proximal End of the nail. Also offered is a Standard and Locking End Cap for closing the distal end of the nail. The Locking End Cap rests and locks against the most distal Transverse 5.0mm Cortical Screw. For completion of long bone fractures, End Caps in 3 lengths (+0, +5 & +10) and in 3 diameters (10, 11 & 12mm) are used for distal IM Nail Length Extension as necessary. As well, all End Caps seal the end of the nail to avoid ingrowth of tissues. All bone hole preparation and bone screw insertion is with the assistance of intra-operative x-ray fluoroscopy. All implant components are offered 'Sterile' for Single Use. With the Intramedullary Nail inserted into the ankle bone, an instrument 'Targeting Arm' with alignment holes is attached to the distal end of the nail. This external Targeting Arm allows proper orientation, preparation, and alignment of the proper cannula for transverse and angled drilling of bone screw holes into the nail and ankle anatomy cortical and cancellous bone. The bone hole preparation is for proper alignment to the referenced transverse and angled holes within the Intramedullary Nail for insertion of Transverse 5.0mm Cortical Bone Screws. All implant components are made from 6-4 Alloyed Titanium material to ASTM F 136 and are anodized with a Type II surface preparation. The IM Nail, End Cap and Transverse Screws may be removed when long bone fracture(s) are healed or the ankle joint space is fused. A full complement of instrumentation (external Targeting Arm Main Jig. guide wire/pins, drill guides/sleeves, cannulated tissue protector sleeves, depth gauge, reamers, reaming rod, drills, drivers, cannulated guide tube & trocar, etc.) is available with the system. A 'sterile single use' disposable pack is available encompassing a guide pin, guide rod, drills, reamer, reaming rod and exchange tube. A implant extraction/removal instrumentation set is also made available.

The provided text is a 510(k) summary for the Oxford Ankle Fusion Nail (AFN) System. This document describes a medical device seeking market clearance based on substantial equivalence to previously approved devices, rather than comprehensive clinical studies proving independent acceptance criteria and performance metrics.

Therefore, the information listed below regarding "acceptance criteria" and various study details is largely not applicable (N/A) in the context of a 510(k) submission for a device like an intramedullary nail. The FDA's 510(k) pathway focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, not on establishing novel performance benchmarks through extensive clinical trials.

The summary emphasizes "equivalence" and "similarity in material, geometry design/markings, and indications" to predicate systems. The "Summary of Safety and Effectiveness" simply states the device is "shown to be safe and effective for use as 'sterile' and for single-use in a surgical setting," which typically refers to non-clinical testing (e.g., biocompatibility, sterilization validation, mechanical testing) and comparison to predicate devices, not specific performance criteria from a clinical study.

Here's an attempt to populate the requested table and sections based on the provided text, indicating "N/A" where the information is not present or not relevant to a 510(k) for this type of device:

Acceptance Criteria and Device Performance Study Analysis

1. Table of Acceptance Criteria and Reported Device Performance

Note: For devices cleared through the 510(k) pathway, detailed, statistically significant acceptance criteria and performance data from clinical studies are often not provided in the summary document. Instead, the focus is on demonstrating that the new device is "substantially equivalent" to existing, legally marketed predicate devices. This typically involves non-clinical (bench) testing, material characterization, and comparison of design and indications for use.

2. Sample size used for the test set and the data provenance

• Sample Size (Test Set): N/A (No clinical test set data from a study to prove acceptance criteria is described in this 510(k) summary.)
• Data Provenance: N/A (As no clinical test set is described, data provenance for such a set is also not applicable.)

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• N/A (No human-adjudicated test set is described. The 510(k) process for this device type typically relies on engineering and material standards, and comparison to predicate devices, rather than expert-established ground truth from patient data for performance evaluation.)

4. Adjudication method for the test set

• N/A (No test set requiring adjudication is described.)

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• N/A (This device is an intramedullary nail, not an AI-powered diagnostic or assistive device. Therefore, MRMC studies involving human readers and AI assistance are not relevant.)

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• N/A (This device is a physical implant, not a software algorithm.)

7. The type of ground truth used

• N/A (For this type of 510(k), "ground truth" in the sense of clinical outcomes or expert labels is generally not derived directly from a new clinical study. Instead, the ground truth is often established by the successful performance and safety record of the predicate devices that the new device is compared against, along with non-clinical testing verifying material properties and mechanical performance.)

8. The sample size for the training set

• N/A (No training set is mentioned or applicable as this is not a machine learning/AI device.)

9. How the ground truth for the training set was established

• N/A (No training set is mentioned or applicable.)

Ask a specific question about this device