(101 days)
The Ascension® Ankle Fusion Nail System is intended for the following:
- . Charcot Foot
- Avascular necrosis of the talus .
- Failed total ankle arthroplasty .
- . Trauma (malunited tibial pilon fracture)
- Severe deformity or instability as a result of talipes equinovarus, cerebral vascular . accident, paralysis or other neuromuscular disease
- . Revision ankle arthrodesis
- . Neuroarthropathy
- . Rheumatoid arthritis
- Osteoarthritis .
- Pseudoarthrosis .
- Post-Traumatic arthrosis .
- Previously infected arthrosis .
- Severe end stage degenerative arthritis t
- Severe defects after tumor resection .
- Pantalar arthrodesis .
The Ascension® Ankle Fusion Nail System is to be implanted by insertion into the long bones for fixation of fractures, or the fixation of long bones that have been surgically prepared for correction of deformity, or arthodesis.
The Ankle Fusion Nail System consists of nails, screws and an end cap. The standard nails are offered in three diameters and 3 lengths (150mm, 180mm and 210mm). Longer lengths up to 460mm will be made upon request. Fixation screws consist of one diameter and 27 lengths, and an end cap offered in one size. All three implant components will be manufactured from titanium 6AL-4V.
The provided text describes a 510(k) submission for the "Ascension® Ankle Fusion Nail System," a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria in the same way a novel device might.
Therefore, the study described does not involve a traditional "acceptance criteria" and "device performance" in the sense of a diagnostic or AI device study. Instead, the "acceptance criteria" for a 510(k) are met by demonstrating substantial equivalence, and the "study" is an engineering analysis comparing the new device to predicates.
Here's a breakdown of the requested information based on the provided text, acknowledging the nature of a 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Similarity in Design: Devices share similar fundamental design principles and configurations. | Claim: "Ascension Orthopedics believes that this system is substantially equivalent to the legally marketed predicate devices based on similarities in design..." |
| Similarity in Materials: Devices utilize comparable materials. | Claim: "...materials..." All implant components (nails, screws, end cap) are manufactured from titanium 6AL-4V, a common material for such devices. |
| Similarity in Indications for Use: The intended medical applications are the same or highly similar. | Claim: "...and indications." The listed indications for use are presented without direct comparison to predicates in a table, but the submission implies they are aligned. |
| Equivalent Functional Performance (specifically bending strength for worst-case components): The critical functional aspects, such as mechanical strength, are comparable or superior. | Result: "An engineering analysis was completed on the proposed device and the predicate devices. Results demonstrate equivalence in bending strength to the legally marketed predicate devices." This analysis focused on "worst-case cross sectional areas...at the screw holes and slots" as these directly affect bending strength. |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable in the context of this 510(k) submission. There was no "test set" of patient data in the clinical study sense. The "study" was an engineering analysis comparing the physical characteristics of the device to its predicates. Data provenance, therefore, refers to the design specifications and material properties of the devices, not patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. No ground truth based on expert clinical assessment was established for a test set. The assessment relied on engineering principles and comparison to existing, cleared devices.
4. Adjudication Method for the Test Set
Not applicable. There was no "test set" requiring adjudication by experts.
5. If a Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No. An MRMC study was not conducted as this is a device clearance based on substantial equivalence, not a comparative clinical effectiveness study of different clinical interventions or diagnostic accuracy.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This is not a software algorithm device.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established performance and safety profile of the legally marketed predicate devices. The new device's material properties, design, and mechanical performance (specifically bending strength) were compared against these established benchmarks.
8. The Sample Size for the Training Set
Not applicable. There was no patient-based "training set" for an algorithm or clinical model.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there was no training set, this information is irrelevant to this submission. The "ground truth" for the equivalence assessment was based on the physical and mechanical properties of the predicate devices themselves, which were presumably cleared based on their own safety and performance data.
§ 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.