(72 days)
The UltiMax Ankle Fusion Rod System is indicated for single use for arthrodesis of the ankle joint.
All components of the UltiMax Ankle Fusion Rod System are manufactured from titanium (6A1-4V ELI) per ASTM F136.
The rod geometry features sharp flutes to obtain initial stability. The rod is bi-diameter to maximize strength in the distal region, tapering down 2mm to accommodate the tibial intramedullary canal. The rod is locked with one or two 5mm transfixing screws in the tibia proximally and are screwed distally in the calcaneous. Rods range in lengths from 150mm == 325mm (25mm increments) and diameters of 11mm and 13mm. Transfixing cortical screws are available in lengths ranging from 60-100mm in 2mm increments.
The rod also features a unique "compression slot" allowing up to 25mm of static or dynamic compression at the ankle joint. This is achieved with compression screws through the distal cannulation being driven against a distal transfixing screw. The compression screws are available in 12mm, 22mm, and 32mm lengths. The rod is fully cannulated for use with a small 2mm guide wire. The small cannulation maintains optimal strength while allowing traditional techniques for rodding.
This looks like a 510(k) submission for a medical device (UltiMax Ankle Fusion Rod System). Unfortunately, the provided text does not contain details about acceptance criteria or a study proving the device meets them.
The document primarily describes:
- Device Description: Materials, dimensions, features (e.g., flutes, bi-diameter, compression slot, cannulation).
- Intended Use: Arthrodesis of the ankle joint.
- Predicate Device Comparison: States that the device is "equivalent to the referenced legally marketed comparison devices" based on intended uses, design, testing, and manufacturing.
- Test Results: A very brief, generic statement: "Testing was performed on the UltiMax Ankle Fusion System. Test results proved the device to be of sound design." This provides no specifics about the tests performed, the acceptance criteria, or the outcomes.
- FDA Clearance Letter: This letter confirms the device's substantial equivalence to predicate devices and allows it to be marketed. It does not detail specific acceptance criteria or study results beyond the FDA's regulatory finding.
Therefore, I cannot populate the table or answer most of your specific questions related to acceptance criteria, study details, sample sizes, expert involvement, or ground truth.
Here's what I can extract from the provided text, and where I must state "Not Provided":
UltiMax Ankle Fusion Rod System
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (e.g., Specific Mechanical Strength, Biocompatibility Standard) | Reported Device Performance (Specific Test Result, Compliance Statement) |
|---|---|
| Not Provided in the document. The document only has a generic statement: "Test results proved the device to be of sound design." | Not Provided in the document. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not Provided. The document only states "Testing was performed" without specifying the number of samples or specimens.
- Data Provenance (e.g., country of origin, retrospective/prospective): Not Provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable/Not Provided. The document describes mechanical testing, not a study involving expert assessment or ground truth establishment in a clinical or diagnostic context.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable/Not Provided. This pertains to studies involving human interpretation or subjective assessment, which is not described here.
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:
- No. This is a mechanical orthopedic implant, not an AI or imaging device that would involve human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a mechanical orthopedic implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable/Not Provided. The "testing" mentioned is almost certainly mechanical and biocompatibility testing against engineering standards or predicate device performance, not clinical ground truth in the sense of diagnosis or outcomes.
8. The sample size for the training set:
- Not Applicable/Not Provided. This concept applies to AI/machine learning models, which is not relevant to this device.
9. How the ground truth for the training set was established:
- Not Applicable/Not Provided.
§ 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.