(134 days)
The Panta 2 Nail Arthrodesis System is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. Indications include:
- Post-traumatic and degenerative arthritis involving both ankle and subtalar joints
- Rheumatoid arthritis
- Revision of failed ankle arthrodesis with subtalar involvement or with insufficient talar body
- Revision of failed total ankle arthroplasty with subtalar intrusion
- Talar deficiency conditions (requiring a tibiocalcaneal arthrodesis)
- Avascular necrosis of the talus
- Neuroarthropathy or neuropathic ankle deformity
- Severe deformity as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease
- Severe pilon fractures with trauma to the subtalar joint.
The Panta 2 Arthrodesis Nail System (Panta 2) is used to perform a tibio-talo- calcaneal arthrodesis, a procedure undertaken for hindfoot problems that affect both the ankle and subtalar joints. The aim is to achieve fusion of the bones using a retrograde Nail that allows re-alignment of the foot on the weight-bearing axis, correction of coronal and sagittal plane deformities, rotational stability as well as axial compression. The Panta 2 System includes instrumentation which allows placement of screws through the central Nail and enables application of compression along with multi-planar screw fixation in the tibia, the talus, and the calcaneus.
The Panta 2 Arthrodesis Nail System is a medical device intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. The device's acceptance was based on non-clinical performance data, demonstrating substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Testing Description) | Standard | Reported Device Performance (Results) |
|---|---|---|
| Nail - Bending Static Comparison Test | ASTM F1264 | The Panta 2 System Nail performed substantially equivalent when compared to the predicate system Nail. |
| Nail - Bending Fatigue Life Comparison Test | ASTM F1264 | The Panta 2 System Nail performed substantially equivalent when compared to the predicate system Nail. |
| Nail - Static Torsional Strength Comparison Test | ASTM F1264 | The Panta 2 System Nail performed substantially equivalent when compared to the predicate system Nail. |
| Screws - Bending Fatigue Strength Test | ASTM F1264 | The Panta 2 System screws performed substantially equivalent when compared to the predicate system screws. |
| Screws - Torsional Properties Test | ASTM F543 | The Panta 2 System screws performed to requirements of the identified standards. |
| Screws – Axial Pullout Strength Test | ASTM F543 | The Panta 2 System screws performed to requirements of the identified standards. |
2. Sample size used for the test set and the data provenance:
The document does not specify the exact sample sizes (e.g., number of nails or screws) used for each mechanical test. The data provenance is non-clinical, meaning it comes from laboratory testing of the devices themselves, not from patient data. Therefore, there is no information about country of origin or whether it's retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device's acceptance was based on non-clinical, mechanical testing, not a clinical study involving human or expert interpretation of data. The "ground truth" here is the performance against established engineering standards.
4. Adjudication method for the test set:
Not applicable. As the acceptance was based on non-clinical mechanical testing results, no human adjudication method was used. The device's performance was objectively measured against the specified standards.
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:
Not applicable. This is a mechanical implant device, not an AI-powered diagnostic or assistive technology that would involve human readers.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
Not applicable. This is a mechanical implant device and does not involve algorithms or AI.
7. The type of ground truth used:
The ground truth for the device's performance was established through recognized industry standards for medical implants (ASTM F1264 and ASTM F543). These standards define the expected mechanical properties and performance of intramedullary fixation rods and bone screws.
8. The sample size for the training set:
Not applicable. There is no "training set" as this is not a machine learning or AI-based device.
9. How the ground truth for the training set was established:
Not applicable. As there is no training set for this device type, there is no ground truth established for it.
§ 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.