(298 days)
The Wrist Arthrodesis Nail System is intended for wrist arthrodesis. Specific indications include posttraumatic arthritis of the joints of the wrist, rheumatoid wrist deformities requiring restoration, complex carpal instability, post-septic arthritis of the wrist, severe unremitting wrist pain related to motion, brachal plexus nerve palsies, tumor resection, and spastic deformities.
The Wrist Arthrodesis Nail System is designed as an intramedullary nailing platform to address wrist arthrodesis procedures utilizing a minimally invasive dorsal approach into the third metacarpal and distal radius by trained physicians. The IMPLATE Wrist Arthrodesis Nails are secured within the intramedullary canals by means of bone screws, and then assembled into a completed construct using a Connector. The IMPLATE Wrist Arthrodesis Nail System is comprised of a titanium (Ti 6AL-4V) Distal Radius Intramedullary Nail, various lengths of titanium (Ti 6AL-4V) Metacarpal Intramedullary Nails, multiple titanium (Ti 6AL-4V) nail Connectors in various lengths and angles, and Unicortical Screws of various lengths, Pins and System specific instrumentation
The acceptance criteria and the study proving the Skeletal Dynamics Wrist Arthrodesis Nail System meets these criteria are described below:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Static four-point bending test (ASTM F82) | Demonstrate bending strength comparable to the predicate device, with no failure. | All subject devices tested passed the acceptance criteria without failure, demonstrating comparable yield point and bending stiffness to the predicate. |
| Dynamic four-point bending test (ASTM F1264) | Achieve a maximum run-out value at 1,000,000 cycles without failure. | The testing confirmed an endurance value of 1,000,000 cycles without evidence of failure. |
| Torque Test (Connector Strength) | Withstand torsional forces without failure. | All subject devices tested passed the acceptance criteria without evidence of failure. |
| Pull Test (Interconnection Strength) | Maintain secure interconnection between the connector, metacarpal, and radius nails without failure. | All subject devices passed the acceptance criteria without evidence of failure. |
| Cadaver Lab (Surgical Procedure Repeatability) | Demonstrate that the surgical procedure is feasible and repeatable. (Implicit acceptance: successful completion and documentation of the procedure). | The lab documented that the procedure is feasible and repeatable, confirming successful and consistent surgical execution. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact numerical sample sizes for each mechanical test performed (e.g., how many nails or connectors were tested). It generally refers to "All subject devices tested." The cadaver lab's sample size is also not specified numerically.
Regarding data provenance, the document does not provide details on the country of origin or whether a retrospective/prospective study design was used for any of the tests. These are non-clinical (mechanical and cadaveric) tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable for this device as the studies conducted are non-clinical (mechanical and cadaveric) and do not involve human subject data or ground truth established by experts in a diagnostic or clinical evaluation context. The "experts" in this context would be the engineers and technicians performing the tests, and the surgeons in the cadaver lab; however, their number and formal qualifications beyond "trained physicians" (for the cadaver lab) are not detailed.
4. Adjudication Method for the Test Set
Adjudication methods like 2+1 or 3+1 are typically used in clinical or diagnostic studies involving human assessment or interpretation (e.g., reviewing medical images). These engineering and cadaveric tests do not involve such adjudication. The acceptance criteria for each test (e.g., "without failure," "confirmed endurance value") serve as the definitive evaluation metric.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic tools or algorithms, often involving human readers interpreting medical data with and without AI assistance. The Wrist Arthrodesis Nail System is a medical implant, and its evaluation focuses on mechanical properties and surgical feasibility.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This device is a mechanical implant, not an algorithm or AI system. The tests performed are for the physical properties and surgical utility of the device itself.
7. The Type of Ground Truth Used
For the mechanical tests, the "ground truth" is defined by the predetermined physical and engineering standards set by ASTM (e.g., F82, F1264) and the specific design requirements of the device (e.g., strength of connectors). Failure to meet these established engineering specifications constitutes a deviation from the "truth" of acceptable performance.
For the cadaver lab, the ground truth is the demonstrable feasibility and repeatability of the surgical procedure in an anatomical context.
8. The Sample Size for the Training Set
This medical device is a physical implant, not an AI or machine learning model. Therefore, there is no "training set" in the context of data used to train an algorithm. The development of the device's design would have involved iterative prototyping and testing, but these are distinct from a training set for an AI system.
9. How the Ground Truth for the Training Set Was Established
As stated above, there is no "training set" for this device in the context of AI. The "ground truth" for the device's design and manufacturing process would be established through engineering principles, material science, and adherence to relevant industry standards (e.g., ASTM) and regulatory requirements.
§ 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.