(86 days)
The indications for use of this internal fixation device include:
- Open and closed tibial fractures
- Pseudoarthrosis and correction osteotomy
- Pathologic fractures, impending pathologic fractures, and tumor resections
- Fractures involving osteopenic and osteoporotic bone
- Nonunion and malunion
The End Cap Lower Extremity and the Nail Holding Screw Tibia / Femur PF may also be used in conjunction with the T2 Alpha Femur Antegrade GT/PF Nailing System.
The IMN Screws System is intended to stabilize the intramedullary nail-bone construct for temporary stabilization.
The T2 Alpha Tibia Nailing System is a fracture fixation system and includes sterile implants (tibial nails in various diameters, compression screw tibia and end caps) as well as non-sterile instruments (targeting devices). The sterile implants are made of titanium alloy (Ti6A14V ELI) per ASTM F136. The adapters and nail holding screws are manufactured from stainless steel. The Targeting Arm Tibia and Adjusting Device Tibia are made of stainless steel. PEEK unreinforced as well as PEEK with 30% and 50% carbon fibers. The Distal Targeting Arm Tibia is made of PEEK with 30% and 50% carbon fibers.
The IMN Screws System includes bone screws (locking screws and advanced locking screws) that are inserted through the intramedullary nail to stabilize the nail-bone construct. All screws are made of titanium allov (Ti6Al4V ELI) per ASTM F136.
The provided FDA 510(k) summary (K193308) for the Stryker T2 Alpha Tibia Nailing System and IMN Screws System does not contain information related to software-based medical devices, AI/ML performance, or human-reader studies. Therefore, I cannot extract the acceptance criteria and study details as requested for such systems.
The document discusses implantable medical devices (intramedullary rods and bone screws) and focuses on demonstrating substantial equivalence to predicate devices through mechanical testing and material compatibility analyses.
Here’s a breakdown of what is available in the document, which falls under traditional medical device clearance, not AI/software:
1. Table of Acceptance Criteria and Reported Device Performance
This table would typically be relevant for software performance metrics (e.g., sensitivity, specificity, AUC). For this device, the "acceptance criteria" are implied by the mechanical testing standards and successful demonstration of substantial equivalence.
| Performance Metric (Implicit Acceptance Criteria) | Reported Device Performance |
|---|---|
| T2 Alpha Tibia Nailing System | |
| Mechanical Properties per ASTM F1264 | Demonstrated substantial equivalence to predicate devices (K191271, K003018). |
| Fatigue Strength Testing (distal) | Demonstrated substantial equivalence to predicate devices (K191271, K003018). |
| MR Conditional (Displacement force, torque, RF-induced heating, image artifacts) | Demonstrated to be MR conditional. |
| Bacterial Endotoxin Testing | Sterile implants meet specified endotoxin limit. |
| IMN Screws System | |
| Mechanical Properties per ASTM F543 and F1264 | Demonstrated substantial equivalence to predicate devices (K191271) and reference devices (K003018, K040762). |
| MR Conditional (Displacement force, torque, RF-induced heating, image artifacts) | Demonstrated to be MR conditional. |
| Bacterial Endotoxin Testing | Advanced locking screws meet specified endotoxin limit. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable. The "test set" here refers to physical samples for mechanical and biological testing, not a dataset for an AI model.
- Sample Size: Not specified in terms of number of devices tested, but mechanical tests were performed.
- Data Provenance: Not applicable in the context of clinical data for AI. These are laboratory-based mechanical and material test results.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. "Ground truth" in this context would be the physical properties confirmed by mechanical tests and material analyses, not human interpretation of medical images or data.
4. Adjudication Method
Not applicable. There is no adjudication process described for the mechanical test results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "No clinical testing of the T2 Alpha Tibia Nailing System has been conducted." and "No clinical testing of the IMN Screws System has been conducted."
6. Standalone (Algorithm Only) Performance
Not applicable. This device is not an algorithm or software.
7. Type of Ground Truth Used
For mechanical testing, the "ground truth" is defined by the physical behaviors and material properties measured according to established ASTM standards (e.g., ASTM F1264 for intramedullary fixation rods, ASTM F543 for metallic bone fixation fasteners). For MR compatibility, it relates to the measured displacement, torque, heating, and artifact characteristics in an MR environment. For bacterial endotoxin, it refers to a specified endotoxin limit.
8. Sample Size for the Training Set
Not applicable. This device does not use a "training set" in the context of AI/ML.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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.