(176 days)
- · Simple, compound first- and second-degree tibial shaft fractures
- · Pseudarthrosis and delayed union
The Intramedullary Nail System is a temporary fixation intramedullary nail designed for fracture fixation and stabilization of the tibia. It consists of Intramedullary nail, Locking screw and End cap.
The Intramedullary nail is available in a variety of lengths and diameters to meet assorted anatomical needs. Each of the nails is secured by a series of screws that pass through holes manufactured into the proximal and distal sections of each nail. The Locking screw passes through the holes at the proximal distal sections of intramedullary nail for preventing rotation and axial compression. The End cap which screws into the threaded end of the intramedullary nail provides intraoperative lengths adjustment and prevents tissues growth into nail threads.
All implants of Intramedullary Nail System are manufactured from Ti-6AI-4V alloy that meets the requirements of ASTM F-136. The materials are wildly used in the industry with well known biocompatibility. No new materials are used in the development of this implant.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Intramedullary Nail System:
This device (Intramedullary Nail System) is a medical device for fracture fixation, and as such, its acceptance criteria and supporting studies are centered on its mechanical performance and biocompatibility rather than diagnostic accuracy or human interpretation. Therefore, many of the requested categories related to AI performance, expert consensus, and ground truth in a diagnostic context are not applicable here.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Static Bending Test (ASTM F1264-03) | Met all design specifications. |
| Static Torsion Test (ASTM F1264-03) | Met all design specifications. | |
| Dynamic Bending Test (ASTM F1264-03) | Met all design specifications. | |
| Pull Out Test (ASTM F543-07) | Met all design specifications. | |
| Material Biocompatibility | Ti-6AI-4V alloy (ASTM F-136) | Complies with ASTM F-136; materials are widely used with known biocompatibility. |
| Substantial Equivalence | Equivalence to Predicate Device (K053261) in safety and effectiveness | Determined to be Substantially Equivalent (SE). |
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, screws) used for the bench tests. The tests were conducted to verify that the proposed device met design specifications and was substantially equivalent to the predicate device. The provenance is not explicitly stated beyond the manufacturing location of the device being China. The tests are de novo mechanical bench tests, not data derived from patients (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 is a medical device for fracture fixation and stabilization, not a diagnostic device requiring expert interpretation for ground truth establishment. The ground truth for mechanical performance is established by standardized testing protocols (ASTM standards) and engineering principles.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which is not the case for these mechanical bench tests.
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 device is an intramedullary nail system, a physical implant for fracture fixation. It is not an AI-powered diagnostic or assistive tool, so an MRMC study is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This refers to an AI algorithm's performance, which is not relevant for this physical medical device. The "standalone" performance here relates to the device's mechanical performance in bench tests, independent of human interaction during its function as an implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance of this device is based on established engineering standards and material specifications from ASTM (American Society for Testing and Materials). Specifically:
- ASTM F1264-03 (Reapproved 2007): Standard Specification and Test Methods for Intramedullary Fixation Devices (for static bending, static torsion, and dynamic bending).
- ASTM F 543-07: Standard Specification and Test Methods for Metallic Medical Bone Screws (for pull-out strength).
- ASTM F-136: Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (for material biocompatibility).
8. The sample size for the training set
Not applicable. There is no "training set" in the context of mechanical bench testing for a physical implant. The device design is informed by engineering principles and existing predicate devices, not machine learning training from a dataset.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device submission.
§ 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.