(67 days)
The Unreamed Interlocking Nail System is provided non-sterile. The implants are inserted into the medullary(bone marrow) canal of long bones(femur, and tibia) for the fixation of fractures.
The interlocking system makes up of Femoral, Tibial Nail and bolt screws. The bolt screws are utilized with the different interlocking nail. The interlocking nails have the same features such as: Dynamic locking: Using the proximal oval hole permits axial loading with A rotational stability. A Anatomical design: Femur: The 1.6m radius of the Unreamed Femoral Nail corresponds closely with the average anatomical curvature of the femur. Tibia: The curvature of 8° in the upper third of the Unreamed Tibial Nail allows for easy insertion and good anatomical fit. A Distal locking: Through two medial holes, additional locking is also possible in the anatomical seat. Easy insertion: The curvature of the posterior aspect of the nail reduces damage to the interior posterior cortical surface during insertion. The dimension of the unreamed interlocking nail ranges in diameter from 8 to 12 mm and total length 255 to 480 mm. The locking bolt screws have high strength, self-tapping and easy locking technique. The dimension of the bolt screw ranges in thread diameter from 3.9, 4.9, and 5.0mm and total length 20 to 125 mm.
The provided text describes a 510(k) submission for a non-sterile unreamed interlocking nail system. This document focuses on establishing substantial equivalence to a predicate device already on the market, rather than a study proving the device meets specific acceptance criteria through performance testing with human subjects or a clinical study.
Therefore, many of the requested elements (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth information) are not present in this type of submission.
Here's an output based on the information available in the provided text, while also explicitly stating what cannot be extracted due to the nature of the document:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the 510(k) summary. A 510(k) submission for this type of device typically demonstrates substantial equivalence through material properties, design features, and intended use compared to a predicate device, rather than performance against pre-defined clinical acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable and not provided. This document relies on comparison to a predicate device, not a performance study with a test set of data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable and not provided. Ground truth establishment for a test set is relevant for performance studies, which are not detailed in this 510(k) submission.
4. Adjudication Method for the Test Set
This information is not applicable and not provided.
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 or at least not described in this 510(k) submission. The submission focuses on substantial equivalence to a predicate device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable and not provided. This device is a surgical implant, not an algorithm or AI system.
7. The Type of Ground Truth Used
This information is not applicable and not provided. The "ground truth" in the context of this 510(k) is the established safety and effectiveness of the predicate device (Synthes-Titanium Unreamed Femoral Nail) to which the Syntec-Taichung device is deemed substantially equivalent. The substantial equivalence is based on:
- Design: Shared features like dynamic locking, anatomical design (femur curvature and tibial curvature), and distal locking.
- Sizes: Similar overall dimensions (diameter, length of nails and screws).
- Material: Both devices use commercially 316LS stainless steel and titanium alloy (Ti-6Al-4V).
- Appliance (Intended Use): Both are for fixation of fractures in the medullary canal of long bones.
8. The Sample Size for the Training Set
This information is not applicable and not provided. This document does not describe a training set for an AI/algorithm driven device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided.
Summary of the Study (as described in the 510(k) document):
The "study" presented in this 510(k) is a comparison to a predicate device to establish substantial equivalence.
- Predicate Device: Synthes-Titanium Unreamed Femoral Nail.
- Comparison Basis: Design, sizes, material, and intended use ("appliance").
- Conclusion: Syntec-Taichung (Taiwan) believes that its non-sterile Unreamed Interlocking Nail System is substantially equivalent to the Synthes-Titanium Unreamed Femoral Nail. The FDA concurred with this assessment, allowing the device to be marketed.
This approach is common for medical devices seeking 510(k) clearance, where a direct comparison to an already legally marketed device demonstrates safety and effectiveness without requiring extensive new clinical trials or performance studies that define specific acceptance criteria.
§ 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.