(70 days)
The Interlocking Nail System is provided non-sterile. The implants are inserted into the medullary(bone marrow) canal of long bones(humerus, femur, and tibia) for the fixation of fractures.
The interlocking system makes up of Humeral, Fibial Nail and bolt screws. The bolt screws are utilized with the different interlocking nails have the same features such as: Proximal locking: Choice of two oval holes for static locking(only three holes for humerus) secures the rotational and axial stability. Anatomical design: Humerus: The curvature of 5° in the upper third of the Reamed Humeral Nail allows for easy insertion and good anatomical fit. Femur: The 1.88m radius of the Reamed Femoral Nail corresponds closely with the average anatomical curvature of the femur. Tibia: The curvature of 15° in the upper third of the Reamed Tibial Nail allows for easy insertion and good anatomical fit. 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 interlocking nail ranges in diameter from 7 to 16 mm and total length 200 to 480 mm. The locking bolt screws have high strength, no tapping necessary and easy locking technique. The dimension of the bolt screw ranges in thread diameter from 3.9 to 6.4 mm and total length 20 to 100 mm.
This document is a 510(k) summary for the Syntec-Taichung Non-sterile Interlocking Nail System. It describes the device and claims substantial equivalence to a predicate device. However, the document does not describe any specific acceptance criteria or a study proving the device meets acceptance criteria.
The 510(k) submission process for Class II devices like this one focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring new clinical trials to prove safety and effectiveness against predefined acceptance criteria.
Therefore, I cannot provide the requested information from the provided text for the following reasons:
- A table of acceptance criteria and the reported device performance: This information is not present in the document. The document states a "Basis of Substantial Equivalence" where it compares the Syntec-Taichung device to the Richards - Trimax Nail System in terms of design, sizes, material, and appliance, but no specific performance metrics or acceptance criteria are listed.
- Sample size used for the test set and the data provenance: There is no mention of a "test set" or a study involving such a set. The substantial equivalence claim is based on comparison to a predicate device's existing market data and characteristics.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no such test set or ground truth establishment is described.
- Adjudication method for the test set: Not applicable, as no such test set or adjudication process is described.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No MRMC study is mentioned. The document is about an orthopedic implant, not an AI or imaging device where MRMC studies are typically performed.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
- The type of ground truth used: Not applicable, as no study requiring ground truth is described.
- The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable, as this is not an AI/machine learning device.
In summary, the provided document is a regulatory submission focused on demonstrating substantial equivalence to a predicate device. It does not contain information about specific acceptance criteria, performance studies, or clinical trial data as would be found for novel devices or those undergoing a PMA (Premarket Approval) process. The FDA's letter confirms that the device is "substantially equivalent" to predicate devices, allowing it to be marketed under the general controls provisions, without requiring new clinical performance studies outlined by 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.