(29 days)
The product is intended to be used in fixation of femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intracondylar notch. Fracture types include basilar neck, intertrochanteric, subtrochanteric fractures and femoral shaft fractures. These femoral fractures may occur as a result of trauma, non-union, malunion, pathological fractures, and impending pathological fractures.
This Special 510(k) submission is intended to address a material modification and design modifications to the predicate Long Length Gamma® Nail System. The subject device, named the Long Length Dyax Nail System, is a line extension of the Long Length Gamma® Nail System. The predicate Long Length Gamma® Nail System is fabricated from stainless steel. The subject Long Length Dyax Nail System is fabricated from titanium alloy. The design change for the nail involves changing the proximal diameter, changing the distal screw hole diameters and distal hole configuration and adding additional lengths of nails. The 5 mm diameter fully threaded locking screws from the T2 Nail System will be compatible with the Long Length Dyax Nails.
The predicate Long Length Gamma® Nail is an intramedullary rod intended to be used in the fixation of femoral fractures' occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intercondylar notch. The predicate design is cannulated, with a medial/lateral and anterior/posterior curve.
The provided document is a 510(k) summary for a medical device called the "Long Length Dyax Nail System." This is a line extension to an existing device (Long Length Gamma® Nail System). The document describes the device, its intended use, and its substantial equivalence to a predicate device, but it does NOT contain information about acceptance criteria, detailed performance data, or a specific study designed to prove the device meets acceptance criteria as would be found in a clinical trial or performance study report.
The core of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to prove effectiveness or safety through a new clinical effectiveness study. Substantial equivalence is often established through technological comparison, material comparison, and sometimes mechanical testing, rather than human expert-based performance evaluations like those described in your request.
Therefore, most of the information requested cannot be extracted from this specific document. However, I can confirm what is available:
1. A table of acceptance criteria and the reported device performance
- Not Available. The document does not provide a table of acceptance criteria or reported device performance data in the context of human-expert evaluation, clinical outcomes, or AI performance metrics. It focuses on device description and substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Available. This information pertains to a study involving a test set, which is not described in this 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Available. This information pertains to a study involving human experts, which is not described in this 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Available. This information pertains to a study involving adjudicated ground truth, which is not described in this 510(k) summary.
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/Not Available. The device is an intramedullary nail for fracture fixation, not an AI or imaging diagnostic device that would typically undergo an MRMC study comparing human reader performance with and without AI assistance. The document does not mention any such study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable/Not Available. This question relates to AI algorithm performance. The device is a physical surgical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable/Not Available. This question relates to a study that would establish ground truth for performance evaluation of a diagnostic or predictive device. No such study or ground truth is discussed for this intramedullary nail. The "truth" for this device's efficacy would be clinical outcomes (e.g., successful fracture healing), but such outcomes data are not presented in this 510(k) summary, which is focused on substantial equivalence.
8. The sample size for the training set
- Not Applicable/Not Available. This question relates to AI algorithm training data. The device is a physical surgical implant, not an AI algorithm.
9. How the ground truth for the training set was established
- Not Applicable/Not Available. This question relates to AI algorithm training data. The device is a physical surgical implant, not an AI algorithm.
What the document does provide in relation to "proof" or "study":
The document states that the new device (Long Length Dyax Nail System) is a "line extension" and demonstrates "substantial equivalence" to a "predicate Long Length Gamma® Nail System" through:
- Technological Comparison: The primary "study" implicitly referenced is a comparison of materials and design.
- Predicate device material: Stainless steel.
- Subject device material: Titanium alloy.
- Design changes: Proximal diameter, distal screw hole diameters, distal hole configuration, and additional nail lengths.
- Intended Use Comparison: "There is no change in intended use for the modified device when compared to the previously cleared product."
- Compatibility: The 5 mm diameter fully threaded locking screws from the T2 Nail System will be compatible.
Essentially, the "study" proving the device meets its acceptance criteria (which is "substantial equivalence" for a 510(k)) is a documented comparison of its features and materials to those of a previously cleared device, rather than a clinical trial with specific performance metrics against pre-defined acceptance criteria. Mechanical testing would typically be performed as part of demonstrating substantial equivalence for an orthopedic implant, but the details of such testing (e.g., fatigue strength, bending rigidity) are not included in this summary.
§ 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.