(119 days)
The Femoral Recon Nail System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused. Specifically, the system is indicated for:
- Subtrochanteric fractures
- Ipsilateral neck/shaft fractures
- Femoral shaft fractures
- Impending pathologic fractures
- Malunions and nonunions
The Femoral Recon Nail (FRN) System is comprised of intramedullary nailing implants designed to provide stabilization of femoral shaft and neck fractures as well as system specific insertion instruments. The Femoral Recon Nail System offers nailing implants in two different designs which enable a Piriformis Fossa (PF) and a Greater Trochanter (GT) entry point for the insertion of the nailing implant in the femur. The implants are manufactured from Titanium alloy, are provided in a range of dimensions and in Left and Right-oriented versions.
The provided text describes a 510(k) premarket notification for the DePuy Synthes Femoral Recon Nail System. This is a medical device for orthopedic fixation, not an artificial intelligence (AI) or software-as-a-medical-device (SaMD) product. Therefore, much of the information requested in the prompt, which is typically relevant for AI/SaMD studies, is not applicable or available in this document.
However, I can extract the information that is present concerning the device's acceptance criteria and the studies performed.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from predicate equivalence) | Reported Device Performance (Non-Clinical Data) |
|---|---|
| Mechanical performance at least equivalent to predicate device for fatigue. | Fatigue testing of constructs with standard locking and recon locking as well as an analytical evaluation performed. This information supports that the mechanical performance of the subject device is at least equivalent to that of the predicate device (Synthes Lateral Entry Femoral Nail System (K040336)). |
| Specified endotoxin requirement. | Devices meet the specified endotoxin requirement of 20EU/device using the LAL test method. |
2. Sample size used for the test set and the data provenance
Not applicable for this type of medical device (intramedullary fixation rod). The "test set" concept with data provenance is typically relevant for AI/SaMD performance evaluation using clinical data. For this device, physical and analytical testing were performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth and expert adjudication are relevant for AI/SaMD performance evaluation against human expert assessment. This document describes a physical medical device.
4. Adjudication method for the test set
Not applicable. Adjudication methods are relevant for AI/SaMD performance evaluation where human experts determine ground truth.
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 is a physical medical device, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
For mechanical performance, the "ground truth" is established through engineering principles, standardized testing methods for fatigue, and comparison to a legally marketed predicate device's established performance. For endotoxin levels, it's a direct measurement against a specified limit using a recognized test method (LAL test).
8. The sample size for the training set
Not applicable. This is a physical medical device. The concept of a "training set" typically applies to AI/machine learning models.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study proving the DePuy Synthes Femoral Recon Nail System meets its acceptance criteria is a non-clinical performance study focused on mechanical and material properties.
- Mechanical Testing: Fatigue testing was performed on constructs with standard locking and recon locking configurations. An analytical evaluation was also conducted. The subject device (DePuy Synthes Femoral Recon Nail System) was compared to the primary predicate device (Synthes Lateral Entry Femoral Nail System, K040336). The conclusion from this testing was that the mechanical performance of the subject device is at least equivalent to that of the predicate device.
- Material Testing: The devices were tested for endotoxin levels using the LAL test method. The results demonstrated that the devices meet the specified endotoxin requirement of 20EU/device.
The document explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence." This indicates that the non-clinical performance data was deemed sufficient by the FDA to establish substantial equivalence to the predicate devices. The basis for acceptance is that the device has the same intended use, similar indications for use, and is similar in design, material, and fundamental technology to the predicate devices, with mechanical performance at least equivalent, and no new questions of safety and effectiveness raised by any technological differences.
§ 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.