(129 days)
SGM Femoral Nail System is intended to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, and combinations thereof. The long SGM Femoral Nail is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, malunions, and revisions.
An intramedullary fixation nail is a metal rod implanted into the medullary cavity of a bone to treat fractures that occur in long bones of the body. SGM Femoral Nail System consists of a series of metal rods, proximal helical blades, bone locking bolts and end caps. The rods are cannulated and are provided with screw holes to accommodate screws of various diameters and lengths. The rods are available in a range of sizes used for specific anatomic locations and fracture configurations. The implantable devices are manufactured from titanium alloy and are provided non-sterile.
The provided document is a 510(k) summary for the SGM Femoral Nail System, a medical device for femoral fracture fixation. It is not a document about an AI/ML medical device. Therefore, the information requested in your prompt regarding acceptance criteria and studies proving the device meets those criteria, specifically concerning AI/ML performance metrics, ground truth establishment, sample sizes for training/test sets, expert adjudication, and MRMC studies, cannot be found in this document.
The document details the substantial equivalence of the SGM Femoral Nail System to a predicate device (Synthes (USA) Trochanteric Fixation Nail (TFN) System) based on similar intended use and technological characteristics. The performance data provided is related to bench testing for mechanical properties of the physical device, reprocessing, and sterilization, not AI/ML algorithm performance.
Here's what can be extracted from the provided text about the device's assessment:
Device: SGM Femoral Nail System (Intramedullary fixation rod)
Regulatory Class: Class II
Acceptance Criteria and Device Performance (Based on provided document):
The acceptance criteria for this medical device, being a mechanical implant, are related to its physical and mechanical properties, as well as its ability to be reprocessed (cleaned and sterilized). The document states that the non-clinical data demonstrates the SGM Femoral Nail System is substantially equivalent to the predicate device. This implies the device's performance met the standards of the predicate and relevant ASTM standards.
| Acceptance Criteria (Type of Test) | Reported Device Performance (Conclusion) |
|---|---|
| Bench Testing (Mechanical Properties): | The device passed a range of mechanical tests according to ASTM standards, demonstrating substantial equivalence to the predicate. Specific results details are not provided, but the conclusion is: "The non-clinical data demonstrates the SGM Femoral Nail System is substantially equivalent to the predicate device." |
| Static Four-Point Bending Test | Performed per ASTM F1264-16 |
| Static Torsional Test | Performed per ASTM F1264-16 |
| Bending Fatigue Test | Performed per ASTM F1264-16 |
| Bending Fatigue Test (Locking Screws) | Performed per ASTM F1264-16 |
| Cut-out Test (Helical Blade) | Performed per ASTM F1264-16 |
| Torsional Properties Test (Locking Bolt) | Performed per ASTM F543-17 |
| Driving Torque Test (Locking Bolt) | Performed per ASTM F543-17 |
| Axial Pullout Strength Test (Locking Bolt) | Performed per ASTM F543-17 |
| Self-Tapping Performance Test (Locking Bolt) | Performed per ASTM F543-17 |
| Single Cycle Construct Strength Test | Performed per ASTM F384-17 |
| Construct Fatigue Strength Test | Performed per ASTM F384-17 |
| Reprocessing and Sterilization: | "Validated manual cleaning and steam sterilization instructions are provided for the end user before implantation... Validation testing confirmed the reprocessing instructions provided by Geasure achieve sterility of the implant and surgical instruments prior to use." This was done per FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued March 17, 2015." |
Since the device is a physical implant and not an AI/ML algorithm, the following points of your prompt are not applicable to the submitted 510(k) summary for K230456:
- Sample size used for the test set and the data provenance: Not an AI/ML test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there's no diagnostic ground truth to establish for AI/ML.
- Adjudication method for the test set: Not applicable for a physical device.
- 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: This is for AI-assisted human performance, not applicable.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for a physical implant's mechanical properties.
- The sample size for the training set: Not applicable; there is no AI/ML training set.
- How the ground truth for the training set was established: Not applicable.
In summary, this document is for a traditional medical device (femoral nail system) and its clearance is based on substantial equivalence to a predicate device through non-clinical (bench) testing, not on AI/ML performance studies.
§ 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.