(114 days)
The Vertex Hip Fracture Nailing System is intended for temporary fixation of stable and unstable fractures of the proximal femur. The Vertex Nail is indicated for use in adult patients for treatment of:
- Pertrochanteric fractures;
- · Intertrochanteric fractures;
- · High subtrochanteric fractures
- · Combinations of the above fractures, including non-union, malunion and tumor resections.
The Long Nail system is additionally indicated for use in adult patients for treatment of:
- · Pertrochanteric fractures associated with shaft fractures;
- · Pathologic fractures in osteoporotic bone (including prophylactic use) of the trochanteric and diaphyseal areas;
- · Impending pathological fractures;
- · Long subtrochanteric fractures;
- · Ipsilateral femoral fractures;
- · Proximal or distal non-unions, malunions, revision procedures and tumor resections.
The Vertex Hip Fracture Nailing (HFN) System is a cephalomedullary fixation system designed to be implanted and interlocked proximally and distally using bone screws by means of a provided surgical instrumentation kit. Like many of the currently marketed intramedullary nails, the Vertex HFN offers several different proximal and distal locking options from which the surgeon may choose, depending on the nature of the fracture. The Vertex HFN System includes long and short cephalomedullary nails, lag screws, bone screws, and endcaps all of varying lengths and diameters. All parts of the system are manufactured from Titanium 6AL4VELi.
The provided FDA 510(k) summary for the Vertex Hip Fracture Nailing System does not contain information about acceptance criteria or a study proving the device meets said criteria in the context of an AI/ML-based medical device. This document is a clearance letter for a traditional medical device (an intramedullary fixation rod) and focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.
Therefore, the requested information, such as sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set sample size, and ground truth establishment for training sets, are not applicable to the content of this document.
The document describes the device's non-clinical performance testing to demonstrate substantial equivalence, which is a different type of evaluation from what is typically done for AI/ML medical devices.
Here's a breakdown of the relevant information that can be extracted, even though it doesn't directly answer the posed questions about AI/ML device testing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Proxy) | Reported Device Performance (Summary) |
|---|---|
| Similar performance to predicate device (Zimmer Biomet Affixus Hip Fracture Nail K183162) and reference devices in mechanical tests. | - Static and Dynamic Axial Compression testing: Performed on the full construct using a test method adapted from ISO 7206-4 (substantially similar to ASTM F384). The implication is that the Vertex Hip Fracture Nailing System demonstrated equivalent or acceptable performance to the predicate/reference devices in these mechanical strength and fatigue tests. |
- Cutout Testing: Performed using an approach described in scientific literature (no applicable ISO/ASTM/AAMI standard). This test assesses the resistance of the lag screw to cutting out of the bone, a critical failure mode. The implication is that the device demonstrated acceptable performance in this regard.
- Engineering Rationale: Provided per ASTM F1264-16 and ASTM F543-07, indicating that the design and materials meet established engineering standards for orthopedic implants. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. The document describes non-clinical (mechanical) testing of physical devices, not testing based on patient data or clinical datasets. Therefore, concepts like sample size for a test set of data, data provenance, or retrospective/prospective data collection are not relevant here.
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 Applicable. Ground truth in the context of AI/ML usually refers to human expert annotations or pathology results. This document describes physical device testing, where "ground truth" would be established by physical measurements and engineering specifications, not expert consensus on medical images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are typically used for resolving discrepancies in expert opinions when establishing ground truth for AI/ML models. This is not relevant to mechanical device testing.
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. The Vertex Hip Fracture Nailing System is a physical surgical implant, not an AI/ML-driven diagnostic or assistive tool for human readers. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. As mentioned, this is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical performance testing, the "ground truth" is implicitly defined by established engineering standards and biomechanical principles. The tests performed (Static and Dynamic Axial Compression, Cutout Testing) have their own inherent "truth" based on measured physical properties and comparisons to established performance benchmarks for similar devices or to the predicate device.
8. The sample size for the training set:
- Not Applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not Applicable. There is no "training set" as this is not an AI/ML device.
In summary, the provided document pertains to the regulatory clearance of a traditional medical device (an orthopedic implant) based on substantial equivalence and non-clinical mechanical performance testing, not an AI/ML-based device. As such, the specific criteria requested for AI/ML device evaluation are not present.
§ 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.