(49 days)
- fresh fractures of the femur to include; non-comminuted midshaft fractures, subtrochanteric fractures, distal third fractures, combination fractures of the shaft and neck, intertrochanteric fractures, combination intertrochanteric and subtrochanteric fractures. 2) osteotomy and reconstructive procedures following tumor resection. 3) revision procedures where other treatments or devices have failed. 4) arthrodesis. This device is a single use implant.
The Holland Titanium Femoral Nail is an interlocking intramedullary rod used in the fixation of fractures of the nail consists of four basic components, TI-Cannulated cancellous screws, TI-pilot threaded screws, Ticannulated end cap extensions, and the TI-femoral recon nail. The nail is a solid titanium alloy component, available in both right and left configurations and one universal nail. Proximally the nail has an 8 degree offset enabling the surgeon to insert the nail through a more lateral insertion point -the greater trochanterand properly seat the nail within the femur. The proximal end of the nail is a solid cylinder with three screw holes. The screw holes are arranged in a way to allow the surgeon options in reconstruction of the fracture fragments. The two most proximal screw holes are angled at 130 degrees from the diameter of the nail, are parallel and in line with one another. These interlocking screws improve fixation of fractures in the head and neck of the femur as well as increasing stability. The third hole from the proximal end is perpendicular to the diameter of the nail and allows for reattachment of the tuberosities if necessary. The proximal end of the nail is slotted, allowing the surgeon to orient instrumentation. The distal portion of the nail is solid and cylindrical in shape. Distally there are two interlocking screw holes. One of the holes is round allowing for a tight fit with respect to the screw, and the other is elongated to allow some flexibility for the screw placement desired by the surgeon. There are different sizes of cannulated endcap extensions. The extensions are used to "cap" the proximal end of the nail thereby preventing ingrowth and allowing the surgeon greater access to the threaded end of the nail, by simply removing the endcap, if it would ever need to be removed. There are two different screw types designed to be used with this nail. The first is the TIcannulated cancellous screw which is a titanium cannulated screw used in the proximal portion of the nail. There are several different sizes of the TI-cannulated cancellous screw (see component listing). The other type of screw used in conjunction with this nail is the TI-pilot threaded screws. These screws are designed to have a diameter of 4mm with a 6mm diameter for the holding threads giving this screw greater strength and not allowing it to migrate during healing.
This document is a 510(k) premarket notification for the Holland Femoral Nail System, a medical device. It focuses on demonstrating substantial equivalence to existing devices rather than presenting a standalone study with acceptance criteria for device performance. Therefore, most of the requested information regarding acceptance criteria and study details for AI/device performance is not available in this document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not contain a table of acceptance criteria or reported device performance in the context of an AI or diagnostic device study. This is a premarket notification for a physical implant (intramedullary fixation rod), and performance is typically assessed through mechanical testing and clinical experience, not specific accuracy metrics.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This document describes a medical implant, not a study evaluating an AI system or diagnostic device with a test set of data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. Ground truth establishment with experts is relevant for diagnostic accuracy studies, not for the substantial equivalence demonstration of an orthopedic implant.
4. Adjudication Method for the Test Set
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done as this is a premarket notification for an orthopedic implant, not a diagnostic or AI device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. There is no algorithm or AI component described in this document.
7. The Type of Ground Truth Used
Not applicable in the context of AI or diagnostic device evaluation. For a physical implant like this, "ground truth" relates to clinical outcomes, mechanical integrity, and biological response, which are assessed through a different regulatory pathway and types of studies (e.g., bench testing, animal studies, clinical trials if a PMA were required, and post-market surveillance). The 510(k) relies on demonstrating similarity to already approved devices.
8. The Sample Size for the Training Set
Not applicable. There is no training set as this is not an AI or machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Summary of Information Available in the Document Relevant to Regulatory Approval (Substantial Equivalence):
- Intended Use: The Holland Femoral Nail System is intended for various fresh fractures of the femur (non-comminuted midshaft, subtrochanteric, distal third, shaft and neck combinations, intertrochanteric, intertrochanteric and subtrochanteric combinations), osteotomy and reconstructive procedures following tumor resection, revision procedures, and arthrodesis. It is a single-use implant.
- Device Description: A solid titanium alloy intramedullary rod, available in right, left, and universal configurations. It features an 8-degree offset proximally, three proximal screw holes (two angled at 130 degrees, one perpendicular), and two distal interlocking screw holes (one round, one elongated). It uses TI-cannulated cancellous screws and TI-pilot threaded screws.
- Substantial Equivalence: The document states that the Holland Femoral Nail System is "equivalent to most other intramedullary nails on the market" in function and overall design.
- Predicate Devices: Examples of commercially available intramedullary femoral nails cited as similar include:
- Synthes Titanium Unreamed Femoral Nail (Synthes)
- Alta® Femoral Nail (Howmedica)
- The document states these predicate devices and the Biomet Holland Nail are "similar in both their intended use and the basic concept by which they are used."
- Potential Risks: The risks are stated to be "the same as with any joint replacement device," including nonunion/delayed union, implant bending/fracture, loosening/migration, metal sensitivity, limb shortening, decreased bone density, pain/discomfort, and nerve damage.
This 510(k) submission successfully demonstrated substantial equivalence, leading to FDA clearance for marketing. The basis for acceptance was the comparison to legally marketed predicate devices, not specific performance metrics from a controlled study with acceptance criteria in the manner requested for an AI/diagnostic device.
§ 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.