(138 days)
The indications for the I.T.S. Intramedullary Nailing System (INS) - Proximal Femur include intramedullary treatment of fractures and stabilization after tumor resection in the area of the proximal femur, as well as combinations that additionally affect the shaft area using the long nails.
The indications for use of the I.T.S. INS Proximal Femur include:
All Nails:
- · Stable and unstable pertrochanteric fractures
- · Intertrochanteric fractures
- · Combinations of fractures listed above
Additionally for Long Nails:
- Subtrochanteric fractures
- · Proximal fractures as listed above associated with shaft fractures
- · Pathological fractures in regions as listed above
- · Nonunions and malunions in regions as listed above
The I.T.S. INS Proximal Femur Nail consists of the following implants:
-
Nails:
The Proximal Femur Nails are designed for the treatment of femoral fractures. The Femur Nails are available in distal diameters ranging from 9 to 14mm and lengths of 180mm (short nail), 240mm (intermediate nail), and 260 to 480mm in 20mm increments (long nail). 180mm and 240mm nails have a single, oblong hole distally, while all nails with a length over 260 have a round hole, an oblong hole and another round hole for distal fixation. The oblong hole allows for both static and dynamic locking configurations. All Trochanteric Nails are locked proximally with a Lag Screw. The set screw engages with the lag screw and allows translation while preventing rotation. Endcaps close the top of the nail and are available in 0mm, 5mm, 10mm, 15mm and 20mm lengths. -
Lag Screw
Lag screws are cannulated with a major diameter of 10.5mm and lengths ranging from 70mm to 130mm in 5mm increments. They are available in titanium alloy (Ti-6Al-4V ELI) per ASTM F136. -
Set Screw
There are two types of set screws available. Inferior short and standard with a diameter of 6.6mm. The Length of the inferior short version is 45mm and the standard lengths are 70 to 130mm in 5mm increments. They are available in titanium alloy (Ti-6Al-4V ELI) per ASTM F136. -
Distal Cortical Locking Screw
Distal locking screws are fully threaded, with a diameter of 5.0mm and lengths ranging from 25mm to 120mm in 5mm increments (2.5mm increments available from 25-70mm). Thev are available in titanium alloy (Ti-6Al-4V ELI) per ASTM F136. -
Instrumentation
I.T.S. INS Proximal Femoral Nail Instrumentation consists of implant-specific targeting devices which help facilitate insertion of the nails, lag screws, and distal locking screws. Targeting devices are manufactured from stainless steel and carbon fibre reinforced PEEK. Other instrumentation includes drills, drill guides, k-wires and screwdrivers.
All nails and screws are provided Sterile for single-use.
The provided text describes a 510(k) submission for the I.T.S. INS Proximal Femur Nail. This is a medical device for intramedullary fixation, and the FDA has determined it to be substantially equivalent to previously marketed predicate devices.
However, the text does not include information about AI/ML device performance, acceptance criteria normally associated with diagnostic algorithms (like sensitivity, specificity), or details about studies involving human readers or ground truth establishment relevant to AI. The nature of this submission is for a physical medical device (an intramedullary nail), not an AI-powered diagnostic tool.
Therefore, many of the requested categories (2, 3, 4, 5, 6, 7, 8, 9) are not applicable to the provided document.
Here's a breakdown of what can be extracted from the text, focusing on the mechanical evaluation of the physical device:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in the format typically used for AI/ML performance (e.g., minimum sensitivity). Instead, the performance is evaluated against consensus standards and compared to predicate devices for substantial equivalence.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Performance | Fatigue Testing of the nail screw construct: Demonstrated that the I.T.S. INS Proximal Femoral Nail is substantially equivalent in mechanical performance to the predicate device. |
| Performance testing following consensus standards ASTM F543 & ASTM F1264: Demonstrated that the I.T.S. INS Proximal Femoral Nail is substantially equivalent in mechanical performance to the predicate device. | |
| Material, Geometry, Design, Indications, and Operational Principles | The I.T.S. INS Proximal Femur Nail is substantially equivalent in material, geometry, design, indications, and operational principles to the legally marketed predicate systems. |
2. Sample size used for the test set and the data provenance
Not applicable. This is a physical medical device, and the testing involved mechanical performance, not a test set of data for an AI algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth establishment by experts is relevant to AI/ML diagnostic performance, not the mechanical testing of an intramedullary nail.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant to expert consensus for AI/ML ground truth, not 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. This device is a physical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no AI algorithm being evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the mechanical testing, the "ground truth" or standard for comparison was defined by consensus standards (ASTM F543 & ASTM F1264) and the mechanical performance of predicate devices.
8. The sample size for the training set
Not applicable. There is no AI algorithm with a training set.
9. How the ground truth for the training set was established
Not applicable. There is no AI algorithm with a training set or ground truth in this context.
§ 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.