(30 days)
The Fixion Interlocking Proximal Femoral Nailing System ("Fixion PF") is intended for use in fixation of fractures in the femur. The Fixion PF is indicated for use in fractures in the femur shaft, proximal fractures, and combinations of these fractures. Proximal femoral fractures include stable and unstable pertrochanteric, intertrochanteric and subtrochanteric (with and without break-off of the minor trochanter), high subtrochanteric fractures and combinations of these fractures. The long Fixion PF may also be used in mid shaft fractures, 5cm below the surgical neck to 5cm proximal to the distal end of the medullar canal.
The Fixion PF is also indicated for use in osteotomy, nonunions and malunions, bone reconstruction following tumor resection, grafting and pathological fractures, revision procedures.
The Fixion Intramedullary Proximal Femoral Nailing System consist of the following main components:
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The Nail Implant is an expandable non-slotted stainless steel cylindrical tube, with a cap protected, female threaded proximal end with holes for Femoral Neck Peg (Hip Peg) and Hip Pin. Other implantable components provided are the Femoral Neck Peg (Hip Peg) and the Hip Pin.
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The Instrument Set consists of a few accessories used during insertion and removal (if required) of the implant.
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The Inflation Device (Pump) is a single-use manual plastic pump that is filled with sterile inflation liquid and used to expand the Nail implant and Femoral Neck (Hip) Peg
Once the Nail and the Femoral Neck Peg are positioned within the medullary canal and femur neck respectively, rotation of the pump handle allows for peg and nail diameter increase to their intended diameter under x-ray and controlled pressure. The Hip Pin may be inserted as well.
The provided text describes a 510(k) summary for a medical device (Fixion™ Interlocking Proximal Femoral Intramedullary Nailing System), which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies. Therefore, much of the requested information (e.g., acceptance criteria table, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) is not available in the given document.
The document primarily outlines:
- The device's description and intended use.
- Its classification and predicate devices.
- The performance standards it meets (primarily ASTM standards for material composition and mechanical testing).
- The claim of substantial equivalence to a previously cleared device (K010988) based on similar intended use, operating principles, design, materials, processes, sterilization, and packaging.
Based on the information provided, here is what can be inferred or stated:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Composition Standards | |
| ASTM F138 - Standard Specification for Stainless steel Bar and Wire for Surgical Implants (316L Stainless Steel) | The Fixion PF Nail is manufactured from 316L Stainless Steel, which meets the requirements of ASTM F138. |
| Surgical grade stainless steel and silicone for accessories | The Fixion PF Nailing System accessories incorporate surgical grade stainless steel and silicone. |
| Handling and Design Standards | |
| ASTM F565 Standard practice for Care and Handling of Orthopedic Implants and Instruments | The Fixion PF Nail is designed to meet the requirements of ASTM F565. |
| Mechanical Performance Standards | |
| ASTM F1264-99 - Standard for Mechanical Performance Considerations for Intramedullary Fixation Devices (4 point bending) | 4 point bending mechanical testing was performed according to ASTM F1264-99. (Specific performance values not provided, but implies meeting the standard). |
| ASTM F384-99 Standard Specification for Metallic Angled Orthopedic Fracture Fixation Devices (Hip Peg testing) | Hip Peg testing was performed according to ASTM F384-99. (Specific performance values not provided, but implies meeting the standard). |
| Substantial Equivalence to Predicate Device (K010988) | |
| Same intended use | The modified Fixion PF Nail has the same intended use. |
| Same operating principles | Basically has the same operating principles. |
| Same design | Basically incorporates the same design. |
| Same materials and processes | Incorporates the same materials and processes. |
| Same sterilization and packaging | Is sterilized and packed, basically, in the same manner. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to mechanical testing against ASTM standards, but does not detail sample sizes for these tests, nor does it refer to human clinical test sets.
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)
This information is not provided. The assessment relies on engineering and material standards, not expert clinical ground truth from a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Not applicable to the type of data presented (mechanical and material compliance).
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
A MRMC comparative effectiveness study was not conducted and is not applicable to this type of device (an orthopedic implant) which does not involve "human readers" or "AI assistance" in its direct function. The device is a surgical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study of an algorithm was not conducted and is not applicable to this device. The device is a physical intramedullary nailing system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's acceptance is based on:
- Compliance with ASTM material standards (e.g., F138 for stainless steel).
- Compliance with ASTM mechanical performance standards for orthopedic devices (e.g., F1264-99 for intramedullary fixation, F384-99 for hip pegs).
- Demonstration of substantial equivalence to existing legally marketed predicate devices, implying similar safety and effectiveness based on similar design, materials, and intended use.
8. The sample size for the training set
This information is not provided and is not applicable. There is no "training set" in the context of this device's mechanical and material compliance testing or substantial equivalence demonstration.
9. How the ground truth for the training set was established
This information is not provided and is not applicable as there is no training set mentioned or relevant for this type of device submission.
§ 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.