(78 days)
The Fixion Interlocking Proximal Femoral Nailing System ("Fixion PF") is intended for use in fixation of fractures in the femur. It is indicated for use in fractures in the femur shaft and proximal fractures and combinations of these fractures. Proximal femoral fractures include stable and unstable pertrochanteric and subtrochanteric (with and without break-off of the minor trochanter), high subtrochanteric fractures and combinations of these fractures. Shaft fractures include those that are 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, and revision procedures.
The Fixion Interlocking Proximal Femoral Nailing System is a single use system that consists of the following 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 and Hip Pin, to fix fractures in the proximal femur.
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The Inflation device is a single-use manual plastic pump that is filled with sterile inflation liquid an used to inflate the nail implant and Femoral Neck Peg.
Once the nail and the Femoral Neck Peg and hip pin are positioned within the medullary canal and femur neck, rotation of the "pump" handle allows for screw and nail diameter increase to their intended diameter under X-ray and controlled pressure.
The provided text describes the "Fixion Interlocking Proximal Femoral Nailing System" (Fixion PF), a medical device designed for fracture fixation in the femur. The submission is a 510(k) summary, aiming to demonstrate substantial equivalence to existing predicate devices.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study Details |
|---|---|---|---|
| Material Compliance | Device manufactured from 316L Stainless Steel meets requirements of ASTM F138. | Device is made from 316L Stainless Steel. | Not explicitly stated if a specific test was performed, but compliance with ASTM F138 is claimed. |
| Mechanical Performance (4-point bending) | Testing performed according to ASTM F1264. | Device found to meet specifications. | Bench tests were performed. Specific performance values (e.g., bending strength, stiffness) are not provided. |
| Mechanical Performance (Hip Peg) | Testing performed according to ASTM F384-99. | Device found to meet specifications. | Bench tests were performed. Specific performance values are not provided. |
| Intended Use Equivalence | Fixation of fractures in the femur. | Substantially equivalent to predicate devices (Fixion™ Interlocking Nail and Synthes Proximal Femoral Nail). | Evaluated based on intended use and indications being the same. |
| Design/Material Equivalence | Made of 316L Stainless Steel, cannulated design. Circular cross-section with reinforcement bars. Fixation achieved by inflation. | Identical to cleared Fixion Interlocking nail components, specifically 316L Stainless Steel and cannulated/circular design. | Comparison to predicate devices. |
| Inflation Mechanism Equivalence | Inflation with sterile saline, a non-compressible biocompatible fluid. | Identical to the cleared Fixion Interlocking nail. No new safety and efficacy issues raised. | Comparison to predicate device. |
| Fixation Equivalence with Peg/Pin | Addition of Femoral Neck Peg and Hip Pin provides equivalent fixation to the end of the nail. | Substantially equivalent to that of the Synthes Proximal Femoral Nail. | Bench tests implicitly support this equivalence regarding performance. |
2. Sample Size Used for the Test Set and Data Provenance
- The document primarily describes bench testing for mechanical properties.
- Sample Size for Test Set: Not specified in the provided text for any of the mechanical tests (ASTM F138, F1264, F384-99). The number of test articles used for these bench tests is not mentioned.
- Data Provenance: The studies were bench tests conducted by the manufacturer (Disc-O-Tech Medical Technologies Ltd.). There is no mention of human subject data, countries of origin, or whether studies were retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- For the mechanical bench tests, the "ground truth" is defined by the standards themselves (ASTM F138, F1264, F384-99). These standards define the test methods and performance considerations.
- There's no indication of external "experts" being involved in establishing the ground truth for these physical tests beyond the expertise inherent in conducting tests according to established ASTM standards. This is not a clinical study where expert review of patient data would be required.
4. Adjudication Method for the Test Set
- Not applicable. This is a submission for a physical medical device, not a diagnostic algorithm requiring human adjudication of results. Bench tests follow defined protocols.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is an orthopedic 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. This device is an orthopedic implant, not an algorithm.
7. The Type of Ground Truth Used
- For mechanical performance: The ground truth is established by ASTM (American Society for Testing and Materials) standards for material properties and mechanical performance of intramedullary fixation devices (ASTM F138, F1264, F384-99).
- For substantial equivalence in intended use and design: The ground truth is established by comparison to legally marketed predicate devices based on their cleared indications for use, materials, and design principles.
8. The Sample Size for the Training Set
- Not applicable. This is a physical device submission demonstrating substantial equivalence through bench testing, not a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set 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.