(90 days)
The Fixion™ Intramedullary Nailing System ("Fixion" Nail") is intended for use in the fixation of long bone fractures, including diaphyseal fractures in the humerus, femur and the tibia. It is indicated for use in shaft fractures 5cm below the surgical neck to 5cm proximal to the distal end of the medullary canal.
The Fixion™ Intramedullary Nailing System is a single use system that features 3 main components: Nail implant, Driver, and Inflation device.
- The Nail implant is an expandable non-slotted stainless steel cylindrical tube, with a conical shaped distal end and a cap protected, female threaded proximal end.
- The Driver is a stainless steel cylinder with plastic handle. used for the nail insertion, location and adjustment at the intramedullary canal. In addition, it serves as a delivery system for the inflation liquid.
The Driver has a male threaded end to be connected to the Nail implant proximal end. A quick connector is located on the Driver to be connected to the Inflation device. - The Inflation device is a single use manual plastic "pump", filled with sterile inflation liquid, similar to a PTCA inflation pump but with higher pressure. The inflation device outlet pipe end has a female quick connector to be connected to the Driver connector.
Once the nail is positioned within the medullary canal, rotation of the "pump" handle allows for nail diameter increase to its intended diameter under X-ray and controlled pressure.
The provided text describes the "Fixion Intramedullary Nailing System," a medical device for fixing long bone fractures. However, it does not include information about acceptance criteria or a study that specifically proves the device meets those criteria in the way envisioned by the prompt (e.g., performance metrics like sensitivity, specificity, or reader improvement with AI).
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a clinical study with performance metrics.
Here's an analysis of why the requested information cannot be fully extracted and what is available:
The document provides details typical for a 510(k) submission, including:
- Intended Use: Fixation of long bone fractures (humerus, femur, tibia).
- Predicate Devices: Several existing intramedullary nails.
- Performance Standards (for materials and mechanical testing): ASTM F138 (stainless steel), ASTM F1264 (4-point bending), ASTM F383 (torsional testing). These are material and mechanical integrity standards, not clinical performance acceptance criteria.
- Substantial Equivalence: Claims equivalence in intended use, indications for use, materials (Stainless Steel 316L canulated design), and fixation mechanism (expansion of nail vs. distal locking mechanisms of predicates).
- Testing mentioned: "The performance characteristics of the Fixion Nail have been tested and approved through a series of in-vitro and animal studies." However, no specific details on these studies, their methodology, acceptance criteria, or results are provided in this summary.
Therefore, I cannot populate the requested table and answer many of the questions as the document does not contain acceptance criteria related to a device's clinical performance (e.g., diagnostic accuracy, effectiveness in human-AI collaboration) or a study proving it meets such criteria.
The prompt seems to be expecting information typically found in submissions for AI/ML-driven diagnostic devices, which require studies to demonstrate performance against clinical endpoints or expert ground truth. This document is for a mechanical orthopedic implant.
If I were to interpret "acceptance criteria" very broadly as "meeting the requirements for market clearance," then the evidence is the FDA's 510(k) clearance itself, based on substantial equivalence. However, this doesn't align with the detailed performance metrics and study design questions in your request.
Based on the provided text, I can state the following:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: The document mentions adherence to ASTM F138, ASTM F1264, and ASTM F383 for material and mechanical properties. The ultimate "acceptance" criteria for market clearance under 510(k) is demonstrating substantial equivalence to predicate devices in terms of intended use, technology, and safety/effectiveness. No specific performance metrics (e.g., fracture healing rates, reduction in non-union) or acceptance thresholds for such metrics are provided.
- Reported Device Performance: The document states, "The performance characteristics of the Fixion Nail have been tested and approved through a series of in-vitro and animal studies." It also claims mechanical equivalence to predicate devices ("equivalent in mechanical properties," "equivalent fixation"). Specific numerical performance data or results from these studies are not provided in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable / Not provided. The document refers to "in-vitro and animal studies" but gives no details on sample sizes, study design (retrospective/prospective), or data provenance. There's no mention of a "test set" in the context of clinical data or AI model evaluation.
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 / Not provided. This information is relevant for studies involving human interpretation or AI model validation against expert ground truth, which is not described here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided.
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 / Not provided. 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 / Not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable / Not provided. For the in-vitro and animal studies mentioned, "ground truth" would likely refer to engineering measurements (e.g., stress/strain, torsion resistance) and animal outcomes (e.g., bone healing, implant stability), but no specifics are given.
8. The sample size for the training set:
- Not applicable / Not provided. This concept (training set) is relevant for AI/ML models, not for an orthopedic implant described in this manner.
9. How the ground truth for the training set was established:
- Not applicable / Not provided.
In summary, the provided document is a regulatory submission for a medical device (an intramedullary nailing system) focusing on demonstrating substantial equivalence to predicate devices, rather than a clinical study report with detailed performance metrics and acceptance criteria for a diagnostic or AI-driven aid.
§ 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.