(185 days)
The AOS Antegrade Femoral Nail is intended for use in intramedullary fixation of fractures of the femur to include the following: Open and closed femoral fractures, Pseudoarthosis and correction osteotomy, Pathologic fractures, impending pathologic fractures, and tumor resections, Supracondylar fractures, including those with severe comminution and intra articular extension, ipsilateral femur fractures, bone lengthening, fractures proximal to a total knee arthroplasty or prosthesis, fractures distal to a hip joint, nonunions and maluions, fractures resulting from osteoprorosis.
The AOS Antegrade Femoral Nail System consists of Titanium Alloy Rods, Screws and End Caps for femur fracture fixation.
This report describes the acceptance criteria and the study conducted to prove that the device, the AOS Antegrade Femoral Nail System, meets these criteria.
Acceptance Criteria and Device Performance
The device is an intramedullary fixation rod for femoral fractures and is deemed substantially equivalent to a predicate device. The acceptance criteria for the AOS Antegrade Femoral Nail System are primarily based on comparative mechanical testing and material equivalence to its predicate device. This is a Class II medical device, and the evaluation focuses on establishing substantial equivalence rather than independent performance metrics defined by specific clinical endpoints in the way some software algorithms might.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Same indications for use as predicate. Similar shape and design as predicate. Same fundamental technology as predicate. Made of the same material as predicate. | The AOS Antegrade Femoral Nail System has the same indications for use, is similar in shape and design, has the same fundamental technology, and is made of the same material (Titanium Alloy) as the predicate device (AOS Modular Femoral System, K012190). |
| Mechanical Performance | Mechanical properties (e.g., strength, durability, fatigue resistance) are demonstrably equivalent or superior to the predicate device per relevant standards. | Subjected to comparative mechanical testing per a test based on ASTM F384. In Vitro testing of accessory screws and components was also performed. The results demonstrate that the AOS Antegrade Femoral Nails and accessories are substantially equivalent to the predicates. |
| Anatomical Compatibility | Demonstrated compatibility with relevant anatomical elements, particularly concerning surgical implantation and placement. | A cadaver study was done to assess various anatomical elements of the system. (Specific performance results from this study are not detailed in the provided text) |
Study Details
The study conducted to prove the device meets the acceptance criteria is a preclinical testing program primarily focused on demonstrating substantial equivalence to a legally marketed predicate device. This is typical for a 510(k) submission for this type of device.
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Sample size used for the test set and the data provenance:
- Mechanical Testing: The specific sample sizes for the comparative mechanical testing (per tests based on ASTM F384 and In Vitro testing of accessory screws) are not explicitly stated in the provided text.
- Cadaver Study: The number of cadavers used in the cadaver study is not explicitly stated.
- Data Provenance: The studies were conducted by Advanced Orthopaedic Solutions, Inc. and are prospective in nature, as they were performed specifically to support the 510(k) submission for this new device. The country of origin for the data is not explicitly stated but is implicitly the USA, where the company and regulatory body (FDA) are located.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For a traditional medical device like an intramedullary nail, the "ground truth" is established through engineering and biomechanical principles, standardized testing methods (e.g., ASTM F384), and anatomical studies. It is not typically established by human experts in the same way an AI algorithm's diagnostic performance might be.
- The "ground truth" for the mechanical testing would be the established performance characteristics of the predicate device and the specified requirements of the ASTM standard. This would be interpreted by engineers and biomechanical testing professionals.
- For the cadaver study, anatomical "ground truth" would be assessed by medical professionals, likely orthopedic surgeons or anatomists, but the number and qualifications are not specified.
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Adjudication method for the test set:
- Adjudication methods like 2+1 or 3+1 are typically used for clinical trials or diagnostic studies involving human interpretation of data. For preclinical mechanical testing, the "adjudication" is inherent in the objective, quantitative nature of the tests and the comparison against a predicate device or industry standard. There is no explicit mention of an adjudication method in the provided text.
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If a multi-reader, multi-case (MRMC) comparative effectiveness study was done:
- No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not performed for this device. This type of study is relevant for AI algorithms or diagnostic imaging systems where human readers' performance with and without AI assistance is being evaluated. The AOS Antegrade Femoral Nail System is a physical implant for fracture fixation, not a diagnostic or AI-driven system.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone (algorithm only) performance evaluation was not performed. This term is only applicable to AI/software as a medical device (SaMD), which this device is not.
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The type of ground truth used:
- The ground truth used for this device's evaluation is primarily engineering specifications, biomechanical performance data (from standardized tests), and anatomical compatibility assessments derived from a cadaver study.
- The ultimate ground truth for substantial equivalence is the legally marketed predicate device.
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The sample size for the training set:
- This device is not an AI/machine learning algorithm, so there is no concept of a "training set" in the context of its development and evaluation.
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How the ground truth for the training set was established:
- As there is no training set for this type of medical device, this question is not applicable.
§ 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.