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510(k) Data Aggregation
(31 days)
AOS ES Retrograde Femoral Nail
The AOS ESTM Retrograde Femoral Nail is intended for use in intramedullary fixation of fractures of the femur to include the following: open and closed femoral fractures, pseudoarthrosis 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 fractures resulting from osteoporosis.
The AOS Extended Short™ (ES) Retrograde Femoral Nail is a single use, open reduction and internal fixation device, for the intramedullary fixation of fractures of the femur. The device is meant as a load sharing device, and it may be removed once the fracture has healed. The device consists of a nail, distal captured cortical and cancellous screws, proximal captured cortical screws, a locking spacer, fixation nuts and washers, and end caps.
This document describes the AOS ES™ Retrograde Femoral Nail, a device for intramedullary fixation of femoral fractures. The 510(k) summary provided here focuses on demonstrating substantial equivalence to a predicate device, rather than establishing de novo performance criteria against clinical outcomes. Therefore, the "acceptance criteria" discussed are primarily related to mechanical performance testing for substantial equivalence, not clinical accuracy or diagnostic performance.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly met by demonstrating "substantially equivalent performance" to the predicate device through functional testing and strength comparison analysis. Specific numerical acceptance criteria are not explicitly stated as this is a 510(k) submission for a Class II medical device, generally aiming for equivalence rather than new performance benchmarks.
| Acceptance Criteria Category | Specific Criteria (Implicit for Substantial Equivalence) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Equivalent functional and strength characteristics to the predicate device (AOS Retrograde Femoral Nail, K132005). | "The results demonstrate that the AOS ES™ Retrograde Femoral Nails and accessories are substantially equivalent to the predicates." |
| Intended Use | Identical intended use as the predicate device. | "The AOS ES™ Retrograde Nail and the AOS Retrograde Nail (K132005) have the same intended use..." |
| Patient Population | Identical patient population as the predicate device. | "...patient population..." |
| Operating Principle | Identical operating principle as the predicate device. | "...operating principle..." |
| Risk Profile | Identical risk profile as the predicate device. | "...and risk profile." |
| Manufacturing Processes | Identical manufacturing, packaging, sterilization, and shipping processes as the predicate device, under the same quality management system. | "They have identical manufacturing, packaging, sterilization parameters, and shipping processes, all of which will be conducted under the same quality management system." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document only mentions "functional testing and strength comparison analysis" without detailing the number of units tested.
- Data Provenance: This refers to pre-clinical (benchtop) testing, not clinical data, as it's a device for mechanical fixation. Therefore, there's no "country of origin of the data" in the clinical sense, and the testing is inherent to the device's design and manufacturing process. It's a prospective design verification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not a diagnostic device requiring expert interpretation of results to establish ground truth. Substantial equivalence was demonstrated through preclinical bench testing, where performance is measured against established engineering and mechanical standards.
4. Adjudication Method for the Test Set
Not applicable. Since the evaluation is based on mechanical performance testing against engineering standards or comparison to a predicate, there's no ambiguity requiring an adjudication method.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This device is a mechanical implant for fracture fixation, not a diagnostic or AI-assisted imaging device that would typically involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device (femoral nail), not an algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" for this type of device is established through:
- Engineering specifications and design requirements.
- Performance data from the predicate device to which substantial equivalence is being claimed.
- Established mechanical testing standards.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, for the same reason as point 8.
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