(29 days)
The EB1® Trochanteric Nail is indicated for the treatment of fractures of the femur including: non-comminuted and comminuted midshaft fracture, subtrochanteric fracture, distal third fracture, combination fractures of the shaft and neck, intertrochanteric fracture, combination intertrochanteric and subtrochanteric fractures. The EBI Trochanteric Nail is also indicated for osteotomies, reconstructive procedures following tumor resection, revision procedures where other treatment or devices have failed, and arthrodesis.
The EB10 Trochanteric Nail System is an interlocking intramedullary rod used in the fixation of fractures of the femur. The system consists of five basic components; trochanteric nails, lag screws, cortical screws, end caps, and set screws.
The provided 510(k) summary for the EBI® Trochanteric Nail System (K050118) details a submission based on substantial equivalence to a predicate device, not a de novo clinical study with specific acceptance criteria for performance metrics like sensitivity or specificity. Therefore, many of the requested categories are not applicable to this type of submission.
Here's a breakdown of the information that can be extracted from the provided text, and where the information is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical strength equivalent to predicate | "mechanically as strong as the predicate device." |
| Substantially equivalent in: | "substantially equivalent* to the predicate device in regards to indications for use, location, design characteristics, material, mechanical strength, and sterility." |
| Safety and Effectiveness | "is as safe and effective and performs as well as the predicate device" |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The submission is based on mechanical testing and comparison to a predicate device, not a human-data-based test set for device performance as would be seen in an AI/software device. There is no mention of a "test set" in the context of patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. As noted above, there is no human-data-based "test set" and thus no ground truth established by experts in this submission.
4. Adjudication Method for the Test Set
Not applicable. There is no human-data-based "test set" requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic or AI-powered devices to assess the impact on human reader performance, which doesn't apply to an intramedullary nail system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (intramedullary nail system), not an algorithm or software device.
7. The Type of Ground Truth Used
The ground truth for this device's performance is established through mechanical testing standards and comparison to a legally marketed predicate device. The key "ground truth" is that its mechanical properties and functional characteristics are equivalent to the predicate device, which has already established its safety and effectiveness in the market.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm or software that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, there is no training set for this type of device.
Summary of the Study Proving Acceptance Criteria:
The study proving the EBI® Trochanteric Nail System meets its acceptance criteria is a non-clinical mechanical testing study (bench testing) paired with a comparative analysis of technological characteristics against a predicate device.
- Study Design: The non-clinical testing involved mechanical load testing of the EBI® Trochanteric Nail System. This was supplemented by a detailed comparison of its design, materials, indications for use, and manufacturing processes with those of the Biomet Holland Femoral Nail System (K983641), which served as the predicate device.
- Proof of Acceptance: The results of the mechanical tests demonstrated that the EBI® Trochanteric Nail System exhibits equivalent mechanical strength to the predicate device. Furthermore, the submission argues for substantial equivalence across various technological characteristics (indications for use, location, design, material, mechanical strength, and sterility). This combined evidence led to the conclusion that the device is "as safe and effective and performs as well as the predicate device."
- Conclusion by FDA: The FDA's 510(k) clearance letter (K050118) confirms that they found the device "substantially equivalent" to legally marketed predicate devices, thereby allowing it to proceed to market. This determination is based on the provided non-clinical testing and comparative analysis.
§ 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.