(242 days)
The ORTHOFIX CHIMAERA Hip Fracture System – trochanteric nailing system is intended for insertion into the medullary canal of a femur for the alignment, stabilization of various types of fractures or deformities.
The ORTHOFIX CHIMAERA Hip Fracture System - trochanteric nailing system is indicated for treatment of stable and unstable pertrochanteric, intertrochanteric fractures of the femur alone or when these fractures occur in combination with shaft fractures extending distally to a point approximal to the intercondylar notch. These includes traumatic fractures, re-fractures, non-union, reconstruction, malalignment, pathological fractures and impending pathological fractures.
The ORTHOFIX CHIMAERA Hip Fracture System – Trochanteric Nailing System consists of implantable components (nails, end caps and screws) and instrumentation.
The proximal part of the nail features a threaded bore to connect the nail to the targeting handle by means of a cannulated bolt. The insertion of the nail into the femur medullary canal is typically performed by some instruments, including: guide wire, awl, reamer and impactor elements.
This document is a 510(k) summary for the Orthofix CHIMAERA Hip Fracture System - Trochanteric Nailing System. It describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
For the Orthofix CHIMAERA Hip Fracture System, the acceptance criteria are based on mechanical performance and biocompatibility. The reported device performance indicates that the device met these criteria.
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Withstand expected loads without failure. | All testing met or exceeded the requirements as established by the test protocols and applicable standards. The components of the Subject device are capable of withstanding expected loads without failure. The mechanical properties of the subject device are equivalent or better than the predicate devices. |
| Biocompatibility | Non-pyrogenicity (absence of bacterial endotoxins). | Additional tests were performed to establish non-pyrogenicity, which likely met the standards as the conclusion states substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly mention "test set" in the context of clinical trials with human subjects. Instead, it refers to mechanical testing and biocompatibility testing.
- Mechanical Testing: The sample sizes for the mechanical tests (e.g., endurance properties, fracture fixation device testing, intramedullary fixation device testing) are not explicitly stated in the provided text. These tests are performed on device components, not human subjects, so the concept of "data provenance" (country of origin, retrospective/prospective) as it applies to clinical data is not applicable. The tests are conducted in a controlled laboratory environment.
- Biocompatibility Testing: Similar to mechanical testing, specific sample sizes for tests like "Bacterial endotoxin test (LAL)" are not provided. These tests are also laboratory-based.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this 510(k) submission. This submission focuses on demonstrating substantial equivalence through mechanical and biocompatibility testing, not on clinical performance or diagnostic accuracy that would require expert-established ground truth. There is no mention of a "test set" in the context of expert review for establishing ground truth.
4. Adjudication Method for the Test Set
This information is not applicable. As stated above, this submission relies on laboratory-based tests (mechanical and biocompatibility) rather than a clinical "test set" that would involve expert 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. The document explicitly states: "Clinical data was not needed to support the safety and effectiveness of the Subject Device."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The device is a hip fracture system (implants and instrumentation), not an AI algorithm or a diagnostic tool. Therefore, the concept of "standalone algorithm performance" is irrelevant.
7. Type of Ground Truth Used
For the mechanical and biocompatibility testing, the "ground truth" is established by the standards and protocols against which the device is tested.
- Mechanical Performance: The "ground truth" is defined by the requirements outlined in standards such as ISO 7206-4, ISO 12107, ASTM F384-12, and ASTM F1264-14. The device is expected to meet or exceed these established performance benchmarks.
- Biocompatibility: The "ground truth" for non-pyrogenicity is defined by the criteria within standards like USP 38: 2014 , USP 38: 2014 , and ANSI/AAMI ST72: 2011.
8. Sample Size for the Training Set
This information is not applicable. The device is a mechanical implant system, not a machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As the device is not a machine learning model, there is no "training set" or corresponding ground truth to be established in that context.
§ 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.