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510(k) Data Aggregation
(30 days)
ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System
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 and subtrochanteric 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, refractures, 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 describes the ORTHOFIX CHIMAERA Hip Fracture System – Trochanteric Nailing System, an intramedullary fixation rod. The information provided is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance data against specific acceptance criteria for a novel device.
Therefore, much of the requested information regarding acceptance criteria, specific study designs, sample sizes for test sets, and ground truth establishment for AI-based devices is not applicable to this submission, as it describes a traditional medical device (hardware) rather than a software or AI-driven diagnostic tool.
The "study" that proves the device meets acceptance criteria primarily refers to mechanical testing to demonstrate the structural integrity and performance of the hardware components.
Here's a breakdown of the available information in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | 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 standard." |
| "A review of the mechanical data indicates that the components of the Subject device continues to be capable of withstanding expected loads without failure." | |
| Compliance with ASTM F1264-16 Standard | "The following standard has been followed to perform mechanical test on the System configuration: ASTM F1264 -16 Standard Specifications and Test Methods for Intramedullary Fixation Devices." |
| Material Biocompatibility: | Implied similar to predicate (not explicitly detailed, but generally a requirement for implantable devices). |
| Sterility: | Implied similar to predicate (not explicitly detailed, but generally a requirement for implantable devices). |
| Intended Use: | "Has the mechanical properties to perform its indications safely." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: This is not applicable in the context of device hardware mechanical testing. The "test set" here refers to the number of physical device components or constructs subjected to mechanical evaluation. The document does not specify the exact number of implants tested, but rather refers to "components" and "System configuration" being tested according to a standard.
- Data Provenance: The testing is laboratory-based mechanical testing, not clinical data provenance. The device manufacturer is Orthofix Srl, based in Italy.
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):
- This is not applicable. For hardware mechanical testing, the "ground truth" is established by the specified mechanical properties and failure limits defined in the ASTM standard (ASTM F1264-16) and internal test protocols, not by expert human interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable. Mechanical testing results are typically objectively measured and compared against defined thresholds from standards or specifications, not subject to human adjudication in the way medical image interpretation is.
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:
- No, an MRMC comparative effectiveness study was NOT done. This type of study is relevant for AI-powered diagnostic devices or software that assist human readers. The ORTHOFIX CHIMAERA Hip Fracture System is a physical implant (hardware). 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:
- No, this is not applicable. The device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is based on mechanical engineering principles and established industry standards (specifically ASTM F1264-16). This standard defines the acceptable mechanical properties and failure modes for intramedullary fixation devices. The device's performance is compared against these objective, quantifiable criteria.
8. The sample size for the training set:
- This is not applicable. There is no "training set" as this is not an AI/machine learning device. The design and manufacturing processes are refined through engineering principles and testing, not machine learning.
9. How the ground truth for the training set was established:
- This is not applicable. As there is no training set for an AI model, there is no ground truth established in this context.
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(242 days)
ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System
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.
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