(20 days)
Each nail within the Orthofix Titanium Nailing System is intended for insertion into the medullary canal of a specific long bone - humerus, femur and tibia for the alignment, stabilization and fixation of various types of fractures or deformities caused by trauma or disease. These include: traumatic fractures, re-fractures, non-union, reconstruction, malunion, malalignment, pathological fractures and impending pathological fractures.
The Orthofix Titanium Nailing system consists of intramedullary nails, locking screws and additional implantable components made of a titanium alloy. The nails included in the system are designed to treat several types of fractures of the humerus, femur and tibia. Nails come in various shapes and diameters and can be cannulated, straight, curved or with a bend. All nails are locked with various types of locking screws, specifically designed for the type of nail and fracture treated. Nails might have several locking options (varying in number and direction of fixation points and type of screws to be inserted), thus allowing a customized fragment adapted approach. Accessories include end caps, nuts and washers. Instrumentation is available for the insertion and removal of nails, screws and end caps.
The provided text is a 510(k) Summary for the Orthofix Titanium Nailing System, which pertains to medical devices (intramedullary nails) used for fracture fixation. This type of regulatory submission does not involve performance studies with acceptance criteria, human readers, or ground truth establishment in the way AI/ML medical devices do. Instead, the entire submission is based on demonstrating substantial equivalence to legally marketed predicate devices.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not applicable to this 510(k) submission.
Here's why and what the document does provide:
1. Acceptance Criteria and Device Performance:
- Not Applicable: For this type of device (intramedullary nails), the "acceptance criteria" are not based on performance metrics like sensitivity, specificity, or AUC as they would be for an AI/ML device. Instead, acceptance is based on demonstrating substantial equivalence to a predicate device.
- Device Performance: The document states that the "size, shape and materials for the subject devices are comparable to the predicate devices." This is the core "performance" claim for substantial equivalence.
2. Sample Size for Test Set and Data Provenance:
- Not Applicable: No clinical or test set was used in the context of an AI/ML device assessment. The evaluation is based on comparing the design, materials, and intended use of the Orthofix system to existing, legally marketed intramedullary nails.
3. Number of Experts and Qualifications:
- Not Applicable: No experts were used to establish ground truth because there was no performance study requiring ground truth. The evaluation is a regulatory comparison.
4. Adjudication Method:
- Not Applicable: No adjudication method was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not Applicable: No MRMC study was conducted. This device is a physical implant, not an AI assistance tool for human readers.
6. Standalone Performance:
- Not Applicable: The concept of "standalone performance" (algorithm only) doesn't apply to a physical medical implant.
7. Type of Ground Truth Used:
- Not Applicable: No ground truth was established or used for performance evaluation. The "ground truth", in a broad sense, is the established safety and effectiveness of the predicate devices to which this device is claiming equivalence.
8. Sample Size for Training Set:
- Not Applicable: No training set was used. This is not an AI/ML device.
9. How Ground Truth for Training Set was Established:
- Not Applicable: No training set or associated ground truth.
Summary of 510(k) Conclusion from the provided text:
"Based upon the similarities in design, materials and intended uses of the Orthofix Titanium Nailing System is substantially equivalent to the predicate devices."
The FDA's letter further confirms this: "We have reviewed your Section 510(k) premarket notification of intent to market the device ... The Food and Drug Administration's finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market."
§ 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.