(182 days)
- Long-term stabilization of major bone defects resulting from
o Radical bone loss due to tumors and/or metastases
o Bone resections following tumors and/or metastases - For use only in the diaphyseal region of humerus, tibia and femur
The OsteoBridge™ IDSF System is intended to be used in the management of segmental diaphyseal bone loss secondary to radical bone loss and/or resection due to tumors in either humerus, tibia or femur in oncology patients. The modular system includes a spacer made of two cylindrical half-shells that clamp over the ends of two intramedullary nails with eight screws. Spacers and intramedullary nails of different sizes can be selected to accommodate varying intramedullary canal diameters and different bone defect sizes. If the defect size is larger than 70 mm, two spacers may be connected with a spacer connector. The nails can be used non-cemented. All components of the OsteoBridge™ IDSF System are manufactured from Ti6Al4V ELI titanium alloy according to ASTM F 136.
The provided FDA 510(k) summary for the OsteoBridge™ IDSF System does not contain any information about an AI/ML-based device. Instead, it describes a traditional medical device (an intramedullary fixation system) and its mechanical testing to demonstrate substantial equivalence to a predicate device.
Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device, as the document does not pertain to such a device. The questions you've asked are relevant for AI/ML device submissions, which typically involve performance metrics like accuracy, sensitivity, specificity, and detailed study designs to prove clinical effectiveness and safety in a real-world setting, often including human reader studies.
The document focuses on:
- Mechanical Testing: Demonstrating the device's physical properties (e.g., fatigue limits, torsional strength) are equivalent to or better than the predicate device.
- Sterilization and Packaging Validation: Ensuring the product is delivered sterile and the packaging is robust.
- Comparison to Predicate Device: Highlighting changes in delivery form, trial components, and connector mechanisms, and demonstrating these changes do not adversely affect safety or effectiveness.
Key takeaway from the provided document:
- No AI/ML component: The device described is a physical implant, not a software algorithm.
- Reliance on Mechanical Testing: Substantial equivalence was demonstrated through extensive mechanical and functional worst-case tests, not clinical performance studies involving human or AI interpretation of medical images/data.
- No Clinical Study Needed: The document explicitly states, "Clinical Data was not needed for these devices to show substantial equivalence." This means there was no in vivo study with human subjects, let alone one involving AI assistance or standalone AI performance.
Due to the nature of the provided document, answering the detailed questions about acceptance criteria and study designs pertinent to an AI/ML device is not possible.
§ 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.