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The device is intended to be used in the management of segmental diaphyseal bone loss of either humerus or tibia or femur in oncology patients secondary to radical bone loss and/or resection due to tumors. The intramedullary rods can be fixed with interlocking screws without or with bone cement.

OsteoBridge® IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System is a series of modular intramedulary rods segments that may be used as either proximal or distal segments. The segments are designed to be attached together to form a complete intramedullary rod using semiciteular hollow attachment shells that are clamped together with multiple screws to create a complete intramedullary rod and bridge the bonaliped with middle section of either humerus, tibia or femur. Reducing bushings allow the use of different diameter nails proximally and distally to provide optimal fit of the intract and with the medillary canal of the proximally and and distal segments of the bone to be fixed. All components of the OsteoBridge® Humeral IDSF -Intramedullary Segment Fixation Rod System are manufactured from Ti-6Al-4V Titanium Alloy conforming to ASTM F-136. The device is divided into three categories/product size ranges that are suitable for each boney application; humerus, tibia or femur (see tables below).

The provided text describes a medical device, the OsteoBridge® IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System, and does not contain information about an AI/ML powered device. Therefore, it is impossible to extract the requested information regarding acceptance criteria and studies that prove an AI device meets these criteria.

The document details the device description, intended use, mechanical testing methods, and standards followed for this intramedullary fixation rod system. It is a traditional medical device submission, not an AI/ML submission.

Therefore, I cannot provide the requested information for the following reasons:

• No AI/ML device: The document pertains to a physical medical device (intramedullary rods) and does not mention any artificial intelligence or machine learning components.
• No acceptance criteria for AI performance: Since there's no AI component, there are no acceptance criteria related to AI performance metrics (e.g., sensitivity, specificity, AUC).
• No study proving AI performance: The mechanical testing described is for the physical device's structural integrity, not for algorithm performance.

Please provide a document related to an AI/ML medical device if you wish for me to extract information on its acceptance criteria and a study proving it meets those criteria.

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The Segmental Defect Replacement System, when used with bone cement, is intended for reconstruction of the humeral diaphysis with an extensive bone lesion due to metastatic disease, myeloma, or lymphoma, that places the humerus at risk for pathologic fracture.

The Clinical Indication for Use is:

"The Segmental Defect Replacement System, when used with bone cement, is indicated for pathologic fractures or impending pathologic fractures of the diaphysis of the humerus secondary to metastatic bone disease and hematologic malignancies."

The Segmental Defect Replacement System is an array of proximal and distal intramedullary rods which, when locked together, replace the resected diseased segment and fixation in the remaining humeral bone The system includes a locking device to secure the rod components, and instrumentation to facilitate stock. insertion.

Modular bistemmed intramedullary rod system with rigid cam locking mechanism designed to provide intraoperative adjustment after cementing components into the proximal and distal segments of the resected humerus.

Materials: Ti-6Al-4V NiTi alloy (locking system)

The provided text describes a 510(k) summary for a "Segmental Defect Replacement System." This document is a premarket notification for a medical device aiming to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics.

Therefore, the specific information requested regarding acceptance criteria, a study proving device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance studies is not present in the provided text.

The document focuses on comparing the proposed device to existing predicate devices based on:

• Intended Use: Reconstruction of the humeral diaphysis with extensive bone lesions due to metastatic disease, myeloma, or lymphoma, placing the humerus at risk for pathologic fracture.
• Design: Modular bistemmed intramedullary rod system with a rigid cam locking mechanism for intraoperative adjustment after cementing components.
• Materials: Ti-6Al-4V, NiTi alloy (locking system).

The document states: "The Segmental Defect Replacement System has been evaluated by use of the static and fatigue tests. It has been shown to be substantially equivalent to the predicate devices." However, it does not provide details about the specific acceptance criteria for these tests, the performance metrics achieved, or the study design/results for demonstrating this substantial equivalence beyond this general statement.

In summary, the provided content is a regulatory submission for substantial equivalence, not a detailed report of a clinical or performance study with defined acceptance criteria and study results.

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