Search Results

The Gianturco-Roehm Bird's Nest® Vena Cava Filter is intended for the prevention of recurrent pulmonary embolism via placement in the vena cava in the following situations:

1. Pulmonary thromboembolism when anticoagulants are contraindicated;
2. Failure of anticoagulant therapy in thromboembolic diseases;
3. Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced:
4. Prophylactically in patients with chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.

The Gianturco-Roehm Bird's Nest® Vena Cava Filter is a permanent cardiovascular intravascular filter intended for percutaneous insertion into the inferior vena cava and positioning below the renal veins and above the iliac veins. The Gianturco-Roehm Bird's Nest® Vena Cava Filter utilizes a fine-wire stainless steel multiplane filtering system. The Gianturco-Roehm Bird's Nest® Vena Cava Filter is placed via standard percutaneous entry (Seldinger) technique with fluoroscopic control.

Access sites for filter delivery include both left and right femoral veins, and left and right internal jugular veins. The 11.0 French delivery catheters are available in a 40 and 45 centimeter length for femoral vein approach and a 75 centimeter length for jugular vein approach.

The Gianturco-Roehm Bird's Nest® Vena Cava Filter is designed for use in venae cavae measuring up to 40 millimeters in diameter. Caval measurements should be performed prior to filter insertion, and care should be taken to ensure proper strut fixation.

I apologize, but the provided text from the FDA 510(k) submission for the Gianturco-Roehm Bird's Nest Vena Cava Filter does not contain details about acceptance criteria or a study that proves the device meets those criteria, as typically described for a new AI/ML-based medical device.

The document is a traditional 510(k) clearance for a physical medical device (vena cava filter) and primarily focuses on demonstrating substantial equivalence to a predicate device. The "Test Data" section only mentions "MRI Testing" to verify MR Conditional marking and that "testing results provide reasonable assurance to support a determination that the device is substantially equivalent to the predicate devices."

Therefore, I cannot extract the specific information requested in your prompt regarding acceptance criteria, study design (sample size, data provenance, expert ground truth, adjudication, MRMC study, standalone performance), or training set details, as these are not present in the provided text.

To answer your request, I would need a document describing the validation study of an AI/ML-based medical device, which typically includes such details.

Ask a specific question about this device