Search Results

The Baxano, Inc. MicroBlade, Shaver and Accessories are designed for accessing, cutting, and biting soft tissue and bone during surgery involving the spinal column.

The modified MicroBlade Shaver device is comprised of a proximal handle, rigid shaft, and flexible cutting platform used for cutting and biting soft tissue and bone. The modified Probe Accessory is comprised of a telescoping proximal handle, cannula, and deployable catheter used to access the decompression site and place the GuideWire. The Distal Handle Accessory is comprised of a handle to accommodate the GuideWire using a wire locking mechanism and wire capture receptacle and allows manual control of the MicroBlade Shaver and Neuro Check devices.

The provided document is a 510(k) premarket notification for a medical device, the MicroBlade Shaver Device and Accessories. It details the device's description, intended use, technological characteristics, and a claim of substantial equivalence to predicate devices based on non-clinical performance data.

However, the document does not contain information related to acceptance criteria, specific performance metrics, or a study design typical of AI/ML device evaluations. It describes bench performance, functional testing, and cadaveric analyses to verify that the device (a mechanical surgical tool) meets design specifications and performance characteristics.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets them in the context of AI/ML performance metrics. The information requested (sample size, data provenance, ground truth, expert qualifications, adjudication, MRMC, standalone performance, training set details) is not applicable to this type of device and the information provided in this 510(k) summary.

The 510(k) summary focuses on demonstrating that the modified device is substantially equivalent to previously cleared versions and does not raise new questions of safety or effectiveness, primarily through non-clinical bench and cadaveric testing.

Ask a specific question about this device