(60 days)
The DuraPro™ Oscillating System is indicated for drilling, burring, removing, and otherwise manipulating hard and soft tissue, bone, and other bone related tissue during spinal and orthopedic procedures.
ExcelsiusGPS® is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody fusion devices.
ExcelsiusHub™ is intended for use as an aid for precisely locating anatomical structures to be used by surgeons for navigating compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody fusion devices.
DuraPro™ Oscillating System consists of electrical The drill handpieces/attachments powered by an oscillating motor with a foot switch, and may be navigated using ExcelsiusGPS® or ExcelsiusHub™. The navigated components are provided non-sterile and are reusable. Attachments are provided sterile and are single-use.
The provided text does not contain information about acceptance criteria and a study proving device performance in the context of an AI/ML medical device. The document is a 510(k) clearance letter for a device called "DuraPro™ Oscillating System," which is a surgical tool.
The document discusses:
- Device Name: DuraPro™ Oscillating System
- Regulation Number: 21 CFR 882.4560 (Stereotaxic Instrument)
- Indications for Use: Drilling, burring, manipulating hard and soft tissue, bone during spinal and orthopedic procedures. It also mentions its use with ExcelsiusGPS® and ExcelsiusHub™ for navigation and guiding surgical instruments for screw and interbody fusion device placement.
- Technological Characteristics: States it has similar characteristics to predicate instruments in design, intended use, material composition, function, and range of sizes.
- Performance Testing: "The navigation and guidance accuracy of the DuraPro™ Oscillating System was evaluated using intra-operative imaging and accuracy verification testing. Testing confirmed that accuracy values meet the product requirement specification."
- Electrical Safety/EMC: Confirmed to meet all standards.
However, none of this information outlines specific acceptance criteria for performance metrics usually associated with AI/ML devices (e.g., sensitivity, specificity, AUC), nor does it describe a study using human readers, ground truth establishment by experts, or training/test set details that would be relevant to an AI/ML performance evaluation. The "Performance Testing" section is very high-level and does not provide the granular details requested in your prompt regarding AI/ML device evaluation.
Therefore, I cannot provide the requested table and details because the source document does not pertain to the evaluation of an AI/ML medical device's performance in the way your prompt describes.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).