(26 days)
The 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.
The High Speed Drill Instruments consist of an array, array sleeves, a drill guard, and drill bits. These instruments are provided non-sterile, except for the drill bits which are provided sterile or non-sterile. These instruments are intended to be used with ExcelsiusGPS® and are manufactured from stainless steel, per ASTM F899, and PEEK.
The provided text summarizes a 510(k) submission for the "ExcelsiusGPS High Speed Drill Instruments" for use with the ExcelsiusGPS system. However, the document does not contain explicit acceptance criteria and corresponding performance data as typically presented in a clinical study report. Instead, it states that "Verification and Validation testing and comparison to the predicate demonstrate that the ExcelsiusGPS® High Speed Drill Instruments can be used in accordance with its indications."
Therefore, based on the provided text, I cannot produce the requested table of acceptance criteria and reported device performance, nor can I answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details. The document focuses on regulatory clearance based on substantial equivalence to a predicate device, rather than detailed clinical performance metrics from a specific study.
Information that is available from the text:
- Device Name: ExcelsiusGPS® High Speed Drill Instruments
- Intended 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.
- Basis of Substantial Equivalence: Technological characteristics (design, intended use, material composition, function, and range of sizes) are the same as predicate instruments. Performance testing (Verification and Validation) was conducted to demonstrate the instruments can be used in accordance with their indications. Bacterial endotoxin testing (BET) was conducted, and biocompatibility was demonstrated by using standard materials or materials from 510(k) cleared devices.
- Regulatory Clearance Document: K190653
§ 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).