(114 days)
Camber Spine Navigation System instruments are intended to be used in the preparation and placement of ORTHROS Posterior Stabilization System and ORTHROS MIS Posterior Stabilization System screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy.
Camber Spine Navigation System contains reusable instruments, provided non-sterile, including inserters, taps, probes, awls, and awl taps. These instruments are intended to be used with the Medtronic StealthStation® Navigation System and its associated NavLock arrays, to assist surgeons in precisely locating anatomical structures for preparation and placement of ORTHROS Posterior Stabilization System and ORTHROS MIS Posterior Stabilization System screws during spinal surgery. The instrumentation is designed for use with the Medtronic StealthStation® Navigation System hardware and software. These instruments are made of medical grade stainless steel according to the ASTM F899 and many include a titanium nitride coating per SAE AMS 2444A.
This document does not contain information about acceptance criteria and a study proving the device meets the acceptance criteria. It is a 510(k) summary and FDA clearance letter for the Camber Spine Navigation System.
The document primarily focuses on:
- FDA Clearance: Announcing the 510(k) clearance for the Camber Spine Navigation System.
- Device Description: Describing the components and intended use of the Camber Spine Navigation System.
- Indications for Use: Specifying the medical conditions and procedures for which the device is intended.
- Substantial Equivalence: Explaining how the device is similar to legally marketed predicate devices.
- Performance Testing (General Statement): Briefly mentioning that performance testing was conducted to verify functionality, accuracy, and compatibility, and to demonstrate substantial equivalence, but does not provide details of the acceptance criteria, the specific study design, or the results of this testing.
Therefore, I cannot extract the requested information regarding:
- A table of acceptance criteria and reported device performance.
- Sample size and data provenance for the test set.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study or effect size.
- Standalone performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document indicates that performance testing was done ("Performance testing demonstrates that the Camber Spine Navigation System instruments are substantially equivalent to the predicate devices."), but it does not provide the details of this testing that would allow me to answer your specific questions about acceptance criteria, study methodology, or results.
§ 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).