(58 days)
The CORUS™ Navigation Access System for use with the CORUS™ Spinal System is intended to be used during spinal surgery to assist the surgeon in locating and preparing facet joints in either open, or minimally invasive procedures. The CORUSTM Navigation Access System is specifically designed for use with the Medtronic StealthStation™ 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 long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.
The CORUS™ Navigation Access System is a manually operated disposable instrument set to be used with the Medtronic StealthStation™ System to assist the surgeon in precise site preparation during open or minimally invasive spinal surgery. The CORUS™ Navigation Access System includes the Navigated Access Chisel, Guide Tube, and Trephine Decorticator. The instruments are manufactured from stainless steel.
The provided text is a 510(k) summary for the CORUS™ Navigation Access System. It describes the device, its intended use, and its technological characteristics. However, it does not contain specific acceptance criteria, performance metrics, or detailed study results that would typically be presented in a clinical validation or performance study.
Instead, the performance data section states:
"The CORUS™ Navigation Access System has been evaluated though an engineering analysis and geometric comparison to the predicate device. A validation was also conducted to demonstrate navigation compatibility with the Medtronic StealthStation™ System. The results show that the subject device is substantially equivalent to the cleared predicates."
This indicates that the manufacturer performed:
- Engineering analysis: Likely involved design reviews, material compatibility, and structural integrity assessments.
- Geometric comparison: Compared the dimensions and design of the CORUS™ system to existing, cleared predicate devices.
- Navigation compatibility validation: This would have assessed if the CORUS™ Navigation Access System correctly interfaces and functions with the Medtronic StealthStation™ System as intended.
Therefore, based only on the provided text, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions 2 through 9, as this information is not present. The document focuses on demonstrating substantial equivalence through engineering analysis and compatibility rather than a clinical performance study with defined criteria and metrics.
If this were a typical clinical performance study, the requested information would be available. Since it is not, the response must reflect the absence of such data in the provided document.
Summary of missing information based on the provided text:
- 1. A table of acceptance criteria and the reported device performance: Not provided. The document states "evaluated though an engineering analysis and geometric comparison" and "A validation was also conducted to demonstrate navigation compatibility," but no specific criteria or results are listed.
- 2. Sample sized used for the test set and the data provenance: Not mentioned.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- 4. Adjudication method: Not mentioned.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not mentioned. No human reader interaction is implied or detailed.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a "manually operated disposable instrument set" that "assists the surgeon." It is not an "algorithm only" device. The validation focused on navigation compatibility.
- 7. The type of ground truth used: Not applicable in the context of the described engineering and compatibility validations.
- 8. The sample size for the training set: Not applicable; this is not an AI/ML device requiring a training set.
- 9. How the ground truth for the training set was established: Not applicable.
§ 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).