(117 days)
The CORUS™ Navigation System-GX 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 CORUS™ Navigation System-GX is specifically designed for use with the Globus Medical ExcelsiusGPS™ which 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 CORUS™ Navigation System-GX disposable instruments are used during the preparation and usage of CORUS™ Spinal System during spinal surgery to assist the surgeon in locating anatomical structures, such as the facet joint, in either open or minimally invasive procedures. The Navigation Access Chisel-G and Navigation Chisel Rasp-G are specifically designed for use with Globus Medical ExcelsiusGPS™ for navigation of the instruments to the facet joint. The instrument set provides access to the posterior spinal facet joint and decortication for bone preparation.
The provided FDA Clearance Letter and 510(k) Summary for the CORUS™ Navigation System-GX (K251060) do not contain detailed information about specific acceptance criteria, study methodologies (like sample sizes for test/training sets, data provenance, ground truth establishment, or expert involvement), or the results of a multi-reader multi-case (MRMC) comparative effectiveness study.
The document states that the device was evaluated through "an engineering analysis and geometric comparison to predicate devices to establish the safety and efficacy for accuracy performance." It also mentions "a functional assessment was conducted to evaluate compatibility and simulated use testing." However, it does not provide the quantitative acceptance criteria or the specific performance metrics achieved in these evaluations.
Therefore, based solely on the provided text, I cannot complete many sections of your request. I will indicate where the information is not present.
Here's a breakdown of the available information:
Acceptance Criteria and Device Performance
Due to the lack of quantitative performance data in the provided document, I cannot create a table of acceptance criteria and reported device performance. The document states:
- "The CORUS™ Navigation System-GX instruments have been evaluated through an engineering analysis and geometric comparison to predicate devices to establish the safety and efficacy for accuracy performance."
- "A functional assessment was conducted to evaluate compatibility and simulated use testing."
- "The results of these engineering analysis and evaluations show that the subject is substantially equivalent to the cleared predicate."
This language indicates that the device met the necessary performance for clearance by demonstrating substantial equivalence, but it does not disclose the specific numerical thresholds or achieved performance metrics.
Study Information Based on Provided Text:
1. A table of acceptance criteria and the reported device performance
Not Available in the Provided Text. The document generally states that "engineering analysis and evaluations show that the subject is substantially equivalent to the cleared predicate," implying that performance criteria were met, but does not list specific criteria or results.
2. Sample sizes used for the test set and the data provenance
Not Available in the Provided Text for "accuracy performance" or "functional assessment" studies. The document mentions "engineering analysis and geometric comparison" and "functional assessment" and "simulated use testing," but it does not specify sample sizes or data provenance (e.g., retrospective/prospective, country of origin).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable/Not Available. The device is a "Stereotaxic Instrument" intended to assist surgeons in locating anatomical structures. The described evaluations ("engineering analysis," "geometric comparison," "functional assessment," and "simulated use testing") suggest a focus on mechanical accuracy, compatibility, and functionality rather than diagnostic interpretation requiring human expert ground truth. Therefore, the concept of "experts establishing ground truth for a test set" in the context of image interpretation is not directly applicable here. The ground truth might be defined by engineering specifications or physical measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable/Not Available. Given the nature of the device and the described evaluations, an adjudication method for image interpretation or diagnosis is not relevant.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was performed. This device is a navigation system instrument, not an AI-assisted diagnostic tool that would typically undergo such a study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Partially Applicable / Inferred. The evaluations described ("engineering analysis and geometric comparison," "functional assessment," "simulated use testing") would inherently involve testing the device's performance in a standalone or controlled environment, ensuring its mechanical and functional specifications are met, independent of a specific surgical procedure on a live patient. The device "does not include its own navigation platform" but works with the Globus Medical ExcelsiusGPS™. The testing would focus on the navigation instruments' accuracy and compatibility with this platform.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Inferred to be Engineering/Physical Specifications. For a stereotaxic instrument, the ground truth for "accuracy performance" would typically be derived from engineering specifications, physical measurements using highly precise measurement tools, or established anatomical models/phantoms. It is not expert consensus on images, pathology, or outcomes data.
8. The sample size for the training set
Not Applicable / Not Available. The document describes "engineering analysis and geometric comparison" and "functional assessment," and "simulated use testing." This type of evaluation is typically for mechanical devices and does not describe a machine learning algorithm that would require a "training set" in the conventional sense.
9. How the ground truth for the training set was established
Not Applicable. See point 8.
§ 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).