(90 days)
Dark Star Navigated Instrument System is intended to be used during the preparation and placement of Dark Star 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 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
The Republic Spine, LLC Dark Star Navigation Instrument System consists of reusable surgical instruments intended for use with the Medtronic® StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures in open procedures for preparation and placement of pedicle screw system implants.
The Dark Star Navigation Instrument System includes taps, awls, probes, and drivers. The Dark Star Navigation Instrument System is to be used with the Dark Star Spinal System.
The instruments are made from stainless steel. The Dark Star Navigation Instrument System is not compatible with implants from other manufacturers and is designed for use only with Medtronic StealthStation Navigation System hardware and software.
The provided text describes the "Dark Star Navigation Instrument System," a medical device intended to assist surgeons in spinal surgery by precisely locating anatomical structures. The 510(k) submission primarily focuses on establishing substantial equivalence to a predicate device (Medtronic Navigated Reusable Manual Instruments).
However, the provided document does not contain any information about an AI/Algorithm component or any studies that would involve AI performance metrics, such as accuracy (sensitivity, specificity, AUC), or a multi-reader multi-case (MRMC) study. The performance data section explicitly states that the device was tested per "ASTM F2554-18, 'Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems.'" This standard focuses on the positional accuracy of computer-assisted surgical systems, which relates to the hardware and software's ability to accurately track and display instrument positions, not the performance of an AI algorithm in interpreting medical images or providing diagnostic assistance.
Therefore, many of the requested fields regarding acceptance criteria, study design for AI evaluation, ground truth, and expert adjudication cannot be extracted from this document as they are not relevant to the type of device and testing described.
Based on the provided text, here is what can be inferred:
1. A table of acceptance criteria and the reported device performance
The document states: "The Dark Star Navigation Instrument System has been tested per ASTM F2554-18, 'Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems.' The results of this non-clinical testing show that performance of the Dark Star Navigation Instrument System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."
The specific numeric acceptance criteria for positional accuracy and the reported performance values from the ASTM F2554-18 testing are not detailed in this document. The document only states that the performance was "sufficient for its intended use."
| Acceptance Criteria (from ASTM F2554-18) | Reported Device Performance |
|---|---|
| Not specified in this document | "Sufficient for its intended use"; Specific numeric results not provided |
Regarding AI/Algorithm-specific criteria, there are none mentioned.
2. Sample size used for the test set and the data provenance
As the performance testing was for the "positional accuracy of computer assisted surgical systems" (hardware/software integration), rather than an image-based AI algorithm, the concept of a "test set" for data provenance (e.g., country of origin, retrospective/prospective) is not applicable in the typical sense for AI studies. The testing would have involved physical measurements and evaluations of the system's accuracy. The sample size for such non-clinical testing (e.g., number of measurements taken, number of test subjects/simulations) is not specified in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the evaluation is not for an AI algorithm's diagnostic or interpretive performance on medical images. The ground truth for positional accuracy would be established by the physical testing methodology described in ASTM F2554-18.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the type of testing described (positional accuracy).
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
There is no indication that an MRMC study was performed or that an AI component for human reader assistance exists in this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
There is no indication of an AI algorithm in the device that would require standalone performance testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the device's performance is based on measurements against the "Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems" (ASTM F2554-18). It is a technical measurement ground truth, not a clinical or pathological one.
8. The sample size for the training set
There is no mention of a training set, as the document does not describe an AI/machine learning component.
9. How the ground truth for the training set was established
There is no mention of a training set or ground truth establishment relevant to AI.
§ 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).