(86 days)
CarboClear® Navigated Instruments are intended to be used during the preparation and placement of CarboClear® Pedicle Screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. CarboClear® Navigated 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.
CarboClear® Navigated Instruments are reusable, manually operated, instruments, including probes, bone taps and a screwdriver. These instruments are intended to be used with the Medtronic StealthStation® Navigation System, to assist surgeons in precisely locating anatomical structures for preparation and placement of CarboClear Pedicle Screws during spinal surgery.
The provided text is a 510(k) summary for the CarboClear® Navigated Instruments. It details the device's intended use, technological characteristics, and comparison to predicate devices, but lacks the specific details about acceptance criteria, numerical performance data, and the study design required to fully answer your request.
Here's an analysis based on the available information:
1. Table of acceptance criteria and the reported device performance:
This information is not explicitly provided in the document. The text mentions "Performance testing demonstrates that the CarboClear® Navigated Instruments are substantially equivalent to the predicate devices" and "Design validation testing, including engineering analysis, compatibility testing and registration, was conducted to verify that the CarboClear® Navigation Instruments are appropriate for their intended use, to ensure functionality, accuracy and compatibility with the Medtronic StealthStation® System using the NavLock Tracker, and to demonstrate substantial equivalence to the predicate instruments."
However, specific metrics for accuracy, functionality, or any other performance aspect, along with their respective acceptance criteria, are not listed.
2. Sample size used for the test set and the data provenance:
This information is not provided in the document. The text mentions "Compatibility testing evaluated the physical compatibility and connection between the NavLock Tracker and CarboClear® Navigated Instruments. Registration testing was performed to ensure that the instruments can be registered to the StealthStation® System." These activities imply testing, but the number of samples or the origin of the data (e.g., country, retrospective/prospective) is not disclosed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. It's likely that "ground truth" in this context would relate to successful navigation, compatibility, and registration, which might involve technical personnel or surgeons, but their number and qualifications are not mentioned.
4. Adjudication method for the test set:
This information is not provided in the document.
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:
This type of study is not applicable to this device. The CarboClear® Navigated Instruments are physical surgical instruments used with a navigation system, not an AI or imaging diagnostic tool that would involve "human readers" or "AI assistance" in the sense of image interpretation. The device's function is to assist surgeons in locating anatomical structures during spinal surgery.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable to this device. The device is explicitly designed for human use ("manually operated instruments") and in conjunction with the Medtronic StealthStation® System. It is not an autonomous algorithm.
7. The type of ground truth used:
Based on the description of performance testing, the "ground truth" would likely be:
- Physical Compatibility/Functionality: Successful connection and operation with the NavLock Tracker and StealthStation® System.
- Dimensional Accuracy: Comparison of physical dimensions of subject instruments to predicate instruments (mentioned in "Engineering analysis included comparative dimensional measurements").
- Registration Success: The ability of the instruments to be accurately registered with the StealthStation® System.
No mention of pathology, outcomes data, or expert consensus (in the sense of clinical diagnosis) for establishing ground truth is made.
8. The sample size for the training set:
This information is not provided and is not applicable in the context of this device. The CarboClear® Navigated Instruments are physical, reusable surgical tools. They are not an AI/ML algorithm that requires a "training set" in the traditional sense for learning or model development. The performance studies described are for verification and validation of the device's design and functionality.
9. How the ground truth for the training set was established:
This information is not provided and is not applicable for the reasons stated above (no training set for this type of device).
§ 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).