(23 days)
FluoroLab Plus will be used for navigational guidance to position instruments during surgical procedures. It will provide a method of navigational guidance of tools through the use of a standard C-arm fluoroscope to capture images and an optical camera for instrument tracking. This increase in control will free the surgeon from the iterative process conventionally used, reduce the length of the surgical procedure, and enable minimally invasive procedure. In addition, since only two fluoroscopic images are needed, the exposure to X-rays is greatly reduced.
FluoroLab Plus will be used to assist in the alignment of surgical instruments by providing the surgeon with intraoperative navigational guidance based on pre-acquired fluoroscopic images. Surgeon will use coordinated-fluoroscopy to allow intra-operative planning of the alignment of surgical tools such as a screw, nail, or needle.
FluoroLab Plus is an integrated system that helps a surgeon more accurately position drill guides, screw drivers, needles, and other surgical instruments using at least two captured fluoroscopic images. The acquired images are displayed on a flat panel monitor. Surgical tools and accessories are instrumented with LEDs or small reflective markers. Their positions and orientations are continuously tracked by an optical camera and updated in reference to the fluoroscopic images to provide constant navigational guidance to the target.
FluoroLab Plus will consist of following basic components:
- Registration phantom
- Calibration grid
- Fluoroscopic image intensifier system (C-arm)
- Computer workstation with monitor and video acquisition box
- Ergonomic cart
- FluoroLab Plus software application
- Optical camera with Tool Interface Unit (TIU)
- Tools and accessories surgical tools and accessories instrumented with LEDs or reflective markers
The provided 510(k) summary for the FluoroLab Plus device does not include explicit acceptance criteria, a detailed study report proving the device meets acceptance criteria, or information on human reader performance with or without AI assistance. The document is primarily a premarket notification for substantial equivalence.
However, based on the information provided, we can infer some details related to the device's characteristics and the submission process.
Here's an analysis based on the given text, noting when information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state specific acceptance criteria (e.g., accuracy thresholds, precision targets, recall/precision metrics). Nor does it contain a table summarizing these criteria against reported performance data from a specific study. The submission focuses on substantial equivalence to predicate devices rather than presenting detailed performance validation against explicit criteria.
The "DESCRIPTION" and "SUMMARY OF TECHNOLOGICAL CHARACTERISTICS" sections describe what the device does and what it consists of, but not quantitative performance criteria it must meet. The "Intended Use" section outlines the functional benefits (e.g., "more accurately position drill guides," "reduce the length of the surgical procedure," "greatly reduced [exposure to X-rays]"), but these are not quantified as acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
The document does not mention a test set sample size or detail the provenance of any data used for testing. The submission is a 510(k) for substantial equivalence, which often relies on comparison to existing legally marketed devices rather than extensive new clinical trial data, especially for Class II devices like this stereotaxic instrument.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not describe any expert-established ground truth or the number and qualifications of experts involved, as it does not detail a specific performance study or test set validation.
4. Adjudication Method for the Test Set
Since no specific test set or expert ground truth establishment is described, there is no mention of an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
The device, FluoroLab Plus, is described as an "integrated system that helps a surgeon more accurately position drill guides, screw drivers, needles, and other surgical instruments." While it offers "navigational guidance," it is a tool for a surgeon, not an AI-powered diagnostic or assistive tool in the modern sense of "AI" (e.g., machine learning for image interpretation). Therefore, an MRMC study comparing human readers with and without "AI assistance" in the context of diagnostic interpretation is not applicable and not mentioned. The device augments a surgeon's ability to navigate tools, rather than enhancing human "reading" of images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is inherently designed for "human-in-the-loop" performance, as it provides "navigational guidance" to a surgeon. It's not a standalone diagnostic algorithm. Therefore, a standalone (algorithm-only) performance study is not discussed and not applicable in the context of this device's function.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The document does not specify any type of ground truth used for performance evaluation, as it does not detail a specific performance study. Given the device's function (navigational guidance for instrument placement), ground truth would likely relate to the accuracy of tool placement relative to a target, based on physical measurements or imaging verification rather than expert consensus on a diagnosis, pathology, or outcomes data. However, no such study is presented.
8. The Sample Size for the Training Set
The document does not mention a training set sample size. This type of stereotaxic instrument, predating widespread use of deep learning AI, would typically be developed through engineering and calibration, not through training on a large dataset in the way a modern AI algorithm would be.
9. How the Ground Truth for the Training Set Was Established
As no training set is described for an AI/ML context, there is no information on how ground truth for a training set was established. The "ground truth" for the device's functionality would be established through engineering specifications, calibration procedures, and accuracy testing in a controlled environment.
§ 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).