(90 days)
The MAYFIELD®/ ACCISS™ Image-guided Stereotactic Workstation and the MAYFIELD®/Optical ACCISS™ Image-guided Stereotactic Workstation (OASYS"), are indicated for use in guidance and localization in open craniotomies and in spinal surgeries. The ACCISS™ Systems are indicated for any medical condition in which the use of stereotactic surgery may be considered safe and effective, and where a reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model of the anatomy.
Spine Applications is software that allows the user to select ("crop") images of the portion of the spine under consideration from images of the entire spinal column. Also included is an accessory, the MAYFIELD® ACCISS" Spine Ring" Assembly (hereafter referred to as Spine Ring). The indications for use of the Arm and Optical Systems have been expanded to include use in spinal surgeries.
With Spine Applications, the Arm and Optical Systems can be used to identify spinal anatomical landmarks on the preoperative patient scans and also on the patient's spine to achieve registration with the imaged data set. After the correlation, the indication of the probe orientation appears on the monitor screen and moves through the CT or MRI data in correct relation to the probe as manipulated by the surgeon. This is the same process as that used in cranial surgery with the Systems.
Spine Applications, in conjunction with the Arm and Optical Systems, is a computer-based system designed for use in the surgical theatre. The Arm System uses a position-sensing articulated Arm with a probe that acts as a localizing device. The Optical System uses a Sensor Assembly positioned above/beside the surgical site that tracks the position and orientation of digitizing probes and other instruments.
To use either System, the computer is loaded with the patient's computed tomography (CT) or magnetic resonance image (MRI) data and these images are correlated to the patient by physically matching points of anatomical landmarks. The System computer interfaces with CT or MR images and provides probe orientation/ probe-tip position. The indication of the probe orientation and probe-tip position appears on the monitor screen and moves through the CT or MRI data in correct relation to the probe as manipulated by the surgeon.
Here's an analysis of the provided text to extract the requested information regarding acceptance criteria and the study proving device performance:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on establishing substantial equivalence to predicate devices for a software module (Spine Applications) and an accessory (Spine Ring) that expand the indications for use of existing image-guided stereotactic workstations to include spinal surgery. It does not define explicit, quantitative acceptance criteria or report specific performance metrics for the device against such criteria.
Instead, the performance section states:
- "The Spine Applications performed to the surgeons' satisfaction with regard to preoperative planning and accuracy."
- "The clinical data for Spine Applications compared favorably with the data for cranial surgery performed using the Systems."
This indicates a qualitative assessment of surgeon satisfaction and a comparative assessment with existing cranial surgery data (which itself is not detailed here for performance metrics).
Therefore, a table of explicit acceptance criteria and corresponding numerical performance cannot be constructed from the provided text.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The text mentions "The Arm System and the Optical System, both with Spine Applications, were used by surgeons under authority of the Institutional Review Boards for the hospitals involved." This implies clinical use, but the number of cases or patients is not specified.
- Data Provenance: The study was conducted under the authority of Institutional Review Boards (IRBs) for "the hospitals involved," indicating a clinical setting. It is implied to be a prospective use study given it was done by surgeons with the new applications. The country of origin is not specified but is likely the USA given the FDA 510(k) context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: Not specified.
- Qualifications of Experts: The text states the systems "were used by surgeons," implying that these surgeons acted as the experts in evaluating the device's performance. Their specific qualifications (e.g., years of experience, subspecialty) are not detailed.
4. Adjudication Method for the Test Set:
- The text does not describe any formal adjudication method (e.g., 2+1, 3+1). The evaluation appears to be based on the "satisfaction" of the surgeons using the device.
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:
- No MRMC comparative effectiveness study is described where human readers' performance with and without AI assistance is compared, nor is an "effect size" mentioned. The study focused on surgeon satisfaction and comparison to cranial surgery data rather than measuring improvement of human readers with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- This device is an image-guided surgery system where a human surgeon is inherently "in-the-loop." The software (Spine Applications) provides guidance to the surgeon. Therefore, a standalone (algorithm-only) performance study, in the typical sense of evaluating diagnostic AI, would not be applicable or described for this type of device. The evaluation is on the system's utility and accuracy when used by a surgeon.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):
- The "ground truth" implicitly used for evaluation was the surgeons' assessment of the "satisfaction with regard to preoperative planning and accuracy" during actual surgical procedures. This can be interpreted as a form of expert assessment/clinical utility in a real-world surgical context, rather than a quantifiable, independent ground truth like pathology or long-term outcomes data.
8. The Sample Size for the Training Set:
- The document does not describe the development or training of new algorithms (AI in the modern sense) with a training set. Instead, it states that "Spine Applications provides the surgeon with image-guided technology, using the identical algorithms currently used for cranial image-guidance." This implies that existing, validated algorithms (presumably for cranial surgery) are being reused or adapted for spinal applications. Therefore, no separate "training set" for new spine-specific algorithms is mentioned.
9. How the Ground Truth for the Training Set Was Established:
- As no new training set or algorithms are described for Spine Applications, the establishment of ground truth for a training set is not applicable or detailed in this document. The existing algorithms from the predicate cranial devices would have had their own validation and associated ground truth established during their original development, which is outside the scope of this 510(k) summary.
§ 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).