(88 days)
The Leksell Image Guidance Surgical System (LIGS) is intended for use in neurosurgical procedures to provide image guidance based on preoperative images which are visualized interactively with the aid of surgical tools.
The Leksell Image Guidance Surgical System (LIGS) device provides image guidance in surgical procedures. The LIGS System imports CT/MRI images and provides a visual display of the images for preplanning surgical paths which are used for guidance during the surgical procedures.
The LIGS System is a modular system which includes an interface with a measurement system used with a manual microscope (ViewScope) or with a motorized microscope tool support system (SurgiScope).
The main components of the LIGS System are:
- ScopePlan .
ScopePlan provides surgical preplanning based on Computer Tomography (CT), Magnetic Resonance Imaging (MRI) or other current 2D and 3D modalities, retrieval of preplanning studies and imaging during the surgical procedure, image correlation with a defined point and image retrieval subsequent to the surgical procedure.
The ScopePlan is to be used with specified commercially available surgical microscopes and accessories.
- Measurement System .
The measurement system is an infra-red detection system which is comprised of locators attached to the patient and tool, infra red detectors, a probe and a processing unit. The locators and the probe contain infra red emitting LED's. The system accurately locates and continually tracks the patient and the tool (typically a microscope).
Tool Support System
.
There are two types of tool support systems which are used with the LIGS System:
· Standard Floor Stand Microscope Support
- · SurgiScope Integrated Tool Support System
The SurgiScope Integrated Tool Support System is a motorized manually operated, computer-monitored device module which is mounted on the ceiling of the operating room. The device holds in place surgical tools, typically a surgical microscope, during operative procedures. The Surgeon, or other medical expert, activates electromechanical components to position and adjust the microscope during an operation. The user has complete control of the microscope tool during all phases of the procedure and must initiate activation and continuously activate by depressing a push button on the microscope handle in order for the system to operate.
This 510(k) submission for the Leksell Image Guidance Surgical System (K961639) does not contain the specific details required to fully address your request regarding acceptance criteria and the study that proves the device meets them. This document is a "Summary of Safety and Effectiveness" from 1996, which typically provides a high-level overview rather than granular study details.
Here's a breakdown of what can be gleaned and what is missing, based solely on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not include a table of acceptance criteria or specific reported device performance metrics (e.g., accuracy in mm, sensitivity, specificity). It only states:
"Validation and verification studies were conducted to evaluated the performance characteristics of the Leksell Image Guidance Surgical System. The results of these studies demonstrated that the Leksell Image Guidance Surgical System is capable of safely and accurately performing the stated intended use."
This is a general statement of compliance, not a detailed report of performance against predefined criteria.
Missing Information: Specific numerical acceptance criteria, and quantitative results from performance studies.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective).
Missing Information: Sample size for test sets, details on whether the data was retrospective or prospective, and country of origin.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The provided text does not mention the number of experts used to establish ground truth or their qualifications. The system is intended for use by "Surgeon, or other medical expert," but this refers to the user of the device, not the individuals establishing ground truth for testing.
Missing Information: Number of experts, their qualifications (e.g., medical specialty, years of experience), and their role in ground truth establishment.
4. Adjudication Method for the Test Set
The provided text does not specify any adjudication method (e.g., 2+1, 3+1, none) for a test set.
Missing Information: Adjudication method used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided text does not indicate if a multi-reader multi-case (MRMC) comparative effectiveness study was done, nor does it provide any effect size of how much human readers improve with AI vs. without AI assistance. The device is a guidance system, not an AI diagnostic tool, so such a study might not be directly applicable in the same way.
Missing Information: Confirmation of MRMC study, and any associated effect size.
6. Standalone (Algorithm Only) Performance Study
The provided text does not explicitly state if a standalone (algorithm only without human-in-the-loop performance) study was done. However, given it's an "Image Guidance Surgical System" with an "infra-red detection system" and "electromechanical components," its primary function is in conjunction with a human surgeon and surgical tools. The performance of the system's "ScopePlan" for preplanning and image correlation would likely involve an "algorithm" component, but no standalone evaluation is detailed.
Missing Information: Explicit statement about standalone performance studies.
7. Type of Ground Truth Used
The provided text does not specify the type of ground truth used (e.g., expert consensus, pathology, outcomes data). The device uses CT/MRI images for preplanning and guidance, so the "ground truth" for its accuracy would likely relate to the precise localization of anatomical structures or targets defined on those images, potentially validated against intraoperative confirmation or other imaging modalities.
Missing Information: Specific type of ground truth used for validation.
8. Sample Size for the Training Set
The provided text does not mention a training set sample size. This type of system from 1996 would likely be based on engineering principles and calibration rather than machine learning models requiring extensive training data in the modern sense.
Missing Information: Training set sample size.
9. How the Ground Truth for the Training Set Was Established
Since there's no mention of a traditional "training set" in the context of modern AI/ML, the document does not describe how ground truth for a training set was established.
Missing Information: How ground truth for a training set was established.
In summary, the provided 510(k) summary (from 1996) offers a general statement of safety and effectiveness but lacks the specific, granular details about study design, sample sizes, ground truth establishment, expert involvement, and quantitative performance metrics that are typically found in more recent regulatory submissions or detailed clinical study reports. This is characteristic of older 510(k) summaries, which were often less comprehensive in their publicly available versions compared to current standards.
§ 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).