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The Leksell® Image Guidance Surgical System (LIGS) is intended for use in cranial and spinal 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 (hereafter the LIGS System) which is the subject of this 510(k) Premarket Notification is a device System intended for use in neurosurgical procedures to provide image guidance based upon preoperative images which are visualized interactively with the aid of surgical tools. The LIGS System imports Computer Tomography (CT) and Magnetic Resonance (MR) images and provides a visual display of the images for pre-planning surgical paths. The images and pre-planned surgical paths can be viewed at a computer workstation in the operating room. The LIGS System is integrated with a Measurement System, which allows the patient in the operating room environment to be correlated with the diagnostic images obtained pre-operatively. The LIGS System may then be used for visual or instrumentation guidance during the surgical procedure.

The LIGS System is a modular System comprised of a set of components which may be used in conjunction with three basic Models of system configuration interfaced with a Measurement (position tracking) System:

1. The SurgiScope® Model is configured around a motorized ceiling mounted Integrated Tool Support System with integrated tool support software.
2. The ViewScope® Model is configured for use with a manual Floorstand Microscope System.
3. The FreeHand Model allows for the tracking of surgical tools without the use of a microscope.

The LIGS System consists of 6 major components that may be combined in different permutations in the SurgiScope®, ViewScope®, and proposed FreeHand Models. The six primary components of the LIGS System may be combined in various configurations, depending upon the features desired by the customer.

The provided document is a 510(k) Premarket Notification for the Leksell® Image Guidance Surgical System (LIGS). It describes the device, its intended use, and states that validation and verification studies were conducted. However, the document does NOT contain the detailed information necessary to fully answer all components of your request, specifically:

• Quantitative Acceptance Criteria: The document states that the system is "capable of safely and accurately performing the stated intended use" but does not define specific, quantifiable acceptance criteria (e.g., accuracy, precision metrics with numerical thresholds).
• Reported Device Performance: While it mentions studies were conducted, it does not provide the results of those studies in a quantifiable manner against any specific performance metrics.
• Sample Size and Provenance of the Test Set: No information is given about the number of patients or cases used for testing, nor where the data originated (country, retrospective/prospective).
• Number and Qualifications of Experts for Ground Truth: There is no mention of experts, their number, or their qualifications for establishing ground truth in any test set.
• Adjudication Method: No information is provided regarding adjudication methods (e.g., 2+1).
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: There is no indication that such a study was performed, nor any data on effect size for human readers with and without AI assistance.
• Standalone Performance: While the system is described, the document doesn't explicitly state "standalone performance" in the context of an algorithm without human-in-the-loop, likely because this system is inherently designed for human interaction.
• Type of Ground Truth: The document doesn't specify if ground truth was established by expert consensus, pathology, or outcomes data.
• Sample Size for Training Set: There is no information about a training set or its size.
• How Ground Truth for Training Set was Established: Since no training set is mentioned, there's no information on how its ground truth was established.

Based on the provided text, here is what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

Missing: Specific, quantifiable numerical acceptance criteria (e.g., accuracy +/- X mm, precision Y%) and the corresponding measured device performance values.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective nature of data).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not specified.

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

• MRMC Study: Not mentioned as being conducted.
• Effect Size: Not applicable, as no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• The LIGS system is described as an interactive image guidance system for use with surgical tools and a surgeon. The concept of "standalone (algorithm only without human-in-the-loop performance)" does not apply directly to this type of device, as its core function is to provide guidance to a human during surgery. Therefore, a standalone performance study in the way it's typically understood for diagnostic AI wouldn't be relevant or detailed here.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Type of Ground Truth: Not specified.

8. The sample size for the training set

• Sample Size: Not specified. This document is focused on regulatory submission and does not detail development or training data.

9. How the ground truth for the training set was established

• Ground Truth Establishment: Not specified.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The document states: "Validation and verification studies were conducted to evaluate 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."

The FDA's clearance letter confirms: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent... You may, therefore, market the device..."

Missing: The specific details, methodology, results, and statistical analysis of these "validation and verification studies" are not provided in the publicly available 510(k) summary. These studies would contain the quantitative data to support the claims of safety and accuracy.

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