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The Intended Purpose of Leksell® Vantage™ Stereotactic System is target localization and fixation of the patient head in a coordinate system in order to perform stereotactic neurosurgical procedures, for example; deep brain stimulation, lesioning, biopsies, targeted injections, aspirations and minimal invasive tumor treatments.

Device Description

The Leksell® Vantage™ Stereotactic System is a device used for minimally invasive neurosurgical procedures. It enables coordinate referencing and fixation of the patient's skull and brain during image acquisition and treatment. The coordinate referencing enables target localization and accurate stereotactic treatment of brain targets; for example for aspirations and biopsies, electrode placements, injections of cells & drugs, heamatoma evacuations as well as lesioning using a number of methodologies.

The system consists of a head frame that is fixated to the patient skull by minimally invasive disposable fixation pins and a number of accessories for frame application and imaging as well as a stereotactic arc and operating room accessories for the sterile surgical procedure.

The system is based on the established Leksell center-of-arc principle, which allows guidance of compatible interventional instruments at any trajectory angle to the brain target. Compatible interventional instruments are based on the Leksell principle of an active working length of 190 mm (as the arc radius) and use the correct mechanical interfacing of the Arc instrument stop and guide holders. Various instruments, such as biopsy needles, cannulas, and electrodes can be used with the system to perform biopsies, hematoma evacuation and injections of radioactive nuclides and cytostatic agents, puncture of cysts, positioning electrodes for stimulation/ recording or lesioning and stereotactic endoscope guidance.

AI/ML Overview

The provided text describes specific acceptance criteria and the results of a study conducted to demonstrate the substantial equivalence of the Leksell® Vantage™ Stereotactic System with CT accessories to its predicate devices.

Here's a breakdown of the requested information:

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

Acceptance Criteria (Test)	Reported Device Performance and Acceptance Criteria Met
Sterilization	Test Method: Sterility validation (EtO) according to ISO 11135:2014 was performed to demonstrate that the device has a sterility assumed level (SAL) of 10-6. Tests were conducted on the predicate device (K171123).
	Results: Results met pre-established acceptance criteria, demonstrating equivalence to the predicate device in terms of sterility.
MR Testing (Safety & Compatibility)	Test Method: Device subjected to compliance testing according to ASTM F2052; ASTM F2119; ASTM F2182, ASTM F2213 and ASTM F2503, and FDA guidance regarding safety and compatibility in the MR environment.
	Results: The device is compliant with FDA guidance and applicable consensus standards, demonstrating substantial equivalence.
Accuracy	Test Method: Accuracy was tested at different levels: Total system accuracy (imaging to treatment), total mechanical accuracy, mechanical accuracy of each component, handling accuracy (e.g., repeated mounting, scale setting), and displacement from head load when fixed in the frame.
	Results: All test cases were passed, demonstrating that the overall system accuracy of the Vantage system with CT accessories is substantially equivalent to the predicate device. The mechanical accuracy specified for both the subject and predicate devices is 0.9 mm.
Design and Usability Validation	Test Method: Design and usability validation was performed by trained, competent, and professionally qualified personnel to ensure the product fulfills its intended use and user needs. The validation also aimed to ensure the effectiveness of risk control measures related to safety functions.
	Results: No unacceptable human factor risks were identified. Residual risks were weighed against the product's benefit and deemed acceptable, demonstrating substantial equivalence to the predicate device when used with CT accessories.

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

The document does not explicitly state sample sizes for the test sets in the performance reports for Sterilization, MR testing, Accuracy, or Design and Usability validation. It refers to "test cases" for accuracy and "trained competent and professionally qualified personnel" for usability.
The provenance of the data (country of origin, retrospective/prospective) is not specified. However, the applicant is "Elekta Instrument AB" from Stockholm, Sweden.

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)

The document mentions "trained competent and professionally qualified personnel" for Design and Usability validation, but does not specify the number or specific qualifications (e.g., years of experience, specialty) of these experts. For Accuracy, Sterilization, and MR testing, it refers to testing methods and compliance with standards, implying technical personnel rather than clinical experts establishing ground truth in the traditional sense for medical imaging AI.

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

The document does not describe any adjudication method (like 2+1, 3+1) for establishing ground truth, as it's not a study involving diagnostic interpretation where multiple experts would provide conflicting assessments requiring adjudication. The tests performed are engineering and usability validations against predetermined criteria and standards.

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

No MRMC comparative effectiveness study was done. The device is a stereotactic system, a mechanical instrument for surgical guidance, not an AI-assisted diagnostic tool for human readers.

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

This refers to a hardware device without AI algorithms. Performance testing was done on the device's physical and functional properties, which could be considered standalone performance for a mechanical system. For example, "Accuracy" testing assessed the system's inherent mechanical precision.

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

The "ground truth" for the various tests appears to be:

Sterilization: The specified sterility assumed level (SAL) of 10-6 according to ISO 11135:2014.
MR Testing: Compliance with applicable consensus safety standards (ASTM F2052, F2119, F2182, F2213, F2503) and FDA guidance.
Accuracy: The predefined mechanical accuracy specification of 0.9 mm, determined through various measurements of the system and its components.
Design and Usability Validation: Fulfillment of intended use and user needs, and effectiveness of risk control measures associated with safety functions, assessed by qualified personnel.

8. The sample size for the training set

This is not applicable. The device is a stereotactic system, not an AI/machine learning model that requires a training set.

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

This is not applicable, as there is no training set for an AI model.

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K Number

K171123

Device Name

Leksell Vantage Stereotactic System

Manufacturer

Elekta Instrument AB

Date Cleared

2017-09-15

(151 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K152558,K031980,K972324,K080355

Intended Use

Device Description

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Leksell® Vantage™ Stereotactic System:

The document (K171123) describes the Leksell® Vantage™ Stereotactic System, a device used for stereotactic neurosurgical procedures. The primary focus of the regulatory submission is to demonstrate substantial equivalence to a previously cleared predicate device (Leksell Stereotactic System, K080355). This means the study design focuses on proving the new device performs as well as the existing one, rather than establishing absolute performance thresholds.

Important Note: The provided text does not include acceptance criteria in a quantitative, pre-defined manner for all performance tests. Instead, it generally states that "Results met pre-established acceptance criteria" or "All test cases were passed." For the "Accuracy" test, it specifically mentions an equivalence to the predicate device's mechanical accuracy of 0.9 mm.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (As Implied/Stated in Document)	Reported Device Performance
Biocompatibility	Pass respective biocompatibility requirements (according to ISO 10993-1, -5, -7, -10).	All tests reported to pass, judged substantially equivalent to predicate device.
Sterilization - devices sold as sterile	Achieve a Sterility Assurance Level (SAL) of 10⁻⁶ (according to ISO 11135:2014).	Results met pre-established acceptance criteria, demonstrating substantial equivalence.
Sterilization - reusable parts	Achieve a Sterility Assurance Level (SAL) of at least 10⁻⁶ when steam sterilized in 134°C-3 min or 132°C-4 min.	Results met pre-established acceptance criteria, demonstrating substantial equivalence.
Cleaning - reusable parts	Be clean when using methods described in IFU, with artificial blood and detection of protein residues after cleaning (according to EN ISO 15883).	All parts passed final validation and met all pre-established acceptance criteria, demonstrating substantial equivalence.
Shelf life and packaging/shipping testing	Maintain sterility after transport and exhibit a shelf life of three years for pre-sterilized parts (according to ASTM F1980-07, ASTM F1886-09, ASTM F1929-15, ASTM F88-15, ISO 11607-1:2006/A1:2014, ASTM D4169-14, ISO 11737-2).	All tests were passed, demonstrating sterility after transport and shelf life of three years, showing substantial equivalence.
MR Testing	Compliance to applicable consensus safety standards (ASTM F2052, F2119, F2182, F2213, F2503) and FDA guidance for safety and compatibility in MR environment.	The result demonstrates compliance to FDA guidance and applicable consensus standards, demonstrating substantial equivalence.
Accuracy	Overall system accuracy substantially equivalent to the predicate device, which has a mechanical accuracy of 0.9 mm.	All test cases were passed, demonstrating that the overall system accuracy of the Vantage system is substantially equivalent to the predicate device. Mechanical accuracy (subject device): 0.9 mm.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state specific sample sizes for each non-clinical performance test (e.g., number of devices or components tested for biocompatibility, sterility, cleaning, or accuracy tests). The testing is described as occurring "on the subject device" or "on different levels of the subject device components."
Data Provenance: The studies are non-clinical, performed by the manufacturer (Elekta Instrument AB). No country of origin for data is specified beyond the manufacturer's location in Stockholm, Sweden. These are prospective tests performed on the new device (Leksell® Vantage™ Stereotactic System).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This device is a medical instrument, not an AI or diagnostic imaging device that requires interpretation of results by human experts to establish ground truth for a test set.
The "ground truth" for the non-clinical tests (e.g., whether a device is sterile, biocompatible, or accurate) is established by objective measurements against scientific and engineering standards, not by expert consensus or interpretation in the way it would be for an AI diagnostic tool.
The document states that "Design and usability validation of the system has been performed by competent and professionally qualified personnel." No specific number or qualifications (e.g., "radiologist with 10 years of experience") are provided as they are not relevant for this type of device testing.

4. Adjudication Method for the Test Set

None applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies evaluating subjective interpretations (e.g., reading medical images) where multiple experts produce differing opinions that need to be resolved. For non-clinical, objective performance testing, results are determined by compliance to pre-defined, measurable standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is not mentioned because this is a physical medical device (stereotactic system), not an AI or imaging software that assists human readers in interpreting cases. The comparison is between the new device's engineering performance and validated standards/predicate device performance, not human diagnostic ability.

6. Standalone (Algorithm only without human-in-the-loop performance) Study

N/A. This question is also not applicable. The device is a physical instrument for neurosurgery, not an algorithm. Its "standalone" performance would be its inherent mechanical accuracy and compliance with various standards, which are evaluated in the non-clinical tests described.

7. Type of Ground Truth Used

The ground truth for the non-clinical tests is based on objective measurements against established engineering, biocompatibility, sterilization, and safety standards (e.g., ISO, ASTM, FDA guidance). For accuracy, the ground truth is a precisely measured distance (0.9 mm Mechanical Accuracy).

8. Sample Size for the Training Set

N/A. This device does not use an "AI algorithm" that requires a training set. The term "training set" is relevant for machine learning models, not for traditional medical devices undergoing performance verification.

9. How the Ground Truth for the Training Set Was Established

N/A. As there is no AI algorithm, there is no training set and therefore no ground truth establishment for a training set.

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