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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.

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.

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

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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Leksell Gamma Knife® PERFEXION ™ is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters e.g. metastatic tumors.

Leksell Gamma Knife® PERFEXION ™ is a radiosurgery system for use in the stereotactic irradiation of intra-cranial structures. Surgery is achieved by delivering a prescribed dose as one or more shots of ionizing radiation to the exact site of the target. The system consists basically of the radiation unit with patient positioning system and the operator console (with control panel and system computer).

This document is a 510(k) summary for the Leksell Gamma Knife® PERFEXION™. It is a Traditional 510(k) submission.

Analysis of Acceptance Criteria and Study Details:

Based on the provided text, the submission is a Traditional 510(k) for a medical device (Radionuclide radiation therapy system), specifically the Leksell Gamma Knife® PERFEXION ™. The purpose of this type of submission is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to establish novel performance criteria or conduct studies proving the device meets new acceptance criteria in the same way an AI/ML device might.

Therefore, many of the requested details regarding acceptance criteria, performance metrics, sample sizes for test/training sets, expert involvement, and ground truth establishment, which are typical for an AI/ML device study, are not applicable or not explicitly detailed in the provided 510(k) summary.

The primary "acceptance criterion" for a Traditional 510(k) is substantial equivalence to a predicate device in terms of safety and effectiveness. The "study" that proves this is the comparison to the predicate device itself.

Here's a breakdown based on your requested information, highlighting what is present and what is not applicable/detailed:

1. Table of Acceptance Criteria and Reported Device Performance

Note: For a medical device like a radiation therapy system, specific performance metrics (e.g., radiation dose accuracy, positional accuracy, treatment time) would be detailed in the underlying engineering and validation studies, but these are summarized by the claim of substantial equivalence in the 510(k) document.

2. Sample size used for the test set and the data provenance

• Not Applicable/Not detailed. This 510(k) submission does not describe a clinical performance study with a "test set" in the context of an AI/ML device performing diagnostic or prognostic tasks. The "test" for a Traditional 510(k) is the demonstration of substantial equivalence through comparison of design, materials, and intended use, often supported by engineering verification and validation (V&V) tests rather than clinical studies with "test sets" of patient data for algorithm performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. No "ground truth" for a test set is discussed, as this is not an AI/ML diagnostic device submission.

4. Adjudication method for the test set

• Not Applicable. No clinical test set requiring adjudication is described.

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

• Not Applicable. This is a hardware/software system for radiation therapy delivery, not an AI-assisted diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

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

• Not Applicable. This is not an algorithm-only device. It's a complete radiation therapy system. While it contains algorithms for dose calculation and positioning, the 510(k) focuses on the system as a whole and its equivalence to a predicate, not isolated algorithm performance.

7. The type of ground truth used

• Not Applicable. The concept of "ground truth" as typically applied to image analysis or diagnostic AI is not present in this 510(k) summary. The "truth" for a radiation therapy system relates to its ability to accurately deliver radiation as intended, which is verified through engineering tests, phantom studies, and quality assurance protocols (not detailed in this summary, but inherent to the device type).

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device where a "training set" is used to develop a model.

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

• Not Applicable.

Summary Regarding the Study(ies) for K063512:

The "study" that proves the device meets (the implied) acceptance criteria for this Traditional 510(k) is the comparison to its predicate device, Leksell Gamma Knife® PERFEXION ™ (K061941). The manufacturer asserts that:

• "The functionality for the Leksell Gamma Knife® PERFEXION ™ is equivalent to its predicate device... in safety and effectiveness."
• "The fundamental technical characteristics are the same to those of the predicate device and are listed on the comparison charts provided in this 510 k submission."

The 510(k) process for this type of device does not typically require new clinical studies with patient test sets, expert ground truth, or training sets as would be seen for a novel diagnostic AI/ML algorithm. Instead, it relies on demonstrating that the new device is as safe and effective as a device already on the market through engineering specifications, design comparisons, and adherence to recognized standards. The provided text doesn't offer details on specific engineering verification/validation studies, such as phantom measurements or simulation results, which would underpin the claim of equivalent technical characteristics.

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Leksell Gamma Knife® PERFEXION ™ is a teletherapy device intended for use in the stereotactic irradiation of intra-cranial structures.

Leksell Gamma Knife® PERFEXION ™ is a radiosurgery system for use in the stereotactic Lessen Gamilia Nime Fire - Fire Erivery is achieved by delivering a prescribed dose as one or more shots of ionizing radiation to the exact site of the target.

The system consists basically of the radiation unit with patient positioning system and the operator console (with control panel and system computer).

This document is a 510(k) summary for the Leksell Gamma Knife® PERFEXION™ and does not contain detailed information about acceptance criteria or specific study results to prove meeting those criteria.

The document primarily focuses on:

• Identifying the device and its manufacturer.
• Classifying the device and its regulation number.
• Identifying predicate devices for substantial equivalence.
• Stating the intended use of the device.
• Confirming its regulatory clearance by the FDA.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, or MRMC studies from this document.

However, based on the provided text, here is what can be inferred and what is missing:

1. Table of acceptance criteria and the reported device performance:

• Missing. The document explicitly states: "The functionality for the Leksell Gamma Knife® PERFEXION ™ is equivalent to its predicate device... The fundamental technical characteristics are similar to those of its predicate device(s) and are listed on the comparison charts provided in this 510(k) submission." This implies that acceptance criteria and performance are likely demonstrated through a comparison to the predicate device's established performance, rather than a separate, detailed performance study with explicit acceptance criteria laid out in this summary. The actual comparison charts are not included in this extract.

2. Sample size used for the test set and the data provenance:

• Missing. No information on a specific "test set" or data provenance (country of origin, retrospective/prospective) is provided. The submission relies on demonstrating substantial equivalence to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Missing. No information on "ground truth" establishment or expert involvement for a test set is provided.

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

• Missing. No information on an adjudication method is provided.

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:

• Missing. This device is a "Radionuclide radiation therapy system" (a hardware system for radiosurgery), not an AI-based diagnostic or assistive software. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.

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

• Missing. This is a physical radiosurgery device, not an algorithm, so a standalone algorithm performance study is not applicable.

7. The type of ground truth used:

• Missing. As no specific performance study is detailed, no ground truth type is mentioned.

8. The sample size for the training set:

• Missing. As this is a hardware device submission, not a machine learning algorithm submission, there is no concept of a "training set" in the context of device performance as described here.

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

• Missing. Not applicable.

In summary, this 510(k) document is a regulatory submission for a physical medical device (Leksell Gamma Knife® PERFEXION™) seeking substantial equivalence to a predicate device. It confirms the device's classification, intended use, and substantial equivalence, but it does not include the detailed performance study data, acceptance criteria, or ground truth methodologies that would typically be found in a submission for, for example, a novel diagnostic AI algorithm.

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