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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.

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:

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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Leksell Gamma Knife® Icon™ 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
• Recurrent glioblastomas
• Trigeminal neuralgia
• Medically refractory essential tremor
• Orbital tumors
• Ocular tumors
• Optic nerve tumors
• Benign diseases (such as meningiomas, vestibular schwannomas, post-surgical pituitary adenomas, craniopharyngioma, hemangioblastomas, schwannomas, arteriovenous malformations, cavernous malformations, chordomas, glomus tumors, hemangiomas)
• Skull base tumors
• Head and neck tumors (such as unknown primary of the head and neck, oral cavity, hypopharynx, nasopharynx, sinonasal, salivary gland)
• Pediatric tumors (such as glioma, ependymoma, pituitary tumors, hemangioblastoma, craniopharyngioma, meningioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformations, cavernous malformations, skull base tumors).

Leksell Gamma Knife® Icon™ 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.

Based on preoperative radiological examinations, the Leksell Gamma Knife® Icon™ unit provides highly accurate external irradiation of intra-cranial structures using collimated beams of ionizing radiation.

Each unit contains 192 sealed sources of Cobalt 60.

The Leksell Gamma Knife® Icon™ system consists of several parts, physically separated into a control room and a treatment room.

• The control room contains an operator console and an office cabinet. The treatment session is controlled and monitored by the operator from the control room. The control room also contains a Leksell GammaPlan computer.
• The treatment room contains the Leksell Gamma Knife unit. A Leksell Gamma Knife unit consists of the radiation unit, the patient positioning system, and a set of covers. A Leksell Gamma Knife® Icon™ unit also includes a Cone Beam CT and an Intra Fraction Motion Management (IFMM) system. The treatment room also contains a camera, patient speakers, a microphone, a treatment room monitor, and a radiation warning lamp.

The system is electrically separated into an office side and a medical side.

• The office side consists of the equipment in the control room, as well as the following equipment in the treatment room: a camera, patient speakers, a microphone, a treatment room monitor and the radiation warning lamp. The office side is powered and controlled by the office cabinet in the control room.
• The medical side consists of the Leksell Gamma Knife unit in the treatment room, and is electrically isolated from the office side. The medical side is powered and controlled by a medical cabinet, placed inside the rear cover of the radiation unit.

The provided text describes a 510(k) premarket notification for the Leksell Gamma Knife® Icon™ device, a teletherapy system for stereotactic irradiation of head structures. This document primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study.

Therefore, much of the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, expert involvement, and adjudication methods for a study proving device performance is not explicitly available in the provided text.

Specifically, the document states: "Clinical testing was not required to support substantial equivalence with the predicate devices." This means a clinical study to directly prove the device meets specific acceptance criteria was not part of this 510(k) submission.

However, based on the information provided, here's what can be inferred and stated:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as quantifiable metrics in the document. The general acceptance criteria are implied to be "conformance to applicable technical requirement specification and user needs" and that "safety and effectiveness have been achieved," as demonstrated by non-clinical testing.
• Reported Device Performance: The document states that "Results from verification and validation testing demonstrate that conformance to applicable technical requirement specification and user needs have been met and safety and effectiveness have been achieved." However, specific numerical performance metrics (e.g., accuracy, precision, sensitivity, specificity) are not provided in this summary. The primary performance claim is related to the improved Intra Fraction Motion Management (IFMM) functionality: "When the system detects that the patient is out of position the system stops delivering dose. In release 11.0 the system is paused and moved the patient out of the radiation unit while in release 11.1 the system only stop the dose delivery and resumes the dose delivery when the patient is back in position."

2. Sample Size for Test Set and Data Provenance:

• Sample Size for Test Set: Not applicable. The document explicitly states, "Clinical testing was not required to support substantial equivalence with the predicate devices." The evaluation relied on "module, integration and system level verification" and "design and usability validation." These are typically done with internal testing setups rather than patient test sets.
• Data Provenance: Not applicable for a clinical test set. The verification and validation testing would have been conducted by the manufacturer, Elekta Instrument AB, in Sweden.

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

• Not applicable as no clinical test set with ground truth established by experts was used. The "design and usability validation" was performed by "competent and professionally qualified personnel," but their specific number, qualifications, or their role in establishing ground truth for a clinical test set are not detailed.

4. Adjudication Method for the Test Set:

• Not applicable as no clinical test set requiring adjudication of ground truth was used.

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

• No, an MRMC comparative effectiveness study was not done. The document states, "Clinical testing was not required."

6. Standalone Performance Study (Algorithm Only):

• A standalone clinical performance study (algorithm only) was not performed or required. The "verification and validation testing" refers to engineering and system-level tests for functionality and safety, not a clinical performance study measuring diagnostic or therapeutic outcomes in a standalone context. The device is a "teletherapy device" which intrinsically involves a human operator to plan and monitor treatment.

7. Type of Ground Truth Used:

• Not applicable for a clinical ground truth. For the non-clinical verification and validation, the "ground truth" would be established by technical specifications, design requirements, and engineering standards for the device's functional performance and safety.

8. Sample Size for the Training Set:

• Not applicable. The device is a hardware/software system for radiation delivery, not typically a machine learning algorithm that requires a "training set" in the conventional sense of AI/ML. The development likely involved iterative testing and refinement, but not a distinct "training set" in the context of supervised learning for image analysis or similar AI applications.

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

• Not applicable, as a training set for an AI/ML algorithm is not described or implied.

In summary, this 510(k) submission for the Leksell Gamma Knife® Icon™ relied on non-clinical verification and validation testing to demonstrate substantial equivalence to predicate devices, focusing on system functionality, safety, and effectiveness. It did not involve a clinical study with patients to establish performance against specific acceptance criteria using a "test set" or "ground truth" derived from patient data with expert adjudication. The core change described is an improvement in the Intra Fraction Motion Management (IFMM) system, where the device pauses or stops dose delivery when the patient is out of position.

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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, recurrent glioblastomas, trigeminal neuralgia, medically refractory essential tremor, ocular tumors, optic nerve tumors, benign diseases (such as meningiomas, vestibular schwannomas, post-surgical pituitary adenomas, craniopharyngioma, hemangioblastomas, schwannomas, arteriovenous malformations, cavernous malformations, chordomas, glomus tumors, hemangiomas). skull base tumors, head and neck tumors (such as unknown of the head and neck, oral cavity, hypopharynx, oropharynx, nasopharynx, sinonasal, salivary gland), and pediatric tumors (such as glioma, ependymoma, pituitary tumors, hemangioblastoma, craniopharyngioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformations, cavernous malformations, skull base 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.

Based on preoperative radiological examinations, the Leksell Gamma Knife Perfexion unit provides highly accurate external irradiation of intra-cranial structures using collimated beams of ionizing radiation.

Each unit contains 192 sealed sources of Cobalt 60.

Leksell Gamma Knife Perfexion systems consists of several units, physically separated in an Office side in the control room and a Medical side in the treatment room.

• The medical side consists basically of the radiation unit with a patient positioning system. The system control and power units are placed inside the cover of the radiation unit.
• The office side consists of the operator console with control panel and office computer.

This document is a 510(k) premarket notification for the Leksell Gamma Knife Perfexion device. The primary purpose of this submission is not to establish new performance criteria for the device itself, but rather to expand the "Indications for Use" for an already cleared device (K133565). Therefore, the provided text explicitly states that clinical and non-clinical testing were NOT required to support substantial equivalence, and no new performance testing has been made. This means there is no study described in this document that proves the device meets specific acceptance criteria based on new performance data.

Instead, the submission argues that the expanded indications for use for the Leksell Gamma Knife Perfexion are substantially equivalent to its predicate devices because the new indications apply to conditions within the previously cleared treatment area (head and neck) and do not affect the safety or effectiveness of the device.

Given this, I cannot provide the requested information in its entirety because the document explicitly states that no new studies or performance tests were conducted for this 510(k) submission.

However, I can extract the relevant statements from the document regarding the lack of new testing and the rationale for claiming substantial equivalence without new performance data:

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

• No new acceptance criteria or reported device performance for new testing are provided in this document. The purpose of this submission (K151159) is to expand "Indications for Use" for an already cleared device, not to present new performance data. The document explicitly states: "The technical characteristics of the device has not changed compared to the previously cleared Leksell Gamma Knife® Perfexion K133565 and no new performance testing has been made."

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

• Not applicable. No new clinical or non-clinical studies were conducted or presented in this submission. The claim of substantial equivalence is based on the device's prior clearance and the nature of the expanded indications.

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)

• Not applicable. No new clinical or non-clinical studies were conducted or presented.

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

• Not applicable. No new clinical or non-clinical studies were conducted or presented.

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 device is a radiation therapy system, not an AI-assisted diagnostic tool for human readers. No MRMC study was conducted.

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

• Not applicable. This device is a medical device for radiation therapy, not a standalone algorithm. The device's performance is tied to its physical components and established treatment parameters, which are stated as unchanged from K133565.

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

• Not applicable. No new performance studies requiring a ground truth were conducted for this particular submission. The substantial equivalence argument relies on prior clearance and a risk analysis review.

8. The sample size for the training set

• Not applicable. No algorithms requiring a training set are discussed in this submission.

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

• Not applicable. No algorithms requiring a training set are discussed in this submission.

Ask a specific question about this device

Leksell Gamma Knife® Icon™ 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, arteriovenous malformations, trigeminal neuralgia, medically refractory essential tremor, meningiomas, vestibular schwannomas, postsurgical pituitary adenomas and recurrent glioblastomas.

Leksell Gamma Knife® Icon™ 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.

Based on preoperative radiological examinations, the Leksell Gamma Knife® Icon™ unit provides highly accurate external irradiation of intra-cranial structures using collimated beams of ionizing radiation.

Each unit contains 192 sealed sources of Cobalt 60.

The Leksell Gamma Knife Icon system consists of several parts, physically separated into a control room and a treatment room.

• The control room contains an operator console and an office cabinet. The . treatment session is controlled and monitored by the operator from the control room. The control room also contains a Leksell GammaPlan computer.
• . The treatment room contains the Leksell Gamma Knife unit. A Leksell Gamma Knife unit consists of the radiation unit, the patient positioning system, and a set of covers. A Leksell Gamma Knife Icon unit also includes a Cone Beam CT and an Intra Fraction Motion Management (IFMM) system. The treatment room also contains a camera, patient speakers, a microphone, a treatment room monitor, and a radiation warning lamp.

The system is electrically separated into an office side and a medical side.

• . The office side consists of the equipment in the control room, as well as the following equipment in the treatment room: a camera, patient speakers, a microphone, a treatment room monitor and the radiation warning lamp. The office side is powered and controlled by the office cabinet in the control room.
• . The medical side consists of the Leksell Gamma Knife unit in the treatment room, and is electrically isolated from the office side. The medical side is powered and controlled by a medical cabinet, placed inside the rear cover of the radiation unit.

This document is a 510(k) summary for the Leksell Gamma Knife® Icon™ device. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence. However, the provided text does not contain the detailed acceptance criteria or a specific study proving the device meets those criteria, as typically found in clinical validation reports or performance testing summaries that would include such information.

The document states: "Testing in the form of module, integration and system level verification was performed to evaluate the performance and functionality of the new and existing features aqainst requirement specification. Regression and re-test of unchanged functionalities in the developed system was done to ensure that the new and updated functionalities did not introduce any undesirable effects."

It also mentions: "Results from verification and validation testing demonstrate that conformance to applicable technical requirement specification and user needs have been met and safety & effectiveness have been achieved."

Despite these general statements about testing, there is no specific table of acceptance criteria, reported device performance, sample sizes, data provenance, ground truth establishment, or details about expert involvement for a study. The document focuses on establishing substantial equivalence to previously cleared devices (Leksell Gamma Knife® Perfexion™ and XVI R5.0) rather than presenting a standalone validation study with detailed performance metrics against predefined acceptance criteria for the new "Icon" features.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be gathered, and what is explicitly not available:

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

• Not Available: The document does not provide a table with specific acceptance criteria (e.g., accuracy thresholds, precision values, sensitivity/specificity targets) or quantitatively reported device performance metrics against these criteria. It generally states that "conformance to applicable technical requirement specification and user needs have been met."

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

• Not Available: The document mentions "module, integration and system level verification" and "regression and re-test," but does not specify the sample size of any test set (e.g., number of patients, number of images, or number of test cases). It also does not provide details on data provenance (country of origin, retrospective/prospective).

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)

• Not Available: The document does not describe the establishment of a "ground truth" using experts for a test set. It mentions that "Design and usability validation of the system has been performed by competent and professionally qualified personnel," but this is a general statement about internal validation rather than a detailed description of expert review for a test set.

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

• Not Available: No information on adjudication methods for a test set 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

• Not Available: This document does not describe an MRMC study or any study involving human readers with or without AI assistance, nor does it provide an effect size. The device described (Leksell Gamma Knife Icon) is a teletherapy system, not an AI-assisted diagnostic tool that typically undergoes MRMC studies comparing human reader performance.

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

• Not Available: The document does not detail a standalone algorithm performance study. The system includes a Cone Beam CT and an Intra Fraction Motion Management (IFMM) system, but the document does not describe their performance in isolation as an algorithm.

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

• Not Available: As no specific test set or ground truth establishment is described, this information is not available.

8. The sample size for the training set

• Not Available: This document makes no mention of a "training set," which implies that the device is not an AI/ML device that requires explicit training data in the same way as, for example, an image analysis algorithm. The system is a hardware device with associated software for planning and delivery.

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

• Not Available: Since no training set is mentioned, the method for establishing its ground truth is also not applicable or available from this document.

In summary: This 510(k) summary focuses on demonstrating substantial equivalence to predicate devices for a medical hardware system (radiosurgery system) rather than providing detailed performance metrics from a clinical validation study typically seen for AI-driven diagnostic devices. The document highlights internal verification and validation against "requirement specification" and "user needs" but without quantitative details.

Ask a specific question about this device

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, arteriovenous malformations, trigeminal neuralgia, medically refractory essential tremor, meningiomas, post-surgical pituitary adenomas and recurrent glioblastomas.

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.

Based on preoperative radiological examinations, the Leksell Gamma Knife Perfexion unit provides highly accurate external irradiation of intra-cranial structures using collimated beams of ionizing radiation.

Each unit contains 192 sealed sources of Cobalt 60.

Leksell Gamma Knife Perfexion systems consists of several units, physically separated in an Office side in the control room and a Medical side in the treatment room.

• The medical side consists basically of the radiation unit with a patient positioning . system. The system control and power units are placed inside the cover of the radiation unit.
• The office side consists of the operator console with control panel and office computer. .

This device, the Leksell Gamma Knife® Perfexion™, is a medical device for stereotactic radiosurgery. The provided documentation is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a de novo study with explicit acceptance criteria for a novel device.

Therefore, the typical acceptance criteria and study design for proving performance in the context of a new device are not directly applicable here. Instead, the "study" that proves the device meets the acceptance criteria is the demonstration of substantial equivalence to its predicate device (K120811). The acceptance criteria for this type of submission are implicitly that the new device is as safe and effective as the predicate and shares fundamental technical characteristics.

Here's an attempt to structure the information based on your request, highlighting where the traditional study components are not directly present or are addressed through literature review and comparison:

Acceptance Criteria and Device Performance

Further Details on the "Study" and Ground Truth Establishment

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

   • No explicit "test set" in the traditional sense of a new clinical trial was used.
   • The "test set" information for demonstrating safety and effectiveness relied on a clinical literature review. The provenance of this data would be from various scientific publications, likely international, covering retrospective and prospective studies performed with Gamma Knife technology (including previous models and the predicate device).

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

   • The document mentions that "scientific advisors found extensive scientific publications" and "reports have been approved by physicians regarding clinical relevance, based on experience of previous models of the system."
   • The number of experts is not specified.
   • Their qualifications are generally described as "physicians" and "scientific advisors" with experience in the field of stereotactic radiosurgery and Gamma Knife systems. Specific years of experience (e.g., "radiologist with 10 years of experience") are not provided.

3. Adjudication method for the test set:

   • Not applicable in the context of a literature review. The "adjudication" was effectively through peer review of published scientific literature and the internal review and acceptance by the notifying company's scientific advisors and physicians.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No, a MRMC comparative effectiveness study was not explicitly done for this 510(k) submission. The submission relies on demonstrating equivalence to the predicate device and literature review for new indications, not a direct comparison of human readers with vs. without AI assistance (as this is a treatment device, not an diagnostic AI).

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

   • Not explicitly applicable. The Leksell Gamma Knife Perfexion is a complete radiosurgery system, not a standalone algorithm. Its performance is inherent to the system delivering radiation based on a treatment plan, which involves human input (e.g., physicians defining targets). The "performance" assessment focuses on the system's ability to safely and effectively deliver radiation as prescribed, consistent with its predicate.

6. The type of ground truth used:

   • For the demonstration of safety and effectiveness, the "ground truth" was derived from:
     • Clinical outcomes data reported in the scientific literature for treatments performed with Leksell Gamma Knife systems (including previous models and the predicate).
     • Expert consensus among physicians and scientific advisors regarding the clinical relevance and safety/efficacy based on existing knowledge and literature.
     • Risk analysis review for safety, which serves as a form of internal validation against established safety standards.

7. The sample size for the training set:

   • Not applicable in the context of a 510(k) submission for a physical device, as there isn't a "training set" for an algorithm in the traditional sense here. Any "training" for the device's development would be part of engineering and design validation, not typically reported with a sample size like for an AI model.

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

   • Not applicable for the same reasons as above. The device's underlying physics and engineering principles are established, and its performance is validated against these principles and against the performance of the predicate device, not through an algorithm's training set as in AI.

Ask a specific question about this device

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, arteriovenous malformations, trigeminal neuralgia, meningiomas and vestibular schwannomas.

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.

Based on preoperative radiological examinations, the Leksell Gamma Knife Perfexion unit provides highly accurate external irradiation of intra-cranial structures using collimated beams of ionizing radiation.

Each unit contains 192 sealed sources of Cobalt 60.

Leksell Gamma Knife Perfexion systems consists of several units, physically separated in an Office side in the control room and a Medical side in the treatment room.

• . The medical side consists basically of the radiation unit with a patient positioning system. The system control and power units are placed inside the cover of the radiation unit.
• The office side consists of the operator console with control panel and office computer. .

The provided text is a 510(k) summary for the Leksell Gamma Knife Perfexion. This document primarily focuses on establishing substantial equivalence to a predicate device and regulatory information. It does not contain a study that demonstrates the device meets specific acceptance criteria in the way a clinical performance study for an AI/ML device would.

The "acceptance criteria" here would be the regulatory requirements for showing substantial equivalence for a medical device that performs radiation therapy, not a set of performance metrics for an AI algorithm.

Therefore, many of the requested sections about acceptance criteria, device performance, sample sizes, ground truth, and expert adjudication are not applicable to the information provided in this 510(k) submission.

Here's a breakdown of what can be extracted and what cannot, based on the provided text:

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

• Acceptance Criteria: Not explicitly stated as performance metrics in the context of a clinical study demonstrating AI/ML performance. The "acceptance criteria" for this 510(k) are implicitly the requirements for showing substantial equivalence (same intended use, similar technical characteristics, safety, and effectiveness) to the predicate device.
• Reported Device Performance: Not presented as a results table from a performance study. The document states that the device's functionality is "equivalent" to its predicate in safety and effectiveness.

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

• Not Applicable: This document does not describe a clinical performance study with a test set. There is no information on sample size or data provenance in this context.

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

• Not Applicable: No test set or ground truth in the context of an AI/ML performance study is mentioned.

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

• Not Applicable: No test set or adjudication method is mentioned.

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 not a study for an AI-assisted device, nor does it describe a comparative effectiveness study.

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

• Not Applicable: This is a physical radiation therapy device, not an algorithm, so the concept of standalone performance does not apply in the manner typically asked for AI/ML devices.

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

• Not Applicable: No ground truth in the context of an AI/ML performance study is mentioned.

8. The sample size for the training set

• Not Applicable: No training set is mentioned as this is not an AI/ML device.

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

• Not Applicable: No training set or ground truth establishment is mentioned.

Summary of Relevant Information from the Provided Text:

• Device Name: Leksell Gamma Knife® Perfexion™
• Intended Use: Stereotactic irradiation of head structures (e.g., metastatic tumors, arteriovenous malformations, trigeminal neuralgia, meningiomas, vestibular schwannomas).
• Device Type: Teletherapy device (radiation therapy system)
• Predicate Device: Leksell Gamma Knife® Perfexion™ (K063512)
• Basis for Substantial Equivalence: "The functionality for the Leksell Gamma Knife Perfexion is equivalent to its predicate device K063512 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." (These comparison charts are not provided in the snippet.)

In conclusion, this 510(k) submission is for a physical radiation therapy device establishing substantial equivalence to a prior version, not an AI/ML device that would typically undergo a performance study with specific acceptance criteria, test sets, and ground truth as described in your prompt.

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