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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, oropharynx, 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® 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
• 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, oropharynx, 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™ and Leksell Gamma Knife® Perfexion™ are radiosurgery systems for use in the stereotactic irradiation of head 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 unit provides highly accurate external irradiation of intra-cranial structures using collimated beams of ionizing radiation.

This submission describes the Leksell Gamma Knife® Icon™ and Leksell Gamma Knife® Perfexion™ devices, which are teletherapy systems for stereotactic irradiation of head structures. The submission focuses on a new control system software version for these devices.

Here's an analysis of the provided text in relation to your request:

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

The document does not explicitly state quantitative acceptance criteria in a numerical form typically associated with AI/ML device performance (e.g., sensitivity, specificity, AUC, Dice score). Instead, the acceptance criteria are implicitly linked to the successful completion of various engineering and design validation tests. The reported device performance is described qualitatively.

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 specify a "test set" in the context of clinical data for performance evaluation. The testing described is primarily non-clinical, focusing on system verification, integration, and design validation. There's no mention of a clinical test set size or data provenance specifically for evaluating the performance of the software upgrade or the device's clinical efficacy.

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)

No information is provided regarding the number or qualifications of experts used to establish a ground truth for a test set, as no clinical test set is described in the provided sections. The "competent and professionally qualified personnel" mentioned for design and usability validation are not further defined.

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

No information on an adjudication method is provided, as no clinical test set evaluation 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

No MRMC comparative effectiveness study is mentioned. The device is a radiation therapy system, not an AI-assisted diagnostic or interpretation tool for human readers.

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

This document describes a medical device, the Leksell Gamma Knife, which is a teletherapy device for stereotactic irradiation. The "new control system software version" is an integral part of this device. It is not an "algorithm only" device in a standalone AI sense, but rather a software component controlling a physical device. Its performance is evaluated through system-level verification and validation.

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

Since clinical testing for device performance is stated as "not required to support substantial equivalence," the concept of a clinical ground truth (like pathology or outcomes data) for evaluation is not relevant to this submission. The "ground truth" for the engineering and design validation tests would be the established technical requirements and user needs.

8. The sample size for the training set

This document does not describe an AI/ML component in the sense of a machine learning model that requires a "training set." The software upgrade is a new control system software version, not a learning algorithm trained on data. Therefore, no training set size is applicable or mentioned.

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

As there is no mention of a training set for an AI/ML model, the establishment of ground truth for such a set is not applicable.

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Leksell GammaPlan® is a computer-based system designed for Leksell Gamma Knife® treatment planning.

Leksell GammaPlan® is designed for use with the Leksell Gamma Knife and is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiation therapy. It processes the inputs of health care professionals (e.g. neurosurgeons, radiation therapists, radiation physicists) such that the desired radiation dose is delivered by the Leksell Gamma Knife to a precisely defined volume.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

The FDA 510(k) summary for Leksell GammaPlan® (K173791) explicitly states that clinical testing on patients was NOT required to demonstrate substantial equivalence to the predicate device (K151666). This means the submission does not contain information about studies designed to prove clinical performance against specific acceptance criteria in a patient population.

Instead, the submission focuses on non-clinical testing to demonstrate that the new version of the device maintains the same fundamental functionality and technical characteristics as the predicate.

Therefore, many of the requested elements for describing a study that proves the device meets acceptance criteria (especially those related to clinical performance, sample sizes, expert involvement, and ground truth in a clinical context) are not applicable to this particular 510(k) submission.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly present specific, measurable acceptance criteria in a table format that would typically be used for clinical performance. Instead, it refers to internal verification and validation against "requirement specification" and "user needs."

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

• Sample size for test set: Not applicable (no patient-based clinical test set or data described).
• Data provenance: Not applicable (no patient-based clinical data described).

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 applicable (no clinical test set requiring expert ground truth).
• Qualifications of experts: The document mentions "competent and professionally qualified personnel" performed design and usability validation, but provides no further details on their specific qualifications or their role in establishing ground truth for a test set. This likely refers to internal development and quality assurance personnel rather than external clinical experts.

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

• Adjudication method: Not applicable (no clinical test set 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

• MRMC study: No, an MRMC comparative effectiveness study was not done. The device is a treatment planning system, not an AI-assisted diagnostic tool for human readers.
• Effect size: Not applicable.

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

• Standalone performance: The non-clinical testing included "module, integration and system level verification" against requirements. This can be interpreted as evaluating the algorithm's (software's) performance in a standalone context, ensuring its internal logic and functions work as specified. However, this is not a diagnostic algorithm's standalone performance, but rather a planning system's functional performance.

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

• Type of ground truth: For the non-clinical testing, the "ground truth" would be the software requirements specifications and design documents. The validation sought to prove the system performed according to these pre-defined specifications. There is no mention of clinical ground truth (expert consensus, pathology, outcomes data) as part of this submission.

8. The sample size for the training set

• Sample size for training set: Not applicable. This device is a treatment planning system and not an AI/ML device that requires a training set in the conventional sense for a diagnostic algorithm. Its development would involve software engineering and testing principles, not machine learning model training.

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

• Ground truth for training set: Not applicable. As with the previous point, there's no mention of a training set or associated ground truth establishment methods for an AI/ML model.

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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® 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 Stereotactic System is intended for localization and diagnosis of intracranial disorders and their surgical treatment including radiosurgery and stereotactic radiation therapy.

Not Found

I am sorry, but the provided text does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or any AI-related effectiveness studies. The document is a 510(k) clearance letter from the FDA for a medical device called the "Leksell Stereotactic System," classifying it as substantially equivalent to a predicate device for specific indications for use.

Therefore, I cannot generate a response that includes:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method for a test set.
5. MRMC comparative effectiveness study details or effect size.
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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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.

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Leksell GammaPlan® is a computer-based system designed for Leksell Gamma Knife® treatment planning.

Leksell GammaPlan® is designed for use with the Leksell Gamma Knife and is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiation therapy. It processes the inputs of health care professionals (e.g. neurosurgeons, radiation therapists, radiation physicists) such that the desired radiation dose is delivered by the Leksell Gamma Knife to a precisely defined volume.

The provided document is a 510(k) Summary for a medical device called Leksell GammaPlan®. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study supporting specific acceptance criteria for performance.

Therefore, the requested information pertaining to acceptance criteria and performance study details cannot be fully extracted from this document.

However, based on the available information, here's what can be provided and what is missing:

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

Missing: The document does not provide specific, quantitative acceptance criteria (e.g., "accuracy must be within X%", "sensitivity Y%", etc.) or detailed quantitative performance metrics for the device. The reported performance is a general statement that criteria were met.

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

• Sample Size for Test Set: Not specified. The document mentions "module, integration and system level verification" and "regression and re-test," but does not provide details on the number of test cases, plans, or simulated data used.
• Data Provenance: Not specified. No information about country of origin or whether the data was retrospective or prospective. The summary explicitly states: "Clinical testing on patients was not required to demonstrate substantial equivalence or safety and effectiveness of the device." This implies the testing was likely done using simulated data or internal test scenarios.

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: The document states that "Design and usability validation of the system has been performed by competent and professionally qualified personnel." No further details on their specific qualifications (e.g., neurosurgeons, radiation therapists, radiation physicists, experience levels) are provided.

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: No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence of the Leksell GammaPlan device itself (a treatment planning system) to a predicate device, rather than evaluating the impact of an AI component on human reader performance. The device is described as "a computer-based system designed for Leksell Gamma Knife® treatment planning," which processes inputs from healthcare professionals, not an AI intended to assist human readers in image interpretation.

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

• Standalone Performance: The document describes "module, integration and system level verification" and "regression and re-test" to evaluate performance against requirements. This implicitly covers standalone algorithm performance as part of the overall system validation. However, it does not explicitly decouple an "algorithm only" performance metric from the system's intended use by healthcare professionals. The Leksell GammaPlan is a tool for treatment planning by professionals, not an autonomous diagnostic algorithm.

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

• Type of Ground Truth: Not explicitly stated. Given that clinical testing was not required, the "ground truth" for the verification and validation testing would likely have involved adherence to expected computational models, dosimetry standards, and functional requirements, rather than clinical outcomes or pathology. It would be based on established physics principles and engineering validation criteria for medical device software.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable/Not specified. The document describes a "treatment planning system," not a machine learning or AI model that requires a separate training set. The system's functionality is based on predefined algorithms and physics models, not learned from a dataset in the way a deep learning model would be.

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

• How Ground Truth for Training Set was Established: Not applicable/Not specified, as there is no mention of a "training set" in the context of this device.

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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, 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.

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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, 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.

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