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Leksell Gamma Knife® 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, chordomas, 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, meningioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformations, skull base tumors)

Leksell Gamma Knife® (available models Icon™, Perfexion™ and Elekta Esprit) is a radiosurgery system 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.

The provided text does not contain detailed information about specific acceptance criteria and a study that proves the device meets those criteria as it relates to a specific performance metric (like diagnostic accuracy). Instead, it focuses on the substantial equivalence of a new device model (Leksell Gamma Knife® - Elekta Esprit) to a predicate device (Leksell Gamma Knife® K173789) through non-clinical performance testing.

Here's an analysis based on the provided text, highlighting what is and isn't available:

Overall Conclusion from the Text: The document claims the new device is substantially equivalent to the predicate device because its fundamental technical characteristics are unchanged despite hardware and software updates to the user interface. Therefore, the performance is assumed to be equivalent, and no new clinical studies were conducted for this 510(k) submission.

Missing Information (per the request, but not available in the provided text):

• A table of acceptance criteria and reported device performance for a specific performance characteristic (e.g., diagnostic accuracy, sensitivity, specificity).
• Sample size used for a "test set" in the context of diagnostic performance.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts, their qualifications, and adjudication methods for establishing ground truth.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone (algorithm only) performance.
• Specific type of ground truth used (pathology, outcomes data, etc.) for performance evaluation.
• Sample size for a "training set" for an algorithm.
• How ground truth for a "training set" was established.

Information Available from the Text (interpreted in the context of "acceptance criteria" as general device functionality and safety):

The "acceptance criteria" here are implicitly related to ensuring the device performs as intended and is as safe and effective as its predicate, primarily through non-clinical testing of hardware and software updates.

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

The document describes non-clinical performance testing to ensure the new model functions as intended and meets requirements.

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

• Sample Size: Not specified in terms of patient cases or images, as the testing was non-clinical and focused on system functionality. It refers to "module, integration and system level verification testing."
• Data Provenance: Not applicable in the context of patient data. The testing was conducted internally by Elekta Solutions AB (Sweden).

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

• Not applicable to this 510(k) submission, as no clinical performance study involving diagnostic accuracy with expert-established ground truth was performed for substantial equivalence. "Design and usability validation... performed by competent and professionally qualified personnel" (Page 5) speaks to the expertise in verifying engineering and human factors aspects, not medical image interpretation.

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

• Not applicable.

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, an MRMC comparative effectiveness study was not done. The submission explicitly states: "No animal or clinical tests were performed to establish substantial equivalence with the predicate device." (Page 5). This device is a radiation therapy system, 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:

• Not applicable in the context of an algorithm's diagnostic performance. The device itself is a treatment system, and its standalone performance refers to its ability to deliver radiation as specified, validated through non-clinical tests.

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

• For the non-clinical testing, the "ground truth" was the device's technical specifications and intended functionality. Verification and validation ensured the device met these engineering and design requirements. There was no medical "ground truth" (e.g., pathology, clinical outcomes) established for diagnostic or treatment efficacy in a clinical setting in this submission.

8. The sample size for the training set:

• Not applicable, as this device is not an AI/ML algorithm trained on a dataset in the sense of image recognition or diagnostic prediction.

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

• Not applicable.

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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.

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
• 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.

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.

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