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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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