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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, 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)
• Refractory mesial temporal lobe epilepsy in adults
• Refractory epilepsy associated with structural changes such as hamartomas, cerebral cavernous malformations, and arteriovenous malformations (adult and pediatric)

Leksell Gamma Knife® (available models Elekta Esprit, Icon™, and Perfexion™) 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 FDA 510(k) clearance letter pertains to the Leksell Gamma Knife® (Elekta Esprit, Icon™, Perfexion™) and describes the basis for its substantial equivalence to a predicate device (K222047).

It's important to note that the document outlines the non-clinical performance testing and explicitly states that no animal or clinical tests were performed to establish substantial equivalence for this specific 510(k) submission. This is because the submission primarily focuses on the replacement of obsolete hardware components and a new control system software version to support these components, along with the addition of new indications (Refractory mesial temporal lobe epilepsy in adults and Refractory epilepsy associated with structural changes) that are deemed to fall within the existing intended use and have a favorable benefit-risk profile based on established knowledge of Gamma Knife treatment for certain neurological conditions.

Therefore, the typical structure for describing acceptance criteria and a study proving device performance (especially for AI/ML-driven devices with specific performance metrics like sensitivity, specificity, etc.) is not fully applicable in this context. The acceptance criteria here are more related to functional performance, safety, and maintaining equivalence with the predicate device after hardware and software updates.

However, I can extract the information relevant to what testing was performed and how the device's continued safety and effectiveness were assured.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

Given that this 510(k) focuses on hardware replacement and a software update to support those replacements, rather than the introduction of a novel AI/ML algorithm with specific diagnostic performance metrics, the acceptance criteria are not in the form of typical clinical performance measures (e.g., sensitivity, specificity). Instead, they revolve around functional validation, safety, and maintenance of equivalence to the predicate device.

Key Acceptance Criteria (Inferred from the document):

• Functional Equivalence: The new hardware and software must maintain the same fundamental scientific technology, clinical workflow, and functionality as the predicate device.
• Safety: The device must continue to meet established safety standards and not introduce new or increased risks.
• Performance: The updated system must perform as intended, ensuring accurate and precise stereotactic irradiation.
• Usability: User interface and labeling updates must support safe and effective use.
• Biocompatibility: All new materials in contact with patients must be biocompatible.

Study that Proves the Device Meets the Acceptance Criteria:

The "study" described is a comprehensive set of non-clinical verification and validation activities.

1. Table of Acceptance Criteria and Reported Device Performance

• "The subject device does not introduce any new clinical requirements or functions."
• "The fundamental technical characteristics... have not changed and are substantially equivalent."
• "The clinical workflow, safety, functionality, and performance is unchanged thus ensuring substantial equivalence." |
  | Safety (Risk Control & Compliance with Standards) | - "The change in design required a new risk control to be added to ensure the same level of safety as predicate device and thus ensuring substantial equivalence."
• Verification testing performed to IEC 60601-1 series, IEC 62304, ISO 10993 series. |
  | Performance (Accuracy & Consistency) | - "Testing in the form of module, integration and system level verification was performed to evaluate the performance and functionality of the new control system and the new hardware against requirement specification."
• "Regression test of unchanged functionalities... to ensure that new and updated functionalities did not introduce any undesirable effects." |
  | Usability | - "Performance testing, including design and usability validation of the system, has been performed by competent and professionally qualified personnel to ensure that the product fulfils the intended use and user needs."
• "The design and usability validation was also made to ensure that the risk control measures associated with functions related to safety (FRS) for the affected functionality... were effective."
• "Updated labeling was in scope of usability evaluation according to IEC 62366-1. The result demonstrate that the labeling support the safe and effective use of the device." |
  | Biocompatibility | - "Biocompatibility testing has been performed to ensure that all materials are biocompatible in relation to the use of the device." |
  | Substantial Equivalence to Predicate Device (Overall) | - "The performance data demonstrate that the subject device is as safe and effective and performs as well as the predicate devices (K222047)."
• "The result of verification and validation as well as conformance to relevant safety standards demonstrate that the Leksell Gamma Knife® meets the established safety and performance criteria and is substantially equivalent to the predicate device." |

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated as a number of "cases" or "patients" in the context of clinical data. The testing involved system-level verification, module testing, integration testing, and regression testing. This implies testing across the functionality of the device.
• Data Provenance: The nature of the testing is non-clinical performance and functional validation. It's conducted by Elekta Solutions AB (Sweden) as part of their design control and quality system processes. It's not based on retrospective or prospective clinical patient data for efficacy or diagnostic performance.

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

• Experts: Not applicable in the sense of clinical experts establishing "ground truth" for disease diagnosis or outcome.
• Qualifications: For performance, design, and usability validation, the document states: "Performance testing, including design and usability validation of the system, has been performed by competent and professionally qualified personnel." No specific number or precise qualifications (e.g., "radiologist with 10 years of experience") are provided within this public summary, as this refers to internal quality and engineering validation teams.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The testing is focused on system functionality, safety, and performance against defined engineering requirements and standards, not on interpreting images or making clinical judgments requiring adjudicated consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• MRMC Study: No. The document explicitly states: "No animal or clinical tests were performed to establish substantial equivalence with the predicate device." Therefore, no MRMC study comparing human readers with and without AI assistance was conducted for this specific 510(k) submission.

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

• Standalone Performance: No. This device is a radiation therapy system, not an AI diagnostic algorithm. While it has control software, "standalone performance" in the context of AI metrics like sensitivity/specificity for disease detection is not relevant here. The software's performance is integral to the entire system's functionality and safety.

7. The Type of Ground Truth Used

• Ground Truth: For non-clinical validation, the "ground truth" is typically defined by:
  • Requirement Specifications: The device's performance is measured against its designed functional and safety requirements.
  • Established Standards: Adherence to recognized national and international standards (e.g., IEC 60601, IEC 62304, ISO 10993, IEC 62366-1).
  • Predicate Device Equivalence: The gold standard is the documented performance and safety profile of the legally marketed predicate device (K222047).

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This 510(k) does not describe the development of a novel machine learning algorithm that requires a distinct training set in the AI sense. The software updates are for system control and enabling new hardware, not for learning from vast datasets.

9. How the Ground Truth for the Training Set was Established

• Ground Truth for Training Set: Not applicable, as there is no mention of a training set for an AI/ML algorithm.

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

Leksell GammaPlan® is a powerful, computer-based treatment planning system specifically designed for the simulation and planning of stereotactic Leksell Gamma Knife® radiosurgery based on tomographic and projectional images.

The basis of treatment planning is the acquisition and processing of digital images by a computer workstation running the treatment planning application software. The program is capable of handling a range of different imaging modalities. Images from tomographic sources such as Computer Tomography (CT), Magnetic Resonance (MR) and Positron Emission Tomography (PET) scanners can be used as well as projectional images from angiograms (AI). This allows the direct comparison between vascular structures in projectional images and tissue structures in CT and MR.

Digital images can be imported into the system via the computer network.

The treatment planning application has the ability to plan a patient's treatment protocol based on a single target or multiple targets.

The basic elements of treatment planning are:

• defining the cranial target or targets .
• . devising the configuration of the collimators to be used during treatment
• determining the parameters of the radiation shots to be delivered by Leksell • Gamma Knife®.

The provided FDA 510(k) summary for the Leksell GammaPlan® (LGP) (K232854) does not contain specific details regarding acceptance criteria and the comprehensive study results in the way requested for a typical AI/ML device.

This submission is for an updated version of a treatment planning system, which is generally software for medical device operation, rather than an AI/ML algorithm that performs autonomous diagnostic or prognostic tasks. As such, the performance testing focuses on software verification and validation against requirements, rather than clinical performance metrics in terms of sensitivity, specificity, etc., with a ground truth established by experts.

However, I can extract the information that is present and indicate where the requested information is not available in the document.

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)

• Sample Size for Test Set: Not specified in the document. The testing described is software verification and validation, not a clinical trial with a "test set" in the sense of patient data for AI model evaluation.
• Data Provenance: Not specified, as it's not a clinical data-driven study. The document mentions "clinically equivalent device" for validation, implying internal testing and possibly simulated or anonymized data, but details are absent.

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 mentions "competent and professionally qualified personnel" performed design and usability validation, but no specific professional qualifications (e.g., radiologist, medical physicist) or experience levels are provided. Ground truth in the context of a treatment planning system primarily relates to the accuracy of computational models and adherence to clinical guidelines, rather than expert interpretation of images for diagnosis.

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

• Adjudication Method: Not specified. It's unlikely this type of adjudication was performed, as the evaluation focused on software functionality and adherence to specifications, not on resolving disagreements in expert clinical assessment.

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 study was not performed. This device is a treatment planning system, not an AI diagnostic or assistance tool intended to improve human reader performance in interpreting medical images. The document states, "No animal or clinical tests were performed to establish substantial equivalence with the predicate device."

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

• Standalone Performance: The device itself is software for treatment planning. Its "standalone" performance would be its ability to correctly calculate and display treatment plans based on inputs, which is covered by the mentioned verification and validation testing. However, this is not "standalone AI algorithm performance" in the typical sense of a diagnostic AI. The system is inherently "human-in-the-loop" as it requires a clinician to define targets and parameters.

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

• Type of Ground Truth: For the type of software described (treatment planning), the "ground truth" for verification and validation typically involves:
  • Specification Compliance: Verification that the software performs according to its written requirements and design specifications.
  • Industry Standards: Conformance to relevant medical device software (e.g., IEC 62304) and medical physics standards.
  • Phantom/Physical Measurement Comparisons: For dose calculations, comparison with physical measurements in phantoms or known analytical solutions (though not explicitly detailed for this specific 510(k)).
  • Clinical Equivalence/Usability: Validation that the software supports intended clinical use, as performed by "competent and professionally qualified personnel."
    The document does not specify "expert consensus," "pathology," or "outcomes data" as ground truth for this submission, as these are more relevant for diagnostic or prognostic AI.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable and not mentioned. This device is a treatment planning system, not a machine learning model that requires a training set in the conventional sense.

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

• Ground Truth for Training Set Establishment: Not applicable and not mentioned, as there is no machine learning "training set" for this device.

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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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TaiChiB Digital Radiotherapy System is a teletherapy device equipped with two radiation beam delivery units within an enclosed gantry.

(1) The electron linear accelerator producing 6MV photon beam is indicated to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
(2) The rotating focused gamma beam emitting unit with multiple Cobalt-60 sources is indicated to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions in the brain and head where radiation treatment is indicated.

TaiChiB Digital Radiotherapy System integrates medical linear accelerator technology and rotating gamma technology for precision radiotherapy and stereotactic radiosurgery.

TaiChiB contains a gantry with a slip ring, 6 MV X-ray Beam Generation Module (BGM), Beam Shaping Module (BSM), Rotating Gamma Subsystem (RGS), Image Guidance System (IGS), Patient Support System (PSS), Treatment Control System (TCS).

The provide text is a 510(k) summary for the TaiChiB Digital Radiotherapy System. This document focuses on demonstrating substantial equivalence to predicate devices rather than detailing a specific study designed to meet pre-defined acceptance criteria for the new device's performance.

Therefore, the requested information regarding acceptance criteria, a study proving the device meets them, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a specific performance evaluation is not available within this document.

The document primarily highlights the device's technical specifications and compares them to predicate devices, stating that "The TaiChiB system is as safe and effective as the predicate device and reference device." and "The verification and validation testing demonstrated that TaiChiB has met its specifications, demonstrated substantially equivalent performance to the predicate and met its intended use."

The "PERFORMANCE DATA" section lists various electrical safety, EMC, and bench tests conducted according to relevant IEC and ISO standards. It also mentions "Hardware and Software Verification and Validation Testing" where test results showed TaiChiB conforms to applicable requirements and assures hazard safeguards functioned properly. However, these are general compliance statements and not specific performance metrics with acceptance criteria for the device's clinical efficacy or accuracy in the context of diagnostic or treatment capabilities. No clinical or animal studies were performed.

Summary of available information from the provided text:

1. A table of acceptance criteria and the reported device performance:
This information is not explicitly provided in the format of acceptance criteria for clinical performance and device performance results. The document instead presents a table comparing the new device's features and specifications to those of its predicate and reference devices, implying that matching or being similar to these established devices constitutes acceptable performance.

Excerpts from the "Detailed Comparisons" table representing device specifications that could be considered performance characteristics:

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The system is a teletherapy device intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions in the brain and head where radiation treatment is indicated.

TaiChiC Rotating Gamma System has been designed to deliver radiation treatments in accordance with a prescribed plan. This system is a stereotactic radiotherapy equipment developed by applying the principle and mature technology of Cobalt-60 rotary focusing. It is suitable for brain and head lesions and tumors requiring radiotherapy, and provides image guided stereotactic radiosurgery and precision radiotherapy.

TaiChiC consists of a gantry with a slip ring, a focusing gamma ray treatment head, image guidance subsystem, couch, power supply and electrical cabinet, main cover and treatment bore etc. TaiChiC combines gamma beam stereotactic radiation therapy technology with contemporary advanced image guidance technology (IGRT) to provide image guided stereiotactic radiotherapy and precision radiotherapy.

The provided text describes the TaiChiC Rotating Gamma System, a teletherapy device for stereotactic radiosurgery and precision radiotherapy, and its substantial equivalence determination by the FDA. However, the document does not contain specific acceptance criteria, reported device performance metrics in a quantitative manner, detailed study designs, or information about human expert involvement for establishing ground truth.

The performance data section broadly states:

• Electrical Safety and Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1 and IEC 60601-1-2 standards.
• Bench Test: Conformance to various IEC standards (60601-2-11, 60601-1-3, 60601-2-68, 61217, 62274, 62366-1, 60601-1-6), RT2, ISO 15223-1, and ISO 10993-1.
• Hardware and Software Verification and Validation Testing: Conducted according to 21 CFR §820, ISO 13485, ISO 14971, and FDA guidance for software in medical devices. The software was considered "major" level of concern.
• Animal or clinical test: Not applicable.

The conclusion states that verification and validation testing demonstrated that the device "met its specifications, demonstrated substantially equivalent performance to the predicate and met its intended use." One quantitative metric mentioned is "Radiologic accuracy

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The Akesis Galaxy RTi Rotating Gamma System, is a teletherapy device intended for the stereotactic irradiation of human head structures for adults.

The Akesis Galaxy RTi, is a medical teletherapy device, which contains (30) Cobalt-60 sources, distributed in a single, compact source carrier or source drawer, which is inside a hemispheric shield. Immediately adjacent to the source unit is the "built-in" primary collimator. An independently rotating secondary collimator hemisphere contains 4 sizes of collimators and a blocking position. consists of a) The y-ray treatment unit, and b) interface to a stereotactic localization system, and c) kV x-ray positioning and verification system

The provided text describes a medical device, the Akesis Galaxy RTi Rotating Gamma System, which is a radionuclide radiation therapy system intended for stereotactic irradiation of human head structures in adults. The submission is a 510(k) premarket notification, indicating the device is being compared to a legally marketed predicate device (Akesis Galaxy RTx Rotating Gamma System).

Based on the provided information, the study focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria in the context of diagnostic accuracy (e.g., sensitivity, specificity) derived from a clinical study with a test set, ground truth, and expert readers.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present specific acceptance criteria in the form of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) for the device's clinical application. Instead, acceptance criteria are aligned with demonstrating substantial equivalence to a predicate device and complying with recognized standards.

Regarding the Absence of Diagnostic Performance Studies for AI/Machine Learning Devices:

It is crucial to note that this 510(k) submission is for a radionuclide radiation therapy system, which is a physical device used for treatment. It is not an AI/machine learning diagnostic device where performance is typically measured in terms of sensitivity, specificity, or AUC against a ground truth established by experts. Therefore, many of the questions regarding sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details are not applicable to this type of device and submission.

The "study that proves the device meets the acceptance criteria" in this context refers to engineering tests, verification and validation activities, and comparisons of technical characteristics to a predicate device, rather than a clinical trial assessing a diagnostic AI algorithm.

Here's a breakdown for the N/A questions:

2. Sample size used for the test set and the data provenance: N/A (Not an AI/diagnostic device clinical study). The performance data cited are related to engineering and safety standards compliance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (Ground truth as understood in AI/diagnostic performance studies is not applicable here).

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

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, as this device does not involve human readers interpreting images with or without AI assistance for diagnosis.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a therapeutic device, not a standalone diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A. The "ground truth" here is compliance with engineering standards and specifications, not clinical diagnostic accuracy.

8. The sample size for the training set: N/A. (Not an AI/machine learning algorithm).

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

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The Akesis Galaxy RTx Gamma System, is a teletherapy device intended for the stereotactic irradiation of human head structures.

The Akesis Galaxy RTx, is a medical teletherapy device, which contains (30) Cobalt-60 sources, distributed in a single, compact source carrier or source drawer, which is inside a hemispheric shield. Immediately adjacent to the source unit is the "built-in" primary collimator. An independently rotating secondary collimator hemisphere contains 4 sizes of collimators and a blocking position.

The rotating gamma system focuses the thirty beams and combining their individual doses at the target. The design of the system automates the treatment delivery by moving the target to the focal point, while the patient's head is immobilized in a headframe which has been fitted prior to the commencement of treatment. The entire system consists of a) the y-ray treatment unit, and b) the stereotactic localization system.

The provided text describes the 510(k) premarket notification for the Akesis Galaxy RTx, a radionuclide radiation therapy system. It details the device's technical characteristics, its comparison to a predicate device, and various performance data submitted in support of its substantial equivalence.

However, the document does not contain any information regarding acceptance criteria or a study proving the device meets those criteria in the context of AI/ML performance for diagnostic or assistive functions related to image analysis or data processing. The device described is a physical radiation therapy system, and the performance data pertains to its safety, electrical compatibility, hardware/software verification, and its ability to meet specifications for radiation delivery.

Therefore, I cannot provide the requested information for an AI/ML device, as the provided text relates to a different type of medical device for radiation therapy.

If you have information about an AI/ML device and its associated acceptance criteria and study data, please provide that text.

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The Akesis Galaxy Rotating Gamma System, is a teletherapy device intended for the stereotactic irradiation of human head structures

The Galaxy Rotating Gamma System is a teletherapy device which contains 30 cobalt - 60 sources distributed on a hemispheric source carrier, which is inside a hemispheric shield. Inside the source unit is the "built in" secondary collimator, which has 4 sizes of collimators and 1 block position. When not treating a patient, all sources are aligned with the block position of the secondary collimator, which in this case acts as a radiation shutter Treatment starts by aligning the sources to the desired collimator size, then both the source unit and the secondary collimator rotates as one unit. By rotating the cobalt -60 y-ray beams during treatment, 30 non overlapping full 360° arcs are formed, resulting in high focal dose uniformity and small focal spot penumbra. The entire system consists of a) The v-ray treatment unit, and b) the stereotactic localization system.

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

Important Note: The provided document is a 510(k) summary for a medical device (Akesis Galaxy Rotating Gamma System). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical trial data or detailed performance metrics against specific acceptance criteria for diagnostic output. Therefore, many of the typical elements requested for AI/diagnostic device studies will either not be applicable or will have limited information.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) submission, explicit "acceptance criteria" against diagnostic performance metrics (like sensitivity, specificity, accuracy) are not provided in the document. Instead, the focus is on engineering performance, safety, and equivalence to a predicate device.

2. Sample Size Used for the Test Set and Data Provenance

No specific "test set" for diagnostic performance is mentioned as this device is a therapeutic radiation delivery system, not a diagnostic imaging or AI algorithm. The performance data provided relates to engineering and safety testing.

• Sample Size for Test Set: Not applicable in the context of diagnostic/AI performance testing. The "test sets" would be the units of the device itself undergoing various engineering and safety tests.
• Data Provenance: Not specified, but likely laboratory and manufacturing testing environments for engineering and safety verification.

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

Not applicable. This device does not establish a "ground truth" in the diagnostic sense, nor does it rely on human expert interpretation for its function. The "ground truth" for engineering and safety testing would be established by validated test procedures, reference standards, and regulatory requirements rather than expert consensus on medical images or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. There's no physician-based adjudication process for the engineering and safety performance of a radiation therapy system described here.

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

No. An MRMC study is typically for evaluating the diagnostic performance of an AI algorithm with and without human assistance. This device is a radiation therapy system, not a diagnostic AI tool, and thus such a study is not relevant or reported in this document.

6. Standalone (Algorithm Only) Performance Study

No. This is not an AI algorithm but a physical medical device. The "standalone performance" is implicitly covered by the engineering and safety tests described, demonstrating that the device functions according to its specifications.

7. Type of Ground Truth Used

For the engineering and safety tests, the "ground truth" consists of:

• Compliance with recognized international standards (e.g., ISO 10993-1, IEC 60601-1, IEC 60601-1-2, IEC 61217, 62274, 62366).
• Compliance with regulatory requirements (21 CFR §820).
• Conformance to the device's own internal design specifications and requirements.

8. Sample Size for the Training Set

Not applicable. This device is a hardware system, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no "training set."

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GammaPod™ is a teletherapy device intended for use in the noninvasive stereotactic delivery of a radiation dose to a partial volume of the breast in conjunction with breast conserving treatment.

The GammaPod™ is a teletherapy device that uses rotating, multi-source Cobalt-60 gamma-ray emitting sources to noninvasively deliver a focal dose of radiation to a partial volume of a human breast of a patient in the prone position while sparing the surrounding normal tissues and structures. The GammaPod system contains 4 main components: i. GammaPod irradiation unit, ii. Imager loader system, iii. Breast immobilization system, and iv. Treatment planning system.

The provided document is a 510(k) summary for the GammaPod™ - Model A, which is a teletherapy device. The submission focuses on a modification to an existing, previously cleared GammaPod device (K172706). The modification involves a change in the number of Cobalt 60 sources from 36 to 25.

Therefore, the acceptance criteria and study information provided pertains to the performance of this modified device compared to its predicate device, rather than a de novo establishment of performance for a completely new device. No clinical studies were conducted for this specific modification.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

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

Since this is a 510(k) for a modification to a predicate device, the "acceptance criteria" are primarily based on demonstrating that the modified device is substantially equivalent to the predicate device and meets established safety and performance standards despite the change in source configuration. The reported performance focuses on showing that the modification maintains the existing performance characteristics.

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 explicitly states: "No clinical testing was conducted for the current device modification." Therefore, there is no clinical test set, clinical sample size, or related data provenance information for this submission. The testing was non-clinical.

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, as no clinical testing was conducted and no "ground truth" in the context of clinical expert review was established for this specific 510(k) modification. The evaluation was based on engineering and physics testing.

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

Not applicable, as no clinical test set was used requiring adjudication.

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 teletherapy system, not an AI-assisted diagnostic tool that would involve human readers interpreting images.

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

This refers to the performance of the device's systems (e.g., the treatment planning system and the irradiation unit's dose delivery) in a controlled, non-clinical setting. The document indicates that such testing was done.

• Treatment Planning System Software Testing: "Testing of the treatment planning system software was conducted to verify accuracy of treatment plans based on the 25-source configuration."
• Radiation Tests: "Radiation tests including radiation safety measures and radiation dosimetric accuracy were conducted to demonstrate compliance with the requirements of the NRC and IEC 60601-2-11."
• Leakage Profile: "The measured radiation leakage profile of the modified GammaPod remains far below the recommended levels of IEC 60601-2-11 and NCRP Report #102."

These tests demonstrate standalone performance regarding the accuracy of dose planning and delivery, and radiation safety, for the modified 25-source configuration.

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

For the non-clinical tests, the "ground truth" was based on:

• Established engineering principles and physics: For dosimetric accuracy and radiation safety.
• Design specifications and calculations: Expected dose distributions and leakage levels based on the new 25-source configuration.
• Regulatory standards: NRC requirements and international standards like IEC 60601-2-11 for radiation safety and performance.

8. The sample size for the training set

Not applicable. This 510(k) submission describes a physical hardware modification and associated software verification. It does not mention any machine learning or AI components that would require a "training set" in the conventional sense for a diagnostic device.

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

Not applicable, as there is no mention of a training set for machine learning or AI models. The verification and validation were based on engineering tests and compliance with established physical and regulatory standards.

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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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