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TrueBeam-TrueBeam STx-Edge: The TrueBeam™, TrueBeam STx and Edge™ Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere radiation therapy is indicated for adults and pediatric patients. The TrueBeam, TrueBeam STx, and Edge Systems may be used in the delivery of radiation for treatment that includes: brain and spine tumors (such as glioma, meningioma, pitutary tumors, spinal cord tumors, hemangioblastoma, orbital tumors, ocular tumors, and skull based tumors), head and neck tumors (such as unknown primary of the head and neck, oral cavity, hypopharynx, nasopharynx, sinonasal, salivary gland, and thyroid cancer), thoracic tumors (such as lung cancer, thymic tumors, and mesothelioma), gynecologic tumors (such as ovarian, cervical, endometrial, vulvar, and vaginal), gastrointestinal tumors (such as gastric, pancreatic, hepatobiliary, colon, rectal, and anal carcinoma), genitourinary tumors (such as prostate, bladder, testicular, and kidney), breast tumors, sarcomas, lymphoid tumors (such as Hodgkin's and non-Hodgkin's lymphoma), skin cancers (such as squamous cell, and melanoma), benign diseases (such as schwannoma, arteriovenous malformation, cavernous malformation, trigeminal neuralgia, chordoma, gand hemangiomas), metastasis (including all parts of the body such as brain, bone, liver, lung, kidney, and skin) and pediatric tumors (such as glioma, ependymoma, pituitary tumors, hemangioblastoma, meningioma, metastasis, meduloblastoma, nasopharyngeal tumors, arteriovenous malformation, and skull base tumors), and medically refractory essential tremor (indicated for adults only).

VitalBeam: VitalBeam® is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediative patients. VitalBeam may be used in the delivery of radiation for treatment that includes: brain and spine tumors (such as glioma, meningioma, craniopharyngiona, pituitary tumors, spinal cord tumors, hemangioblastoma, orbital tumors, optic nerve tumors, and skull based tumors), head and neck tumors (such as unknown primary of the head and neck, oral cavity, hypopharynx, larynx, oropharynx, sinonasal, salivary gland, and thyroid cancer), thoracic tumors (such as lung cancer, esophageal cancer, thymic tumors, and mesothelioma), gynecologic tumors (such as ovarian, cervical, endometrial, vulvar, and vaginal), gastrointestinal tumors (such as gastric, pancreatic, hepatobiliary, colon, rectal, and anal carcinoma), genitourinary tumors (such as prostate, bladder, testicular, and kidney), breast tumors, sarcomas, lymphoid tumors (such as Hodgkin's and non-Hodgkin's lymphoma), skin cancers (such as squamous cell, and melanoma), benign diseases (such as schwannoma, arteriovenous malformation, cavernous malformation, trigeminal neuralgia, chordoma, glomus tumors, and hemangiomas), metastasis (including all parts of the body such as brain, bone, liver, lung, kidney, and skin) and pediatric tumors (such as glioma, pituitary tumors, hemangioblastoma, craniopharyngioma, meningioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformation, cavernous malformation, and skull base tumors).

The TrueBeam and VitalBeam Radiotherapy System is a medical linear accelerator that delivered therapeutic radiation to patient in accordance with the physician's prescription.

The system consists of two major components – a photon, electron and diagnostic kV X-ray radiation beam producing component that is installed in a radiation-shielded vault and a control console area located outside the treatment room.

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria for an AI/ML component. The document is a 510(k) summary for Varian Medical Systems' TrueBeam, TrueBeam STx, Edge, and VitalBeam radiotherapy systems (K231317).

It focuses on demonstrating substantial equivalence to a predicate device (K213977) by outlining the device's intended use, indications for use, technological characteristics, and compliance with various safety and performance standards. It explicitly states: "No animal or clinical tests are being submitted to establish substantial equivalence with the predicate device."

Therefore, I cannot fulfill your request for:

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

The document discusses hardware and software verification and validation, human factors validation, and electrical safety/EMC testing, all against established standards, but not a specific study evaluating an AI/ML component against performance acceptance criteria. The "Templated-based fiducial detection algorithm for Auto Beam Hold" is mentioned as a new feature, suggesting an algorithmic component, but no specific performance study for this algorithm is detailed in the provided summary.

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TrueBeam-TrueBeam STx-Edge: The TrueBeam™, TrueBeam STx and Edge™ Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere radiation therapy is indicated for adults and pediatric patients. The TrueBeam, TrueBeam STx, and Edge Systems may be used in the delivery of radiation for treatment that includes: brain and spine tumors (such as glioma, meningioma, craniopharyngioma, pituitary tumors, hemangioblastoma, orbital tumors, ocular tumors, optic nerve tumors, and skull based tumors), head and neck tumors (such as unknown primary of the head and neck, oral cavity, hypopharynx, nasopharynx, nasopharynx, sinonasal, salivary gland, and thyroid cancer), thoracic tumors (such as lung cancer, esophageal cancer, thymic tumors, and mesothelioma), gynecologic tumors (such as ovarian, cervical, endometrial, vulvar, and vaginal), gastrointestinal tumors (such as gastric, pancreatic, hepatobiliary, colon, rectal, and anal carvinoma), gentourinary tumors (such as prostate, bladder, testicular, and kidney), breast tumors, sarcomas, lymphoid tumors (such as Hodgkin's and non-Hodgkin's lymphoma), skin cancers (such as squamous cell, and melanoma), benign diseases (such as schwannoma, arteriovenous malformation, cavernous malformation, trigeminal neuralgia, chordoma, glomus tumors, and hemangiomas), metastasis (including all parts of the body such as brain, bone, liver, lung, kidney, and pediatric tumors (such as glioma, ependymoma, pituitary tumors, hemangioblastoma, meningioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformation, avernous malformation, and skull base tumors), and medically refractory essential tremor (indicated for adults only). VitalBeam: VitalBeam® is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients. VitalBeam may be used in the delivery of radiation for treatment that includes: brain and spine tumors (such as glioma, meningioma, craniopharyngioma, pitutary tumors, spinal cord tumors, hemangioblastoma, orbital tumors, optic nerve tumors, and skull based tumors), head and neck tumors (such as unknown primary of the head and neck, oral cavity, hypopharynx, larynx, oropharynx, sinonasal, salivary gland, and thyroid cancer), thoracic tumors (such as lung cancer, esophageal cancer, thymic tumors, and mesothelioma), gynecologic tumors (such as ovarian, cervical, endometrial, vulvar, and vaginal), gastrointestinal turnors (such as gastric, pancreatic, hepatobiliary, colon, rectal, and anal carcinoma), genitourinary tumors (such as prostate, bladder, testicular, and kidney), breast tumors, sarcomas, lymphoid tumors (such as Hodgkin's and non-Hodgkin's lymphoma), skin cancers (such as squamous cell, basal cell, and melanoma), benign diseases (such as schwannoma, arteriovenous malformation, trigeminal neuralgia, chordoma, glomus tumors, and hemangiomas), metastasis (including all parts of the body such as brain, bone, liver, lung, kidney, and skin) and pediatric tumors (such as glioma, pituitary tumors, hemangioblastoma, craniopharyngioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformation, cavernous malformation, and skull base tumors).

The TrueBeam and VitalBeam Radiotherapy System is a medical linear accelerator that delivered therapeutic radiation to patient in accordance with the physician's prescription. The system consists of two major components – a photon, electron and diagnostic kV X-ray radiation beam producing component that is installed in a radiation-shielded vault and a control console area located outside the treatment room.

The provided text is a 510(k) Premarket Notification summary for the Varian Medical Systems TrueBeam™, TrueBeam STx™, Edge™, and VitalBeam radiotherapy delivery systems. This submission primarily focuses on expanding the indications for use to include "medically refractory essential tremor" for the TrueBeam™, TrueBeam STx™, and Edge™ Systems.

The document states that the subject device has the same technological characteristics as its previously cleared predicate device (K213977). Therefore, the provided text does not describe a new study to prove the device meets acceptance criteria for a newly designed or significantly modified product. Instead, it relies on the previously established performance, safety, and effectiveness of the predicate device and a literature review to support the expanded indication.

Here's an analysis based on the information provided, recognizing that it's a 510(k) for an expanded indication rather than a de novo submission for a new device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a specific table of acceptance criteria with numerical performance targets (e.g., accuracy, precision) for the device itself and its reported performance as these were established during the clearance of the predicate device (K213977).

Instead, the "Summary of Performance Testing" for the current submission K223839 states:

The "acceptance criteria" here implicitly refer to the continued safety and effectiveness of the device for its core functions, as established by the predicate device, and the literature-supported safety and efficacy of Stereotactic Radiosurgery (SRS) for medically refractory essential tremor when delivered by a linear accelerator.

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

• For the device's core performance: Not applicable to this specific submission, as it relies on previous testing of the predicate device (K213977).
• For the expanded indication (medically refractory essential tremor): The "Summary of Clinical Data" mentions a literature review of over 1300 patients treated with SRS for tremor conditions.
  • Data Provenance: The data comes from published literature, implying a retrospective compilation of studies that likely originated from various countries and institutions. The document does not specify particular countries or whether the studies were prospective or retrospective, but typical clinical literature reviews will encompass both.

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

• For the device's core performance: Not applicable to this specific submission as it relies on the predicate.
• For the expanded indication: The "ground truth" for the efficacy and safety of SRS for tremor conditions is established through published clinical outcomes. The decision to include "medically refractory essential tremor" as an indication is based on a review of these published studies. The document does not explicitly state how many experts conducted this literature review for Varian, nor their specific qualifications. However, such reviews are typically conducted by regulatory affairs professionals, sometimes with input from clinical experts (e.g., radiation oncologists, neurosurgeons) who would understand the clinical context and outcomes.

4. Adjudication Method for the Test Set:

Not applicable. This submission relies on a literature review of outcomes for an existing therapy, not on a new test set requiring multi-reader adjudication of images or data.

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

No, an MRMC comparative effectiveness study was not done as described in this document. The submission is not about human readers improving with AI assistance; it's about the safety and efficacy of a medical linear accelerator system for an expanded treatment indication.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

Not applicable. This device is a radiotherapy delivery system, a hardware and software system that always involves human operators (radiation oncologists, medical physicists, radiation therapists) in its use for treatment planning and delivery. It is not an "algorithm-only" diagnostic AI device.

7. Type of Ground Truth Used:

• For the device's core performance: Not explicitly stated in this document but would typically involve physical measurements, phantom studies, and possibly clinical outcome data from previous device versions/studies.
• For the expanded indication (medically refractory essential tremor): Clinical outcomes data from a literature review. This includes reported tremor improvement and complication rates from published studies using both linear accelerators and Gamma Knife for SRS treatment of tremor.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set in the typical sense. The "training" for the device's functionality would have been part of its original development and testing (for the predicate device), but this submission does not describe an AI training process.

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

Not applicable, as there is no mention of a training set for an AI/ML model in this submission.

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TrueBeam-TrueBeam STx-Edge:
The TrueBeam, TrueBeam STx, and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere radiation therapy is indicated for adults and pediatric patients.
The TrueBeam, TrueBeam STx, and Edge Systems may be used in the delivery of radiation for treatment that includes: brain and spine tumors (such as glioma, meningioma, craniopharyngioma, pituitary tumors, spinal cord tumors, hemangioblastoma, orbital tumors, ocular tumors, optic nerve tumors, and skull based tumors), head and neck tumors (such as unknown primary of the head and neck, oral cavity, hypopharynx, nasopharynx, sinonasal, salivary gland, and thyroid cancer), thoracic turnors (such as lung cancer, esophageal cancer, thymic tumors, and mesothelioma), gynecologic tumors (such as ovarian, cervical, endometrial, vulvar, and vaginal), gastrointestinal tumors (such as gastric, pancreatic, hepatobiliary, colon, rectal, and anal carcinoma), genitourinary tumors (such as prostate, bladder, testicular, and kidney), breast turnors, sarcomas, lymphoid tumors (such as Hodgkin's and non-Hodgkin's lymphoma), skin cancers (such as squamous cell, basal cell, and melanoma), benign diseases (such as schwannoma, arteriovenous malformation, cavernous malformation, trigeminal neuralgia, chordoma, glomus tumors, and hemangiomas), metastasis (including all parts of the body such as brain, bone, liver, lung, kidney, and skin) and pediatric tumors (such as glioma, ependymoma, pituitary tumors, hemangioblastoma, meningioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformation, and skull base tumors).

VitalBeam:
VitalBeam® is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.
VitalBeam may be used in the delivery of radiation for treatment that includes: brain and spine tumors (such as glioma. meningioma, craniopharyngioma, pituitary tumors, spinal cord tumors, hemangioblastoma, orbital tumors, optic nerve tumors, and skull based tumors), head and neck tumors primary of the head and neck, oral cavity, hypopharynx, larynx, oropharynx, sinonasal, salivary gland, and thyroid cancer), thoracic tumors (such as lung cancer, esophageal cancer, thymic tumors, and mesothelioma), gynecologic tumors (such as ovarian, cervical, endometrial, vulvar, and vaginal), gastrointestinal tumors (such as gastric, pancreatic, hepatobiliary, colon, rectal, and anal carcinoma), genitourinary tumors (such as prostate, bladder, testicular, and kidney), breast tumors, sarcomas, lymphoid tumors (such as Hodgkin's and non-Hodgkin's lymphoma), skin cancers (such as squamous cell, basal cell, and melanoma), benign diseases (such as schwannoma, arteriovenous malformation, trigeminal neuralgia, chordoma, glomus tumors, and hemangiomas), metastasis (including all parts of the body such as brain, bone, liver, lung, kidney, and skin) and pediatric tumors (such as elioma, evendymoma, pituitary tumors. hemangioblastoma, craniopharyngioma, metastasis, medulloblastoma, nasopharyageal tumors, arteriovenous malformation, cavernous malformation, and skull base tumors).

The TrueBeam and VitalBeam Radiotherapy System is a medical linear accelerator that delivered therapeutic radiation to patient in accordance with the physician's prescription.

Here's a summary of the acceptance criteria and the study information based on the provided text, formatted to your requests. However, please note that the document is a 510(k) summary for a radiotherapy system, which focuses on demonstrating substantial equivalence to a predicate device for regulatory approval. It is not a clinical study of an AI/ML device, and therefore many of the requested fields related to AI performance, ground truth establishment, and expert involvement are not applicable or not provided in this type of document.

Acceptance Criteria and Device Performance

This document describes a medical device (TrueBeam, TrueBeam STx, Edge, and VitalBeam radiotherapy systems) that has undergone updates. The "acceptance criteria" here refer to conformance to regulatory standards and a demonstration of substantial equivalence to a predicate device, rather than performance metrics for an AI algorithm. The performance is assessed through verification, validation, and safety standards testing.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is not an AI/ML device with specific performance metrics like sensitivity, specificity, or AUC, the "performance" here refers to compliance with safety and functional standards.

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

This document describes a regulatory submission for a radiotherapy system, not an AI/ML diagnostic or prognostic device that typically uses "test sets" of patient data for performance evaluation in the typical sense. The testing described is primarily hardware and software verification and validation, along with compliance to international standards. Therefore, information about a "sample size for a test set" or "data provenance" (country, retrospective/prospective) related to patient data for AI evaluation is not applicable and not provided in this document.

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

Given that this is not an AI/ML device being evaluated for diagnostic or prognostic accuracy on patient data, the concept of "ground truth" and "experts establishing ground truth" in the context of a "test set" is not applicable here. The "experts" involved would be engineers, physicists, and regulatory specialists confirming compliance with technical and safety standards.

4. Adjudication Method for the Test Set

As this is not an AI/ML study involving human interpretation of data where adjudication is needed, an "adjudication method" is not applicable and not described in the document.

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

No, an MRMC comparative effectiveness study comparing human readers with and without AI assistance was not done and is not relevant for this type of medical device submission. This document pertains to a radiotherapy treatment delivery system, not an AI-assisted diagnostic or interpretation tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

This is not applicable as the TrueBeam is a medical linear accelerator for radiation therapy delivery, not an AI algorithm intended for standalone performance evaluation in the way this question implies. Any "algorithms" (e.g., iCBCT reconstruction) are components of the system, and their performance is evaluated as part of the overall system's functional and safety requirements, not as standalone AI products.

7. The Type of Ground Truth Used

The "ground truth" in this context is the adherence to established engineering, safety, and regulatory standards, along with the device's functional specifications. It's established through:

• Engineering specifications and design documents: Dictating how the device should perform.
• International Consensus Standards: Like IEC 60601 series, IEC 62304, ISO 13485, ISO 14971, which define safety and performance requirements.
• Verification and Validation Testing: Empirical testing to confirm the device meets these specifications and standards.
• Clinical use (implied/previous predicate data): The safety and efficacy of radiation therapy itself, and the predicate device, form the basis. The current submission demonstrates that the updated device maintains that safety and efficacy.

It is not expert consensus on patient pathology, or outcomes data in the sense of a clinical trial for a novel AI diagnostic.

8. The Sample Size for the Training Set

This is not applicable as the device is not an AI/ML system that undergoes "training" on a dataset in the typical machine learning sense. The development of the device follows traditional engineering design, verification, and validation processes. While some components like the iCBCT algorithm might involve data for development, the concept of a "training set" for the whole system, as understood for AI, isn't present in this document.

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

Since there is no "training set" in the AI/ML context for the device as a whole, this question is not applicable. In the case of component algorithms (like iCBCT), any "ground truth" for their development would be based on known physics, simulation data, and expert validation of imaging quality, but this detail is not provided in a 510(k) summary focused on substantial equivalence.

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