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TrueBeam-TrueBeam STx-Edge: The TrueBeam ™ radiotherapy delivery system is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

VitalBeam: The VitalBeam system is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

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 an AI/ML device or its acceptance criteria. Instead, it is an FDA 510(k) clearance letter for the Varian Medical Systems TrueBeam, TrueBeam STx, EDGE, and VitalBeam (4.1) radiation therapy systems.

The document discusses:

• Device Name & Regulation: TrueBeam, TrueBeam STx, EDGE, and VitalBeam (4.1), regulated as a Medical Charged-Particle Radiation Therapy System (21 CFR 892.5050, Class II, Product Code: IYE).
• Intended Use & Indications for Use: The devices are intended for stereotactic radiosurgery and precision radiotherapy for various lesions, tumors, and conditions throughout the body in adult and pediatric patients. A key update in version 4.1 is the incorporation of changes to the CBCT image reconstruction algorithm to allow for the use of CBCT images in the simulation and planning for adaptive radiation therapy. However, it explicitly states that TrueBeam v4.1 cannot deliver adaptive dosimetry on a real-time, per-fraction basis, but supports off-line adaptive treatment planning or delivery.
• Predicate Device: TrueBeam / TrueBeam STx / Edge / VitalBeam (K231317), which is version 4.0.
• Technological Characteristics: The subject device (v4.1) and predicate device (v4.0) share the same medical linear accelerator, couch, integrated treatment and imaging consoles, multi-leaf collimators, and supported treatment techniques. The significant difference is the software change to the CBCT image reconstruction algorithm for adaptive radiation therapy planning.
• Performance Data: Verification and validation of the modified software and hardware were conducted to assess image quality and dose calculation accuracy against planning CT images for suitability in adaptive planning. Software was considered a "major" level of concern. Human factors validation study was conducted per IEC 62366. The system complies with various IEC and ISO standards related to safety, EMC, quality management, risk management, and biocompatibility.
• Clinical Testing: No animal or clinical tests were submitted to establish substantial equivalence.

Since the device described is a medical linear accelerator for radiation therapy and not an AI/ML device, the specific questions regarding AI/ML acceptance criteria, test set details (sample size, provenance, expert adjudication, MRMC studies, standalone performance), ground truth, and training set details are not applicable to the provided text. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and compliance with regulatory standards for a radiation therapy system.

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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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The TrueBeam and Edge Systems are 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.

The TrueBeam 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 turnors (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 carcinomaly tumors (such as prostate, bladder, testicular, and kidney), breast tumors, sarcomas, lymphoid tumors (such as 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, craniopharyngioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformation, cavernous malformation and skull base tumors).

The TrueBeamTM Radiotherapy Delivery System is a medical linear accelerator that integrates the previously cleared Trilogy Radiotherapy system and associated accessories into a single device.

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 describes the regulatory clearance for the Varian TrueBeam, TrueBeam STx, and Edge Radiotherapy Delivery Systems but does not contain information about acceptance criteria or a study proving device performance against such criteria.

The document is a 510(k) premarket notification decision letter from the FDA, along with the device's Indications for Use and a 510(k) summary. It primarily addresses the substantial equivalence of the new devices to a previously cleared predicate device (K162472).

Here's what can be extracted and what is missing based on your request:

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

• Not provided. The document focuses on regulatory compliance and equivalence to a predicate device, not on specific performance metrics or acceptance criteria for a validation study.

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

• Not provided. There is no mention of a test set with patient data. The "testing" referred to is primarily hardware and software verification and validation, as well as adherence to safety standards.

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. This information is for studies involving interpretation or diagnosis, which is not the focus of this clearance document.

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

• Not applicable. As above, this is for studies involving interpretation or diagnosis.

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 radiotherapy delivery system, not an AI-assisted diagnostic or interpretive tool. Therefore, an MRMC study related to human reader performance with AI assistance is irrelevant to this submission.

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

• Not applicable. This is a hardware and software system for delivering radiation therapy, not a standalone algorithm in the sense of AI for diagnosis or interpretation. The document mentions software verification and validation, but this is for the control of the device, not for an autonomous diagnostic function.

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

• Not applicable. Ground truth, in the context of diagnostic or interpretive AI, is not relevant to this device's clearance. The "ground truth" for a radiotherapy delivery system would relate to its physical performance (e.g., dose delivery accuracy, beam shaping accuracy) which is assessed through engineering tests and phantom measurements, not human-read data.

8. The sample size for the training set:

• Not provided. This device is not an AI/ML model that would have a "training set" in the typical sense. Its software is developed and validated against requirements and specifications, not trained on data to learn a task.

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

• Not applicable. No training set as per the typical understanding of AI/ML.

Summary of available information related to validation/testing from the provided document:

• Type of Testing: Hardware and software verification and validation testing, as well as conformance to FDA Quality System Regulation (21 CFR §820), ISO 13485 (Quality Management System), ISO 14971 (Risk Management), and other FDA recognized consensus standards (listed in the table on page 4). This includes electrical safety (IEC 60601-1) and electromagnetic compatibility (IEC 60601-1-2).
• Software Level of Concern: The software for this device was considered "major" level of concern, meaning "A failure or latent flaw in the software could directly result in serious injury or death to the patient or operator."
• Conclusion: The tests demonstrated "conformance to applicable requirements specifications and assured hazard safeguards functioned properly." The conclusion states that the devices are substantially equivalent to their predicate device based on these tests.

In essence, the provided document is a regulatory approval notice based on demonstrating safety, effectiveness, and substantial equivalence to a predicate device through engineering validation and adherence to recognized standards, rather than a clinical performance study with specific acceptance criteria for diagnostic accuracy or similar metrics.

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The TrueBeam and Edge Systems are 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.

The TrueBeam 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, larynx, oropharynx, 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 carcinoma), genitourinary tumors (such as prostate, bladder, testicular, and kidney) 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, craniopharyngioma, meningioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformation, cavernous malformation and skull base tumors).

The TrueBeamTM Radiotherapy Delivery System is a medical linear accelerator. The system consists of two major components: 1) a photon, electron, and diagnostic kV X-ray radiation beam-producing component that is installed in a radiation-shielded vault in a healthcare facility and 2) a control console using the device software in an area located outside the treatment room.

Here's an analysis of the provided text regarding acceptance criteria and device performance evaluation, formatted to answer your specific questions.

Device: TrueBeam, TrueBeam STx, and Edge Radiotherapy Delivery System
Manufacturer: Varian Medical Systems, Inc.
FDA Submission: K162472
Date: January 19, 2017

It is important to note that the provided document is an FDA 510(k) clearance letter and associated summary, not a detailed study report. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting raw performance data against specific, quantifiable acceptance criteria in the manner one might find in a clinical trial or a more exhaustive performance study. The "performance testing" section primarily describes the types of testing conducted (e.g., hardware/software V&V, biocompatibility, electrical safety, EMC) and confirms that "passing criteria were met." It does not provide numerical performance metrics or specific acceptance thresholds for output parameters like dose accuracy, beam profile, or treatment delivery precision.

Therefore, the following answers are based on the information available in this specific document. Many of your questions, particularly those related to detailed AI/algorithm study design (like MRMC studies, ground truth establishment methods for large datasets, or specific expert qualifications for image-based diagnostics), are not applicable to this type of device (a radiotherapy delivery system) or the nature of this regulatory submission. This document describes a medical linear accelerator, which is a hardware-based radiation delivery system, not an AI/software diagnostic tool.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) summary for a radiotherapy delivery system, the "acceptance criteria" are not reported as specific performance metrics (e.g., accuracy, sensitivity, specificity) for a diagnostic algorithm. Instead, the acceptance criteria are implicit in the conformance to established standards, successful completion of verification and validation (V&V) testing, and demonstration of substantial equivalence to a predicate device. The document states that "passing criteria were met" for all tests.

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

This document does not describe a "test set" in the context of a dataset for an AI algorithm evaluation (e.g., images for classification). The testing described is primarily bench testing and verification and validation (V&V) of system functions. Therefore, there is no information on:

• The sample size of a specific test set (e.g., patient data).
• Data provenance (country of origin, retrospective/prospective) for a clinical dataset. The V&V testing typically involves engineering tests, phantom measurements, and software functionality checks, not necessarily a large patient cohort study for performance validation.

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

This information is not applicable to this type of device and submission. The ground truth for a radiotherapy delivery system's performance is typically established through:

• Physical measurements (e.g., dosimeters, ionization chambers) against known physical principles and standards.
• Engineering specifications and design documents.
• Mathematical models of radiation physics.
• Software testing against expected outputs.
• Comparison to existing, validated devices.

Clinical experts (like radiologists) are involved in defining the clinical indications for the device's use, but not in establishing "ground truth" for the device's technical performance in the way they would for an image-based diagnostic AI.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in studies involving human interpretation of medical images or clinical outcomes, where there can be inter-reader variability. The testing described for this device is physical and software-based V&V, not human-reader performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done or reported in this document. MRMC studies are specific to evaluating how AI assistance affects human reader performance with medical images. This device is a radiotherapy delivery system, not an imaging or diagnostic AI tool that assists human readers.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

While the device contains significant software components, the "standalone" performance concept (algorithm-only performance) as typically discussed for AI diagnostics is not applicable in the same way. The software controls the hardware to deliver radiation. The performance is assessed based on the accuracy and precision of the system's (hardware + software) delivered radiation, not an independent diagnostic output. The document states that "Software verification and validation bench testing were conducted. Results showed passing criteria were met..." This confirms the algorithm's functionality within the system.

7. The Type of Ground Truth Used

For a radiotherapy delivery system, the "ground truth" for performance evaluation is typically established through:

• Physics principles: Expected dose distribution, beam energy, and geometric accuracy based on fundamental physics.
• Reference standards: Calibrated measurement devices (e.g., electrometers, phantom materials).
• Predicate device comparison: Performance is compared to an existing, legally marketed device to demonstrate substantial equivalence.

It would not be expert consensus, pathology, or outcomes data in the context of device performance testing, though these are crucial for defining the clinical utility and safety in the broader context of radiation therapy.

8. The Sample Size for the Training Set

This information is not applicable. This is not an AI/machine learning device that relies on a "training set" of data in the common sense (e.g., labeled images for deep learning). The software within a linear accelerator is typically developed through traditional software engineering paradigms rather than data-driven machine learning models requiring large training datasets for feature extraction and model building.

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

As there is no "training set" in the context of machine learning, this question is not applicable.

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The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.

The TrueBeam and Edge Systems may be used in the delivery of radiation for treatment that includes: bram and spine tumors (such as glioma, meningioma, craniopharyngioma, pituitary tumors, spinal cord tumors, hemangioblastoma, orbital tumors, optic nerve tumors, and skull based 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 ung cancer, esophageal cancer, thymic tumors, and mesothelioma), gynecologic tumors (such as ovarian, endometrial, vulvar, and vaginal), gastrointestinal tumors (such as gastric, hepatobiliary, colon, rectal, and anal carcinoma), genitourinary tumors (such as prostate, bladder, testicular, and kidney), breast tumors, sarcomas, lymphoid tumors (such as Hodgkin's lymphoma), skin cancers (such as squamous cell, and melanoma), benign diseases (such as schwannoma, arteriovenous malformation, cavemous malformation, trigeninal 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, pitutary tumors, hemangioblastoma, craniopharyngioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformation, cavernous malformation and skull base tumors).

The TrueBeamTM Radiotherapy Delivery System is a medical linear accelerator that integrates the previously cleared Trilogy Radiotherapy system and associated accessories into a single device.

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.

This document describes the regulatory submission for the TrueBeam and Edge Radiotherapy Delivery System. The acceptance criteria and supporting studies are based on performance testing and adherence to recognized standards, rather than direct clinical performance data from a specific study with clearly defined performance goals like sensitivity/specificity.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document extensively references hardware and software verification and validation testing, biocompatibility evaluation, and electrical safety and EMC testing. These types of tests typically involve controlled laboratory environments and specific test protocols rather than human patient data sets in the way clinical studies for diagnostic algorithms would.

• Test Set Sample Size: The document does not specify a "sample size" in terms of patient data. Instead, the "sample" for testing would be the device itself and its components. For software testing, it would involve test cases and scenarios designed to cover various functionalities and potential failure modes. For hardware, it would be the physical units and their sub-assemblies. The scale of these tests is not quantified in the provided text.
• Data Provenance: Not applicable in the context of patient data. The provenance relates to the testing environment and standards adherence rather than patient demographics or origin.

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)

This information is not provided. For this type of device (a radiotherapy delivery system), "ground truth" is established through engineering specifications, scientific principles, and adherence to recognized standards for performance, safety, and effectiveness, not through expert consensus on medical images or patient outcomes in the same way an AI diagnostic device would.

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

Not applicable. As described above, the "test set" refers to engineering and software validation, not a clinical study involving expert adjudication of medical findings.

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 is a radiotherapy delivery system, not an AI-assisted diagnostic tool designed to be used by human readers for interpretation. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device.

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

This is not an "algorithm only" device in the sense of a diagnostic AI. It is a medical device system that includes algorithms for its operation and control. The performance described here is the integrated system's conformance to safety and performance standards, which implicitly includes the performance of its internal algorithms as part of the overall system. The testing described (hardware and software verification/validation) assesses the device's standalone performance according to its specifications.

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

The "ground truth" for this device's validation is established by:

• Engineering specifications and design requirements: The device is designed to meet specific technical parameters and safely deliver radiation.
• International and national standards: Compliance with standards like IEC 60601 series, ISO 13485, ISO 14971, ISO 10993-1, and FDA's quality system regulations. These standards define accepted benchmarks for safety, performance, and manufacturing quality.
• Predicate device equivalence: The device is considered "substantially equivalent" to an already cleared device (K1405528), meaning its performance characteristics are comparable and it raises no new questions of safety or effectiveness.

8. The sample size for the training set

Not applicable. This document describes a medical device, not a machine learning model that requires a "training set" of data for learning.

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

Not applicable, as there is no "training set" for this type of device.

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TrueBeam is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

The TrueBeam™ Radiotherapy Delivery System is a medical linear accelerator that integrates the previously cleared Trilogy Radiotherapy system and associated accessories into a single device. 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 K123291 - Premarket Notification [510(k)] Summary TrueBeam Radiotherapy Treatment System is a 510(k) premarket notification for a medical device. This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed studies with acceptance criteria and performance metrics for novel functionalities.

Therefore, the requested information regarding acceptance criteria and a study proving device performance (including sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance) is not available in the provided text.

The document states:

• "Summary of performance testing: Results of verification and validation testing showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly."

This is a general statement indicating that testing was performed, but it does not provide the specific acceptance criteria, method of testing, or detailed performance results that would allow for the completion of the requested table and study breakdown. The focus of this 510(k) is on the "Technological Characteristics" compared to a predicate device, highlighting changes like the addition of a 6 rotational Couch, 2D/3D Matching, 4D CBCT, Multi-scan CBCT Acquisition, and Motion Management Interface (MMI), rather than presenting a performance study for these new features against specific clinical endpoints.

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The TrueBeam ™ system is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

The TrueBeam™ Radiotherapy Delivery System is a medical linear accelerator that integrates the previously cleared Trilogy Radiotherapy system and associated accessories into a single device. 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.

Here's an analysis of the provided text regarding the TrueBeam Radiotherapy Treatment System.

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It does not contain the detailed performance study results that would typically include specific acceptance criteria and performance metrics for a novel AI/software device. Medical linear accelerators like the TrueBeam are complex systems with established engineering and physics-based performance standards, which are evaluated through extensive verification and validation (V&V) testing. The summary confirms that such testing was done, but doesn't elaborate on the specific acceptance criteria or quantitative results as one might expect for a diagnostic AI product.

Therefore, many of the requested fields regarding detailed study design (like sample size for test sets, ground truth establishment, expert qualifications, MRMC studies) are not present in this type of regulatory document for this kind of device. I will indicate where information is not available.

Acceptance Criteria and Device Performance for TrueBeam Radiotherapy Treatment System

However, specific quantitative acceptance criteria (e.g., "accuracy > 95%", "sensitivity > X") and corresponding reported device performance metrics are not detailed in this 510(k) summary. For a medical linear accelerator, acceptance criteria would typically involve precise measurements of radiation beam characteristics (e.g., dose output, flatness, symmetry), mechanical precision (e.g., gantry rotation accuracy, collimator alignment, couch positioning), safety interlocks, and software functionality. These are engineering and physics-based performance criteria rather than typical "AI performance metrics" (like AUC, sensitivity, specificity). |
| 2 | Sample Size for Test Set and Data Provenance | Not applicable/not provided. The "test set" concept, as typically applied to AI or diagnostic algorithms using patient data, does not directly apply here in the same way. The performance testing for a radiotherapy system involves physical measurements, simulations, and system-level validation, not typically a "test set" of patient cases with associated ground truth for a diagnostic output. |
| 3 | Number of Experts and Qualifications for Ground Truth | Not applicable/not provided. Ground truth for a radiotherapy device's performance would be established through physical dosimetry, imaging phantoms, and engineering specifications, often validated by medical physicists and engineers, rather than a panel of clinicians establishing "ground truth" on patient cases in an AI context. |
| 4 | Adjudication Method for Test Set | Not applicable/not provided. See point 2 and 3. |
| 5 | MRMC Comparative Effectiveness Study | No. This is a hardware/software system for radiation delivery, not a diagnostic AI tool that assists human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device. |
| 6 | Standalone Performance Study (Algorithm Only) | The core functionality of a linear accelerator is inherently "standalone" in its physical operation, delivering radiation based on a treatment plan. The "summary of performance testing" implies a standalone evaluation of the TrueBeam system's components and integrated function against specifications. This is not an "algorithm-only" standalone performance in the sense of a pure AI diagnostic tool, but rather the integrated system's performance. The document states "Results of verification and validation testing showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly." This confirms standalone performance evaluation against defined requirements. |
| 7 | Type of Ground Truth Used | For the performance of a medical linear accelerator, ground truth would be based on:

• Engineering Specifications: Design limits and required performance parameters.
• Physical Measurements: Dosimetry data (e.g., ion chamber, film, diode measurements) for radiation output, field shape, and dose distribution in phantoms.
• Imaging Phantoms: For kV imaging system accuracy (spatial resolution, contrast, artifact levels).
• Safety Standards: Compliance with electrical, mechanical, and radiation safety codes.
  The document does not explicitly detail these, but they are standard for such devices. |
  | 8 | Sample Size for Training Set | Not applicable/not provided. This device is a complex electromechanical system with integrated software, not an AI model trained on a "training set" of data in the typical machine learning sense. Its functionality is based on deterministic engineering, physics principles, and validated control algorithms, not statistical learning from a large dataset. |
  | 9 | How Ground Truth for Training Set Was Established | Not applicable/not provided. See point 8. |

Summary of Study:

The provided 510(k) summary for the TrueBeam Radiotherapy Treatment System describes a medical linear accelerator that integrates components of a previously cleared device (Trilogy Mx Radiotherapy System). The "study" proving the device meets acceptance criteria is the comprehensive verification and validation (V&V) testing performed by Varian Medical Systems. This testing is standard for medical devices and ensures that the device meets its design specifications, performs as intended, and adheres to safety requirements.

The document indicates that "Results of verification and validation testing showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly." This statement serves as the proof specified in the context of the 510(k) submission. However, it does not provide the granular details of those tests, the specific quantitative acceptance criteria, or the exact performance numbers that would be found in detailed engineering and testing reports.

The key changes from the predicate device involved:

• Expansion of energy used (4-25MV vs. 6-25MV).
• Addition of LaserGuard II.
• Addition of a supplemental capacitive collision detection system (kV CCDS) on the kV source for enhanced proximity detection.

The 510(k) process is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing exhaustive clinical efficacy studies for a novel technology (which would typically require a PMA). The regulatory approval (K111106) confirms the FDA's agreement that the TrueBeam system is substantially equivalent to existing devices and can be marketed.

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