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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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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 (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, 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, ependymoma, pituitary tumors, hemangioblastoma, craniopharyngioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformation, cavernous malformation and skull base tumors).

VitalBeam is a medical linear accelerator.

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 VitalBeam device is a medical linear accelerator for radiation therapy. The provided document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed study results for acceptance criteria in the way a clinical trial for a new drug or diagnostic might.

Based on the provided information, the acceptance criteria and performance are related to engineering and safety standards, as well as verification and validation (V&V) testing. There is no information about clinical performance or studies involving human readers, training sets, or ground truth established by experts in the context of AI or diagnostic performance metrics like sensitivity/specificity.

Here's an analysis of the provided text in relation to your request:

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

The document does not explicitly present a table of clinical acceptance criteria (e.g., sensitivity, specificity, accuracy) and corresponding device performance values. Instead, it focuses on adherence to engineering and safety standards.

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 describes "Hardware and software verification and validation bench testing." This implies internal engineering tests, rather than a clinical study with patients or patient data. Specific sample sizes for these bench tests are not provided, nor is information about the provenance of any "data" in the context of clinical images or patient data (as this is an equipment submission, not an AI diagnostic algorithm).

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 applicable to the type of safety and engineering testing described in the 510(k) summary for a linear accelerator. The "ground truth" here refers to whether the device meets its engineering specifications, not a medical diagnosis.

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

Not applicable. This is not a study assessing diagnostic performance requiring adjudication of labels.

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. The VitalBeam is a radiation therapy delivery system, not an AI diagnostic or assistive tool for human readers. The document highlights new features like 'Hyperarc™ new automated treatment type' and 'CBCT changes' which involve advanced imaging and treatment delivery techniques. While these are technological advancements, their evaluation in this 510(k) does not involve MRMC studies in the typical sense of AI diagnostics.

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

The document describes "Software verification and validation testing" for a "major" level of concern software. This testing demonstrates the software's ability to function correctly according to its specifications. While this is testing the "algorithm only" in a sense, it's about the performance of the machine control software, not a diagnostic algorithm where "standalone" performance typically refers to metrics like AUC, sensitivity, or specificity.

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

The "ground truth" for the verification and validation (V&V) testing involved adherence to engineering specifications and safety standards. For example, ensuring that radiation doses are delivered accurately, safety interlocks function as designed, and imaging systems perform within established parameters. This is verified against engineering and physics principles, not medical diagnostic ground truths like pathology.

8. The sample size for the training set

Not applicable. This is a V&V summary for a medical device (linear accelerator), not an AI algorithm development where a specific training set size would be relevant.

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 algorithm.

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The VitalBeam System is intended to provide stereotactic radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.

The VitalBeam System 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, 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), gastrontestinal tumors (such as gastric, hepatobiliary, colon, rectal, and anal carcinoma), genitourinary tumors (such as prostate, bladder, testicular, and kidney), breast tumors, sarcomas, lymphoid turnors (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 VitalBeam™ Radiotherapy Delivery System is a medical linear accelerator based on the previously cleared TrueBeam Radiotherapy system and associated accessories.

The system consists of two major components: a beam-producing component that is installed in a radiation-shielded vault (hereafter referred to as the treatment room) and a control console located outside the treatment room.

The provided text describes the VitalBeam Radiotherapy Delivery System, a medical linear accelerator system. It is a 510(k) premarket notification, indicating that the device aims to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission focuses on comparing the new device's safety and effectiveness to a predicate, rather than providing a detailed study proving the device meets specific acceptance criteria in the manner of a diagnostic AI device.

Therefore, much of the requested information (acceptance criteria for performance metrics, sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance for AI, etc.) is not present in this document because it pertains to the performance evaluation of a diagnostic or algorithmic device, not a therapeutic hardware device like a linear accelerator.

The document mostly discusses the device's technical specifications, intended use, indications for use, and a comparison to a predicate device based on features and adherence to recognized standards.

Here's an attempt to answer the questions based on the provided text, highlighting what is available and what is not:

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

The document does not explicitly present a table of acceptance criteria for specific performance metrics (e.g., sensitivity, specificity, accuracy) paired with reported performance results as would be typical for a diagnostic algorithm. Instead, the "acceptance criteria" for a radiotherapy delivery system in a 510(k) context largely revolve around demonstrating substantial equivalence to a predicate device and conformance to applicable safety and performance standards.

The document states:

• Acceptance Criteria (Implicit): Conformance to applicable requirements specifications, assurance of hazard safeguards functioning properly, and compliance with recognized consensus standards (listed below). The ultimate "acceptance criterion" for 510(k) clearance is demonstrating that the device is as safe and effective as a legally marketed predicate.
• Reported Device Performance: "Results of verification and validation testing showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly."

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

This information is not provided. The document describes a medical device (linear accelerator) for delivering radiation, not a diagnostic algorithm that would typically use test data sets of patient images or clinical records. The "testing" mentioned is likely engineering verification and validation testing of the hardware and software components, not clinical data analysis in the sense of AI performance evaluation.

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 applicable and is not provided. The device described is a radiotherapy delivery system, not a diagnostic tool requiring expert-established ground truth for a test set.

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

This information is not applicable and is not provided for the same reasons as above.

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

This information is not applicable and is not provided, as the VitalBeam Radiotherapy Delivery System is not a diagnostic AI device that would assist human readers.

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

This information is not applicable and is not provided. The VitalBeam is a hardware system for delivering radiation therapy, not a standalone algorithm.

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

This information is not applicable and is not provided. "Ground truth" in the context of diagnostic performance is not relevant for this type of device submission.

8. The sample size for the training set

This information is not applicable and is not provided. The device is a hardware system, not an AI model that would have a "training set."

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

This information is not applicable and is not provided for the same reasons as above.

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