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The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

The UNIQUE is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, turnors and conditions anywhere in the body when radiation treatment is indicated.

The Varian Multileaf Collimator is intended to assist the clinician in the delivery of external beam radiation to defined target volumes during radiosurgery and radiotherapy while sparing surrounding normal tissue and critical organs from excess radiation.

The High Energy Linear Accelerator is a radiotherapy treatment unit. The equipment consists of a gantry, couch, stand and control console. The device is permanently installed. The radiotherapy treatment beam is generated by a linear accelerator assembly consisting of an electron gun, waveguide and collimator.

The UNIQUE is a radiotherapy treatment unit. The equipment consists of a gantry, couch, stand and control console. The device is permanently installed. The radiotherapy treatment beam is generated by a linear accelerator assembly consisting of an electron gun, waveguide and collimator.

The Varian Multileaf Collimator (MLC) is an accessory X-ray collimator designed to be mounted on a Varian radiotherapy linear accelerator. The MLC head is mounted on a Varian Linear Accelerator, where it shapes the radiation beam before it is delivered to the patient. The MLC head is permanently bolted onto the casting that holds the X-Jaws and Y-Jaws of the Varian Linear Accelerator gantry.

This document is a 510(k) premarket notification for a Varian Medical Systems linear accelerator and multileaf collimator. It explicitly states that no animal studies or clinical tests were included in this pre-market submission.

Therefore, based on the provided text, there is no information available to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the manner requested by the prompt. The submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical tests, software verification and validation, and regression testing, rather than clinical performance data.

Specifically, the document states:

• "No animal studies or clinical tests have been included in this pre-market submission."
• "Verification testing was performed to demonstrate that the performance and functionality of the new C-Series operating system and MLC controller existing features met the design input requirements for CCMC."
• "Regression testing was performed to verify the integrity of any changes."
• "Validation testing was performed on production equivalent devices, under clinically representative conditions by qualified personnel."

As such, I cannot provide the requested information about:

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

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The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

The Varian High Energy Linear Accelerator models provide various selections among the features, specifications, and accessories that have been most recently cleared as the Varian High Energy Linear Accelerator, K131807.

The High Energy Linear Accelerator is a radiotherapy treatment unit. The equipment consists of a gantry, couch, stand and control console. The device is permanently installed. The radiotherapy treatment beam is generated by a linear accelerator assembly consisting of an electron gun, waveguide and collimator.

The High Energy (HE) Linear Accelerator device is modified to provide a yield monitoring capability, which triggers an interlock in response to detected beam deviations when specific target hardware anomalies are present. The yield monitoring capability provides an additional check for unexpected changes in radiation beam output, beyond the existing beam checks and dosimetry interlocks provided by the dual ion chamber design. The purpose of the yield monitoring capability is to prevent an undetected decrease in dose output, which can occur in the case of failures within the target hardware. If such hardware failures are present, the yield monitoring capability triggers an interlock and treatment is prevented if 6X, 6FFF, or 6SRS beams do not meet specified output limits. For additional detail please see the Description of Modifications included in the submission.

The Primary Position Readout (PRO) and Secondary Position Readout (SPRO) are enhanced by the addition of a firmware check for polarity mismatch. The function of the PRO and SPRO remains unchanged. The enhancement provides a secondary check of the positions reported by the PRO and SPRO for all motion axes: jaws, gantry, couch and collimator. The firmware enhancement is an improvement that verifies the polarity of both the PRO and SPRO components, and notifies the user in the case of a polarity mismatch. Notifications continue until the polarity has been corrected.

All other features and technological characteristics of the Varian High Energy Linear Accelerator models remain as cleared by K131807.

The provided text does not contain information about acceptance criteria for device performance, nor details of a study proving the device meets acceptance criteria. The document is a 510(k) premarket notification for a Varian High Energy Linear Accelerator, focusing on showing substantial equivalence to a predicate device and outlining modifications.

Specifically, it states:

• "Clinical Tests No clinical tests have been included in this pre-market submission"
• "The non-clinical data support the safety of the device and the software verification and validation demonstrate that the High Energy Linear Accelerator device with the new yield interlock functionality and firmware check for polarity mismatch performs as intended."

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, or details of a study proving the device meets acceptance criteria using the provided text. The document indicates that the submission relies on non-clinical data and software verification/validation rather than a clinical performance study.

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The Varian High Energy Linear Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

The Varian High Energy Linear Accelerator models provide various selections among the features, specifications, and accessories that have been most recently cleared as the Varian High Energy Linear Accelerator, K100890.
The changes to the Varian High Energy Linear Accelerator provide support for treatments using the high intensity photon treatment mode, also known as FFF (Flattening Filter Free). Additionally, couch motion rules are modified to enable the use of patient support systems where the targeted anatomy and the treatment isocenter area below the surface of the couch top. Modifications that augment existing safety controls are also included.
All other features of the Varian High Energy Linear Accelerator models remain as cleared by K100890.

Here's a summary of the acceptance criteria and study information for the Varian High Energy Linear Accelerator, based on the provided 510(k) summary:

The 510(k) K112839 describes modifications to the Varian High Energy Linear Accelerator, primarily to support high-intensity photon treatment mode (FFF - Flattening Filter Free) and updated couch motion rules. The submission asserts substantial equivalence to its predicate device, K100890.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the functional and safety requirements, as well as compliance with applicable international standards. The performance is reported by demonstrating that the modified device functions equivalently or with improved safety features compared to the predicate device.

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

The document does not specify a "test set" in the context of clinical data or patient samples. The testing described is primarily bench testing for verification and validation of functional requirements, use cases, hazard mitigation, and compliance with international standards. Therefore, the concept of sample size and data provenance (country, retrospective/prospective) related to patient data is not applicable here.

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

Not applicable. This submission focuses on engineering and regulatory compliance testing of a medical device, not on diagnostic accuracy requiring expert interpretation of medical images or patient outcomes for a "ground truth" establishment.

4. Adjudication Method for the Test Set

Not applicable. As described above, the testing involved engineering verification and validation against pre-defined specifications and standards, not clinical adjudication of diagnostic or treatment outcomes by experts.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically used for AI-powered diagnostic devices to assess the impact of AI assistance on human reader performance. The Varian High Energy Linear Accelerator is a treatment delivery device, and the changes described relate to its operational capabilities and safety features, not to diagnostic image interpretation or AI assistance for human readers.

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

Not applicable. The device is a linear accelerator for radiation therapy, not a standalone AI algorithm. Its operation inherently involves human-in-the-loop (e.g., medical physicists, radiation oncologists, radiation therapists) for treatment planning and delivery. The "standalone" concept for an algorithm does not fit the nature of this device.

7. Type of Ground Truth Used

The "ground truth" for the performance testing effectively consisted of:

• Pre-defined specifications and functional requirements for the device.
• Hazard mitigation requirements based on risk analysis.
• Applicable international medical device standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-1).

The testing aimed to demonstrate that the device met these engineering and safety benchmarks, rather than clinical outcomes or pathological diagnoses.

8. Sample Size for the Training Set

Not applicable. The Varian High Energy Linear Accelerator is a hardware and software system for radiation therapy delivery. It does not utilize a "training set" in the machine learning sense for its operational functions as described in this submission. Its software development and configuration are based on established engineering principles and requirements, not statistical learning from a large dataset.

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

Not applicable, as there is no "training set" in the context of machine learning for this device. The software and hardware capabilities are developed and validated against engineering specifications and regulatory standards.

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The Varian High Energy Linear Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

The Varian High Energy Linear Accelerator models provide various selections among the features, specifications, and accessories that have been most recently cleared as Trilogy Radiotherapy Delivery System (K081188, K072916).

The 8.0 release of the C-Series control software provides additional features, safety improvements, and usability improvements.

All other features of the Varian High Energy Linear Accelerator models remain as cleared by K081188, K072916.

This document is a 510(k) summary for the Varian High Energy Linear Accelerator. It is a submission to the FDA to demonstrate substantial equivalence to a predicate device. This type of submission focuses on comparing the new device to an existing legally marketed device and typically doesn't involve clinical studies with acceptance criteria in the same way a novel device might.

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

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

The provided text does not contain explicit acceptance criteria or reported device performance in the context of a clinical study. This document is a 510(k) summary, which aims to prove substantial equivalence to a predicate device (Varian Trilogy Radiotherapy System: K081188, K072916). Substantial equivalence is typically demonstrated through:

• Comparison of technological characteristics: Showing the new device has the same intended use and similar technological characteristics, or that any differences do not raise new questions of safety and effectiveness.
• Performance testing (bench, non-clinical): Demonstrating that engineering specifications and safety requirements are met. This is usually detailed in the full 510(k) submission, not typically summarized with explicit "acceptance criteria" tables in the public summary.

Therefore, since no clinical study results with acceptance criteria are presented in the provided text, this table cannot be populated as requested.

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

Not applicable. No test set for a clinical study is described. The 510(k) summary indicates that the Varian High Energy Linear Accelerator models provide various selections among features, specifications, and accessories that have been most recently cleared as the Trilogy Radiotherapy Delivery System. The 8.0 release of the C-Series control software provides additional features, safety improvements, and usability improvements. The assessment is likely based on engineering and software validation rather than a clinical efficacy study with a patient test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. As no clinical study with a test set is described, there's no mention of experts establishing ground truth for such a set.

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

Not applicable. No test set is described for a clinical study requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The Varian High Energy Linear Accelerator is a medical device for radiation therapy delivery, not an AI-assisted diagnostic tool involving human readers. 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

Not applicable. This device is a linear accelerator, a hardware system for delivering radiation therapy, not a standalone algorithm.

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

Not applicable. No ground truth collection for a clinical study is described. The "ground truth" for a device like this would likely pertain to its technical specifications, calibration accuracy, dose delivery precision, and safety mechanisms, which are verified through engineering tests and validation, not clinical ground truth in the diagnostic sense.

8. The sample size for the training set

Not applicable. As this is not an AI/machine learning diagnostic or prognostic algorithm, there is no "training set" in the context of data used to train a model. Software development and hardware testing would involve various forms of internal testing and validation, but these are not referred to as "training sets."

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

Not applicable. As there is no training set mentioned, there is no ground truth established for it in the context of this 510(k) summary.

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