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The TrueBeam and Edge Systems are intended to provide stereotactic radiotherapy for lesions, 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 carvinoma), 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 TrueBeam™ and Edge™ Radiotherapy Delivery Systems are medical linear accelerators that integrate 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 is a 510(k) Premarket Notification for the TrueBeam/Edge Radiotherapy Delivery Systems from Varian Medical Systems, Inc. The purpose of this submission is to demonstrate substantial equivalence to previously cleared predicate devices.

The document states that no changes have been made to the device and no new testing has been performed. This implies that the current submission relies on the performance data and acceptance criteria established for the predicate devices. Therefore, the specific details regarding acceptance criteria and a study proving the device meets them are not explicitly provided for this specific submission. Instead, the submission asserts that the device is substantially equivalent to previously cleared devices which would have undergone such scrutiny.

Based on the provided text, here is what can be inferred and what information is not available:

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

• Not explicitly provided in this document for the current submission. The document states, "No changes have been made to the device and no new testing has been performed." This implies reliance on previous testing and acceptance criteria for predicate devices like K123291 (TrueBeam Radiotherapy System and Accessories).

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

• Not available in this document. Since no new testing was performed for this submission, these details would be found in the documentation for the predicate devices.

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 available in this document. As no new testing was performed, this information is not included here. This would have been established during the testing of the predicate devices.

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

• Not available in this document. Similar to the above, this information pertains to the testing of predicate devices, not this specific submission which states no new testing.

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 and not available.
  • This device is a radiation therapy delivery system, not an AI or imaging interpretation device that would involve human readers interpreting AI outputs.
  • The document explicitly states, "No changes have been made to the device and no new testing has been performed."

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

• Not applicable and not available. This is a hardware system for radiation delivery, not an algorithm that would be tested in a standalone manner for performance metrics like sensitivity or specificity.

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

• Not available in this document. This information would be relevant to the performance testing of the predicate devices, which is not detailed here.

8. The sample size for the training set:

• Not applicable and not available. This is a radiation therapy delivery system, not an AI/machine learning algorithm requiring a "training set" in the typical sense.

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

• Not applicable and not available. As above, this is not an AI/machine learning algorithm with a training set.

Summary of what is provided by the document regarding performance and equivalence:

The core of this 510(k) submission is that the TrueBeam and Edge Radiotherapy Delivery Systems are substantially equivalent to their previously cleared predicate devices.

• Predicate Devices: TrueBeam Radiotherapy System and Accessories (K123291), CyberKnife Robotic Radiosurgery System and CyberKnife VSI Systems (K102650), Agility™ (K123808).
• Reason for Substantial Equivalence Claim:
  • "The device itself is unchanged from the previous submission K123291."
  • "The principles of operation, technological characteristics and labeling are substantially equivalent."
  • The only change highlighted for this submission is the addition of specific examples of lesions, tumors, and conditions to the Indications for Use statement, which "does not change the therapeutic effect of the device" and "fall within the previously cleared general indication."
  • "No changes have been made to the device and no new testing has been performed."

Therefore, for the current submission (K140528), the "proof" that the device meets acceptance criteria is the argument of substantial equivalence to predicate devices that have already met their respective acceptance criteria through prior studies and FDA clearance. The document explicitly states that no new testing was performed for this specific submission because the device itself is unchanged.

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