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The UNIQUE 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 UNIQUE 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 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.

An extensive system of interlocks is designed to prevent or terminate beam-on unless essential treatment parameters are in place and system operating conditions relevant to safe operation are correct.

The changes to the UNIQUE establish motion zone rules, which limit the motions of couch and gantry that can be initiated or directed from outside the treatment room. The purpose of the zone rules is to increase patient safety by reducing the possibility of collision between the gantry and the patient.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Varian UNIQUE device:

The provided document (K132705) is a 510(k) summary for a medical linear accelerator, the Varian UNIQUE. It focuses on demonstrating substantial equivalence to a predicate device (UNIQUE K101751) due to specific changes primarily related to enhanced patient safety features concerning gantry and couch motion.

Key takeaway: This document describes a modification to an existing medical device where the primary focus is on safety features (motion zone rules and interlocks). It is not a study demonstrating the diagnostic or therapeutic performance of an AI-powered device, but rather a verification and validation of engineering changes to a linear accelerator.

Therefore, many of the requested elements (like AI-specific performance, MRMC studies, expert ground truth for imaging, training set details) are not applicable to this type of submission.

Acceptance Criteria and Reported Device Performance

Study Details (as applicable to this type of device modification)

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

   • This document does not describe a "test set" in the context of imaging data or a diagnostic algorithm.
   • The "test set" for this modification would refer to testing of the device's hardware and software functionalities.
   • Provenance: Not specified, but generally, Varian Medical Systems, Inc. is a U.S.-based company, and such engineering tests are typically conducted internally at their facilities.
   • Retrospective/Prospective: The testing described (Verification and Validation) is inherent to the product development lifecycle and would be considered prospective in relation to the design changes.

2. 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 in the sense of medical image interpretation.
   • Ground Truth: For device functionality, the "ground truth" is defined by the design input requirements and technical specifications for the motion zone rules and interlocks.
   • Experts: "Qualified personnel" performed the validation testing. These would be engineers, QA specialists, and potentially clinical representatives experienced with linear accelerators, but not radiologists establishing ground truth for disease.

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

   • Not applicable as this is not an imaging or diagnostic study requiring expert consensus. The testing would follow engineering test protocols.

4. 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

   • No, an MRMC comparative effectiveness study was not done.
   • The device is a medical linear accelerator; it does not involve human readers interpreting images with or without AI assistance for diagnostic purposes. The changes are to hardware/software interlocks for patient safety during treatment delivery.

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

   • The device itself (the linear accelerator) operates in conjunction with human operators (radiotherapy technologists, dosimetrists, radiation oncologists). The "motion zone rules" and "interlocks" are algorithmic components within the device's software that automatically prevent unsafe operations.
   • Standalone testing of these sub-systems (e.g., verifying the interlock logic in isolation) would have been part of the verification process, but not as a standalone AI diagnostic tool.

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

   • The ground truth for this type of device modification is established by engineering design specifications, safety standards, and validated functional requirements. For example, the ground truth for the expanded "collision protection" is that the gantry should not collide with the couch in specified scenarios, regardless of imaging arm position, and the system correctly prevents such collisions.

7. The sample size for the training set

   • Not applicable. This is not an AI/machine learning model where a "training set" is used to develop an algorithm for diagnosis or prediction. The changes are deterministic software and hardware logic.

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

   • Not applicable, as there is no "training set" in the AI/ML sense.

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