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1. Both the RAD II KV Imager and RAD II Simulator are used in the field of Radiation Therapy as diagnostic imaging devices for patient positioning verification prior to radiation therapy treatments for cancer.
2. Both the RAD II KV Imager and RAD II Simulator are permanently mounted to the Therapy Head of Linear Accelerators and Cobalt Teletherapy devices.
3. The RAD II KV Imager is an "On Board Imager" intended for usage as a patient positioning verification device.
4. The RAD II KV Imager uses digital imaging to acquire its images, and positioning software to verify and/or adjust patient positioning prior to radiation therapy treatment via a Clinac as prescribed by a Radiation Oncologist.
5. The RAD II Simulator is a "Therapy Attached" Simulator intended for developing and or verifying patient treatment protocols as prescribed by Radiation Oncologist.
6. The RAD II Simulator device uses standard x-ray film to acquire its images, which are reviewed by the Therapist and or Oncologist to either verify or adjust patient positioning prior to radiation therapy treatment via a Clinac as prescribed by a Radiation Oncologist.

The RAD II KV Imaging device is mounted directly to the head of a Linear Accelerator or Cobalt Therapy device. This "Therapy Attached" application has been in use as the RAD II Simulator since 1983 (510K # K834281). With the addition of an FDA approved Digital Imager and Patient Positioning Software, the RAD II KV Imager operates as an "On Board Imaging Device" for Image Guided Radiation Therapy (I.G.R.T.) Protocols.

This 510(k) summary for the Acceletronics RAD II Simulator & RAD II KV Imager focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a standalone study proving performance against those criteria.

Therefore, many of the requested sections regarding specific acceptance criteria, detailed study results, sample sizes, expert qualifications, and ground truth establishment are not provided in this document. The document primarily relies on comparing the technological characteristics and intended use of the RAD II devices to previously cleared devices.

Here's a breakdown of the information available and what is not provided:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a table of acceptance criteria with specific performance metrics (e.g., accuracy, precision, sensitivity, specificity) for the RAD II Simulator & RAD II KV Imager. Instead, it claims substantial equivalence based on:

• Technological Characteristics: As detailed in Exhibit C-4 (page 2), comparing components like X-ray tube, generator, imager type (digital vs. film), and software with predicate devices.
• Intended Use: For verification of patient position and treatment fields in radiation therapy.

Example Comparison (from Exhibit C-4, not formal acceptance criteria):

2. Sample size used for the test set and the data provenance

• Not provided. The submission focuses on substantial equivalence based on technical specifications and intended use, not on specific clinical or performance testing data with a defined test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not provided. There is no mention of a test set with established ground truth or expert involvement in such a process within this document.

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

• Not provided. Due to the absence of a described test set and ground truth establishment, no adjudication method is mentioned.

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/Not provided. This submission is for a device that aids in patient positioning and image acquisition in radiation therapy. It is not an AI-assisted diagnostic tool for human readers in a way that an MRMC study on reader improvement would typically be conducted. Therefore, no information on human reader improvement with/without AI assistance is presented.

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

• Not provided. The document does not describe a standalone performance study. The device is intended to be used by radiation therapists and oncologists for patient positioning verification. The "standalone" performance in this context would likely refer to the image quality and accuracy of positioning measurements, but specific studies are not detailed.

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

• Not provided. As there is no described performance study or test set, the type of ground truth used is not mentioned.

8. The sample size for the training set

• Not applicable/Not provided. This device is a hardware and software system for image acquisition and patient positioning, not a machine learning model that requires a "training set" in the conventional sense. The "Theraview Software" is mentioned, but its development process (e.g., if it uses machine learning and thus a training set) is not detailed.

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

• Not applicable/Not provided. (See point 8)

Summary of what is available and the overall approach:

The manufacturer, Acceletronics, Inc., is seeking 510(k) clearance for the RAD II Simulator & RAD II KV Imager by demonstrating substantial equivalence to predicate devices. This means they are asserting their device is as safe and effective as devices already on the market without needing to conduct extensive new clinical trials to prove efficacy from scratch.

• Predicate Devices: Several predicate devices are identified, including Varian Medical Systems On-Board Imager, Varian Medical Systems Portal Vision, Elekta Synergy, Oldelft Simulux-HP, and Haynes Radiation Ltd., Inc. RAD II Simulator.
• Description of Equivalence: The submission highlights that the RAD II KV Imager operates as an "On Board Imaging Device" for Image Guided Radiation Therapy (IGRT) protocols, similar to predicate devices A-C. The RAD II Simulator is likened to predicate devices D&E as a "Radiation Therapy Simulator."
• Technological Characteristics Comparison (Exhibit C-4): This table compares specific components and features (X-ray tube, generator, imager type, software) of the RAD II systems with the predicate devices, emphasizing their similarities. The key difference noted for the RAD II KV Imager is its advanced digital imaging compared to the older film-based RAD II Simulator, and some differences in imager/cassette mounting designs.
• Intended Use Statement: The intended uses for both the KV Imager (patient position verification) and the Simulator (developing and verifying treatment protocols) are clearly stated and aligned with the intended uses of the predicate devices.

In essence, the "study" mentioned is the comparison of the device's technical specifications and intended use to legally marketed predicate devices, which is the basis for a 510(k) clearance. Clinical performance data or specific acceptance criteria with supporting studies are generally not required for substantial equivalence claims unless there are significant technological differences or new indications for use.

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