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The AKTINA "Velos" Constancy Check Device, model 55-145, is intended for use in external beam radiation therapy in a similar way to that of the Tracker Therapy Beam Evaluation System (by Keithley Instruments, Inc.) previously cleared for marketing under K874893.

More specifically, its intended use is for daily, morning checks of machine output by staff technologists, under the supervision of a medical physicist. Not intended as a substitute for machine calibrations or validations of machine beam energy, these checks are quality assurance steps to safeguard accepted standards of good practice in Radiation Oncology.

This device is intended to be used as a means of verifying machine output on a daily basis in the delivery of external beam radiation therapy.

"Velos" is designed to operate by either:

being mounted on standard beamblock trays or,
placed on a table, when measurements are needed from various SID's
and functions in an efficient and reliable way through reduction of setup time, remote control readings via CCTV, output constancy checks at all gantry angles (for compliance with TG-43) and fixed geometry for elimination of distance errors.

The provided document is an FDA 510(k) clearance letter and a summary of safety and effectiveness for a medical device called the "Velos Constancy Check Device (CCD), Model 55-145." This document primarily focuses on the device's substantial equivalence to a predicate device and its intended use, rather than detailing a specific study with acceptance criteria and performance metrics of the new device itself.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, and expert involvement are not available in the provided text. The document is about regulatory clearance based on equivalence, not a detailed performance study of the new device against specific, pre-defined acceptance criteria.

However, I can extract the information that is present:

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

This information is not explicitly stated in the provided document. The document focuses on the new device (Velos CCD) being "similar in design and construction, utilizes the same materials, and has the same intended use and performance characteristics" as the predicate device. It doesn't present a table of specific acceptance criteria for the Velos CCD and its measured performance against them.

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 available in the provided document. No specific test set or study data are presented for the Velos CCD to demonstrate its performance.

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 available in the provided document. No specific test set or ground truth establishment process is described.

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

This information is not available in the provided document.

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

There is no indication of an MRMC study or AI-related comparison in the document. The device is a "Constancy Check Device" for external beam radiation therapy, implying it's an objective measurement tool rather than an AI-driven diagnostic aid for human readers.

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

This information is not explicitly stated as a formal study. The device itself is designed as a standalone measurement tool. Its function is to "verify machine output on a daily basis," which implies it provides objective readings without human interpretation in the loop of the measurement itself. However, the document doesn't describe a specific standalone performance study with metrics.

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

This information is not available in the provided document.

8. The sample size for the training set

This information is not applicable and not available in the provided document. The Velos CCD is described as a physical device, not an algorithm that requires a training set.

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

This information is not applicable and not available in the provided document.

Summary of available information:

The provided document, an FDA 510(k) clearance, primarily details the regulatory pathway for the "Velos Constancy Check Device (CCD), Model 55-145." It asserts "substantial equivalence" to a predicate device (Keithly Instruments, Inc., Tracker Therapy Beam Evaluation system, K874893) based on similar design, construction, materials, intended use, and performance characteristics.

• Intended Use: "to be used as a means of verifying machine output on a daily basis in the delivery of external beam radiation therapy." More specifically, for "daily, morning checks of machine output by staff technologists, under the supervision of a medical physicist."
• Performance Standards: "Performance standards for these devices have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act." This indicates that the device did not need to meet FDA-mandated performance standards.
• Proof of Performance: The document states that the new device "has the same intended use and performance characteristics" as the predicate device. This "sameness" is the basis for its substantial equivalence, rather than a detailed performance study presented within this document. The description of its function ("functions in an efficient and reliable way through reduction of setup time, remote control readings via CCTV, output constancy checks at all gantry angles (for compliance with TG-43) and fixed geometry for elimination of distance errors") outlines its design advantages and functional capabilities, but not quantified performance against specific criteria.

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