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In order to ensure the day to day performance of radiation generating equipment, many quality assurance tests are performed. This testing includes such tests as machine output, beam alignment, distance indicators. In all quality assurance testing a test object or measurement device is used to either validate a system parameter or measure some aspect of system performance. These test objects/devices can easily be classified as one of two types, passive or active. An active device is one that can make a measurement or perform a test without user evaluation or interpretation, while a passive device merely provides an environment or condition for testing, but the result requires the user or operator to make an evaluation and determination. Examples of passive devices are test phantoms or film cassettes.

The Mick Radio-Nuclear Isocentric Beam Checker is a passive device, designed to be placed between the incident radiation beam and a piece of film. Radiographic exposure of the Isocentric Beam Checker results in the production of an image on the film which can then be analyzed by the operator for consistency from the prior test exposure. The Isocentric Beam Checker does not alter, change or moderate the radiation field in any manner. It has radio-opaque objects embedded into it that are visualized on standard x-ray film when inserted in a radiation beam. The inspection of the radio-opaque marks on the film is then used in quality assurance.

The Mick Radio-Nuclear Isocentric Beam Checkers are a passive device, designed to be placed between the incident radiation beam and a piece of film. Radiographic exposure of the Isocentric Beam Checker results in the production of an image on the film which can then be analyzed by the operator for consistency from the prior test exposure. The Isocentric Beam Checker does not alter, change or moderate the radiation field in any manner. It has radio-opaque objects embedded into it that are visualized on standard xray film when inserted in a radiation beam. The inspections of the radio-opaque marks on the film are then used in quality assurance.

The provided text is a 510(k) summary for the "Isocentric Beam Checker." This document does not describe a study that establishes acceptance criteria or proves the device meets them. Instead, it describes a device that is a passive quality assurance tool and asserts its substantial equivalence to a predicate device.

Here's why the requested information cannot be extracted from this document:

• Nature of the Device: The Isocentric Beam Checker is a passive device. It doesn't have an "algorithm" or "AI" that analyzes images or makes determinations. It provides radio-opaque objects that are visualized on X-ray film, and then a human operator analyzes the film.
• Regulatory Context: This is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a standalone study in the way a novel diagnostic software might.
• Contents of the Document: The document outlines the device's classification, intended use, description, and claims substantial equivalence. It explicitly states, "No new issues of safety or effectiveness are introduced by using this device." There is no mention of a performance study with a test set, ground truth, experts, or any of the other details requested for proving device performance in the context of an algorithm or AI. It also notes that "Performance standards for radiologic quality assurance instruments have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act."

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or expert involvement because this information is not present in the provided 510(k) summary.

The document refers to "performance characteristics" in the context of substantial equivalence, but it does not define specific metrics or a study to evaluate them for this particular device.

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