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The BinkieRT is intended to be used for repeat positioning and immobilization of a patient's tongue and jaw while undergoing or receiving a course of external beam radiation therapy for treatment of cancer and other diseases. It is intended to be used by or under the direction of a licensed physician. BinkieRT is meant for use with 6 MV photon beams only.

It is a patient-specific medical device that is mounted in the oral cavity of the patient to fix the temporomandibular joint in the treatment of head and neck radiation, and the planned dose is accurately delivered to the target area, and the tongue is moved in one direction to be spaced apart to minimize the exposure of normal tissue to the surrounding area. The device consists of a Jaw Positioner (Impression, Maxiila, Mandibula), a Tongue Positioner (Head, Paddle), and a Column (Rotation Guide).

The provided document is a 510(k) summary for the BinkieRT device and does not contain detailed information about a study with acceptance criteria and reported device performance in the format requested.

The document primarily focuses on demonstrating substantial equivalence to a predicate device, which means proving that the new device is as safe and effective as a legally marketed device. This often relies on non-clinical (bench) testing rather than full clinical studies, which is explicitly stated in the "Clinical Test Summary" section: "Clinical testing was not required to demonstrate the substantial equivalence of the BinkieRT to its predicate devices."

However, I can extract the information related to the bench tests and the "acceptance criteria" (or verification metrics) mentioned within those tests.

Here's a breakdown of the available information based on your request, structured to address each point as much as possible, even if the information is not fully present for all points:

1. Table of Acceptance Criteria and Reported Device Performance

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

• X-ray backscatter shielding performance: The document states "Subjects were exposed to a 6 MV high energy photon beam," but does not specify the number of subjects (e.g., how many BinkieRT devices or test phantoms were used).
  • Data Provenance: Bench test, not specified as human or animal subjects. Performed in a laboratory setting. No country of origin for the data is explicitly stated, but the manufacturer is based in South Korea. The test is retrospective in the sense that it evaluates the manufactured product.
• EVA dental impression depth comparison test: The document states "using a force gauge (i.e., occlusal force qauqe) and anthropomorphic jaws," and "a force of ~800N was applied to the EVA once before treatment and repeated after each 2.25 Gy fraction of a total 67.5 Gy dose to the BinkieRT (i.e., 30 fractions)." This implies testing on at least one BinkieRT device (specifically, its EVA impression component) repeatedly. The exact number of devices/samples tested is not specified.
  • Data Provenance: Bench test, not specified as human or animal subjects. Performed in a laboratory setting. No country of origin for the data is explicitly stated, but the manufacturer is based in South Korea. The test is retrospective in the sense that it evaluates the manufactured product.

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

• This information is not provided in the document. The tests described are bench tests with objective measurements (Dose Enhancement Ratio, impression depth) and do not involve expert interpretation or ground truth establishment in the clinical sense.

4. Adjudication method for the test set

• This information is not applicable/not provided. The tests described are bench tests with objective measurements, not requiring adjudication.

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

• No, an MRMC comparative effectiveness study was not done. This device is a physical tongue and jaw positioner for radiation therapy, not an AI/software device that would involve human readers or AI assistance in interpretation. The "Clinical Test Summary" explicitly states that clinical testing was not required.

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

• No, this is not an algorithm or AI device. The tests performed are bench tests on the physical characteristics and performance of the device.

7. The type of ground truth used

• X-ray backscatter shielding performance: The "ground truth" or reference for comparison is a "baseline" dose (backscattered radiation produced without the subject in the photon beam). This is a physically measured baseline.
• EVA dental impression depth comparison test: The "ground truth" or reference for comparison is the initial impression depth measurements before repeated force application. This is a physically measured baseline.

8. The sample size for the training set

• This question is not applicable. This device is a physical product and not an AI/machine learning algorithm, so there is no "training set."

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

• This question is not applicable as there is no "training set" for this physical device.

In summary, the provided document details non-clinical bench testing for the BinkieRT device to demonstrate its performance against specific physical criteria related to its function, rather than diagnostic accuracy studies typically associated with AI/software devices. Therefore, many of your requested points related to clinical studies, human readers, and AI algorithms are not applicable to this submission.

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