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The product is to be used by radiation oncologist, dosimetrist, and radiation therapy physicist to check the correctness of the x-ray treatment fields from high energy treatment machines that are planned to be or have been applied to a patient. This product is to be used in addition to the treatment planning system to provide a means for additional and redundant verification that the plan is in fact successfully accomplished. This product is not a treatment planning system and is not to be used as one. This product only checks the applied dose based on the measurement of each x-ray field and a theoretical calculation. This product does not provide any quality assurance that the fields are in fact correctly applied to and correctly aligned with the patient anatomy as planned. In addition, the product may be used to display the above dose on other fused image sets which could provide additional clinical information to the radiation oncologist regarding the treatment.

Dosimetry Check with Exit Dose is a software program intended to provide a means for testing the dosimetry of radiation therapy treatments applied to a patient using high energy x-rays. This test is performed from measurements made during treatment of the patient by measuring the radiation fields after they have passed through the patient with a suitable imaging device such as an electronic portal imaging device or other measuring devices or media. The following software functions are then performed:

1. The patient's CT scan treatment plan image set is traced to provide the water equivalent path to points on the measured exit dose plane.
2. A deconvolution process is performed with a kernel that is a function of radius and the thickness transversed to convert the exit images back to x-ray intensity in air fluence prior to patient entry. The kernel is derived prior from phantom measurements with the same imaging device or media.
3. The derived in air fluence is now the same starting point as when the radiation fields are measured directly prior to patient entry.
4. The existing Dosimetry Check (FDA 510(k) K010225) software functions are then used to compute the dose to the patient using the in air fluence for each treatment beam and to evaluate the correctness of the dose to the patient.

I am sorry, but the provided text does not contain the information required to populate the requested table and answer the questions regarding acceptance criteria, study details, and performance metrics. The document is a 510(k) summary and FDA clearance letter for a device called "Dosimetry Check with Exit Dose". It describes the device's function and indications for use but does not include:

• Specific acceptance criteria for device performance.
• Details of a study conducted to prove the device meets acceptance criteria (e.g., sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types for training/test sets).

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