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The Personalized PseudoPatient™ PV is intended for the quality assurance of patient specific brain treatments done prior to and/or interfractionally to delivery by external beam radiotherapy, including IMRT and VMAT. It is also intended for quality assurance of the radiation delivery system.

The Personalized PseudoPatient™ PV is a precise model of a patient's CT-scan. Bone structure and external contour are 3D printed using bone equivalent material. The PseudoPatient™ is a pre-treatment end-to-end verification device. The device verifies the TPS dose calculations as well as the following parts of the treatment chain: patient immobilization, image guidance, and treatment delivery. The 3D printed, Personalized PseudoPatient™ PV is loaded with one of the following available types of dosimeters: ion chamber (IC) insert (or any kind of insert for point dosimetry), and/or film insert (FL). The insertcan be relocated depending on demands of treatment. The ion chamber inserts are specifically designed for the detector type indicated by the end user and constructed of Poly(methyl methacrylate) (PMMA). The PseudoPatient™ FL is equipped with a Real Water (RW3) insert to accommodate a dosimetry film (filled with water by the end-user).

The provided text does not contain specific acceptance criteria, detailed study results, or information about the performance evaluation of the Personalized PseudoPatient™ PV device. The document is a 510(k) premarket notification letter and a summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed technical performance study report.

Here's a breakdown of the information that is available based on your request, and what is missing:

Information from the document:

• Device Name: Personalized PseudoPatient™ PV
• Intended Use: Quality assurance of patient-specific brain treatments (prior to and/or interfractionally to delivery by external beam radiotherapy, including IMRT and VMAT) and quality assurance of the radiation delivery system.
• Predicate Device: ScandiDos AB Delta4 Phantom (K151426)
• Technological Characteristics (similarities to predicate): Ease of alignment for positioning, accurate dose verification and absolute measurement, compatibility with any treatment planning systems (TPS), patient QA and machine QA capabilities, design for third-party dosimeters, tissue and bone equivalent materials, overall size similar to average patient anatomy, dosimeter usage, same intended use, biocompatibility (non-patient contacting), sterility (non-sterile).
• Type of Testing Mentioned: "Verification testing of the final device is performed for each unit produced to confirm accuracy of the printer and accuracy of the finished device to the patient anatomy." This involves comparing dimensions of a simultaneously printed structure using validated software and calibrated equipment. "Verification testing is performed for each lot of material used for the finished device. This testing confirms the material is equivalent to bone by measuring the Hounsfield units of a 3D printed structure."

Missing Information (which would be required to fulfill your request fully):

1. A table of acceptance criteria and the reported device performance: The document states that "Validation of the calculated absolute dose and dose distribution using the device proved to be clinically acceptable," but it does not provide specific quantitative acceptance criteria (e.g., +/- 3% dose agreement, 95% gamma pass rate at 3%/3mm) or the actual reported performance values against such criteria.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this device is a phantom for dose verification, not an AI diagnostic tool requiring expert interpretation of medical images.
4. Adjudication method: Not applicable for this type of device and testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a QA phantom, not a diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly detailed in terms of a formal study, though the verification testing mentioned suggests an algorithm-only component for dimensional and material accuracy.
7. The type of ground truth used:
   • For dimensional accuracy: Known dimensions of a printed structure.
   • For material equivalence: Defined Hounsfield units of bone-equivalent material.
   • For dose verification: Implied ground truth would be expected dose calculations from a Treatment Planning System (TPS) or a known dose, against which the measured dose from the phantom's dosimeters is compared. However, the document doesn't specify how "clinically acceptable" was determined.
8. The sample size for the training set: Not applicable; this device is a physical phantom, not a machine learning model that undergoes training on a dataset.
9. How the ground truth for the training set was established: Not applicable.

In summary, the document indicates a general approach to verifying the manufacturing accuracy and material properties of the phantom, and broadly claims "clinically acceptable" dose validation. However, it lacks the specific quantitative metrics, study designs, and detailed results typically associated with acceptance criteria and performance reports for AI/diagnostic devices.

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