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The Qfix® Symphony Patient Transport System is indicated to aid in the support, positioning, and transfer of a patient for procedures involving imaging, including MRI; and external beam radiation therapy treatment with electrons, photons or protons; and other procedures requiring transfer of a patient. The Symphony is designed to interface with other positioning devices, such as couchtops, inserts, thermoplastic masks, and positioning pads.

Qfix, has developed the Symphony™ Patient Transport System to seamlessly move patients among multiple imaging modalities such as MR and CT to treatment modalities, such as those utilizing photon or proton and other procedures requiring the transfer of a patient. The Symphony™ Patient Transport System is designed to utilize a low-friction air bearing to transfer patients from one surface to another, eliminating the need to manually lift the patient. Additionally, the design enables clinicians to set up a patient on the Symphony™ for subsequent transfer and immobilization throughput in cancer treatments and other procedures. Qfix intends to market the Symphony™ Patient Transport System which consists of the Symphony™ trolley and several transfer surfaces including; a standard transfer surface, a head/neck transfer surface, and a brachytherapy solution which are compatible with existing patient positioning devices. The Symphony™ Patient Transport System is designed to optimize workflow efficiencies and improve patient outcomes.

The provided document describes the Qfix® Symphony™ Patient Transport System and its safety and effectiveness information. However, it does not contain the detailed information required for a comprehensive answer regarding acceptance criteria and a specific study proving the device meets those criteria.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information for Acceptance Criteria: The document describes categories of testing and general outcomes (e.g., "compliance," "verification," "MR Conditional"). It does not provide specific, quantifiable acceptance criteria (e.g., "magnetic attraction force must be less than X Newton at Y distance," "attenuation must be less than Z%").

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

• Test Set Sample Size: Not specified. The document mentions "magnetic attraction tests with MRI scanners at 0.35T, 1.5T, and 3T" and "electronic functionality tests" but doesn't state how many devices or components were tested. Similarly, "usability studies" are mentioned without a participant count.
• Data Provenance: The studies were conducted by Qfix ("Qfix, has developed the Symphony™ Patient Transport System..."), implying in-house testing. The location is presumed to be the USA, as Qfix is based in Avondale, PA, USA. The studies appear to be prospective as they were conducted to verify and validate the new device.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. For "clinical user assessments" and "usability studies," the implication is that healthcare professionals were involved, but their specific qualifications (e.g., "radiologist with 10 years of experience") are not detailed.

4. Adjudication method for the test set

• Adjudication Method: Not specified. Given the nature of mechanical, electrical, and MRI safety testing, "adjudication" in the sense of expert consensus for a diagnostic outcome is likely not applicable. For usability studies, a formal adjudication of subjective feedback is not described.

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

• MRMC Study: No, an MRMC study was not done. The device is a patient transport system, not an AI-assisted diagnostic tool for human readers.
• Effect Size: Not applicable.

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

• Standalone Study: Yes, in a sense, the mechanical, electrical, radiographic, and MRI safety tests are "standalone" as they evaluate the device itself without direct human interaction or interpretation of results in the way an AI algorithm might be tested. The usability studies did involve humans, but they were assessing the device's physical and interactive characteristics, not the performance of an algorithm.

7. The type of ground truth used

• Ground Truth: For the various performance tests (mechanical, electrical, MRI safety, radiographic), the "ground truth" was established by engineering standards and physical measurements. For example, magnetic field strength, force measurements, electrical readings, and material attenuation properties served as the objective ground truth. For usability, the "ground truth" was derived from user feedback and observations during the clinical user assessments.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This device is a physical medical device, not an AI or machine learning model that requires a training set.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this device.

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