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The device is indicated to assist in the proper positioning of patients for radiation therapy including electron, photon and proton treatments, and simulation including CT and MR image acquisition.

The Respiratory Plate with Cushion and Respiratory Belt are components of a modularbased patient positioning system that indexes directly to a treatment or simulation couch.

The Respiratory Plate is comprised of a compression plate, mount, index screw, and screw wheel. Rotation of the screw wheel lowers and raises the compression plate. The mount is attached to the positioning system bridge using pins, and the bridge is indexed to the system platform using a clamping mechanism. A Cushion is mounted on the compression plate via pocket features on the Cushion. The Cushion is comprised of three compartments of beads plus an air chamber. The Cushion is inflated with air to the desired pressure using a hand-held pump accessory with reference pressure qauge.

The Respiratory Belt is comprised of a central air chamber with indexing scale. Velcro straps, hand pump, pressure gauge, and clamps. The Velcro straps allow the Belt to be tightened or loosened around the patient. The Belt is inflated using a hand pump and the pressure is monitored with a reference pressure gauge. Clamps are used to attach the Velcro straps to the positioning system platform.

The Respiratory Plate with Cushion and Respiratory Belt are reusable devices that are provided non-sterile and are manufactured of non-magnetic materials with the exception of the pressure gauge. The devices are used in a healthcare facility/hospital.

The provided document describes a 510(k) premarket notification for the CIVCO Medical Solutions Body Pro-Lok™ Respiratory Plate with Cushion and Body Pro-Lok™ Respiratory Belt. The document focuses on demonstrating substantial equivalence to a predicate device and addresses safety and effectiveness through non-clinical testing.

Based on the provided text, the device is a patient positioning system intended to assist in radiation therapy and imaging. The acceptance criteria and the "study" that proves the device meets them are related to non-clinical testing for safety and compatibility rather than clinical performance or diagnostic accuracy. Therefore, many of the typical questions regarding AI/algorithm performance, ground truth, and expert consensus are not directly applicable to this type of device submission.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are implicit in the ASTM standards cited, which dictate passing or failing tests for specific physical properties. The reported performance is whether the device passed or no artifact was observed.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated as a number of devices. The "test set" would be the submitted physical devices themselves, or representative samples, used for the non-clinical testing.
• Data Provenance: The testing was non-clinical (laboratory/bench testing) conducted in accordance with referenced ASTM and ISO standards. Country of origin of the data is not specified beyond the compliance with international standards. The testing is prospective in the sense that it was conducted specifically for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Not applicable. This is a non-clinical device safety and compatibility testing, not a diagnostic or AI performance study requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

• Not applicable. This involves objective physical testing according to standards, where results are measured against defined pass/fail criteria, not subjective interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• Not applicable. This is a non-clinical device submission for a patient positioning system, not an AI or diagnostic imaging device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This device is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• For the non-clinical tests (RF heating, torque, displacement, image artifact, biocompatibility), the "ground truth" is defined by the objective physical measurements and established pass/fail criteria of the referenced ASTM and ISO standards. For example, a temperature increase above a certain threshold would be a "fail".

8. The Sample Size for the Training Set

• Not applicable. This is a physical device submission, not an AI or machine learning product that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As above, this is a physical device.

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