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CIVCO Patient Positioning Devices are used to aid in the support and positioning of patients during MR, radiological, and other procedures.

CIVCO Patient Support Devices have been used for many years and were previously cleared under 510(k)'s for use in radiological and other medical procedures. This 510(k) is to have these Class II products cleared for use in an MR environment. Various sizes and shapes of patient positioning devices are offered in order to install on a specific system which the device is used on and/or the body region to be positioned. Devices are sold non-sterile and may be re-used for multiple patient or single patient use if set-up for a single patient.

This document describes the 510(k) submission for CIVCO MR & Radiological Patient Positioning Devices, which seeks to clear existing Class II patient positioning devices for use in an MR environment. The submission focuses on demonstrating substantial equivalence to previously cleared devices.

Here's an analysis of the provided text with respect to acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

   The document doesn't explicitly define "acceptance criteria" in a quantitative, objective manner (e.g., a specific numerical threshold for performance metrics). Instead, it relies on demonstrating substantial equivalence to predicate devices by showing that the proposed device has equivalent intended uses, manufacturing, quality systems, device body contacting category, and safety parameters. The "reported device performance" is essentially the claim of "Same" or "Equivalent" to the predicate for these parameters, with specific testing conducted for MR compatibility and biocompatibility.

   Parameter	Acceptance Criteria (Implied)	Reported Device Performance
   Intended Use / Indications for Use	Must be equivalent to predicate device for safety & effectiveness.	CIVCO Patient Positioning Devices are used to aid in the support and positioning of patients during MR, radiological, and other procedures. (Expanded from predicate's "radiological and other procedures" to include MR, but still for support and positioning).
   Manufacturing	Must be the same or demonstrably equivalent.	Same (Machined, injection molded, formed, assembled, painted).
   Quality Systems	Must be the same or demonstrably equivalent.	Same (FDA/QSR cGMP 21CFR Part 820. ISO 9001 / ISO 13485).
   Device Body Contact Category	Must be the same or demonstrably equivalent.	Same (Surface devices, intact skin; limited contact duration (< 24 hours)).
   Safety (Biocompatibility)	Must meet established safety standards.	Testing in accordance with ISO 10993-Part 1 Biological Evaluation of Medical Devices, FDA Blue Book Memorandum #G95-1, and FDA-Good Laboratory Practices (GLP). (Implicitly, the device meets these standards as part of the "Same" claim for safety characteristics).
   Safety (MR Environment)	Must be safe for use in MR environments.	Products have been tested to demonstrate that they can be safely used in both radiological and in MR environments. All products in this submission are non-metallic and marked as MR safe with the exception of the Clam-Lok Cushion (MR conditional labeling). This directly addresses the main difference from the predicate (MR compatibility).
   Effect on Safety & Effectiveness (Changes)	Changes in design, materials, or labeling should not affect safety and effectiveness.	Changes have been determined to not have the potential to affect the safety and effectiveness of the device. (Stated in the "Substantial Equivalence Summary" section).

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

   The document does not specify a "test set" in the context of an algorithm or AI model performing a task on data. This is a submission for physical medical devices. The "testing" mentioned refers to physical property testing (e.g., biocompatibility and MR compatibility) of the device materials and design.

   • Data Provenance: Not applicable in the sense of patient data. The provenance for the physical testing would be the raw materials and finished products from the manufacturer (CIVCO).
   • Sample Size: Not explicitly stated for specific material or product tests. However, the nature of these tests typically involves a representative sample of materials or devices to ensure compliance with standards.

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

   Not applicable. This is not an AI/algorithm-based diagnostic device where expert ground truth is typically established for image or data interpretation. The "ground truth" here is compliance with established physical and biological safety standards for medical devices and MR compatibility.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   Not applicable. This is not a study involving human readers or interpretation of diagnostic output that would require an adjudication method.

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:

   Not applicable. This document pertains to physical patient positioning devices, not an AI or algorithm that assists human readers.

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

   Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   The "ground truth" for this device's acceptance is based on adherence to established international and national standards for medical device safety and performance, specifically:

   • ISO 10993-Part 1 Biological Evaluation of Medical Devices: For biocompatibility.
   • FDA Blue Book Memorandum #G95-1: For biocompatibility guidance.
   • FDA-Good Laboratory Practices (GLP): For the conduct of non-clinical laboratory studies.
   • MR compatibility standards: Although not explicitly named, the testing "to ensure these differences have no effect on safety and effectiveness of the device" in an MR environment implies adherence to recognized MR safety standards.
   • Predicate Device Equivalence: The ultimate ground truth for this submission is demonstrating that the device is substantially equivalent to legally marketed predicate devices, in terms of safety and effectiveness.

8. The sample size for the training set:

   Not applicable. This is not an AI/machine learning device that uses a "training set."

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

   Not applicable. As there is no training set, there is no ground truth established for one.

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