(14 days)
CIVCO Patient Positioning Devices are used to aid in the support and positioning of patients during MR, radiological, and other procedures.
The MR & Radiological Patient Positioning devices are used to aid in patient positioning and immobilization during radiotherapy procedures. The following models of the Patient Positioning Devices are included in this submission: . Bellyboard 126000 Bellyboard, which includes the following: 301101 Bellyboard Cushion o SBRT Accessories MTSBRT011 SBRT Patient Transfer System, which includes the following: MTSBRT012 Gurney Plate Assembly MTSBRT032 Transfer System Trans Slot MTSBRT033 Transfer System Longitudinal Slot MTSBRT014 Ski Assembly 20-CFHN-017 Type-S Strap Devices are sold non-sterile and may be reused for multiple patient or single patient use if set-up for a single patient. The proposed devices are non-implanted devices i that are large in size and manufactured of non-magnetic and plastic materials.
The provided text describes the regulatory submission for CIVCO MR & Radiological Patient Positioning Devices and their testing for MR compatibility. It is a 510(k) summary, not a study report for a novel AI device with specific performance metrics like those typically found in clinical trials. Therefore, much of the requested information (e.g., sample size for test/training sets, number of experts for ground truth, MRMC study details) is not applicable or cannot be extracted directly from this document.
However, I can extract the acceptance criteria and reported device performance related to MR compatibility, as well as general information about the testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (General Category) | Reported Device Performance/Outcome |
|---|---|
| RF heating | Devices passed acceptance criteria. |
| Magnetic induced torque | Devices passed acceptance criteria. |
| Magnetically induced displacement force | Devices passed acceptance criteria. |
| Image artifact (specifically for SBRT Patient Transfer System) | Image artifact was observed in a specific area. (Device labeled MR conditional to account for this.) |
| Biocompatibility | Completed for patient contacting materials (implied satisfactory, as overall conclusion is substantial equivalence and safety/effectiveness). |
| Safety & Effectiveness in MR environment | Demonstrated that changes in design and materials do not affect safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a number of patient cases or device units tested in a clinical performance manner. The testing was non-clinical and focused on the device itself for MR compatibility.
- Data Provenance: The testing was non-clinical, involving direct device testing following ASTM standards. It is not patient or country-specific data but rather laboratory/device performance data. Therefore, it's neither retrospective nor prospective in the typical clinical study sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This was non-clinical engineering and materials testing for MR compatibility, not a study requiring expert clinical assessment for ground truth.
4. Adjudication Method for the Test Set
- Not applicable. This was non-clinical engineering and materials testing, not a study requiring adjudication of expert interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission concerns MR compatibility of patient positioning devices, not diagnostic or AI performance with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
- The "ground truth" here is objective physical measurements and observations against established engineering standards (ASTM F2182-9, F2119-07, F2052-06, F2213-06) for MR compatibility, along with biocompatibility testing results.
8. The Sample Size for the Training Set
- Not applicable. This document does not describe an AI/machine learning study with training sets.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This document does not describe an AI/machine learning study.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.