(145 days)
Patient Positioning Devices are used to aid in the support and positioning of patients during an MRI.
The Civco Patient Support Devices have been used for many years and were previously cleared under 510(k)'s before the classification was reduced to Class I exempt. This 510(k) is to have these identical Class I products cleared for use in an MRI environment.
This 510(k) submission (K080072) is for "MRI Patient Positioning Devices" and focuses on demonstrating substantial equivalence to previously cleared devices. The core of the submission revolves around proving the safety and effectiveness of these devices for use in an MRI environment, as they were previously Class I exempt and are now being cleared for MRI use.
The document does not provide a typical "study" with specific acceptance criteria and reported device performance in the way one might expect for an AI/software device or a diagnostic device. Instead, the "study" is a series of tests to ensure MRI compatibility and safety.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance/Conclusion |
|---|---|
| Safety for use in an MRI environment | "These products have been tested to demonstrate that they can be safely used in an MRI environment." (No specific quantitative metrics or test results are provided in this summary, but the FDA clearance implies these tests were satisfactory.) |
| Equivalent intended uses | Claimed: "the proposed devices have equivalent intended uses... as compared to the predicate devices." (The intended use "aid in the support and positioning of patients during an MRI" is consistent with the predicate devices' presumed function.) |
| Equivalent manufacturing materials | Claimed: "the proposed devices have equivalent... manufacturing materials... as compared to the predicate devices." |
| Equivalent operating principles | Claimed: "the proposed devices have equivalent... operating principals... as compared to the predicate devices." (As simple positioning devices, their operating principle is passive support.) |
| Equivalent physical, operational specifications | Claimed: "the proposed devices have equivalent... physical, operational specifications as compared to the predicate devices." |
| No significant differences affecting safety and effectiveness | Claimed: "There are no significant differences between the proposed and predicate devices except that they have now been tested for use in an MRI environment. The product labeline, including brochures has been updated. These differences have no effect on safety and effectiveness." (The key 'difference' is the MRI testing, which is presented as an addition to safety, not a compromise.) |
2. Sample Size for the Test Set and Data Provenance
The document does not specify a "test set" in the context of data for an algorithm. Instead, it refers to the physical devices themselves. The sample size would be the number of physical MRI Patient Positioning Devices tested for MRI compatibility. This number is not disclosed in the provided text.
Data provenance (country of origin, retrospective/prospective) is not applicable here as it's not a data-driven study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. "Ground truth" in the context of device performance for physical products like patient positioning devices (especially for MRI compatibility) typically involves engineering tests, material compatibility assessments, and MRI safety protocols, rather than expert interpretation of data.
4. Adjudication Method for the Test Set
Not applicable. There's no interpretive test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a diagnostic device or an AI assistant for human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for the device's main claim (MRI safety) would be established through:
- Engineering Standards and Test Results: Compliance with recognized MRI safety standards (e.g., ASTM F2503 for "MR Safe," "MR Conditional," "MR Unsafe"). These standards outline specific tests for magnetic attraction, RF-induced heating, image artifact, etc.
- Material Compatibility: Assessment of the materials used in the devices for their magnetic properties and potential for heating in an MRI environment.
- Regulatory Compliance: Meeting the requirements of the FDA for safe medical devices.
The document only states "These products have been tested to demonstrate that they can be safely used in an MRI environment," implying these types of tests were performed.
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.