(79 days)
The Movable Add-on Couch is designed to be used with the Outlook MRI system and in an X-Ray environment. The indications for use are the same as for standard MR imaging.
The Movable Add-on couch augments the patient handling capabilities of the Outlook MRI system. It interfaces directly with the Outlook patient couch.
The Movable Add-on Couch enables transfer of the patient together with the upper couch plate to and from a movable base directly into the Outlook patient handling system. This makes it possible to do MR imaging without having to lift patient from the supporting surface. The patient can be transported to other imaging modalities using the movable base.
The movable couch also has a radio-translucent upper part making it possible to do fluoroscopic examinations, e.g. with an X-Ray C-arm system, of the patient while on the couch.
The upper couch plate is made of sandwiched bakelite/PVC-foam material. The movable base has two parts; the X-Ray transparent part made of bakelite and the load-carrying parts and coMwrs made of aluminum.
The provided text describes a 510(k) pre-market notification for a medical device, the "Movable Add-on Couch for Outlook." This submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the manner typically seen for algorithmic software.
Therefore, the requested information elements related to an algorithm's performance study (such as sample size for test sets, expert consensus, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this submission. The submission is for a physical device, an MRI patient couch, and its evaluation relies on direct comparisons of physical specifications and intended use.
Here's an analysis based on the provided text, focusing on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
For a physical device like a patient couch, "acceptance criteria" are generally based on meeting specified physical and functional parameters, often compared to a predicate device. The submission presents a Substantial Equivalence Chart which effectively serves as the comparison against these parameters.
| Parameter | Acceptance Criteria (Predicate Device) | Reported Device Performance (Movable Add-on Couch for Outlook) |
|---|---|---|
| Length | 2400 mm | 2400 mm |
| Width of couch plate | 625 mm | 625 mm (+ handle 55mm) |
| Height to the edge of the couch | 880 mm (Outlook standard couch K945827) | 880 mm (upper position) |
| Portable | no (Outlook standard couch K945827) | yes |
| Maximum patient weight | 200 kg (Outlook standard couch K945827) | 200 kg |
| Movement, horizontal | manual (Outlook standard couch K945827) | manual |
| Movement, vertical | no (Outlook standard couch K945827) | motorized, battery powered |
| X-Ray Absorption | rejection limit 1.2 mm (NRF X-Ray Table K944973) | equal to or below 1.5 mm aluminum |
| Intended for Use | MR examinations; stationary (Outlook standard couch K945827) | MR and X-Ray examinations; movable |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the "acceptance criteria" (i.e., demonstrating substantial equivalence) is the comparison presented in the "Substantial Equivalence Chart" itself. This is a direct comparison of physical and functional specifications between the Movable Add-on Couch for Outlook and its identified predicate devices:
- Outlook standard couch (K945827) for most physical dimensions, patient weight, and MR-related functions.
- NRF X-Ray Table (K944973) for the X-Ray Absorption parameter.
The narrative emphasizes that the Movable Add-on Couch "augments the patient handling capabilities of the Outlook MRI system" and has a "radio-translucent upper part" for X-ray examinations. The stated performance (e.g., length, width, max patient weight, X-ray absorption) is presented as meeting or being comparable to the predicate devices. The differences (portability, vertical movement, X-ray capability, handle width) are highlighted as enhancements or different features that do not raise new questions of safety or effectiveness.
Regarding the other requested information for algorithm performance, these are NOT APPLICABLE as the submission is for a physical device:
- 2. Sample size used for the test set and the data provenance: Not applicable. No test set of data (images, etc.) was used for an algorithm.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No expert review of algorithm output was conducted.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No adjudication of algorithm output was conducted.
- 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 is not an AI/algorithm-enabled device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. "Ground truth" in this context would refer to accurate measurements and engineering specifications, not clinical data for an algorithm.
- 8. The sample size for the training set: Not applicable. No algorithm training was performed.
- 9. How the ground truth for the training set was established: Not applicable. No algorithm training was performed.
§ 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.