(29 days)
- Imaging of the extremities (Foot and Hand), joints (knee, shoulder, ankie, wrist and elbow), and body (chest, abdomen and pelvis). MJAJ-192A is intended to be used on the Toshiba Vantage Titan 3T MR System.
The 4ch Flex SPEEDER (MJAJ-192A), is a phased array coil that can receive NMR signal from the extremities, joints, and trunk of the human body. The 4ch Flex SPEEDER is mechanically flexible, and can wrap around various regions mentioned above. The 4ch Flex SPEEDER (MAJA-192A) consists of four coil elements and PC board. The coil elements shape single loop and the four single loop coil elements are arranged to the row. The coil is decoupled during transmission from QD whole body by means of activating the PIN diodes. MJAJ-192A is intended to be used on the Toshiba Vantage Titan 3T MR System.
This submission describes a new coil (4ch Flex SPEEDER, MJAJ-192A) for a Magnetic Resonance (MR) diagnostic device. The acceptance criteria and the study for this device primarily focus on safety and imaging performance, rather than diagnostic accuracy like an AI-powered system.
Here's an analysis of the provided text with respect to your request:
Acceptance Criteria and Device Performance
Since this is an MR coil, the acceptance criteria are not in terms of traditional diagnostic performance metrics like sensitivity/specificity but rather in physical and imaging quality characteristics. The document doesn't explicitly state a table of acceptance criteria with corresponding performance metrics in the format you requested, as it's a 510(k) summary for substantial equivalence to a predicate device. However, we can infer the key criteria that were assessed for safety and image quality.
Inferred Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Safety Parameters: | |
| Maximum static field strength | 3 T (Matches intended use with Toshiba Vantage Titan 3T MR System) |
| Maximum dB/dt | "1st operation mode specified in IEC60601-2-33 (2002)" (Compliance with standard) |
| Maximum SAR | "1st operation mode specified in IEC60601-2-33 (2002)" (Compliance with standard) |
| Peak and A-weighted Acoustic Noise Level | "Not applicable" (Implies the coil itself doesn't generate significant acoustic noise beyond the MRI system) |
| Biocompatibility | "All materials used in contact with the patient have a history of use or test data that demonstrates its biocompatibility, i.e., non-toxic, non-irritating." (Stated compliance) |
| Imaging Performance: | |
| Image Quality | "Sample phantom images and clinical images are presented in Appendix F & G." (Implies demonstration of sufficient image quality, likely visual comparison to predicate) |
| Anatomical Coverage | "The extremities, joints, and trunk of the human body" (As per intended use and coil flexibility) |
Study Information
The provided document describes a 510(k) submission for substantial equivalence. This type of submission relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device. It typically doesn't involve a separate, large-scale clinical study for diagnostic efficacy in the way an AI algorithm might.
-
Sample size used for the test set and the data provenance:
- The document mentions "Sample phantom images and clinical images are presented in Appendix F & G." However, it does not specify the sample size (e.g., number of patients or images) used for these clinical images.
- The provenance of the data (country of origin, retrospective/prospective) is not explicitly stated in this summary.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided as the study likely did not involve establishing a diagnostic ground truth with human experts in the typical sense for an AI device. The evaluation of an MR coil's performance usually involves technical experts (e.g., medical physicists, MRI technologists) and radiologists for visual image quality assessment, often without a formal "ground truth" establishment for diagnostic accuracy being explicitly detailed in a 510(k) summary.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided. Given the nature of a 510(k) for an MR coil, formal adjudication methods for diagnostic discrepancies are generally not applicable or described in this summary.
-
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:
- No, an MRMC comparative effectiveness study was not done as this device is an MR coil, not an AI-powered diagnostic tool intended to assist human readers. Therefore, there is no effect size related to human reader improvement with or without AI assistance. The study focuses on the coil's intrinsic performance and equivalence to a predicate.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a passive MR coil, not an algorithm. Its performance is always in conjunction with an MR system and human operator/radiologist.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the imaging performance, the "ground truth" would likely be the visual quality and diagnostic utility of the images produced by the coil, often assessed by radiologists who compare them to images obtained with the predicate device. This is typically a qualitative or semi-quantitative expert assessment rather than a formal diagnosis-level ground truth like pathology for a disease. The summary states "Sample phantom images and clinical images are presented," indicating visual comparison was part of the evaluation.
-
The sample size for the training set:
- Not applicable. This device is an MR coil, not an AI algorithm, so there is no training set in the context of machine learning.
-
How the ground truth for the training set was established:
- Not applicable. As there is no training set, this question is not relevant.
In summary: The provided document is a 510(k) summary for an MR coil, demonstrating substantial equivalence to a predicate device based on safety parameters and general imaging performance. It does not contain the detailed clinical study information typically found for AI/CAD devices relating to diagnostic accuracy, reader performance, or specific ground truth methodologies. The "study" here is primarily focused on technical verification and validation, along with qualitative assessment of clinical images to show equivalence.
§ 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.