(8 days)
The MJAH-137A Atlas SPEEDER Head/Cervical Coil is intended for the use of diagnostic imaging of the human body, fluid visualization, 2D and 3D imaging, MR angiography and MR fluoroscopy.
This coil is intended to be used on the Atlas Vantage, model numbers MRT-1503/S3, /S4 and Atlas Titan, model number MRT-1504.
The Atlas SPEEDER Head/cervical is a phased Array Coil that can receive NMR signal from head, cervical region and upper chest.
The coil is configured in three sections; a head base, a removable anterior coil, and NV chest coil. There are two types of anterior coil; 1) Head anterior coil for head imaging, and 2) Neck anterior coil for cervical imaging. The Neck anterior coil includes an adjustable NV coil which is combined with Head anterior coil.
During transmission by the QD body coil this coil is deactivated by means of PIN diodes located on the internal circuit board. Upon deactivation of the transmit cycle the coil switches on to the receive mode.
This document is a 510(k) Summary of Safety and Effectiveness for a medical device, specifically an MRI coil (Atlas SPEEDER Head/Cervical Coil). It focuses on establishing substantial equivalence to existing devices rather than presenting a study to prove performance against specific acceptance criteria. Therefore, much of the requested information regarding study design, sample sizes, expert ground truth, and comparative effectiveness is not present in the provided text.
However, I can extract the relevant information that is available and indicate where the requested information is absent.
Acceptance Criteria and Device Performance
The document does not explicitly state quantitative "acceptance criteria" for the device's imaging performance. Instead, it relies on demonstrating basic safety parameters and presenting "sample phantom images and clinical images" to show its qualitative imaging capabilities. The primary "acceptance" for this 510(k) submission is the FDA's determination of substantial equivalence to predicate devices, not performance against predefined metrics.
Below is a table summarizing the safety parameters mentioned and the implied "performance" in the context of a 510(k).
| Acceptance Criteria (or Safety Parameters) | Reported Device Performance (or Compliance) |
|---|---|
| Maximum static field strength | 1.5 T |
| Maximum dB/dt | 1st operation mode specified in IEC60601-2-33 (2005) |
| Maximum SAR | 1st operation mode specified in IEC60601-2-33 (2005) |
| Peak and A-weighted Acoustic Noise Level | Not applicable |
| Biocompatibility | All materials used in contact with the patient will have a history of use or test data that demonstrates its biocompatibility, i.e., non-toxic, non-irritating. |
| Imaging Performance | Sample phantom images and clinical images are presented in Appendix F & G (Qualitative demonstration of imaging capability). |
Study Details from the Provided Text:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document mentions "sample phantom images and clinical images are presented in Appendix F & G." However, it does not specify the sample size for these images (number of phantom scans or number of clinical cases/patients).
- Data provenance (country of origin, retrospective/prospective) is not provided.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention the use of experts to establish ground truth for any test set or clinical image review. This type of detail is typically not included in a 510(k) summary focused on substantial equivalence.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned. No formal adjudication method for image interpretation or ground truth establishment is described.
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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. The device is an MRI coil, not an AI-powered diagnostic tool, so this type of study is irrelevant to its 510(k) submission.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/No. This device is a passive hardware component (an MRI coil) and does not involve an algorithm with standalone performance.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the "sample phantom images," the ground truth would be the known properties of the phantom itself.
- For the "clinical images," the document does not specify how ground truth was established, or if formal ground truth was established at all beyond clinical reports or visual assessment. In a 510(k) for an MRI coil, the "ground truth" for showing image quality typically relies on the visual diagnostic quality as assessed by qualified personnel, often implicitly. No pathology or outcomes data is mentioned.
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The sample size for the training set:
- Not applicable. This device is a hardware component (MRI coil); it does not involve training a machine learning model.
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How the ground truth for the training set was established:
- Not applicable. As above, there is no training set for a machine learning model.
§ 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.