(23 days)
The Atlas SPEEDER Head/Neck is intended for use with Toshiba 3T MR systems to produce diagnostic images of the head, neck, and feet that can be interpreted by a trained physician.
The Atlas SPEEDER Head/Neck is a receive-only, 16-channel phased array coil designed for magnetic resonance imaging (MRI) using the Toshiba 3T MR systems. The Atlas SPEEDER Head/Neck is intended to be used for imaging the head, neck, and feet.
The Atlas SPEEDER Head/Neck is a reusable, non-invasive device with limited exposure with regard to duration of contact with the body. All coil elements are enclosed in a rigid plastic housing which is fire-rated, has impact and tensile strength, and is biocompatible.
The Atlas SPEEDER Head/Neck includes one posterior section and three anterior pieces, a neurovascular (NV) adaptor used for head, brain, and neurovascular imaging, a cervical spine (C-spine) adaptor used for neck and cervical spine imaging, and a base adaptor used when claustrophobia or space contraints are an imaging issue.
The Atlas SPEEDER Head/Neck also includes the accessories listed in Table 0-1. The accessories consist of pads, straps, a mirror and a phantom holder.
The provided text describes a 510(k) premarket notification for a medical device called "Atlas SPEEDER Head/Neck." The document focuses on demonstrating substantial equivalence to a predicate device and provides information on various tests conducted. However, it does not explicitly state acceptance criteria in a table format alongside specific device performance values for quantitative measures (like SNR thresholds, spatial resolution, etc.) that would typically be used to justify acceptance.
The document discusses "pre-determined acceptance criteria" for SNR and uniformity in the bench testing section, but does not detail what those criteria are or the precise reported performance values against them. Similarly, for clinical imaging, it states the device produces "diagnostic quality images" without outlining the specific criteria for this quality or how it was assessed quantitatively.
Therefore, many of the requested details, especially those pertaining to a detailed acceptance criteria table, MRMC studies, specific effect sizes, and detailed ground truth procedures for clinical performance, are not explicitly present in the provided text.
Based on the available information, here is a description of the acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Acceptance Criteria (as implied or stated in document) | Reported Device Performance (as stated in document) |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1, -5, -10 standards. | All patient-contacting materials either have a history of safe use or were tested for cytotoxicity, irritation, and sensitization per ISO 10993, and were found to be compliant. |
| Electrical Safety | Compliance with AAMI/ANSI ES60601-1. | Device was tested and found to be compliant with AAMI/ANSI ES60601-1. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-2-33. | Device was tested and found to be compliant with IEC 60601-2-33. |
| Surface Heating | Maximum surface temperature not to exceed 41°C. | The measured temperature of the surface of the coil never exceeded 41°C. |
| Signal-to-Noise Ratio (SNR) | Conformance to "pre-determined acceptance criteria" per NEMA MS 6-2008. | Found to conform to pre-determined acceptance criteria. (Specific values not provided) |
| Image Uniformity | Conformance to "pre-determined acceptance criteria" per NEMA MS 6-2008. | Found to conform to pre-determined acceptance criteria. (Specific values not provided) |
| Clinical Diagnostic Quality | Production of "diagnostic quality images" for intended anatomies. | Produced diagnostic quality images of the head, neck, and feet. (Specific criteria for "diagnostic quality" not provided) |
2. 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 "clinical images from volunteer scanning of the head, neck and feet were obtained." However, it does not specify:
- The exact sample size (number of volunteers or scans) used for this clinical performance testing.
- The country of origin of the data.
- Whether the study was retrospective or prospective, though "volunteer scanning" implies a prospective study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
The document states that images "can be interpreted by a trained physician" but does not specify:
- The number of experts involved in assessing the diagnostic quality of the images.
- Their specific qualifications or experience levels.
- If a formal ground truth establishment process involving experts for the clinical images was conducted as part of the submission, beyond the general statement of diagnostic quality.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not mention any specific adjudication method used for the clinical performance images.
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
- No MRMC study appears to have been done or reported. The device is a receive-only coil for an MR system, not an AI or CAD (Computer-Aided Detection/Diagnosis) system. Therefore, the concept of human readers improving with AI assistance is not applicable to this device type.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable as the device is an MRI coil, not an algorithmic diagnostic tool. Its performance is evaluated on its ability to produce raw diagnostic images, which are then interpreted by a human physician.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the "Clinical Diagnostic Quality" assessment, the implicit ground truth is expert interpretation (a "trained physician" interpreting the images). However, the document does not detail how this "diagnostic quality" was formally established or measured beyond this general statement. There is no mention of pathology or outcomes data being used to establish ground truth for image diagnostic quality.
8. The sample size for the training set
This question is not applicable as the device is a hardware component (MRI coil), not a machine learning model that requires a training set. The performance data is based on bench tests and clinical image acquisition.
9. How the ground truth for the training set was established
This question is not applicable as there is no training set for this hardware device.
§ 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.