(56 days)
The Atlas SPEEDER Head/Neck is intended for use with Toshiba 1.5T 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 1.5T 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 is a 510(k) Summary for the "Atlas SPEEDER Head/Neck" magnetic resonance coil. It describes the device, its intended use, and the performance data submitted to support its substantial equivalence to a predicate device. While it mentions performance data, it does not include acceptance criteria or a detailed study proving the device meets those criteria in the format requested.
Specifically, the document states: "The Atlas SPEEDER Head/Neck was tested to and found to be compliant with AAMI/ANSI ES60601-1 and IEC 60601-2-33." and "The SNR and uniformity of the Atlas SPEEDER Head/Neck was analyzed per and found to conform to NEMA MS 6-2008." It also mentions surface heating measurements. However, it does not provide the specific "acceptance criteria" (e.g., a minimum SNR value, specific uniformity metrics with thresholds) or the results of a detailed study designed to meet those specific criteria.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in quantitative terms in the document. The document refers to compliance with standards (AAMI/ANSI ES60601-1, IEC 60601-2-33, NEMA MS 6-2008) which would contain the criteria, but the specific values are not extracted or presented here.
- Reported Device Performance:
- Biocompatibility: Lexan 940A polycarbonate and Polane S polyurethane enamel have a history of use in MR applications and other medical devices (K122638 and K140998).
- Electrical Safety & EMC: Compliant with AAMI/ANSI ES60601-1 and IEC 60601-2-33.
- Surface Heating: Never exceeded 41°C (maximum limit).
- Bench Testing (SNR & Uniformity): Analyzed per and found to conform to NEMA MS 6-2008.
| Acceptance Criteria (Not explicitly stated with values, only referenced standards) | Reported Device Performance |
|---|---|
| Biocompatibility standards/requirements | Lexan 940A polycarbonate and Polane S polyurethane enamel have a history of use in MR applications and other medical devices (cleared through 510(k) numbers K122638 and K140998). |
| Electrical Safety (AAMI/ANSI ES60601-1) | Compliant |
| Electromagnetic Compatibility (IEC 60601-2-33) | Compliant |
| Surface Heating (Max temperature limit of 41°C) | Measured temperature never exceeded 41°C in either plugged in or unplugged configurations. |
| SNR and Uniformity (NEMA MS 6-2008) | Analyzed per and found to conform to NEMA MS 6-2008. (Specific SNR and uniformity metrics/values are not provided, only compliance to the standard). The document implies it "performs as well as or better than the predicate device" based on this testing. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. This document only details bench testing and compliance with standards, not a clinical trial with a "test set" of patients.
- Data Provenance: Not specified.
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)
- Not applicable. The document describes a medical device, not an AI or diagnostic algorithm that requires expert ground truth establishment for a test set. The images produced "can be interpreted by a trained physician," implying human interpretation, but no specific study involving experts establishing ground truth for the device's diagnostic output is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No diagnostic test set requiring adjudication is described.
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. This is an MR coil, not an AI system. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is an MR coil, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The testing described focuses on physical performance parameters (electrical safety, heat, SNR, uniformity) of the MR coil itself, not diagnostic accuracy requiring a "ground truth" in the clinical sense.
8. The sample size for the training set
- Not applicable. This is an MR coil; there is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not applicable.
§ 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.