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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.

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.

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