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The Octave SPEEDER Spine is intended for imaging the thoracolumbar spine.

The MJAS-167A is intended to be used on a Toshiba 1.5T MR System

The Octave SPEEDER Spine is a receive-only phased Array Coil that can receive NMR signal from spine. The coil consists of a 12 rectangular loop surface coil. 3 loops (1 section) are aligned perpendicular to a body axis and 4 sections are aligned to a body axis. Users select the sections according to region of interest via a system user interface. The PC board switches transmit mode and receive mode with PIN diode. This coil is detuned during transmission by our QD whole body coil by means of activating the PIN diodes (transmit mode) and tuned during no transmission by means of not activating the PIN diodes (receive mode).

The provided text is a 510(k) summary for the Octave SPEEDER Spine, a magnetic resonance diagnostic device. It details the device's classification, contact information, manufacturing site, date of submission, intended use, description, safety parameters, and substantial equivalence to a predicate device.

However, the document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way you've outlined for AI/algorithm-based devices.

Here's why and what the document does provide:

• Device Type: The Octave SPEEDER Spine is a receive-only phased array coil, essentially a hardware component for an MRI system. It's not an AI or algorithm-based device that would typically have performance metrics like sensitivity, specificity, or AUC against a ground truth.
• "Acceptance Criteria" in this Context: For this type of hardware, "acceptance criteria" generally refers to meeting safety standards and demonstrating that the device functions as intended within the MRI system, and that its image quality is comparable to or better than previously cleared devices.
• "Study" Information: The document refers to "testing" but not a formal study with detailed methodology, sample sizes, and expert reviews as would be expected for an AI product.

Here's a breakdown of what can be extracted or inferred based on your requested headings, with clarifications where the information is absent for an AI-focused interpretation:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified in the provided text. The document mentions "phantom images and clinical images" but does not give a number of phantoms or patients/cases.
• Data Provenance: Not specified. "Clinical images" would imply collected data, but details like country of origin or whether it was retrospective/prospective are not present.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This is not applicable and not mentioned. For a hardware device like an MRI coil, "ground truth" in the context of diagnostic interpretation by experts is not the primary assessment method. Image quality is typically assessed against physical phantoms (known configurations) and qualitatively by experts for clinical utility, but not in terms of diagnostic accuracy with a "ground truth" label in the way an AI would be.

4. Adjudication method for the test set

• Not applicable and not mentioned.

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 not an AI device. No MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No. This is not an AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• For the phantom imaging, the "ground truth" would be the known configuration of the phantom itself.
• For "clinical images," image quality is likely judged subjectively by imaging specialists and objectively by predefined metrics, rather than against a specific diagnostic "ground truth" derived from pathology or outcomes, as the coil's role is to acquire the image, not to interpret it diagnostically with an automated tool.

8. The sample size for the training set

• Not applicable / not mentioned. This device does not use a "training set" in the context of machine learning.

9. How the ground truth for the training set was established

• Not applicable / not mentioned. This device does not have a "training set."

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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).

Study Details from the Provided Text:

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. How the ground truth for the training set was established:

   • Not applicable. As above, there is no training set for a machine learning model.

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Imaging of:

• The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, neck, TMJ, heart, blood vessels). [Application terms include MRCP (MR Cholangiopancreatography), MR Cisternography, MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan, Cine Imaging and Cardiac tagging.]
• Fluid Visualization
• 2D / 3D Imaging
• MR Angiography / MR Vascular Imaging
• Blood Oxygenation Level Dependent (BOLD) imaging
• Perfusion / Diffusion Imaging
• Proton Spectroscopy

The Vantage Titan (Model MRT 1504/S3) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Titan uses the same magnet as the other Vantage MRJ Systems. It includes the Toshiba Pianissimo™ technology (scan noise reduction technology), and has a 1.4 m short magnet. The design of the gradient coil and the WB coil of the Vantage Titan provides the maximum field of view of 55 x 55 x 50 cm.

The Vantage Titan MRI System is comparable to the current EXCELART Vantage Atlas-X MRI System (K063361), cleared November 21, 2006 with the following modifications.

• Gantry bore diameter has been increased from 600mm to 690mm at bore center.
• Maximum power of RF amplifier has been increased from 20KW to 35KW.
• RF amplifier cabinet has been added.
• Gradient power supply has been modified to increase the output current from 300A to 550A.
• Transformer cabinet has been modified to cover the system power requirement.

The provided 510(k) Premarket Notification for the Toshiba Vantage Titan MR system (K080038) does not describe acceptance criteria or a study proving that the device meets those criteria in the context of device performance regarding image quality or clinical efficacy.

Instead, this submission is centered around demonstrating substantial equivalence to a previously cleared predicate device (EXCELART Vantage Atlas-X, K063361), following modifications to hardware and software. The primary focus is on ensuring that the modifications do not alter the system's safety parameters or intended use, and that imaging performance remains equivalent to the predicate.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

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