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The CTL Body / Spine Array Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the spine region (cervical, thoracic and lumbar anatomy) in Magnetic Resonance Imaging Systems. The indications for use are the same as for standard MR Imaging. The CTL Body / Spine Coil is designed for use with Array the Rhapsody™1.0T MRI scanner manufactured by Siemens Medical Systems.

The CTL Body / Spine Array Coil is designed to provide Magnetic Resonance Images of the spine anatomy. The CTL Body / Spine Array Coil is designed for use with the Siemens Rhapsody™ 1.0Tesla scanner.

Anatomic Regions: Spine Nuclei Excited: Hydrogen

The indications for use are the same as for standard imaging:

The Siemens Rhapsody™ 1.0Tesla system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images vield information that can be useful in the determination of a diagnosis.

Device Description

The CTL Body Spine Array Coil is a multi-element phased array receive-only coil. The coil is shaped to conform to the contours of the spine and has a removable anterior section for imaging the anterior cervical region. The coil also has three bridges consisting of coil elements for enhanced imaging of the thoracic and lumbar spine. The elements and associated circuitry are enclosed in a housing made of plastic materials, which are fire rated and have high impact and tensile strength.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the CTL Body / Spine Array Coil, which is an accessory for Magnetic Resonance Imaging (MRI) systems. The document states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information about specific acceptance criteria, a study proving device performance against those criteria, or quantitative performance data (like sensitivity, specificity, accuracy, etc.).

Below is a template for the requested information, with sections filled out based on the available text where possible, and explicitly stating when information is "Not Available in Text".

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Safety: Device must ensure no RF burns and prevent the formation of resonant loops.	Safety: The device is a receive-only coil and does not transmit RF power, thereby preventing RF burns. Decoupling isolates coil elements from RF fields during RF transmission. The length and stiffness of cables do not permit looping.
Intended Use: Imaging of the spine.	Intended Use: Similar to predicate devices (Premier 7000 C/T/L Spine Coil K980157 and Magna 5000 CTL Spine Coil K994345) for imaging of the spine.
Indications for Use: Identical to routine MRI imaging, specifically for the Siemens Rhapsody™ 1.0T MRI scanner to produce images of spine anatomy based on proton distribution, NMR parameters (T1, T2), and soft tissue structure, useful for diagnosis by a trained physician.	Indications for Use: Identical to predicate devices (Premier 7000 C/T/L Spine Coil K980157 and Magna 5000 CTL Spine Coil K994345) and routine MRI imaging. Designed for use with the Siemens Rhapsody™ 1.0T MRI scanner.
Material Composition: Use of MRI-compatible materials.	Material Composition: Polyurethane Plastic, Polycarbonate Plastic. Similar to Magna 5000 CTL Spine Coil (K994345).
Design: Receive-only phased array design with decoupling.	Design: Receive-only phased array design with RF Chokes with Switching Diodes for decoupling. Similar to predicate devices.
Image Quality / Diagnostic Efficacy: (Quantitative metrics like SNR, spatial resolution, contrast-to-noise ratio, diagnostic accuracy, etc.)	Not Available in Text. The submission focuses on substantial equivalence based on device features and intended use rather than presenting a performance study with quantitative acceptance criteria for image quality or diagnostic efficacy.

Study Information

The provided document is a 510(k) summary for a medical device accessory and does not describe a specific clinical performance study with acceptance criteria, a test set, ground truth, or statistical analysis in the way a clinical trial for a diagnostic device algorithm might. Instead, it demonstrates substantial equivalence to legally marketed predicate devices through a comparison of product features, intended use, and safety aspects.

Therefore, the following information is Not Available in Text as it pertains to a performance study that was not described in this 510(k) summary.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not Available in Text (No specific performance study described.)
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 Available in Text
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not Available in Text
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: Not Available in Text (This device is an MRI coil accessory, not an AI-based diagnostic algorithm. This question is not applicable.)
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not Available in Text (This is an MRI coil, not a standalone algorithm. This question is not applicable.)
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not Available in Text
The sample size for the training set: Not Available in Text
How the ground truth for the training set was established: Not Available in Text

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