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To be used in conjunction with Toshiba 1.5T Magnetic Resonance Scanners with DL96 connectors to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis, head, neck and spine in pediatric and adult populations that can be interpreted by a trained physician.

The NeoCoil 1.5T 16ch Flex SPEEDER is a receive-only phased array coil system designed to provide high resolution imaging for the upper and lower extremities, chest. abdomen, pelvis, head, neck, and spine in pediatric and adult populations that can be interpreted by a trained physician. The system is compatible with 2D, 3D, parallel and isotropic imaging, as well as, coil signal intensity correction. The system consists of:
. Two formable, flexible and detachable antennae of different size that can be wrapped or orientated flat, in order to accommodate various anatomic shapes and sizes.
. Optional accessories designed for patient comfort and reduced motion artifacts.
The NeoCoil 1.5T 16ch Flex SPEEDER coil is tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation.

The NeoCoil 1.5T 16ch Flex SPEEDER Coil is a receive-only phased array coil system for magnetic resonance imaging. The current submission (K123272) describes an expansion of indications for use to include pediatric populations, with no changes to the physical, performance, design, or material characteristics of the coil itself compared to its legally marketed predicate device (K121362). The primary additions are updated labeling and a Pediatric Stabilizer accessory for head, neck, and spine imaging in pediatric patients.

1. Table of acceptance criteria and the reported device performance:

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

• Bench Testing: The document does not specify a numerical sample size for the bench tests. These tests would involve specific coil units and test setups. The description notes that "additional SNR and Uniformity measurements demonstrate acceptable performance" with the Pediatric Stabilizer.
• Clinical Testing: The document does not provide a specific numerical sample size (number of patients) for the clinical performance testing. It states that "Clinical data submitted exhibits a mix of scanner configurations, pulse sequences, imaging options, field of view and anatomy in the axial, sagittal and coronal planes as recommended in the FDA guidance, Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices, issued November 14, 1998." It also confirms that "Clinical performance testing includes imaging from the pediatric subpopulations specified in Table 1 of the FDA guidance, Premarket Assessment of Pediatric Medical Device issued May 14, 2004."
• Data Provenance: Not explicitly stated, but based on the overall context of a 510(k) submission to the US FDA, it is highly likely to be prospective data collected for the purposes of device clearance. However, the document does not specify the country of origin of the data.

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

This information is not provided in the document. The clinical images are intended to be "interpreted by a trained physician," but no details are given on the number or qualifications of experts involved in establishing ground truth for the performance testing itself.

4. Adjudication method for the test set:

This information is not provided in the document. The general statement is that images are "interpreted by a trained physician," but no specific adjudication method (e.g., 2+1, 3+1, none) for the test set is 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is an MRI coil, not an AI-based diagnostic tool. The document describes the performance of the coil itself, not the impact on human reader performance or the use of AI.

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

Not applicable. The device is an MRI coil, a hardware component, and not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant to this submission.

7. The type of ground truth used:

For the bench testing, the ground truth for parameters like Max B1, Surface Temperature, SNR, and Uniformity would be based on physical measurements against established engineering and clinical performance standards (e.g., NEMA MS 6-2008, IEC 60601 series).

For clinical performance testing, the document implies that the images produced were of diagnostic quality and could be "interpreted by a trained physician." This suggests the ground truth was clinical diagnostic interpretation by physicians, but the specific method of establishing this (e.g., expert consensus, comparison to gold standard pathology, or patient outcomes) is not detailed. The phrase "performance adequate to support the Indications for Use" implies successful visualization of the anatomical regions as intended for diagnosis.

8. The sample size for the training set:

Not applicable. This device is a passive MRI coil, not an AI or machine learning algorithm that requires a training set.

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

Not applicable. As stated above, this device does not utilize a training set in the context of machine learning.

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