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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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To be used in conjunction with Toshiba Magnetic Resonance Scanners with DL96 connectors to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis, head, neck, and spine 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. 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.

Here's an analysis of the provided text regarding the acceptance criteria and study for the NeoCoil 1.5T 16ch Flex SPEEDER Coil:

Acceptance Criteria and Device Performance Study

The NeoCoil 1.5T 16ch Flex SPEEDER Coil is a receive-only phased array coil system designed for high resolution imaging. The submission focuses on demonstrating its substantial equivalence to a predicate device (1.5T GEM Flex Coil, K113474) and its safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states, "The device's performance meets the requirements of pre-defined acceptance criteria and intended uses."

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a specific numerical sample size for the "clinical performance testing" or the test set used for evaluating the acceptance criteria. It mentions:

• "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."
• This suggests retrospective data across various clinical scenarios, but the specific origins (e.g., country) are not detailed. It implies a diverse set of imaging scenarios rather than a single, controlled prospective study with a defined sample size.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not specify the number of experts used or their qualifications for establishing ground truth for any test set. The "Indications for Use" state that images "can be interpreted by a trained physician," implying clinical interpretation, but no details on expert review for the study itself are provided. The study primarily focuses on demonstrating technical performance and equivalence, rather than diagnostic accuracy that would typically require expert ground truth.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method (e.g., 2+1, 3+1, none) for the test set. Given the nature of the tests (bench testing for electrical, thermal, and imaging parameters), expert adjudication of images for diagnostic purposes (which would require a ground truth panel) was likely not the primary method for evaluating these specific acceptance criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study comparing human readers with and without AI assistance was not conducted or reported in these documents. This device is an MRI coil, not an AI-powered diagnostic algorithm.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

While the device itself is a standalone hardware component that produces images, there is no mention of an "algorithm only" performance study in the context of an AI device. The coil's performance was assessed as a standalone component of the MRI system.

7. The Type of Ground Truth Used

For the bench tests evaluating electrical, thermal, and NEMA MS 6-2008 standards:

• The ground truth was based on pre-defined performance standards and objective measurements (e.g., temperature readings, arc detection, SNR and uniformity metrics).
• For the "Unplugged Surface Temperature" test, the ground truth was defined by an "acceptable level of risk."

For the "clinical performance testing":

• The ground truth appears to be a qualitative assessment that the coils "demonstrated performance adequate to support the Indications for Use," implying that the images produced were clinically usable and comparable to what would be expected for diagnostic imaging. There is no mention of a reference standard like pathology, biopsy, or long-term outcomes.

8. The Sample Size for the Training Set

The document does not mention a "training set" as this device is a hardware component and not a machine learning algorithm requiring a separate training phase.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

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