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The Infant Array is a receive-only RF coil, used for obtaining high resolution images and spectra of the infant brain, spine, heart, torso and extremity in GE, Siemens and Philips 1.5T and 3.0T magnetic resonance imaging systems and magnetic resonance compatible incubators. Indications for use are same as that for standard MR imaging and spectroscopy.

The Infant Array when used in conjunction with GE, Siemens and Philips 1.5T and 3T MRI systems or Infant Array when used with the MRI compatible incubator and in conjunction with the abovementioned MRI systems provide imaging of the infant's brain, spine, heart, torso and extremities. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.

The Infant Array is a 20-element receive-only radio-frequency (RF) coil array well suited for routine and parallel imaging. The Infant Array (IA) consists of an Infant Head Spine Array (IHSA) and an anterior Cardiac section (CAR). The IHSA can be used alone for spine and brain examinations or in conjunction with the anterior cardiac section necessary for cardiac and torso MRI exams. The anterior cardiac section cannot be used alone. This anterior cardiac section is supported on a sliding adjustable height gantry. Coil elements and associated circuitry are enclosed in a rigid former to prevent any exposure to patient or environment. The plastic materials used are fire rated and have a high impact and tensile strength. The coil design facilitates scanning of low birth weight pre-term babies, term newborns and small infants with different body sizes and maximizes comfort and ease of use.

20 element, receive-only RF coil array. The Infant Array consists of two sections: infant head spine array (IHSA) and anterior cardiac section (CAR), which is positioned above the IHSA and supported on a sliding adjustable height gantry. Coil elements and associated circuitry are enclosed in a rigid former to prevent any exposure to patient or environment.

Here's a summary of the acceptance criteria and study information for the Infant Array device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "Testing was performed to demonstrate that the Infant Array meet the predetermined acceptance criteria." However, specific numerical acceptance criteria (e.g., signal-to-noise ratio requirements, specific image quality metrics) are not explicitly defined or reported within the provided text. The performance is primarily described through its intended use and similarity to predicate devices.

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally mentions "testing" and "usage," but no details on the patients or data used, or how they were collected.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

The document does not provide any information on the number of experts used to establish ground truth or their qualifications. It only states that images should be "interpreted by a trained physician."

4. Adjudication Method for the Test Set:

The document does not mention any adjudication method for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done. The focus is on demonstrating substantial equivalence to predicate devices, not on comparing reader performance with and without AI assistance.

6. Standalone Performance Study:

The document does not explicitly state that a standalone (algorithm only without human-in-the-loop performance) study was performed. The device is a hardware component (RF coil), not an algorithm. The testing would have focused on the physical and functional performance of the coil itself.

7. Type of Ground Truth Used:

The document does not specify the type of ground truth used, as it doesn't detail specific performance metrics beyond the general ability to obtain images useful for diagnosis. Given that the device is an RF coil, the "ground truth" would likely relate to objective image quality metrics (e.g., SNR, image uniformity, spatial resolution) rather than disease detection or classification which would involve a separate diagnostic algorithm or human interpretation.

8. Sample Size for the Training Set:

The document does not mention a training set sample size. As the Infant Array is a hardware device (RF coil) and not a machine learning algorithm, the concept of a "training set" in the context of AI/ML models is not directly applicable.

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

The concept of "ground truth for the training set" is not applicable to this device, as it is a hardware component rather than an AI/ML diagnostic tool.

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The Neonate (Head, Body) Coil is a quadrature transmit/receive coil used for obtaining diagnostic images and spectra of the (pre- and term) infant head in 1,5 and 3,0 Tesla General Electric, Siemens Medical Solutions and Philips Medical Systems' Magnetic Resonance Imaging (MRI) scanners and magnetic resonance compatible incubator systems. Indications for use are same as that for standard MR imaging.

The Neonate Coils when used in conjunction with the MRI systems or Neonate coils when used with the MRI compatible incubator and in conjunction with the MRI systems provide imaging of the infant head and body (torso). When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.

The Neonate (Head, Body) Coil is a 12 element quadrature, transmit/receive coil. Coil elements and associated circuitry are enclosed in a rigid former to prevent any exposure to patient or environment. The coil design facilitates scanning of pre-term and term newborn babies with different head and body sizes and maximizes comfort and ease of use.

Here's a breakdown of the acceptance criteria and study information for the Advanced Imaging Research Neonate Coils based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not list specific numerical acceptance criteria or performance metrics (e.g., signal-to-noise ratio, image resolution, specific absorption rate limits with associated values). Instead, it describes general safety and functionality aspects that the device meets.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: The document does not specify a quantitative sample size (e.g., number of subjects, number of images) for the test set. It states "Testing was performed to demonstrate that the 3.0 T Neonate Head Coils meet the predetermined acceptance criteria." Test-set subjects would likely be phantoms or a limited number of human subjects for safety testing, but specific numbers are not provided.
• Data Provenance: Not specified. This type of device (MR coil) typically undergoes technical performance and safety testing, which often involves engineering tests and phantom studies rather than extensive clinical data. The document does not indicate if any human subject data, retrospective or prospective, was used for performance evaluation beyond safety.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. For this product which is a coil, the "ground truth" during testing would likely be based on established engineering standards for MRI coil performance, safety limits, and image quality measurements, rather than clinical interpretation requiring expert radiologists to establish a diagnostic ground truth. The interpretation of images for diagnosis is stated to be by a "trained physician," but this is for clinical use, not for establishing ground truth during the device's technical acceptance testing.

4. Adjudication Method for the Test Set

Not applicable/Not specified. Given the nature of the device (MRI coil) and the type of testing implied (technical performance and safety), an "adjudication method" as typically used in clinical studies for diagnostic accuracy (e.g., 2+1 reads) is not relevant or described. Acceptance would be based on meeting engineering specifications and safety standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was it done? No, an MRMC comparative effectiveness study was not performed or described. This type of study assesses reader performance with and without an AI algorithm, which is not applicable to an MRI coil itself. The device is a hardware component.
• Effect Size: Not applicable.

6. Standalone (Algorithm Only) Performance Study

• Was it done? No, a standalone algorithm performance study was not done. The device is an MRI coil, a hardware component, not a software algorithm.

7. Type of Ground Truth Used

The ground truth for the "testing" mentioned in the document would be based on engineering specifications, physical measurements, and safety standards (e.g., SAR limits, electrical isolation, signal-to-noise ratio measurements using phantoms, geometric distortion assessment). It is not based on expert consensus, pathology, or outcomes data in the traditional sense of a diagnostic medical device.

8. Sample Size for the Training Set

Not applicable. The device is an MRI coil (hardware). There is no "training set" in the context of machine learning or AI algorithms for this product.

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

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

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