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IMRIS Flex coils HC150 (1.5T Head coil) and HC300 (3T Head coil) are used in conjunction with respective MR Systems IMRIS 1.5T MAGNETOM and IMRIS 3T MAGNETOM as an imaging device for clinical procedures.

IMRIS Flex coils produce images of the human head and upper C-spine internal structures.

When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis and therapy options.

The IMRIS 1.5T Head Coil (HC150) is a receive-only eight channel phased array coil. The coil is divided into a bottom and a top array of 4 channels each. The HC150 is a pair of receive-only phased array coils designed for use with the IMRIS 1.5T system. The IMRIS 1.5T (Neuro II-SE) uses the Siemens MAGNETOM 1.5T MRI system (MAGNETOM Espree).

The IMRIS 3T Head Coil (HC300) is a receive-only eight channel phased array coil. The coil is divided into a bottom and a top array of 4 channels each. The HC300 is a pair of receive-only phased array coils designed for use with the IMRIS 3T system. The IMRIS 3T (Neuro III-SV) uses the Siemens MAGNETOM 3T MRI system (MAGNETOM Verio).

The IMRIS HC150/HC300 head coils balance surgical requirements with the MRI reguirements to provide MR imaging in intra-operative and interventional procedures. Coils are used to acquire MR images of the head and upper C-spine during intra-operative /interventional procedures. The IMRIS HC150/HC300 head coils can also be used as standard diagnostic head coils for diagnostic examinations.

Here's an analysis of the provided text regarding the acceptance criteria and study for the IMRIS HC150/HC300 head coils:

Summary of Device and Regulatory Context:

The submission concerns the IMRIS HC150 (1.5T Head Coil) and HC300 (3T Head Coil), which are receive-only eight-channel phased array coils designed for use with IMRIS 1.5T and 3T MRI systems, respectively. Their intended use is to produce images of the human head and upper C-spine for clinical procedures, providing information useful for diagnosis and therapy options when interpreted by a trained physician. The device is classified as a Class II medical device (21 CFR 892.1000, Product Code: MOS). The submission is a 510(k) premarket notification, seeking substantial equivalence to previously cleared IMRIS 1.5T/3T Split Array Head (SAH) coils.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The provided document does not specify the sample size used for the test set (number of images, scans, or subjects). It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature of the image acquisition). It only states that tests were performed according to NEMA standards.

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

The provided document does not mention the use of experts or the establishment of ground truth for any test set in the context of image interpretation or diagnostic accuracy. The study described focuses on technical performance metrics (SNR, uniformity) and equivalence to predicate devices, not on human interpretation of images for diagnosis.

4. Adjudication Method for the Test Set:

Since the study described focuses on technical performance metrics (SNR, uniformity) as opposed to diagnostic accuracy evaluated by human readers, there is no mention of an adjudication method for a test set. This type of study would typically not involve adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The provided text describes a study focused on technical performance metrics (SNR, uniformity) of the new coils compared to predicate coils, not on human reader performance with or without AI assistance. Therefore, no effect size for human reader improvement with AI is mentioned.

6. Standalone Performance Study (Algorithm Only):

No, a standalone performance study of an algorithm without human-in-the-loop performance was not done. The device in question (HC150/HC300) is a physical MRI coil, not an AI algorithm. The performance evaluation focuses on the coil's ability to acquire good quality images, which are then intended to be interpreted by a physician.

7. Type of Ground Truth Used:

For the technical performance tests (SNR and image uniformity), the "ground truth" is established by the NEMA standard itself and objective measurements. There is no mention of expert consensus, pathology, or outcomes data used to establish ground truth for these metrics. The performance is compared against the performance of the predicate devices.

8. Sample Size for the Training Set:

The provided document does not mention a training set as this is not a study involving an AI algorithm or machine learning model that would require a training set. The device is a physical MRI coil.

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

As there is no training set, there is no mention of how ground truth for a training set was established.

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