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The 1.5T 8ch Flex Suite manufactured by Shenzhen RF Tech Co.,Ltd is receive-only coil and is designed for use as general purpose coil. The 1.5T 8ch Flex Suite is designed to be use with GE 1.5T MRI systems to produce diagnostic images of upper and lower extremities, head, spine and cardiac that can be interpreted by a trained physician.

The 1.5T 8ch Flex Suite is receive-only phased array coil for imaging the upper and lower extremities, head and spine in adult population. The 1.5T 8ch Flex Suite consists of three flexible and lightweight coil of different size that can be wrapped or orientated flat, in order to accommodate various anatomic shapes and sizes.

The 1.5T 8ch Flex Suite 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 provided text describes a 510(k) premarket notification for a medical device, the "8ch Flex Suite," an MRI receive-only coil. However, the document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific performance acceptance criteria for an AI/ML algorithm.

Therefore, the requested information regarding acceptance criteria, study details for AI/ML performance, sample sizes for test and training sets, expert involvement, and ground truth establishment cannot be extracted from this document, as it pertains to a different type of device clearance (an MRI coil, not an AI diagnostic algorithm) and a different regulatory pathway (substantial equivalence, not a de novo or PMA requiring detailed performance studies against defined criteria for an algorithm).

The document mentions "Clinical images evaluation testing for the proposed device was evaluated by connected to compatible MRI system," and that "Based on above testing, the proposed 8ch Flex Suite was found to have a safety and effectiveness profile that is similar to the predicate device." This suggests image quality and clinical utility were assessed, but the specifics of how this was done, what metrics were used, or any quantitative "acceptance criteria" for image performance are not provided. The comparison focuses on technical specifications and intended use matching a predicate device.

To directly answer your request based on the provided text:

• 1. A table of acceptance criteria and the reported device performance: Not applicable/provided. The document focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics and intended use, not on specific performance metrics for an AI/ML algorithm against predefined acceptance criteria.
• 2. Sample sized used for the test set and the data provenance: Not applicable/provided. There is no mention of a "test set" in the context of an AI/ML algorithm's performance. The clinical evaluation refers to the performance of the coil itself.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/provided. No ground truth establishment for an AI/ML algorithm is described.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/provided.
• 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: Not applicable/provided. This device is an MRI coil, not an AI assistance tool for human readers.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/provided. This is not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/provided.
• 8. The sample size for the training set: Not applicable/provided. This is not an AI/ML device.
• 9. How the ground truth for the training set was established: Not applicable/provided.

In summary, the provided document is a 510(k) summary for an MRI coil, not an AI/ML diagnostic device. Therefore, the information requested about AI/ML acceptance criteria and performance studies is not contained within this text.

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The 1.5T 8ch Flex Suite manufactured by Shenzhen RF Tech Co., Ltd is receive-only coil and is designed for use as general purpose coil. The 1.5T 8ch Flex Suite is designed to be use with GE 1.5T MRI systems to produce diagnostic images of upper and lower extremities, head and spine that can be interpreted by a trained physician.

The 1.5T 8ch Flex Suite is receive-only phased array coil for imaging the upper and lower extremities, head and spine in adult population. The 1.5T 8ch Flex Suite consists of three flexible and lightweight coil of different size that can be wrapped or orientated flat, in order to accommodate various anatomic shapes and sizes.
The 1.5T 8ch Flex Suite 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 1.5T 8ch Flex Suite is flexible and can be wrapped around the anatomy of interest, which is similar to its predicate device.
The 1.5T 8ch Flex Suite is general purpose receive only coil with 8 elements and intergraded preamplifiers.
The 1.5T 8ch Flex Suite is based on phased array technique for combining the images from 8 different channels. The 1.5T 8ch Flex Suite is tuned to the proton frequency of 63.86MHz.

Here's a breakdown of the acceptance criteria and study information for the 8ch Flex Suite, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a receive-only MRI coil, not an AI-powered diagnostic device. Therefore, the "acceptance criteria" discussed are primarily related to the coil's physical, electrical, and imaging performance, ensuring it functions safely and effectively as an MRI accessory. The document doesn't present a standard table of "acceptance criteria" for diagnostic accuracy common in AI/standalone device submissions (e.g., sensitivity, specificity, AUC).

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical and limited clinical testing. The "performance" is implicitly tied to meeting the standards and showing comparable image quality to the predicate.

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

• Test Set Sample Size: The document does not specify a numerical sample size for the clinical test set (i.e., how many patients/scans were used). It only states that "Analyses in axial, sagittal and coronal planes were run on the 8ch Flex Suite."
• Data Provenance: Not specified. The document does not mention the country of origin of the data or whether it was retrospective or prospective.

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

This information is not provided in the document. The "clinical tests" described are for evaluating image quality for substantial equivalence, not typically for establishing a diagnostic ground truth against a specific disease. The interpretation is stated to be by a "trained physician" for the intended use, but the number or qualifications of experts for the comparative study are not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the "clinical tests" described (comparing image quality for substantial equivalence), a formal adjudication method for diagnostic ground truth might not have been central to this type of submission.

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

• No, an MRMC comparative effectiveness study was not done. The document describes clinical tests to demonstrate substantial equivalence of image quality between the 8ch Flex Suite and a predicate device. It does not involve human readers interpreting images with and without AI assistance, nor does it address an effect size of AI on human reader performance. This device is an MRI coil, not an AI diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study

• Not applicable. The 8ch Flex Suite is an MRI coil, a hardware component for image acquisition, not an algorithm or AI software that performs standalone diagnostic functions.

7. Type of Ground Truth Used

• For the "clinical tests" described, the implicit ground truth is comparable image quality sufficient for diagnostic interpretation by a trained physician when compared against the predicate device. It's not about definitive diagnosis of a specific pathology through expert consensus, pathology, or outcomes data in the way an AI diagnostic algorithm would be evaluated. The aim is to show the coils produce diagnostically acceptable images.

8. Sample Size for the Training Set

• Not applicable. This device is an MRI coil and does not involve AI or algorithms that require a training set.

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

• Not applicable. As stated above, there is no training set for an MRI coil.

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