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• Imaging of the extremities (Foot and Hand), joints (knee, shoulder, ankie, wrist and elbow), and body (chest, abdomen and pelvis). MJAJ-192A is intended to be used on the Toshiba Vantage Titan 3T MR System.

The 4ch Flex SPEEDER (MJAJ-192A), is a phased array coil that can receive NMR signal from the extremities, joints, and trunk of the human body. The 4ch Flex SPEEDER is mechanically flexible, and can wrap around various regions mentioned above. The 4ch Flex SPEEDER (MAJA-192A) consists of four coil elements and PC board. The coil elements shape single loop and the four single loop coil elements are arranged to the row. The coil is decoupled during transmission from QD whole body by means of activating the PIN diodes. MJAJ-192A is intended to be used on the Toshiba Vantage Titan 3T MR System.

This submission describes a new coil (4ch Flex SPEEDER, MJAJ-192A) for a Magnetic Resonance (MR) diagnostic device. The acceptance criteria and the study for this device primarily focus on safety and imaging performance, rather than diagnostic accuracy like an AI-powered system.

Here's an analysis of the provided text with respect to your request:

Acceptance Criteria and Device Performance

Since this is an MR coil, the acceptance criteria are not in terms of traditional diagnostic performance metrics like sensitivity/specificity but rather in physical and imaging quality characteristics. The document doesn't explicitly state a table of acceptance criteria with corresponding performance metrics in the format you requested, as it's a 510(k) summary for substantial equivalence to a predicate device. However, we can infer the key criteria that were assessed for safety and image quality.

Inferred Acceptance Criteria and Reported Device Performance

Study Information

The provided document describes a 510(k) submission for substantial equivalence. This type of submission relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device. It typically doesn't involve a separate, large-scale clinical study for diagnostic efficacy in the way an AI algorithm might.

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

   • The document mentions "Sample phantom images and clinical images are presented in Appendix F & G." However, it does not specify the sample size (e.g., number of patients or images) used for these clinical images.
   • The provenance of the data (country of origin, retrospective/prospective) is not explicitly stated in this summary.

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

   • This information is not provided as the study likely did not involve establishing a diagnostic ground truth with human experts in the typical sense for an AI device. The evaluation of an MR coil's performance usually involves technical experts (e.g., medical physicists, MRI technologists) and radiologists for visual image quality assessment, often without a formal "ground truth" establishment for diagnostic accuracy being explicitly detailed in a 510(k) summary.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • This information is not provided. Given the nature of a 510(k) for an MR coil, formal adjudication methods for diagnostic discrepancies are generally not applicable or described in this summary.

4. 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, an MRMC comparative effectiveness study was not done as this device is an MR coil, not an AI-powered diagnostic tool intended to assist human readers. Therefore, there is no effect size related to human reader improvement with or without AI assistance. The study focuses on the coil's intrinsic performance and equivalence to a predicate.

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

   • Not applicable. This device is a passive MR coil, not an algorithm. Its performance is always in conjunction with an MR system and human operator/radiologist.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the imaging performance, the "ground truth" would likely be the visual quality and diagnostic utility of the images produced by the coil, often assessed by radiologists who compare them to images obtained with the predicate device. This is typically a qualitative or semi-quantitative expert assessment rather than a formal diagnosis-level ground truth like pathology for a disease. The summary states "Sample phantom images and clinical images are presented," indicating visual comparison was part of the evaluation.

7. The sample size for the training set:

   • Not applicable. This device is an MR coil, not an AI algorithm, so there is no training set in the context of machine learning.

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

   • Not applicable. As there is no training set, this question is not relevant.

In summary: The provided document is a 510(k) summary for an MR coil, demonstrating substantial equivalence to a predicate device based on safety parameters and general imaging performance. It does not contain the detailed clinical study information typically found for AI/CAD devices relating to diagnostic accuracy, reader performance, or specific ground truth methodologies. The "study" here is primarily focused on technical verification and validation, along with qualitative assessment of clinical images to show equivalence.

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Imaging of the extremities (Foot and Hand), joints (knee, shoulder, ankle, wrist and elbow), and body (chest, abdomen and pelvis)

The 4ch Flex SPEEDER is a phased array coil that can receive NMR signal from the extremities, joints, and trunk of the body. The 4ch Flex SPEEDER is mechanically flexible, and can wrap around various regions as mentioned above. The 4ch Flex SPEEDER consists of four coil elements and PC board. The coil elements shape single loop and the four single loop coil elements are arranged to the row. The coil is decoupled during transmission from QD whole body by means of activating the PIN diodes.

Acceptance Criteria and Study Details for the 4ch Flex SPEEDER

The provided document describes the 4ch Flex SPEEDER, a phased array coil for Magnetic Resonance Diagnostic Devices. The document is a 510(k) Summary of Safety and Effectiveness, aiming to demonstrate substantial equivalence to previously cleared devices.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary for the 4ch Flex SPEEDER, as is common for medical device accessories demonstrating substantial equivalence, does not explicitly state quantitative acceptance criteria or provide a table of performance metrics in the same way a de novo device might. Instead, its primary method of demonstrating equivalency is through comparing its intended use, design, and performance characteristics to legally marketed predicate devices.

The document states: "Sample phantom images and clinical images are presented in Appendix F & G of this submission." This indicates that visual assessment of image quality from both phantom and clinical studies was submitted to demonstrate performance equivalent to the predicate devices. The implicit acceptance criterion is that the image quality (resolution, signal-to-noise ratio, artifact levels, etc.) produced by the 4ch Flex SPEEDER, as evidenced by these sample images, is comparable to, and not worse than, the image quality of the predicate devices.

Since specific quantitative metrics are not provided in this summary, a table for acceptance criteria vs. reported performance cannot be generated with numerical values. However, based on the submission's structure, we can infer the qualitative performance assessment:

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

The 510(k) summary does not specify the sample size for a formal test set in terms of number of patients or images. It mentions "Sample phantom images and clinical images are presented in Appendix F & G." This suggests a qualitative, rather than large-scale quantitative, comparison for equivalence.

The data provenance (country of origin, retrospective/prospective) is also not specified in the provided summary.

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

The 510(k) summary does not mention the use of experts to establish ground truth for a test set. This type of review by experts is more common for software algorithms or AI devices where diagnostic accuracy is explicitly being measured against a gold standard. For a coil accessory demonstrating substantial equivalence, the focus is typically on the physical and electrical performance leading to acceptable image quality.

4. Adjudication Method

Given that no formal test set with ground truth establishment by experts is described, there is no adjudication method mentioned or implied.

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

No MRMC comparative effectiveness study is mentioned in the 510(k) summary. The device is a hardware accessory (an MRI coil), not an AI algorithm or a diagnostic software tool that directly interprets images. Therefore, the concept of improving human reader performance "with AI vs without AI assistance" is not applicable to this device submission.

6. Standalone Performance Study

The focus of this submission is on the standalone performance of the 4ch Flex SPEEDER as an MRI coil, rather than its performance in conjunction with an AI. The "sample phantom images and clinical images" would reflect the standalone performance of the coil when integrated into a standard MRI system. However, the summary does not detail the methodology or metrics of such a study beyond mentioning the provision of images.

7. Type of Ground Truth Used

For a hardware component like an MRI coil, the "ground truth" for image quality is typically established by physical phantom measurements (e.g., signal-to-noise ratio, uniformity, resolution targets) and the assessment of clinical diagnostic utility by qualified radiologists (though not explicitly detailed in this summary). There is no mention of pathology or outcomes data being used for ground truth in this submission.

8. Sample Size for the Training Set

The concept of a "training set" is typically associated with machine learning or AI models. Since the 4ch Flex SPEEDER is a hardware coil, there is no training set in the context of an algorithm. Its design and development would have involved engineering specifications, simulations, and iterative prototyping and testing, not data training.

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

As there is no training set for this hardware device, this question is not applicable.

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