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The Flex Body SPEEDER is intended for use with Canon 1.5T MR systems to produce diagnostic images of general human anatomy that can be interpreted by a trained physician.

The Flex Body SPEEDER is a receive-only, phased array coil designed for magnetic resonance imaging (MRI) using the Canon 1.5T MR systems. The Flex Body SPEEDER is intended to be used for imaging general human anatomy, such as the torso, pelvis, joints, bones and extremities. The Flex Body SPEEDER is a reusable, non-invasive device with limited exposure with regard to duration of contact with the body. The coil elements are encapsulated in polycarbonate and aramid felt which are fire-rated and provide impact and tensile strength, then covered with a polyurethane coated nylon fabric which has been evaluated for biocompatibility.

The provided text is a 510(k) Summary for the Flex Body SPEEDER and describes performance testing for substantial equivalence. However, it does not explicitly detail acceptance criteria and a study design in the format of an AI/human-in-the-loop diagnostic device study. The device is a receive-only, phased array coil for MRI, not an AI-powered diagnostic device that interprets images. Therefore, the questions related to AI performance metrics (e.g., standalone AI performance, MRMC studies, ground truth establishment for training/test sets, sample sizes for training/test sets, expert adjudication, effect size of AI assistance) are not directly applicable to this submission.

Instead, the performance data provided focuses on the physical and functional aspects of the MRI coil.

Here's an attempt to answer the relevant questions based on the provided text, while acknowledging the limitations for questions pertaining to AI diagnostic studies:

1. A table of acceptance criteria and the reported device performance

The document mentions that the SNR and uniformity were analyzed per NEMA MS-6 and NEMA MS-9 and found to conform to predetermined acceptance criteria, but it does not explicitly state the numerical acceptance criteria or the reported numerical performance values for SNR and uniformity.

2. Sample size used for the test set and the data provenance

The document states, "clinical images from volunteer scanning of general human anatomy were obtained from the Flex Body SPEEDER."

• Sample size: Not explicitly stated, but implies a "volunteer scanning" was conducted, indicating a small clinical dataset for qualitative assessment.
• Data provenance: Not explicitly stated, but typically clinical image acquisition for such submissions is done in a controlled site, likely in the same country as the manufacturer (USA, given the FDA submission). It's a prospective data acquisition from "volunteer scanning."

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

This device does not involve expert interpretation to establish "ground truth" in the sense of a diagnostic finding (e.g., presence/absence of disease) for an AI algorithm. Instead, the "ground truth" here is the qualitative assessment of image quality for diagnostic use by a "trained physician."

• Number of experts: Not specified.
• Qualifications of experts: "Trained physician." Their specific experience (e.g., years, specialization) is not detailed.

4. Adjudication method for the test set

Not applicable in the context of adjudicating diagnostic labels, as this is an image acquisition device, not a diagnostic interpretation device. The "adjudication" implied is that the images "can be interpreted by a trained physician," implying they are deemed suitable for clinical diagnosis. No formal multi-reader adjudication process like 2+1 or 3+1 is described.

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, and it would not be applicable. This device is an MRI coil, not an AI diagnostic algorithm that assists human readers.

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

No, a standalone algorithm performance study was not done, and it would not be applicable. This device is an MRI coil, not an AI diagnostic algorithm.

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

The "ground truth" concept for this device relates to diagnostic image quality. The assessment was that the "Flex Body SPEEDER produces diagnostic quality images of the intended anatomies." This is based on qualitative assessment by a "trained physician" (implied "expert review") of the images' suitability for diagnostic interpretation, rather than a specific disease outcome or pathology.

8. The sample size for the training set

Not Applicable. The device does not involve an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

Not Applicable. The device does not involve an AI algorithm that requires a training set with established ground truth.

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The Flex Body SPEEDER is intended for use with Canon 3.0T MR systems to produce diagnostic images of general human anatomy that can be interpreted by a trained physician.

The Flex Body SPEEDER is a receive-only, phased array coil designed for magnetic resonance imaging (MRI) using the Canon 3T MR systems. The Flex Body SPEEDER is intended to be used for imaging general human anatomy, such as the torso, pelvis, joints, bones and extremities. The Flex Body SPEEDER is a reusable, non-invasive device with limited exposure with regard to duration of contact with the body. The coil elements are encapsulated in polycarbonate and aramid felt which are fire-rated and provide impact and tensile strength, then covered with a polyurethane coated nylon fabric which has been evaluated for biocompatibility.

The provided text describes the Flex Body SPEEDER, a receive-only, phased array coil for MRI, and its performance testing. However, it does not include detailed acceptance criteria or a specific study designed to prove the device meets those criteria in the context of diagnostic performance (e.g., accuracy, sensitivity, specificity).

The "Performance Data" section discusses various types of testing but focuses on safety, electromagnetic compatibility, and basic image quality metrics (SNR and uniformity) rather than diagnostic efficacy.

Here's a breakdown of the information that is available and what is missing based on your requested structure:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information/Cannot Determine from Text:

• Specific quantitative acceptance criteria for SNR, uniformity, or what constitutes "diagnostic quality images."
• Specific metrics or thresholds used to evaluate "diagnostic quality images."

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

• Sample Size: The text states "clinical images from volunteer scanning." The exact number of volunteers or images is not specified.
• Data Provenance: The text states "volunteer scanning," which implies a prospective collection of data. There is no information about the country of origin.

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

• This information is not provided. The text mentions "images can be interpreted by a trained physician," but it doesn't detail how multiple experts were used to establish a ground truth for specific diagnostic findings in the context of a performance study.

4. Adjudication Method for the Test Set

• This information is not provided. Given that no specific diagnostic performance study with expert review is detailed, an adjudication method is not mentioned.

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

• No, an MRMC comparative effectiveness study was not done (or at least not detailed in this document). The document focuses on demonstrating that the device produces diagnostic quality images on its own, not on comparing human readers with and without AI assistance. The Flex Body SPEEDER is an MRI coil, not an AI diagnostic tool.

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

• Again, the Flex Body SPEEDER is an MRI coil, not an algorithm. The clinical performance discussed is about the images produced by the coil, which are then interpreted by a trained physician. So, there isn't a "standalone algorithm" performance in the sense of AI. The closest analogous information is the bench testing for SNR and uniformity and the review of clinical images for diagnostic quality, where the coil is performing "standalone" in terms of image acquisition quality.

7. Type of Ground Truth Used

• For the "Performance Testing - Clinical," the "ground truth" for "diagnostic quality images" appears to be the subjective assessment by a trained physician that the images are clear enough for diagnosis. It is not based on pathology, outcomes data, or expert consensus in a formal sense of diagnostic accuracy comparison. For the bench tests (SNR, uniformity), the ground truth is against predetermined acceptance criteria based on NEMA MS-6 and NEMA MS-9 standards.

8. Sample Size for the Training Set

• This information is not applicable/provided. The Flex Body SPEEDER is a physical MRI coil, not an AI device that requires a training set.

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

• This information is not applicable/provided for the same reason as point 8.

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