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The 18ch T/R Knee Coil is intended for use with GE 3.0T MR systems to produce diagnostic images of the knee that can be interpreted by a trained physician.

The 18ch T/R Knee Coil is a transmit/receive. 18-channel phased array coil designed for magnetic resonance imaging (MRI) using the GE 3T MR systems. The 18ch T/R Knee Coil is intended to be used for imaging the knee.

The 18ch T/R Knee Coil is a reusable, non-invasive device with limited exposure with regard to duration of contact with the body. All coil elements are enclosed in a rigid plastic housing which is fire-rated, has impact and tensile strength, and has been tested for biocompatibility.

The 18ch T/R Knee Coil also includes the accessories listed in Table 1. The accessories consist only of patient comfort pads.

The provided text is a 510(k) Summary for a medical device called the "18ch T/R Knee Coil," a transmit/receive, 18-channel phased array coil designed for magnetic resonance imaging (MRI) of the knee. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics typically found for AI/software devices.

Therefore, many of the requested points related to acceptance criteria, sample sizes for test/training sets, ground truth establishment, expert adjudication, and MRMC studies are not applicable or cannot be extracted from this type of regulatory submission for a hardware device like an MRI coil.

However, I can extract the relevant performance data and conclusions regarding the substantial equivalence to the predicate device.

Here's a breakdown of the information that can be extracted and where the requested information is not applicable:

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

For an MRI coil, "acceptance criteria" are typically related to fundamental safety and performance standards rather than diagnostic accuracy metrics. The document references compliance with these standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable for the type of device and study described. This document pertains to the regulatory clearance of an MRI hardware component based on engineering and bench testing, not a clinical study involving patient data with a "test set" in the context of an algorithm or diagnostic accuracy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. Ground truth for diagnostic interpretation is not relevant for the engineering and safety testing of an MRI coil.

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

This information is not applicable. No adjudication method was used as there was no clinical test set requiring expert interpretation.

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

This information is not applicable. This device is an MRI coil, not an AI, CAD, or software device. No MRMC study was performed.

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

This information is not applicable. This is a hardware device, not an algorithm.

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

This information is not applicable. Ground truth in the context of diagnostic accuracy is not relevant here. The "ground truth" for this device's performance is compliance with established engineering, electrical safety, and imaging standards (e.g., NEMA standards for SNR and uniformity).

8. The sample size for the training set

This information is not applicable. This is not an AI/ML device with a training set.

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

This information is not applicable. This is not an AI/ML device.

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The MJAH-137A Atlas SPEEDER Head/Cervical Coil is intended for the use of diagnostic imaging of the human body, fluid visualization, 2D and 3D imaging, MR angiography and MR fluoroscopy.

This coil is intended to be used on the Atlas Vantage, model numbers MRT-1503/S3, /S4 and Atlas Titan, model number MRT-1504.

The Atlas SPEEDER Head/cervical is a phased Array Coil that can receive NMR signal from head, cervical region and upper chest.

The coil is configured in three sections; a head base, a removable anterior coil, and NV chest coil. There are two types of anterior coil; 1) Head anterior coil for head imaging, and 2) Neck anterior coil for cervical imaging. The Neck anterior coil includes an adjustable NV coil which is combined with Head anterior coil.

During transmission by the QD body coil this coil is deactivated by means of PIN diodes located on the internal circuit board. Upon deactivation of the transmit cycle the coil switches on to the receive mode.

This document is a 510(k) Summary of Safety and Effectiveness for a medical device, specifically an MRI coil (Atlas SPEEDER Head/Cervical Coil). It focuses on establishing substantial equivalence to existing devices rather than presenting a study to prove performance against specific acceptance criteria. Therefore, much of the requested information regarding study design, sample sizes, expert ground truth, and comparative effectiveness is not present in the provided text.

However, I can extract the relevant information that is available and indicate where the requested information is absent.

Acceptance Criteria and Device Performance

The document does not explicitly state quantitative "acceptance criteria" for the device's imaging performance. Instead, it relies on demonstrating basic safety parameters and presenting "sample phantom images and clinical images" to show its qualitative imaging capabilities. The primary "acceptance" for this 510(k) submission is the FDA's determination of substantial equivalence to predicate devices, not performance against predefined metrics.

Below is a table summarizing the safety parameters mentioned and the implied "performance" in the context of a 510(k).

Study Details from the Provided Text:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • The document mentions "sample phantom images and clinical images are presented in Appendix F & G." However, it does not specify the sample size for these images (number of phantom scans or number of clinical cases/patients).
   • Data provenance (country of origin, retrospective/prospective) is not provided.

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

   • The document does not mention the use of experts to establish ground truth for any test set or clinical image review. This type of detail is typically not included in a 510(k) summary focused on substantial equivalence.

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

   • Not applicable/Not mentioned. No formal adjudication method for image interpretation or ground truth establishment is described.

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. The device is an MRI coil, not an AI-powered diagnostic tool, so this type of study is irrelevant to its 510(k) submission.

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

   • Not applicable/No. This device is a passive hardware component (an MRI coil) and does not involve an algorithm with standalone performance.

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

   • For the "sample phantom images," the ground truth would be the known properties of the phantom itself.
   • For the "clinical images," the document does not specify how ground truth was established, or if formal ground truth was established at all beyond clinical reports or visual assessment. In a 510(k) for an MRI coil, the "ground truth" for showing image quality typically relies on the visual diagnostic quality as assessed by qualified personnel, often implicitly. No pathology or outcomes data is mentioned.

7. The sample size for the training set:

   • Not applicable. This device is a hardware component (MRI coil); it does not involve training a machine learning model.

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

   • Not applicable. As above, there is no training set for a machine learning model.

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