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The Polarean XENOVIEW 3.0T Chest Coil is to be used in conjunction with compatible 3.0T Magnetic Resonance Imaging (MRI) scanners and approved xenon Xe 129 hyperpolarized for oral inhalation of lung ventilation in adults and pediatric patients aged 12 years and older.

The Polarean XENOVIEW 3.0T Chest Coil (hereafter Chest Coil) is a flexible, single channel, transmit-receive (T/R) RF coil tuned to 123xe frequency on a 3.0T MRI magnetic field in order to image 129Xe nuclei while the patient is positioned inside a compatible multi-nuclear-capable MRI scanner. The Chest Coil is intended to be worn by a patient who inhales hyperpolarized 100%e gas (XENOVIEW) to obtain an MR image of the regional distribution of hyperpolarized 199xe in the lungs. The coil is constructed of a durable, flexible circuit board material within which the antenna elements and all electronic components are contained. These components are electrically isolated from the rest of the coil packaging by being enclosed within suitable non-conductive. water-rated, and flame-rated materials. A layer of padding is located on either side of the coil circuitry to provide patient comfort and protection against potential heating generated by circuitry components. The RF coil is a "fixed matching and tuning device" (i.e. not tunable by the operator), thereby eliminating the need to tune and match it for every patient.

The provided document describes the Polarean XENOVIEW 3.0T Chest Coil (subject device) and its substantial equivalence to a predicate device (K231647). The submission focuses on adding compatibility with General Electric Healthcare (GEHC) 3T MR750 and Premier MRI scanners.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative table format with corresponding reported device performance for a diagnostic measurement. Instead, it outlines performance and safety standards against which the device was tested. The "performance" here refers to the device's functional integrity and safety within an MRI environment, rather than a diagnostic accuracy performance (e.g., sensitivity, specificity).

Implicit Acceptance Criteria and Demonstrated Performance:

Note: The document states "confirm the safety and performance" for each category, but does not provide specific numerical outcomes or thresholds that were met. The acceptance is implied by the statement that the device was "verified and validated in accordance with documented Verification & Validation plans and protocols to ensure conformance with established performance criteria" and the conclusion that it is "as safe, as effective, and performs as well as or better than" the predicate.

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

The document explicitly states: "No clinical tests were required to demonstrate substantial equivalence." This means there was no patient-based test set for evaluating diagnostic or clinical performance. The testing was non-clinical (bench testing) and therefore, concepts of sample size, data provenance (country of origin, retrospective/prospective) are not applicable in the context of clinical studies for this device.

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 as no clinical studies were performed, and thus no ground truth derived from expert review or clinical outcomes was established for a test set. The validation was based on engineering and safety standards.

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

This information is not applicable as no clinical studies were performed, and thus no expert adjudication of clinical data was needed.

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. The device is a physical MRI coil, not an AI-powered diagnostic tool, and no clinical studies were required or conducted.

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

This information is not applicable. The device is a physical MRI coil, not an algorithm.

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

For the non-clinical testing, the "ground truth" was adherence to established international and national standards for medical device safety and performance, specifically related to MRI coils (e.g., NEMA, IEC, ISO standards). There was no clinical ground truth established from patient data.

8. The sample size for the training set

This information is not applicable as no algorithmic training was involved. The device is a physical MRI coil.

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

This information is not applicable as no algorithmic training was involved.

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The Polarean XENOVIEW 3.0T Chest Coil is to be used in conjunction with compatible 3.0T Magnetic Resonance Imaging (MRI) scanners and approved xenon Xe 129 hyperpolarized for oral inhalation of lung ventilation in adults and pediatric patients aged 12 years and older.

The Polarean XENOVIEW 3.0T Chest Coil (hereafter Chest Coil) is a flexible, single channel, transmit-receive (T/R) RF coil tuned to 123Xe frequency on a 3.0T MRI magnetic field in order to image 129%e nuclei while the patient is positioned inside a compatible multi-nuclear-capable MRI scanner. The Chest Coil is intended to be worn by a patient who inhales hyperpolarized 1ª3 xe gas (XENOVIEW) to obtain an MR image of the regional distribution of hyperpolarized 149Xe in the lungs.

The coil is constructed of a durable, flexible circuit board material within which the antenna elements and all electronic components are contained. These components are electrically isolated from the rest of the coil packaging by being enclosed within suitable non-conductive, water-rated, and flame-rated materials. A layer of padding is located on either side of the coil circuitry to provide patient comfort and protection against potential heating generated by circuitry components. The RF coil is a "fixed matching and tuning device" (i.e. not tunable by the operator), thereby eliminating the need to tune and match it for every patient.

This document describes the XENOVIEW 3.0T Chest Coil (Model 44315-03) and its substantial equivalence to a previously cleared predicate device (Model 44315-01, K212239). The primary difference is the expanded compatibility to include Philips 3T MRI scanners, in addition to the Siemens 3T MRI scanners supported by the predicate.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it refers to conformance with established performance criteria and specific industry standards. The reported "performance" aligns with meeting the requirements of these standards.

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

This document describes non-clinical testing performed on the device itself. Therefore, there is no "test set" in the context of patient data. The testing involves physical devices (XENOVIEW 3.0T Chest Coil) and MRI scanners.

• Sample Size for Test Set: Not applicable as it's not a clinical study involving patient data. The testing was conducted on "the new model of the Chest Coil."
• Data Provenance: Not applicable. The testing was non-clinical (bench testing, electrical safety, EMC, biocompatibility).

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

Not applicable. This is not a clinical study or a study relying on expert interpretation of diagnostic images. The ground truth for the non-clinical tests is based on the specifications of the standards (e.g., NEMA, IEC, ISO) and the physical properties of the device and MRI systems.

4. Adjudication Method for the Test Set

Not applicable. There is no expert adjudication for non-clinical performance and safety testing against engineering standards.

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

No. The document explicitly states: "No clinical tests were required to demonstrate substantial equivalence." This indicates that no MRMC comparative effectiveness study was performed.

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

No. This device is a medical accessory (an RF coil for MRI), not an AI algorithm. Therefore, a standalone performance study in the context of AI is not relevant.

7. The Type of Ground Truth Used

For the non-clinical testing, the "ground truth" is defined by:

• Established industry standards: NEMA MS, IEC 60601 series, ISO 10993 series. The device's performance against these standards constitutes the "truth" that it is safe and performs as intended.
• Physical and electrical characteristics: The fundamental properties and measurements of the coil (e.g., frequency of operation, SNR, SAR, heating) as measured in a controlled laboratory environment.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. As there is no training set, there is no ground truth for it.

In summary, the provided document describes the safety and performance verification of an MRI chest coil through non-clinical laboratory testing against established engineering and safety standards, rather than through clinical trials or AI performance evaluations.

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The Polarean XENOVIEW 3.0T Chest Coil is to be used in conjunction with compatible 3.0T Magnetic Resonance Imaging (MRI) scanners and approved xenon Xe 129 hyperpolarized for oral inhalation of lung ventilation in adults and pediatric patients aged 12 years and older.

The Polarean XENOVIEW 3.0T Chest Coil (hereafter Chest Coil) is a flexible, single channel, transmit-receive (T/R) RF coil tuned to 129Xe frequency on a 3.0T MRI magnetic field in order to image 129Xe nuclei while the patient is positioned inside a compatible multi-nuclear-capable MRI scanner. The Chest Coil is intended to be worn by a patient who inhales hyperpolarized 129Xe gas (XENOVIEW) to obtain an MR image of the regional distribution of hyperpolarized 129Xe in the lungs.

The coil is constructed of a durable, flexible circuit board material within which the antenna elements and all electronic components are contained. These components are electrically isolated from the rest of the coil packaging by being enclosed within suitable non-conductive, water-rated, and flame-rated materials. A layer of padding is located on either side of the coil circuitry to provide patient comfort and protection against potential heating generated by circuitry components. The RF coil is a "fixed matching and tuning device" (i.e. not tunable by the operator), thereby eliminating the need to tune and match it for every patient.

The provided document is a 510(k) summary for the Polarean XENOVIEW 3.0T Chest Coil. It details the device's characteristics, its intended use, and its comparison to a predicate device to establish substantial equivalence. However, this document does not describe a study that proves the device meets specific acceptance criteria in the context of an AI/algorithm-driven medical device performance study. The device in question is a chest coil, which is a hardware component used in MRI, not an AI algorithm.

Therefore, many of the requested elements (like MRMC studies, standalone algorithm performance, number of experts for ground truth, training set details) are not applicable to this type of device submission and are not present in the provided text.

The document focuses on demonstrating substantial equivalence to a predicate device through:

• Bench testing: Verifying the coil's physical and electrical performance (e.g., signal-to-noise ratio, SAR, RF coil heating).
• Electrical Safety and Electromagnetic Compatibility (EMC) testing: Ensuring safety standards compliance.
• Biocompatibility testing: Confirming the materials are safe for human contact.

Below, I'll address the applicable points based on the provided text, and explicitly state when information is not available or not relevant for this type of device.

Acceptance Criteria and Device Performance (for a hardware component)

The document specifies conformance to various standards as part of its verification and validation. These can be considered the "acceptance criteria" for a hardware device like an MRI coil.

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

Regarding the study proving the device meets acceptance criteria:

The document broadly states that the device was "verified and validated in accordance with documented Verification & Validation plans and protocols to ensure conformance with established performance criteria." It lists the types of tests performed and the standards they conform to.

2. Sample sized used for the test set and the data provenance:

   • Sample Size: Not specified for hardware testing. This usually involves testing a certain number of manufactured units or prototypes to ensure reproducible performance.
   • Data Provenance: Not applicable in the context of clinical image data. These are engineering and safety tests.

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

   • Not applicable. Ground truth, in the context of AI/ML, refers to expert-labeled data. For hardware testing, the "ground truth" is adherence to engineering specifications and safety standards, which is assessed by qualified engineers and testing facilities, not medical experts.

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

   • Not applicable. This is relevant for image interpretation or diagnosis consensus, not hardware testing.

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. The device is an MRI chest coil, a hardware component, not an AI algorithm intended to assist human readers.

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

   • Not applicable. The device is hardware, not an algorithm. Bench testing mentioned would be "standalone" in the sense of testing the hardware component itself.

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

   • For hardware, the "ground truth" is defined by the technical specifications, performance limits, and safety standards (e.g., NEMA standards, IEC standards, ISO standards for biocompatibility). Test results are compared directly to these established limits.

8. The sample size for the training set:

   • Not applicable. The device is a hardware component; there is no "training set" in the machine learning sense.

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

   • Not applicable. There is no training set. Engineering specifications and regulatory standards serve as the basis for evaluation.

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