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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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XENOVIEW VDP is image processing software that analyzes a pulmonary hyperpolarized 129-Xe MR image and a proton chest MR image to provide visualization of lung ventilation in adults and pediatric patients aged 12 years and older.

XENOVIEW VDP is an image analysis platform that quantifies normalized xenon intensity of a ventilated space using a pulmonary hyperpolarized 129-Xe ventilation MR image and accompanying proton chest MR image. The XENOVIEW VDP image analysis process includes loading and viewing images, image registration and seqmentation, normalization and statistical analysis of 129Xe signal intensity distribution within the ventilation scan, and ultimately reporting the fraction of ventilated lunq volume as a percentage of thoracic cavity volume. This software will be used by clinicians to assist in the interpretation and numerical classification of hyperpolarized 129-Xe ventilation MR images. The HP 129Xe ventilation MR images are generated using an MRI scanner and appropriate RF chest coil with a patient that has inhaled XENOVIEW (xenon Xe 129 hyperpolarized). The software provides a user-friendly interface and simple workflow that helps quide the user through the image analysis process, including the loading of images, registration of the anatomical image sets to the HP 129Xe image sets, segmentation of the lung, and automated classification of normalized ventilation distribution into multiple intensity levels via analysis of hyperpolarized 129Xe signal intensity within the segmented lung volume. The results of the image analysis are output as medical images of the classified ventilation, a summary report, and data files containing quantitative statistical analysis results.

The provided document is a 510(k) Premarket Notification from the FDA, seeking substantial equivalence for the XENOVIEW VDP device. While it summarizes non-clinical testing for software verification and validation, it explicitly states that clinical studies were not required. Therefore, the document does not contain the detailed clinical study information requested to describe acceptance criteria and proof of performance through clinical trials.

The document focuses on demonstrating substantial equivalence to a predicate device (GE Medical Systems Thoracic VCAR K103480) based on technological characteristics and non-clinical performance.

Here's an analysis based on the information provided in the document, and what is missing:

The document states:

• "Summary of Clinical Testing: XENOVIEW VDP did not require clinical studies to support substantial equivalence."

This immediately indicates that information regarding a clinical study proving the device meets specific acceptance criteria as you've requested (e.g., sample size, expert consensus, MRMC studies, specific performance metrics against ground truth from a clinical study) will not be present.

Therefore, for aspects relating to clinical study data, such as a table of acceptance criteria met by a clinical study, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone performance from a clinical study, the answer is that this information is not available in the provided text because clinical studies were not required for this 510(k) submission.

The "acceptance criteria" discussed in this document pertain to the software verification and validation testing and demonstration of substantial equivalence to a predicate device, not performance within a clinical setting.

However, I can still address the aspects for which information is provided or implied by the nature of a 510(k) submission not requiring clinical trials:

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

• Acceptance Criteria (from a 510(k) perspective for software verification/validation): The document relies on "software verification and validation testing per FDA's guidance 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' (May 11, 2005)." This guidance typically involves demonstrating that the software functions as intended and meets its specifications, including requirements for accuracy, reliability, and security of its image processing functions. Specific quantitative performance metrics for disease detection accuracy against clinical ground truth are not provided because a clinical study was not conducted or required.
• Reported Device Performance: The document states, "The safety and performance of the XENOVIEW VDP software has been evaluated and verified in accordance with software specifications through software verification and validation testing." No specific numerical performance metrics (e.g., sensitivity, specificity, accuracy for a clinical outcome) are reported as this was not a clinical trial. The performance reported here refers to the successful completion of engineering validation tests.

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

• Clinical Test Set: Not applicable/not provided, as clinical studies were not required.
• Software Verification/Validation Test Set: The document does not specify the sample size or provenance of data used for the software verification and validation tests. This type of detail is typically found in the full 510(k) submission, not the public summary letter. These tests would likely use a combination of synthetic, historical, or internally generated data to test functionality, robustness, and accuracy of image processing steps (e.g., registration, segmentation, quantification of xenon intensity). Provenance might be internal datasets or publicly available phantom/synthetic data.

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

• Clinical Test Set: Not applicable/not provided, as clinical studies were not required. For software verification, ground truth would likely be established by engineering specifications, known inputs, or validated reference images, rather than clinical experts.

4. Adjudication method for the test set:

• Clinical Test Set: Not applicable/not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. The document explicitly states that "XENOVIEW VDP did not require clinical studies to support substantial equivalence." An MRMC study is a type of clinical study.

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

• Clinical Standalone Performance: Not applicable/not provided. The document describes the device as "image processing software that analyzes a pulmonary hyperpolarized 129-Xe MR image and a proton chest MR image to provide visualization of lung ventilation." Its function is to assist clinicians, not to make a diagnosis independently. While its internal algorithms perform computations "standalone," the performance evaluation described here (non-clinical) does not speak to its standalone diagnostic performance in a clinical context.

7. The type of ground truth used:

• Clinical Trial Ground Truth: Not applicable/not provided.
• Software Verification/Validation Ground Truth: For the non-clinical software verification and validation, ground truth would be based on "software specifications." This means the expected outcome of processing an image (e.g., correct segmentation mask, accurate numerical quantification of xenon intensity per voxel/region) is predefined based on the design requirements and validated algorithms. This is not derived from expert clinical consensus, pathology, or patient outcomes data as it would be in a clinical study.

8. The sample size for the training set:

• Not provided. The document describes a medical device (software for image processing), focusing on its functionality and equivalence, not an AI/ML model for which a distinct "training set" would typically be discussed in a submission. While the software likely uses algorithms that were developed or "trained" at some point (e.g., for image registration or segmentation), the FDA submission for this device (XENOVIEW VDP) does not provide details on a specific training dataset from a machine learning perspective. It's listed as a "Medical Imaging Software" (K223071), not explicitly as an AI/ML device in the way recent submissions are categorized.

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

• Not provided. As above, the summary does not detail the training or ground truth for internal algorithms, focusing instead on the external validation of the software's functionality and performance against its specifications.

In summary, the provided FDA 510(k) letter for XENOVIEW VDP establishes substantial equivalence based on non-clinical software verification and validation testing in accordance with FDA guidance, and a comparison of technological characteristics to a predicate device. It explicitly states that clinical studies were not required or performed for this submission. Therefore, the detailed clinical study-related information requested (e.g., acceptance criteria confirmed by clinical data, sample sizes from clinical trials, expert ground truth for clinical cases, MRMC studies) is not present in the document.

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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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