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Probe: The DxTx e²Coil probes are recommended for high-resolution magnetic resonance imaging, including spectroscopy, of the prostate and surrounding pelvic tissue in the male human anatomies and are specifically designed for use with the appropriate e²Coil Interface Device and Intermediate Cable Assembly. The one-time use, disposable e²Coil probe has been designed to be inserted into the human rectum. The e²Coil probe may be inserted by a trained healthcare professional, depending on state or country law, who has training in e²Coil probe insertion.

Interface Device: The Siemens 3.0T Endo Interface II with Tim 4G SlideConnect (e²Coil™) provides interface and support functions to allow the use of 3.0T disposable e²Coil probes with Siemens 3.0T MRI Systems with a Tim 4G connector. Only trained healthcare professionals are intended to operate this device.

The e²Coil™ Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector is a combination of the following two devices for improving the diagnostic MR image of the prostate and its surrounding pelvic tissues:

• Siemens 3.0T Endo Interface Gen II with Tim 4G Slide Connect (e2Coil)
• Endorectal MRI Coil II for 3.0T MR Imaging of the Prostate (e2Coil) – Siemens
  • Coil contains two loops and four channels

The intended contact duration of the device is less than 60 minutes.

No components of this device contain medicinal substances, tissues or blood products.

The patient contacting device component materials are Latex, PVC, and Polymer.

The provided FDA 510(k) clearance letter and summary describe the acceptance criteria and the study that proves the device meets those criteria for the e²Coil™ Imaging System.

Here's an breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes for each test set (e.g., number of coils for mechanical testing, number of measurements for SNR). The nature of the device (an MRI coil) suggests that testing would involve a representative number of manufactured units rather than patient data.

The data provenance is internal testing performed by the manufacturer, DxTx Medical, Inc., for regulatory submission. There is no mention of external data or patient data provenance in this summarized document.

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

This information is not provided in the document. The studies performed (biocompatibility, electrical safety, mechanical, MR safety, SNR, uniformity) are primarily objective engineering and scientific tests based on established standards (e.g., ISO, IEC, NEMA), rather than interpretations by medical experts to establish a "ground truth" in the diagnostic sense.

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

This is not applicable to the types of performance tests conducted for this device. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where expert consensus is needed to establish ground truth for diagnostic accuracy, which is not the focus of these engineering and safety tests.

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 is not applicable. The e²Coil™ Imaging System is an MRI coil, a hardware component, not an AI-powered diagnostic software. Therefore, an MRMC study related to human readers improving with AI assistance would not be relevant to this device.

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

This is not applicable, as the device is an MRI coil, not a standalone algorithm.

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

The "ground truth" for the performance characteristics measured in this submission is based on established engineering and scientific standards and physical properties. For example:

• Biocompatibility: Adherence to ISO 10993-1:2018 and FDA Guidance 635.
• Electrical Safety & EMC: Compliance with IEC 60601-1.
• Mechanical Testing: Compliance with IEC 60601-1.
• MR Safety: Compliance with IEC 60601-2-33.
• SNR & Uniformity: Adherence to NEMA MS 1 and NEMA MS 3/IEC 62464-1 standards.

These are objective, measurable criteria, not subjective interpretations requiring expert consensus or clinical outcomes data in the usual sense.

8. The sample size for the training set:

Not applicable. This device is an MRI coil, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set for this device.

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The 16CH Flex SPEEDER Medium 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 16ch Flex SPEEDER Large coil 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 16ch Flex Speeder Medium and 16ch Flex Speeder Large coils are a receive-only, 16-channel phased array coil designed for magnetic resonance imaging (MRI) using the Canon 1.5T MR systems. The 16ch Flex Speeder Medium and 16ch Flex Speeder Large coils are intended to be used for general anatomies.

This document describes the acceptance criteria and the study conducted to prove that the 16ch Flex SPEEDER Medium 1.5T and 16ch Flex SPEEDER Large 1.5T coils meet these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Clinical images were obtained from "volunteer scanning of general human anatomy." The exact number of volunteers is not specified.
• Data Provenance: The document does not explicitly state the country of origin. The study appears to be prospective, as clinical images were "obtained for the 16CH Flex SPEDER Medium and Large 1.5T from upper and lower extremities, chest, abdomen, pelvis, head, neck and spine."

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

• The document states that the diagnostic images are "interpreted by a trained physician." It does not specify the number of physicians, their specific qualifications (e.g., years of experience), or how ground truth was established by these physicians for the test set.

4. Adjudication Method for the Test Set

• The document does not describe any specific adjudication method (e.g., 2+1, 3+1). It only mentions that images are "interpreted by a trained physician," implying a single interpretation per image for diagnostic quality assessment.

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

• No MRMC comparative effectiveness study was done. The study compares the new device to pre-determined acceptance criteria and implicitly to the predicate device in terms of performance (e.g., "performs as well as or better than the predicate device"), but not in terms of human reader improvement with AI assistance. This is an MRI coil, not an AI-driven device.

6. Standalone Performance Study

• A standalone performance study was done for the device itself. The document describes non-clinical bench testing (SNR, uniformity, electrical safety, EMC, surface heating) and clinical imaging with volunteers to assess diagnostic image quality. This refers to the performance of the coil as a medical device without explicit human-in-the-loop performance measurement.

7. Type of Ground Truth Used

• For technical performance (SNR, uniformity, electrical safety, EMC, surface heating): Ground truth was established against engineering specifications and industry standards (NEMA MS-9, IEC, AAM/ANSI EN60601-1).
• For diagnostic image quality: The ground truth was established through visual assessment by a "trained physician" of "diagnostic quality images." This is essentially expert consensus/interpretation of the acquired images.

8. Sample Size for the Training Set

• This information is not applicable as this is a physical medical device (MR coil) and not an AI/machine learning algorithm requiring a separate training set.

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

• This information is not applicable.

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The InkSpace Imaging Small Body Array is a receive-only coil, used for obtaining diagnostic images of general human anatomy in adult and pediatric patients such as cardiac, spine, shoulder, elbow, knee, foot, and prostate in Siemens 1.5T magnetic resonance imaging systems. These images, when interpreted by a trained physician, yield information that may assist in diagnosis.

The InkSpace Imaging Small Body Array is a phased array, receive-only coil intended to work with Siemens 1.5T MRI scanners for body MR imaging examinations. The coil is comprised of 24 total channels, with two individual flexible pads, each containing 12 individual elements. The elements are flexible to conform to patients' anatomies.

The provided text does not describe a study involving a device that uses AI or machine learning, nor does it provide a comparative effectiveness study with human readers. Instead, it describes a Magnetic Resonance (MR) Receive-only Coil and its substantial equivalence to a predicate device.

Therefore, many of the requested elements about acceptance criteria for AI performance, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment are not applicable based on the provided document.

However, I can extract information related to the device's performance testing from the document:

Device: InkSpace Imaging Small Body Array (a receive-only coil for MRI systems)

1. Table of acceptance criteria and the reported device performance:

The document refers to performance testing in accordance with the "Magnetic Resonance (MR) Receive-only Coil – Performance Criteria for Safety and Performance Based Pathway" guidance document. It lists the tests performed, implying these tests are the acceptance criteria. The performance results are stated to have met established specifications.

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

• Sample Size: The document does not specify exact sample sizes (e.g., number of coils tested, number of images reviewed) for the nonclinical tests. It refers to "sample clinical images" for the acquired image quality analysis.
• Data Provenance: Not specified in terms of country of origin. The test data are generated from nonclinical bench testing and analysis of sample clinical images. The data is retrospective in the sense that the images are existing data used for evaluation.

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

• Number of Experts: "a board-certified radiologist" (implies one, though it could be a general statement about the type of expert).
• Qualifications: "board-certified radiologist."

4. Adjudication method for the test set:

• The document mentions a "review of their clinical quality by a board-certified radiologist." This implies a single expert review, not an adjudication process involving multiple experts for consensus.

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. An MRMC study was not performed. This device is a passive component (MRI coil), not an AI/ML algorithm that assists human readers.

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

• N/A. This is not an algorithm; it's hardware. Its performance is assessed through its physical and electromagnetic properties, with the final output (images) being subject to human interpretation.

7. The type of ground truth used:

• For "Acquired Image Quality," the ground truth was established by the subjective "clinical quality" assessment by a "board-certified radiologist." Other tests (SNR, Uniformity, etc.) likely relied on objective measurements against engineering specifications.

8. The sample size for the training set:

• N/A. This device does not involve a training set as it's a hardware component, not an AI/ML model.

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

• N/A. (See point 8)

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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 dS Wrist Coil 8ch 1.5T is intended to be used in conjunction with Philips 1.5T Magnetic Resonance Scanner to produce diagnostic images of the wrist that can be interpreted by a trained physician.

The dS Wrist Coil 8ch 1.5T is an 8-channel phased-array coil with rigid volume coils of 8 elements that closely encircle the wrist for high SNR. This coil for Prodiva and MR5300 is a one-piece, hinged design for easy patient set-up. To reduce patient motion artifacts, the dS Wrist coil includes one rigid base plate to fixate the coil & allowing for overhead and at the side examinations. This coil is only available in 1.5T. This coil is used independently and cannot be combined with any other coils

This FDA 510(k) summary describes a new medical device, the Philips dS Wrist Coil 8ch 1.5T, which is a magnetic resonance (MR) receive-only coil for wrist imaging. The document claims the device is substantially equivalent to a predicate device (8ch Wrist Coil, K222325). However, it does not provide a table of acceptance criteria and reported device performance, nor details of a study proving the device meets specific acceptance criteria related to diagnostic performance for image quality.

Instead, it lists non-clinical and clinical performance testing performed to demonstrate safety and effectiveness. The clinical testing merely states that "Acquired Image quality was assessed by U.S. Board Certified radiologist to confirm that images produced on the subject coil have sufficient quality for diagnostic use." This is a very high-level statement and lacks the specificity required to answer your questions regarding acceptance criteria, study details, and quantifiable performance.

Therefore, many of your questions cannot be answered from the provided text. Below, I will answer what is inferable from the document and explicitly state where information is missing.

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

Missing Information: The document does not provide specific quantifiable acceptance criteria (e.g., SNR values, image uniformity metrics thresholds) or detailed reported performance against such criteria. The statement is qualitative.

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

Missing Information: The document does not specify the sample size for the clinical test set, the country of origin of the data, or whether it was retrospective or prospective.

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)

Inferred Information: The ground truth (or assessment of image quality for diagnostic use) was established by "U.S. Board Certified radiologist."

Missing Information: The exact number of radiologists, their specific years of experience, or any further specific qualifications are not provided.

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

Missing Information: The document does not mention any adjudication method for the radiologists' assessments.

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

Missing Information: The device described is a medical imaging coil, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study regarding "human readers improve with AI vs without AI assistance" is not applicable and not mentioned.

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

Missing Information: The device is a hardware component (an MR coil), not an algorithm. Therefore, a standalone algorithm performance study is not applicable and not mentioned.

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

Inferred Information: For the clinical performance assessment, the "ground truth" for sufficient image quality was based on the qualitative assessment of "U.S. Board Certified radiologist." This can be considered a form of expert consensus or expert review.

8. The sample size for the training set

Missing Information: The document does not describe any machine learning or AI component that would require a "training set." This question is not applicable to an MR coil.

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

Missing Information: As there is no mention of a training set or AI/ML components, this question is not applicable to the device described.

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The dS Knee Coil 8ch 1.5T is to be used in conjunction with Philips 1.5T Magnetic Resonance Scanner to produce diagnostic images of Knee that can be interpreted by a trained physician.

The dS Knee Coil 8ch 1.5T is an 8 channel phased array, receive only coil with a rigid volume and designed to be used in conjunction with 1.5T Magnetic Resonance Scanner for high resolution imaging of the left or right knee. The split design and single handle allows easy setup. The coil can be slightly rotated relative to its base plate to ease coil setup and enhance patient comfort. The coil conforms snugly to the anatomy for excellent signal-to-noise ratio. This coil is used independently and cannot be combined with any other coil and is available for Philips 1.5T Prodiva and MR 5300 MR Systems.

The provided text K242879 is a 510(k) summary for the Philips dS Knee Coil 8ch 1.5T. It describes the device, its indications for use, and a summary of performance data. However, this document does not contain the detailed clinical study results or acceptance criteria in the format requested, particularly for an AI/software-based medical device performance evaluation.

The document states:

• "Acquired Image quality was assessed by a U.S. Board Certified radiologist to confirm images produced on the subject coil are sufficient quality for diagnostic use."
• "Substantially equivalent performance is demonstrated by meeting all criterion in the quidance "Magnetic Resonance (MR) Receive-only Coil –Performance Criteria for Safety and Performance Based Pathway" issued on December 11, 2020."

This indicates that the performance evaluation for this hardware device (a medical coil) focused on image quality for diagnostic use, rather than the performance of an AI algorithm or software. Therefore, many of the requested elements, such as MRMC studies, standalone algorithm performance, ground truth establishment for training, and sample sizes for AI model development, are not applicable or detailed in this document because it's not an AI/ML device submission.

Based only on the provided text, I can infer some information relevant to the intent behind your questions, but I cannot provide the specific details of an AI/ML study.

Here's how I can interpret the provided text in the context of your request, filling in with "Not Applicable" or "Not specified" where the document does not provide the information for an AI/ML device:

Study Type: This is a performance study for a hardware medical device (MRI coil), not an AI/ML software device. The evaluation focuses on assuring the generated images are of diagnostic quality.

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

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

• Sample Size: Not specified for the clinical image quality assessment. The document only mentions "Acquired Image quality was assessed."
• Data Provenance: Not specified. It's likely prospective imaging data acquired with the device for validation, but the document doesn't explicitly state this.

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)

• Number of experts: Singular ("a U.S. Board Certified radiologist").
• Qualifications: "U.S. Board Certified radiologist." Specific experience level (e.g., 10 years) is not mentioned.

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

• Adjudication method: Not applicable/not specified. The assessment appears to be a single read. This is a hardware image quality assessment, not an AI diagnostic study usually requiring complex adjudication.

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

• MRMC study: No, this was not an MRMC study. It was an assessment of the image quality produced by the coil, not a study comparing human reader performance with or without AI assistance.
• Effect size: Not applicable.

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

• Standalone performance: Not applicable. This is not an AI algorithm. The performance being evaluated is the image generation capability of the MRI coil.

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

• Type of ground truth: Expert assessment by a U.S. Board Certified radiologist to confirm "sufficient quality for diagnostic use." This is a form of expert consensus on image utility, rather than a clinical ground truth for a specific diagnosis (like pathology).

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is a hardware device, not an AI/ML model that requires a training set.

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

• Ground Truth for Training Set: Not applicable.

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The dS FootAnkle Coil 8ch 1.5T is intended to be used in conjunction with Philips Magnetic Resonance Scanner to produce diagnostic images of the foot and ankle that can be interpreted by a trained physician.

The dS FootAnkle Coil 8ch 1.5T is a phased-array, receive-only coil with rigid volume consisting of 8 elements. This coil is a ski-boot-shaped coil designed for optimum coverage and highresolution visualization of the ankle and entire foot down to the toes. The coil design and element lavout allow for either large field of view (FOV) imaging of the whole foot or small FOV high resolution imaging of ankle joints. The coil is easy to set up and can be used with the patient's foot positioned vertically. These coils are used independently and cannot be combined with any other coils and are available for 1.5T Prodiva/ MR 5300 MR Systems.

The provided text is a 510(k) summary for the dS FootAnkle Coil 8ch 1.5T. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving that an AI/software device meets specific performance acceptance criteria through a clinical study.

Therefore, many of the specific details requested in your query (e.g., acceptance criteria for diagnostic algorithm performance, multi-reader multi-case studies, ground truth establishment methods for training sets of AI, sample sizes for AI test/training sets, adjudication methods) are not present in this document because the device in question is an MR coil, not an AI diagnostic software.

However, I can extract information related to the performance testing that was performed to support the substantial equivalence of the MR coil.

Here's what can be gathered from the provided text, with explanations where information is not applicable:

Acceptance Criteria and Device Performance for the dS FootAnkle Coil 8ch 1.5T

This document describes the regulatory submission for an MR coil, not an AI diagnostic software. As such, the "acceptance criteria" and "device performance" are related to the physical and imaging characteristics of the coil, not the diagnostic performance of an AI algorithm. The study described is a demonstration of equivalence and image quality for an MR coil.

1. Table of Acceptance Criteria and Reported Device Performance

The document references two FDA guidance documents for performance criteria:

• "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices, issued November 18, 2016" (General MR Device Guidance)
• "Magnetic Resonance (MR) Receive-only Coil – Performance Criteria for Safety and Performance Based Pathway, issued December 11, 2020" (Specific Coil Performance Guidance)

While the specific numerical acceptance criteria from these guidances are not explicitly listed in the 510(k) summary, the document states that the device "met all criterion in the guidance" and that "No new safety or efficacy concerns are raised".

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

• Sample Size: The document does not specify the exact number of cases or images used for the "Clinical Performance" assessment. It only states "Acquired Image quality was assessed..." The extent of this "assessment" (e.g., number of patients/scans reviewed) is not detailed.
• Data Provenance: Not explicitly stated (e.g., specific country, retrospective/prospective). However, the experts used were "U.S. Board Certified radiologists," suggesting data consistent with US clinical practice.

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

• Number of Experts: Two
• Qualifications: "U.S. Board Certified radiologists." No specific years of experience are mentioned.

4. Adjudication Method for the Test Set

• Not applicable/Not described. The assessment was to "confirm images produced on the subject coil are sufficient quality for diagnostic use," implying a qualitative assessment by the two radiologists, rather than a quantifiable "ground truth" establishment requiring adjudication for diagnostic accuracy.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. This was not an MRMC study comparing human readers with and without AI assistance. It was an assessment of image quality from an MR coil by two readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not Applicable. This is an MR coil, not a standalone algorithm. The performance is inherently linked to the image acquisition process.

7. The Type of Ground Truth Used

• For the "clinical performance," the "ground truth" was the qualitative assessment by two U.S. Board Certified radiologists that the "images produced on the subject coil are sufficient quality for diagnostic use." This is not a diagnostic "ground truth" for disease presence, but rather a performance "ground truth" for image utility.

8. The Sample Size for the Training Set

• Not Applicable. This is an MR coil, not an AI device that undergoes training.

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

• Not Applicable. As above, this is an MR coil, not an AI device.

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The intended use of the iLoop Interventional Coil 0.55T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the human body. Used in a magnetic resonance tomograph, the iLoop Interventional Coil 0.55T is intended to produce transversal, sagittal, coronal and oblique images of the internal structures of the body. This device may be used for interventional procedures.

The iLoop Interventional Coil 0.55T is a 1-channel receiver coil that can be used for MR imaging before, during and after MR-guided interventions with a Siemens MRI System with field strength 0.55T. The iLoop Interventional Coil 0.55T can also be used as a standard diagnostic coil for diagnostic examination of the human body. The iLoop Interventional Coil 0.55T is a coil that can be used on many different regions of the body. Used in conjunction with a sterile, self-adhesive OP-drape, the coil enables the workflow for MR-guided interventions

The provided text is a 510(k) summary for the iLoop Interventional Coil 0.55T, a medical device. It does not describe a study involving an AI or algorithm for medical imaging analysis, nor does it detail acceptance criteria and performance of such a device in the context of diagnostic accuracy (e.g., sensitivity, specificity, AUC).

Instead, this document focuses on the substantial equivalence of a new MR coil to a legally marketed predicate device. The performance testing mentioned (e.g., Image Signal to Noise (SNR), Image Uniformity, Surface heating) is related to the physical and electrical characteristics of the coil itself, rather than the diagnostic interpretive performance of an AI system.

Therefore, I cannot extract the information required for the requested table and study description (e.g., sample size for test/training sets, expert qualifications, MRMC studies, standalone performance, ground truth methods) as they pertain to AI/algorithm-based diagnostic devices, because this document is about a different type of medical device (an MR coil).

The "SUMMARY OF PERFORMANCE TESTING" section (page 5 of the PDF, marked with {5} in your input) outlines engineering and safety tests for the physical coil, not a clinical study to evaluate an AI's diagnostic performance. It states: "J) CLINICAL TESTING: Not required." This explicitly confirms that clinical studies to evaluate diagnostic accuracy were not performed or required for this device's clearance.

Thus, I cannot fill out the requested table or describe such a study based on the provided text.

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The Contour Hand/Wrist is intended for use with Siemens 0.55T MR systems to produce diagnostic images of hand and wrist anatomy that can be interpreted by a trained physician.

The Contour Hand/Wrist is a receive-only, 12-channel phased array coil designed for magnetic resonance imaging (MRI) using the Siemens 0.55T MR systems. The Contour Hand/Wrist is intended to be used for imaging hand and wrist anatomy.

The provided text describes a 510(k) premarket notification for a medical device called "Contour Hand/Wrist (Q7000232)," which is a magnetic resonance (MR) diagnostic device. The documentation focuses on demonstrating substantial equivalence to a legally marketed predicate device, the "Contour Knee." However, it does not contain the detailed information required to fully answer all aspects of your request regarding acceptance criteria and the study that proves the device meets them, particularly for a software-based AI device.

The device described, "Contour Hand/Wrist," is a hardware component (a receive-only, 12-channel phased array coil) for an MRI system, not an AI software. The performance testing mentioned (SNR, uniformity, image quality) is typical for MR coils, not AI algorithms.

Therefore, many of your specific questions, especially those related to AI algorithm performance (e.g., MRMC study, standalone algorithm performance, AI assistance effect size, training set details, ground truth for AI) cannot be answered from this document.

However, I can extract information relevant to the device's performance assessment as described:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the document, the acceptance criteria are related to the physical characteristics and imaging performance of the MRI coil. The document states:

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

• Test Set (Clinical Images): The document states "clinical images from volunteer scanning of hand/wrist anatomy were obtained." It does not specify the sample size (number of volunteers or images).
• Data Provenance: The images were obtained from a Siemens 0.55T MR system in an unspecified location (likely the manufacturer's facility or a collaborating site). The document does not explicitly state if it was retrospective or prospective, but "volunteer scanning" implies prospective collection for the test.

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

• Not Applicable in the AI Sense: This device is an MRI coil, not an AI algorithm that produces interpretations needing expert ground truth. The "diagnostic quality images" verification is implicitly against the expectation that a "trained physician" can interpret them.
• The document states the images "can be interpreted by a trained physician," implying the assessment of 'diagnostic quality' is based on the inherent ability of the images to be interpretable by medical professionals, rather than a comparison to a pre-established ground truth for specific pathologies. No explicit number of experts or their qualifications for assessing image quality are provided.

4. Adjudication method for the test set:

• Not Applicable: There is no indication of an adjudication method as would be used for clinical endpoints or AI algorithm performance assessment. The "diagnostic image quality" evaluation seems to be a qualitative assessment based on the technical characteristics of the images produced by the coil.

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: This is not an AI device. No MRMC study was conducted or is applicable for this type of device.

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

• Not Applicable: This is a hardware component. It does not perform as a standalone algorithm.

7. The type of ground truth used:

• Implied Technical / Interpretability Ground Truth: For the "diagnostic image quality," the ground truth is the inherent quality, clarity, and detail present in the images that allows a "trained physician" to make a diagnosis. It's not a ground truth for specific disease presence, but rather for imaging capability. For SNR and Uniformity, the ground truth is the NEMA MS-9 standard.

8. The sample size for the training set:

• Not Applicable: This is not an AI device. There is no training set in the context of machine learning.

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

• Not Applicable: As above, no training set for AI.

In summary, this document is a 510(k) for an MRI hardware coil, not an AI diagnostic software. Therefore, most of the detailed questions regarding AI acceptance criteria and study design are not addressed and are not relevant to this specific premarket notification. The study described focuses on demonstrating the technical performance (SNR, uniformity) and diagnostic image quality of the MR coil itself.

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The Contour Shoulder is intended for use with Siemens 0.55T MR systems to produce diagnostic images of shoulder anatomy that can be interpreted by a trained physician.

The Contour Shoulder is a receive-only, 12-channel phased array coil designed for magnetic resonance imaging (MRJ) using the Siemens 0.55T MR systems. The Contour Shoulder is intended to be used for imaging Shoulder anatomy. The Contour Shoulder is a reusable, non-invasive device with regard to duration of contact with the body. The central coil elements are enclosed in a rigid plastic housing which is fire-rated, has impact and has been tested for biocompatibility. The flexible wing coll elements are encapsulated in polycarbonate and aramid felt which is fire-rated, has impact and tensile strength, then covered with a polyurethane coated nylon fabric which has been evaluated for biocompatibility.

The provided text describes a 510(k) premarket notification for a medical device called "Contour Shoulder." This document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study report with specific acceptance criteria and performance metrics in the format requested.

Therefore, I cannot provide a table of acceptance criteria and reported device performance because the document does not present them in that manner. The information available is high-level and focused on general performance and safety.

However, I can extract the available information regarding the "study" that supports the device:

Study Information Pertaining to Contour Shoulder (K233656):

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

   • Acceptance Criteria (Implicit/General):
     • Signal-to-noise ratio (SNR) and image uniformity (per NEMA MS-9 and MS-6 methods) meet pre-determined acceptance criteria. (The specific numerical criteria are not provided).
     • Produce diagnostic quality images of shoulder anatomy.
     • Electrical safety and electromagnetic compatibility (per IEC standards).
     • Performance is "as well as or better than the predicate device."
   • Reported Device Performance:
     • SNR and image uniformity were measured and analyzed according to NEMA standards. (The specific numerical results are not provided).
     • Clinical images from volunteer scanning demonstrated that the Contour Shoulder produces diagnostic quality images of the intended anatomy.
     • Electrical safety and electromagnetic compatibility data support the safety of the device.
     • Bench testing and clinical images demonstrate performance and effectiveness.

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

   • Test Set Sample Size: "volunteer scanning" is mentioned for clinical images. The exact number of volunteers is not specified.
   • Data Provenance: The study involved acquiring clinical images from a Siemens 0.55T MR system. The country of origin is not explicitly stated, but the company (Quality Electrodynamics) is based in Mayfield Heights, Ohio, United States. The images were obtained from "volunteer scanning," implying a prospective collection for the purpose of this submission.

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

   • The document states that the images "can be interpreted by a trained physician."
   • The number of experts involved in assessing diagnostic quality for the clinical images is not specified.
   • The qualifications are generally stated as "trained physician," with no further specifics (e.g., years of experience, subspecialty).

4. Adjudication method for the test set:

   • The document does not specify any adjudication method. It only mentions that images can be interpreted by a trained physician.

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, an MRMC comparative effectiveness study was not done. This device is a hardware component (a coil for an MRI system), not an AI-powered diagnostic tool. Therefore, the concept of "human readers improving with AI vs without AI assistance" is not applicable.

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

   • This is a hardware device (an MR coil), not an algorithm. Therefore, no standalone algorithm-only performance was assessed.

7. The type of ground truth used:

   • For the clinical images, the ground truth was based on the ability of the images to be "interpreted by a trained physician" to demonstrate "diagnostic quality images of shoulder anatomy." This implies expert interpretation/consensus as the ground truth for image diagnosticity. No pathology or outcomes data are mentioned.
   • For the technical performance (SNR, uniformity, electrical safety), the ground truth was based on bench testing against NEMA and IEC standards.

8. The sample size for the training set:

   • This is a passive imaging device (MR coil) and not an AI/machine learning algorithm that requires a training set. Therefore, no training set was used or is applicable.

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

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

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