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The SureWave Elastography device is intended for use with Siemens 1.5T and 3.0T MRI systems to generate shear wave vibrations in the body of adult patients during an MRI exam that are translated into images representing tissue stiffness. The images may be used for diagnostic purposes when interpreted by a trained physician.

The SureWave Elastography device is an accessory to the MRI system comprised of both hardware and software components. The hardware induces shear wave vibrations in the body through a transducer which is driven by a mobile tower and two flexible rotating axes. The transducer is fastened to the patient's body and contains a rotatable eccentric mass which induces vibrations in the body during an MRI scan. The SureWave Elastography reconstruction software uses the acquired image data from the MRI system to create images that show tissue stiffness.

The provided text describes the non-clinical and clinical tests performed to demonstrate the substantial equivalence of the SureWave Elastography device to its predicate devices. However, it does not explicitly define acceptance criteria in a table format with specific thresholds. It rather focuses on demonstrating similarity and accuracy to known values and predicate devices.

Based on the information provided, here's a structured response, with some sections noting what information is not present in the document.

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

The document does not explicitly state acceptance criteria in a quantitative table format with predefined thresholds. However, the study aims to demonstrate accuracy and repeatability comparable to, or better than, the predicate device and known phantom values. The reported performance is summarized below:

• Computed stiffness values were "at least as accurate if not more accurate than the predicate method." |
  | Specific Phantom Values: | | | | |
  | Expected: 0.82 kPa | Close to 0.82 kPa | 0.76 ± 0.01 kPa (95% CI) | 0.73 ± 0.02 kPa (95% CI) |
  | Expected: 2.02 kPa | Close to 2.02 kPa | 2.53 ± 0.94 kPa (95% CI) | 2.01 ± 0.07 kPa (95% CI) |
  | Expected: 2.77 kPa | Close to 2.77 kPa | 3.83 ± 0.44 kPa (95% CI) | 3.27 ± 0.32 kPa (95% CI) |
  | Expected: 5.80 kPa | Close to 5.80 kPa | 5.80 ± 0.67 kPa (95% CI) | 5.20 ± 0.09 kPa (95% CI) |
  | Repeatability | Within 10% of the mean of the respective method, and comparable/better than predicate. | Within 10% of the mean. | Within 10% of the mean. | "Slightly better than that of the predicate." |
  | Equivalency to Predicate (SureWave 2D) | Strong agreement with predicate, low bias. | Linear regression slope: 1.02 (R² = 0.99). Bland-Altman bias: 4%. | Not applicable. | "Excellent agreement," "no significant difference observed," "equivalent." |
  | Equivalency to Predicate (SureWave 3D) | Strong linear relationship. Expected bias due to volumetric analysis. | Not applicable. | Linear regression R² = 0.99. Bland-Altman bias: approximately 20%. | "Strong linear relationship." Bias expected and potentially indicates more accuracy. |

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

• Accuracy Test (Phantom):
  • Sample Size: Not explicitly stated as a "sample size" for a test set, but referred to as "MRE acquisitions from SureWave Elastography 2D, SureWave Elastography 3D, and the predicate MRE methods." The number of acquisitions per method for the general QA phantom repeatability testing was 240 measurements. It is implied similar extensive measurements were taken for the multi-component QA phantom.
  • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective clinical data). The phantom study is a bench test, not human data.
• Equivalency Test (Volunteer):
  • Sample Size: 22 healthy adult volunteers.
  • Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "healthy adult volunteers," implying a prospective human study.

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

• Phantom Studies: Ground truth for the phantom was established by the phantom manufacturer ("expected stiffness values established by the phantom manufacturer"). No human experts were involved in establishing this ground truth.
• Volunteer Studies: For the healthy volunteer equivalency study, the "ground truth" was effectively established by the predicate device's measurements. The document states that the SureWave Elastography measurements were plotted against the predicate device to assess their relationship and bias. No independent expert consensus or interpretation was described as establishing a separate ground truth for this human volunteer data beyond the predicate device as the comparison standard.

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

• No adjudication method (e.g., expert consensus or multi-reader review beyond the device's output) is described for either the phantom or volunteer test sets. The focus appears to be on direct numerical comparison of the device's output against known phantom values or predicate device measurements.

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 MRMC comparative effectiveness study involving human readers and AI assistance is described. The study focuses on the device's performance in terms of stiffness measurement accuracy and repeatability, and its equivalence to a predicate device, not on diagnostic improvement for human readers. The device outputs images that are "interpreted by a trained physician," but the study does not evaluate this physician interpretation process.

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

• Yes, the conducted tests, precisely the phantom and volunteer studies, evaluate the standalone performance of the SureWave Elastography device in generating stiffness measurements. The device produces quantitative stiffness values (kPa) and qualitative stiffness maps, confidence overlays, and wave images. The accuracy and repeatability of these outputs were directly assessed. While a trained physician interprets the images, the study's focus is on the device's ability to accurately produce those measurements, independent of a specific physician's interpretation improvement.

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

• Phantom Studies: The ground truth was known physical properties of the phantom components, as provided by the phantom manufacturer.
• Volunteer Studies: The ground truth for comparison was the measurements obtained from the legally marketed predicate device.

8. The sample size for the training set

• The document does not provide information about a training set size. The described tests relate to the validation or verification of the device's performance, implying it has already been developed. As this is a 510(k) submission for a device that generates physical properties (stiffness) rather than AI-based diagnostic interpretations, it's possible a separate "training set" in the machine learning sense was not explicitly required or detailed in this summary.

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

• As no training set is described, information on how its ground truth was established is also not present in the document.

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

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

The document K223429 outlines the Contour Knee, a 12-channel phased array coil designed for magnetic resonance imaging (MRI) of knee anatomy using Siemens 0.55T MR systems.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states "clinical images from volunteer scanning of knee anatomy were obtained."

• Sample Size: Not explicitly stated for the "volunteer scanning." It refers to "sample clinical images," implying a limited but representative set, rather than a large cohort. It does not provide specific numbers of volunteers or images.
• Data Provenance: The data was obtained from "a Siemens 0.55T MR system." The country of origin is not specified but is implied to be where Quality Electrodynamics, LLC conducts its testing. The data is prospective in nature, as it involves active "volunteer scanning" with the device for the purpose of demonstrating diagnostic quality.

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: The indication for use states that the images "can be interpreted by a trained physician." This implies that the images demonstrating diagnostic quality were assessed by at least one, and likely more, trained physicians. No specific specialties (e.g., radiologist) or years of experience are provided, but "trained physician" is a general qualification required for interpreting medical images.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The assessment of diagnostic quality appears to be based on the general ability of the images to be interpreted by a trained physician, rather than a multi-reader consensus process.

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 Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was reported or indicated.
• The Contour Knee is a hardware device (an MRI coil) and not an AI/software device. Therefore, the concept of "human readers improve with AI vs. without AI assistance" is not applicable to this product. The study focused on the coil's ability to produce diagnostic quality images compared to a predicate device, not on diagnostic accuracy improvements for human readers.

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

• No standalone (algorithm-only) performance was done.
• As noted above, this is an MRI coil, not an algorithm or AI. Its performance is inherent in the quality of the raw images it produces.

7. The Type of Ground Truth Used

The ground truth for the device's performance was established via:

• Bench Testing: For SNR, uniformity, electrical safety, and EMC, the ground truth was based on objective measurements against established engineering standards (NEMA MS-9, IEC standards).
• Expert Interpretation: For diagnostic image quality, the ground truth was based on the ability of "trained physicians" to interpret the images of knee anatomy, implying a subjective assessment of diagnostic interpretability by medical professionals. This is a form of expert consensus/opinion, though a formal consensus process is not detailed. There is no mention of pathology or outcomes data being used as ground truth.

8. The Sample Size for the Training Set

No information about a "training set" is provided. Since this is an MRI coil and not an AI or machine learning algorithm, the concept of a training set is not applicable. The device's design and engineering would be based on physical principles, not data-driven training.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

4. Adjudication method for the test set

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

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done, and it would not be applicable. This device is an MRI coil, not an AI diagnostic algorithm that assists human readers.

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

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

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

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

8. The sample size for the training set

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

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

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information/Cannot Determine from Text:

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

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

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

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

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

4. Adjudication Method for the Test Set

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

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

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

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

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

7. Type of Ground Truth Used

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

8. Sample Size for the Training Set

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

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

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

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The Contour 24 is intended for use with Siemens 1.5T MR systems to produce diagnostic images of general human anatomy that can be interpreted by a trained physician.

The Contour 24 is a receive-only, 24-channel phased array coil designed for magnetic resonance imaging (MRI) using the Siemens 1.5T MR systems. The Contour 24 is intended to be used for imaging general human anatomy, such as the abdomen and pelvis. The Contour 24 is a reusable, non-invasive device with limited exposure with regard to duration of contact with the body. The coil elements are encapsulated in polycarbonate and aramid felt which are fire-rated and provide impact and tensile strength, then covered with a polyurethane coated nylon fabric which has been evaluated for biocompatibility.

I am sorry, but the provided text does not contain the detailed information needed to fill out your request about acceptance criteria and a study proving device performance in the requested format.

The text mentions that "The SNR and uniformity of the Contour 24 was analyzed per NEMA MS-9 and was found to conform to predetermined acceptance criteria" and that "clinical images from volunteer scanning of general human anatomy were obtained from the Contour 24. These images were used to demonstrate that the Contour 24 produces diagnostic quality images of the intended anatomies." However, it does not provide:

• A specific table of acceptance criteria and reported device performance values.
• Sample sizes for test sets, data provenance, or details on ground truth establishment (number of experts, qualifications, adjudication methods).
• Information on MRMC comparative effectiveness studies or standalone performance.
• Sample size or ground truth establishment for the training set.

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The 16ch Foot/Ankle SPEEDER coil is intended for use with Canon 3.0T MR systems to produce diagnostic images of the foot and ankle that can be interpreted by a trained physician.

The 16ch Foot/Ankle SPEEDER is a receive-only, 16-channel phased array coil designed for magnetic resonance imaging (MRI) using Canon 3.0T MR systems. The 16ch Foot/Ankle SPEEDER is intended to be used for foot and ankle imaging.

The 16ch Foot/Ankle SPEEDER is a reusable, non-invasive device with limited exposure with regard to duration of contact with the body. All coil elements are enclosed in either a rigid plastic housing which is fire-rated, has impact and tensile strength, and has been tested for biocompatibility, or fire-rated flexible flaps that do not come into direct contact but can be easily adjusted to accommodate patients.

The provided text describes a 510(k) premarket notification for a medical device (16ch Foot/Ankle SPEEDER) and does not contain information about a study proving the device meets acceptance criteria related to an AI/algorithm's performance.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device for a physical MRI coil. The performance data discussed relates to:

• Biocompatibility Testing: Ensuring materials in contact with the patient are safe.
• Electrical Safety and Electromagnetic Compatibility: Conformance to safety standards (AAMI/ANSI ES60601-1 and IEC 60601-2-33), and surface heating tests (measured temperature never exceeded 41°C).
• Performance Testing - Bench: Signal-to-Noise Ratio (SNR) and uniformity analyzed per NEMA MS 6 and NEMA MS 9, conforming to predetermined acceptance criteria.
• Performance Testing - Clinical: Obtaining diagnostic quality images from volunteer scanning.

Therefore, many of the requested items (sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth for training) are not applicable to this document as it does not describe an AI/algorithm-based diagnostic device or a study involving such.

Based on the available information, here is a breakdown of what can be extracted:

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

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 states "clinical images from volunteer scanning of the foot and ankle were obtained". It does not specify the number of volunteers (sample size) or the country of origin of the data. The data collection was 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)

• Not applicable as this is not an AI/algorithm device requiring expert ground truth for "truth" labels. The "ground truth" for the device's performance is its ability to produce diagnostic quality images, interpreted by a "trained physician".

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

• Not applicable. Image interpretation is stated to be by "a trained physician", implying standard clinical practice rather than a formal adjudication process for a study.

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 done. This device is a passive MRI coil and does not involve AI assistance for image interpretation.

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

• No, a standalone algorithm performance study was not done. This device is a physical MRI coil.

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

• The implicit "ground truth" for the clinical performance relates to the ability of the images produced by the coil to be "diagnostic quality images of the intended anatomy" and "interpreted by a trained physician". This suggests a clinical judgment of image utility rather than a specific pathological or outcomes-based ground truth.

8. The sample size for the training set

• Not applicable. This is not an AI/algorithm that requires a training set.

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

• Not applicable.

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The 16ch T/R Hand Wrist Coil is intended for use with GE 1.5T MR systems to produce diagnostic images of the hand and wrist that can be interpreted by a trained physician.

The 16ch T/R Hand Wrist Coil is a transmit/receive, 16-channel phased array coil designed for magnetic resonance imaging (MRI) using the GE 1.5T MR systems. The 16ch T/R Hand Wrist Coil is intended to be used for imaging the hand and wrist.

The 16ch T/R Hand Wrist 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 provided text is a 510(k) summary for a medical device (16ch T/R Hand Wrist Coil) and does not describe an AI/ML powered device or a study involving such a device where acceptance criteria are set for AI performance metrics. Instead, it describes performance testing for a magnetic resonance imaging (MRI) coil.

Therefore, I cannot extract the requested information regarding AI device acceptance criteria, study details, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The document discusses various performance tests relevant to an MRI coil, which are outlined below for completeness, but these do not directly address the prompt's request for AI device specific information.

1. Table of Acceptance Criteria and Reported Device Performance (Non-AI related):

The following information cannot be extracted from the provided text as it pertains to AI/ML powered devices, which is not the subject of this 510(k) summary:

• Sample sizes used for the test set and the data provenance: Not applicable to a physical MRI coil. Clinical images were obtained from volunteer scanning, but the sample size is not specified for the diagnostic quality assessment.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for an MRI coil is its ability to produce good images for clinical interpretation, not an AI-derived diagnosis. The images are interpreted by a "trained physician".
• Adjudication method: Not applicable.
• 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.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: For the clinical image assessment of the coil, the "ground truth" is that the images are of "diagnostic quality" as interpreted by a trained physician. This is an outcome of the coil's performance, not a predefined ground truth for an algorithm.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

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The Contour 24 is intended for use with Siemens 3.0T MR systems to produce diagnostic images of general human anatomy that can be interpreted by a trained physician.

The Contour 24 is a receive-only, 24-channel phased array coil designed for magnetic resonance imaging (MRI) using the Siemens 3.0T MR systems. The Contour 24 is intended to be used for imaging general human anatomy, such as the abdomen and pelvis.

The Contour 24 is a reusable, non-invasive device with limited exposure with regard to duration of contact with the body. The coil elements are encapsulated in polycarbonate and aramid felt which are fire-rated and provide impact and tensile strength, then covered with a polyurethane coated nylon fabric which has been evaluated for biocompatibility.

Acceptance Criteria and Study for Contour 24

The Contour 24 is a receive-only, 24-channel phased array coil designed for Magnetic Resonance Imaging (MRI) using Siemens 3.0T MR systems. It is intended for imaging general human anatomy, such as the abdomen and pelvis. The device's performance was evaluated through bench testing and clinical imaging to demonstrate its safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: The summary states that "clinical images from volunteer scanning of general human anatomy were obtained." However, the exact number of volunteers or images used in the clinical performance testing is not specified in the provided document.
• Data Provenance: The document does not explicitly state the country of origin. The study appears to be prospective as it involved obtaining "clinical images from volunteer scanning."

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

The document states that the images "can be interpreted by a trained physician." However, it does not specify the number of experts (trained physicians) used to establish the ground truth for the clinical test set, nor does it provide their specific qualifications (e.g., years of experience, subspecialty).

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the clinical test set. The term "interpreted by a trained physician" suggests individual interpretation, but no consensus or review process is mentioned.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this 510(k) summary. The study focused on demonstrating that the Contour 24 produces diagnostic quality images, not on comparing its performance against humans with or without AI assistance, or quantifying an effect size of AI improvement.

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

The device, Contour 24, is an MRI receive coil, a hardware component that produces images. It is not an algorithm or AI system, so a standalone (algorithm-only) performance study is not applicable to this device. The "performance" being evaluated is the quality of the images it enables, which are then interpreted by a human physician.

7. Type of Ground Truth Used

For the clinical performance testing, the ground truth was based on the ability of "trained physicians" to "interpret" the diagnostic images. This implies expert interpretation/clinical diagnosis based on the generated images. The document does not mention pathology or outcomes data as the ground truth.

8. Sample Size for the Training Set

Since the Contour 24 is a passive hardware device (an MRI coil) and not an AI or algorithm-driven system, there is no "training set" in the context of machine learning. The performance is intrinsically linked to its physical design and engineering.

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

As there is no training set for an AI/ML algorithm associated with this hardware device, this question is not applicable.

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The 8ch Knee-Foot SPEEDER Coil is intended for use with Toshiba 1.5T MR systems to produce diagnostic images of the knee, wrist, hand, foot and ankle that can be interpreted by a trained physician.

The 8ch Knee-Foot SPEEDER coil is a receive-only, 8-channel phased array coil designed for magnetic resonance imaging (MRI) using the Toshiba 1.5T MR systems. The 8ch Knee-Foot SPEEDER coil is intended to be used for imaging the knee, wrist, hand, foot and ankle. The 8ch Knee-Foot SPEEDER 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 flame and impact resistant, and has been tested for biocompatibility. The 8ch Knee-Foot SPEEDER coil also includes the comfort pads listed in Table 10-1, which are provided with the coil shipment.

Please note: The provided document is a 510(k) summary for a medical device (an MRI coil), not a clinical study report for an AI/software as a medical device (SaMD). Therefore, much of the requested information regarding acceptance criteria for algorithm performance, human reader studies, ground truth establishment, and training/test set details for AI-driven devices is not directly available in this document.

This document focuses on the coil's physical performance (electrical safety, biocompatibility, SNR, uniformity) and its ability to produce diagnostic images interpretable by a physician, rather than the performance of an AI algorithm interpreting those images.

However, I will extract and infer as much information as possible from the provided text to address your points, acknowledging where the information is not present due to the nature of the device.

This document describes the 8ch Knee-Foot SPEEDER Coil, an 8-channel phased array coil intended for use with Toshiba 1.5T MR systems to produce diagnostic images of the knee, wrist, hand, foot, and ankle. The document is a 510(k) summary demonstrating substantial equivalence to a predicate device.

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

Since this is an MRI coil and not an AI algorithm, the acceptance criteria are related to physical and imaging performance rather than diagnostic accuracy metrics like sensitivity, specificity, or AUC for an AI.

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

• Test Set Sample Size: The document mentions "clinical images from volunteer scanning." It does not specify the number of volunteers or the number of images/imaging exams obtained.
• Data Provenance: The document does not explicitly state the country of origin. It is a US FDA submission, implying the testing likely occurred in a region compliant with US standards, but specific geographic origin of the volunteers/data is not provided. The study was "prospective" in the sense that images were explicitly obtained for the device's performance testing.

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." It does not specify the number of physicians involved in assessing image quality, nor their qualifications (e.g., specific sub-specialty or years of experience). The assessment appears to be a general determination of "diagnostic quality" rather than a detailed ground truth for specific pathologies.

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

Not applicable/not specified. The focus is on the coil's ability to produce images, and the assessment of "diagnostic quality" is not described as requiring formal adjudication among multiple readers.

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. This device is an MRI coil, not an AI algorithm. Therefore, no MRMC study involving AI assistance for human readers was performed or reported.

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

Not applicable. This device is an MRI coil, not an AI algorithm.

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

The ground truth for the clinical performance aspect was the qualitative assessment of "diagnostic quality" by a "trained physician." This is not a detailed, pathology-confirmed ground truth, but rather an assessment that the images produced by the coil were fit for their intended diagnostic purpose.

8. The sample size for the training set

Not applicable. This device is an MRI coil. There is no "training set" in the context of machine learning. The images were collected for "performance testing - clinical."

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

Not applicable, as there is no training set for an AI algorithm.

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The 16ch T/R Hand Wrist Coil is intended for use with GE 3.0T MR systems to produce diagnostic images of the hand and wrist that can be interpreted by a trained physician.

The 16ch T/R Hand Wrist Coil is a transmit/receive, 16-channel phased array coil designed for magnetic resonance imaging (MRI) using the GE 3.0T MR systems. The 16ch T/R Hand Wrist Coil is intended to be used for imaging the hand and wrist.

The 16ch T/R Hand Wrist 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 provided text describes the performance data for the 16ch T/R Hand Wrist Coil, a magnetic resonance diagnostic device. Below is a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for the "clinical images from volunteer scanning." The term "volunteer scanning" suggests a prospective collection of data.
• Data Provenance: The document states "clinical images from volunteer scanning of the hand and wrist were obtained from the 16ch T/R Hand Wrist coil." The specific country of origin is not mentioned, but the manufacturing company (Quality Electrodynamics, LLC.) is based in the USA.

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

• Number of Experts: Not specified.
• Qualifications of Experts: The document states images "can be interpreted by a trained physician," but does not specify the qualifications of the physician(s) who established ground truth for the test set.

4. Adjudication Method for the Test Set

• The document does not describe an adjudication method for the test set. It mentions images were used to "demonstrate that the 16ch T/R Hand Wrist coil produces diagnostic quality images," implying an assessment of image quality, but not a specific adjudication process involving multiple readers or complex diagnostic decision-making.

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

• The document does not mention that an MRMC comparative effectiveness study was done.
• The study focuses on the coil's performance in isolation ("standalone") to demonstrate its ability to produce diagnostic quality images.

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

• Yes, a standalone performance assessment was conducted for the device itself and its physical and image quality characteristics. The bench testing (SNR, uniformity) and the clinical imaging demonstrating diagnostic quality are evaluations of the device's inherent performance. There's no AI algorithm mentioned, so "algorithm only" isn't directly applicable in the usual sense for AI/ML devices. Instead, it's the raw performance of the imaging hardware.

7. Type of Ground Truth Used for the Test Set

• The ground truth for the clinical image quality assessment appears to be based on an expert assessment of "diagnostic quality." This implies a qualitative judgment by a presumably trained physician (as per the Indications for Use) that the images are sufficient for diagnosis. It is not pathology, or explicit outcomes data.

8. Sample Size for the Training Set

• No training set is applicable or mentioned in the context of this device. This is a medical device for MR imaging hardware (a coil), not an AI/ML algorithm that requires a 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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