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The carotid coil is a receive-only coil, used for high resolution imaging of the bifurcation of the carotid artery in 1.5T and 3T General Electric, Siemens and Philips Magnetic Resonance Imaging (MRI) systems. Nucleus Excited: Proton 1H Anatomic regions: Carotid. The Carotid Coil is used for obtaining diagnostic images of carotid in magnetic resonance imaging systems. These images, when interpreted by a trained physician, yield information that may assist in diagnosis.

Carotid Coil is a phased array, receive-only coil. It consists of eight elements optimized for high signal-to-noise ratio. Semi-flexible design makes the coil reliable and comforts the patient. The enclosure, which may contact the patient, is made up of biocompatible material.

The provided document is a 510(k) Summary for a Magnetic Resonance Diagnostic Device, Carotid Coil. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of its clinical performance against specific acceptance criteria for diagnostic accuracy.

Therefore, many of the requested items (e.g., acceptance criteria for diagnostic performance, sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth for test/training set, training set sample size) are not applicable or not provided in this type of submission document, as it is a submission for a medical device (coil) used for imaging, not a diagnostic algorithm.

Here's a breakdown of what can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not outline specific acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy) of a device that interprets images. The "performance tests" mentioned refer to technical parameters of the coil itself.

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

• Not Applicable / Not Provided. This document describes a physical medical device (an MRI coil), not a diagnostic algorithm that processes data. Therefore, there is no "test set" in the context of diagnostic performance evaluation. The "performance tests" refer to the engineering and technical performance of the coil.

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 / Not Provided. See point 2.

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

• Not Applicable / Not Provided. See point 2.

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 a study of an AI or diagnostic algorithm, but a physical MRI coil. An MRMC study would not be relevant here.

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

• Not Applicable. This is a physical MRI coil, not an algorithm.

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

• Not Applicable / Not Provided. The "ground truth" concept as applied to diagnostic algorithms is not relevant for this submission about an MRI coil. The "ground truth" for the coil's performance would be its technical specifications verified by engineering tests.

8. The sample size for the training set

• Not Applicable / Not Provided. This is a physical MRI coil, not a machine learning algorithm.

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

• Not Applicable / Not Provided. See point 8.

Additional Information provided in the 510(k) Summary:

• Device Type: Magnetic Resonance Imaging Coil (receive-only, phased array, 8 elements).
• Intended Use: High resolution imaging of the bifurcation of the carotid artery in 1.5T and 3T GE, Siemens, and Philips MRI systems. Nucleus Excited: Proton 1H.
• Indications for Use: Obtaining diagnostic images of the carotid for interpretation by a trained physician to assist in diagnosis.
• Predicate Device: Carotid Coil, manufactured by Shanghai Chenguang Medical Technologies Co., Ltd. (510k number K092962).
• Demonstration of Performance: Substantial equivalence was demonstrated through:
  • Performance tests (technical specifications of the coil).
  • Bio-compatibility tests (compliance with ISO 10993-5 and ISO 10993-10).
  • IEC60601-1 compliance tests (compliance with UL 60601-1).
• Conclusion: The device is considered safe and effective and substantially equivalent to the predicate device based on similarities in design features, overall indications for use, and technological characteristics.

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The Pediatric Body-Cardiac Coil is a receive-only coil, used for obtaining diagnostic images of pediatric cardiac and body in Philips Achieva 3.0T magnetic resonance imaging systems. These images, when interpreted by a trained physician, yield information that may assist in diagnosis.

The Pediatric Body-Cardiac Coil is a phased-array receive-only coil. It consists of eight elements optimized for high signal-to-noise ratio. It includes two parts (upper part and the bottom). The upper part can be easily taken down from the bottom. So the Pediatric Body-Cardiac Coil could be operated expediently. The enclosure is 3.5mm thick PC, which is UL 94V 0 rated and can withstand highest peak RF voltage up to 4200V and drop and impact.

The provided document describes a 510(k) submission for a medical device, a "Pediatric Body-Cardiac Coil." The nature of this device (a receive-only coil for MRI systems) means that its acceptance criteria and the study proving it meets those criteria are focused on its technical performance and safety, rather than on diagnostic accuracy as would be the case for an AI-powered diagnostic tool.

Therefore, the requested information regarding diagnostic performance (e.g., effect size of human readers with AI assistance, sample size for test/training sets for diagnostic accuracy, expert qualifications for ground truth) is not applicable to this type of device.

Below is an interpretation of the available information regarding acceptance criteria and the study that proves the device meets them, tailored to the nature of this MRI coil.

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

Based on the provided 510(k) summary, the acceptance criteria are primarily related to safety, effectiveness, and substantial equivalence to a predicate device. Performance is framed in terms of achieving these criteria through various tests.

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

This is not applicable in the context of an MRI coil's technical performance and safety testing. The "test set" would refer to the physical device undergoing various engineering, electrical, and materials tests, not a dataset of patient images for diagnostic performance. The document does not specify the number of coils tested, which is common for such submissions.

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

This is not applicable. Ground truth, in the context of diagnostic devices, refers to the confirmed diagnostic state of a patient (e.g., presence or absence of a disease). For a passive medical device like an MRI coil, "ground truth" would relate to the accuracy of its technical specifications (e.g., measured RF voltage withstand capacity, material safety ratings), which are typically established through engineering testing and material certifications rather than expert consensus on patient data.

4. Adjudication method for the test set

This is not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human readers when establishing ground truth for diagnostic studies. Since this device is an MRI coil and its performance is assessed via technical tests, there's no diagnostic adjudication in this context.

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. This device is a passive MRI coil, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI-assistance comparison was performed or is relevant.

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

This is not applicable. As stated, this is an MRI coil, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance would be derived from:

• Engineering Test Results: Measurements of RF voltage withstand, signal-to-noise ratio (implied by "optimized for high signal-to-noise ratio"), and other electrical properties.
• Material Certifications: UL 94V-0 rating for the PC enclosure.
• Biocompatibility Test Results: Data from tests confirming the materials are biologically safe.
• Compliance with Standards: Verification against IEC60601-1.

8. The sample size for the training set

This is not applicable. There is no "training set" for an MRI coil in the machine learning sense. The design and manufacturing process would involve engineering design, prototyping, and testing, but not a data-driven training set like an AI model.

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

This is not applicable for the reasons mentioned above.

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The Pediatric Head-Spine Coil is a receive-only coil, used for obtaining diagnostic images of pediatric head and spine in magnetic resonance imaging systems. This coil is designed to be used in a Philips Achieva MRI 3.0T system. These images, when interpreted by a trained physician, yield information that may assist in diagnosis.

The Pediatric Head-Spine Coil is an 8-channel phased array, receive-only coil. It consists of eight elements optimized for high signal-to-noise ratio. Four elements are in the head area and four elements reside in the back portion of the device. It includes two parts (upper part and the bottom). The upper part can be easily taken down from the bottom. So the Pediatric Head-Spine Coil could be operated expediently. The enclosure is 3.5mm thick PC, which is UL 94V_0 rated and can withstand highest peak RF voltage up to 4200V and drop and impact.

The provided text is a 510(k) summary for a Pediatric Head-Spine Coil (Model: 5000012701). This device is a passive component of an MRI system (a receive-only coil) and its effectiveness is determined by its ability to produce diagnostic images. The information provided heavily focuses on regulatory compliance and comparison to a predicate device, rather than detailed performance study results that would typically involve acceptance criteria for diagnostic accuracy metrics (like sensitivity, specificity, or AUC) as one might expect for an AI/CADe device.

Based on the provided text, the device's acceptance criteria are primarily related to its safety and ability to function equivalently to a predicate device in producing diagnostic images.

Here's an attempt to structure the information based on your request, highlighting where specific details (typical for AI/CADe studies) are not available in this submission:

Acceptance Criteria and Device Performance Study for Pediatric Head-Spine Coil (Model: 5000012701)

This 510(k) submission for the Pediatric Head-Spine Coil focuses on demonstrating substantial equivalence to a legally marketed predicate device (K081322) and compliance with relevant safety and performance standards, rather than a clinical efficacy study with specific diagnostic performance metrics typically seen with AI/CADe devices.

The "acceptance criteria" can be inferred from the regulatory requirements for showing substantial equivalence and the "study" is the overall demonstration of this equivalence and compliance.

1. Table of Acceptance Criteria and Reported Device Performance

Note: For this type of device, "performance tests" typically refer to engineering benchmarks (e.g., Signal-to-Noise Ratio, uniformity, geometric distortion) conducted in a lab or phantom study, ensuring the coil functions as designed and produces images suitable for diagnosis without explicitly measuring clinical outcomes or diagnostic accuracy in human subjects.

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

• Test Set Sample Size: Not applicable in the context of clinical images or patient data for diagnostic accuracy. The "tests" mentioned are likely performance and safety tests on the device itself (e.g., phantom imaging, electrical safety, biocompatibility, mechanical durability).
• Data Provenance: Not applicable for clinical image data. The provenance of the device's components and manufacturing is "Shanghai Chenguang Medical Technologies Co., Ltd." in P.R.C.

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

• Not applicable. This submission does not describe a study involving expert readers establishing ground truth for diagnostic accuracy, as it's a device for image acquisition, not interpretation or diagnosis. The images are "interpreted by a trained physician" but this is part of the intended use, not a study methodology cited here.

4. Adjudication method for the test set

• Not applicable. No external adjudication method is mentioned for diagnostic accuracy, as no clinical performance study involving human interpretation of images for ground truth was conducted or described in this summary.

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 an MRI coil, not an AI or CADe system designed to assist human readers.

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

• No, a standalone performance study was not done. This device is an MRI coil, a hardware component for image acquisition, and does not have an "algorithm-only" performance to evaluate.

7. The type of ground truth used

• The concept of "ground truth" as typically defined for diagnostic accuracy studies (e.g., pathology, expert consensus) is not directly applicable to this device's regulatory submission. The "ground truth" for the device's technical performance would be engineering specifications and standards against which its functionality and safety were measured. For example, "performance tests" would verify if the coil produces images with expected signal integrity, resolution, and uniformity, implicitly considered "true" to its design specifications.

8. The sample size for the training set

• Not applicable. This submission relates to an MRI coil (hardware), not a machine learning or AI algorithm, so there is no training set in that context.

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

• Not applicable. As there is no training set mentioned for an AI/ML algorithm, this question is not relevant to the provided submission.

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The Carotid Coil is a receive-only coil, used for obtaining diagnostic images of carotid in magnetic resonance imaging systems. These images when interpreted by a trained physician, yielding information that may assist in diagnosis.

The Carotid Coil is an 8-channel phased array, receive-only coil, used for obtaining diagnostic images of carotid in magnetic resonance imaging systems. These images, when interpreted by a trained physician, yields information that may assist in diagnosis.

The provided text is a 510(k) summary for a medical device called the "Carotid Coil". It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria, performance studies with quantitative results, or information typically found in a clinical study report for AI/machine learning devices. The document is from 2009, prior to the widespread use of AI/ML in medical devices regulated under these detailed performance criteria.

Therefore, many of the requested items cannot be extracted from this document.

Here's a breakdown of what can and cannot be provided based on the input:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document states that the device was proven safe and effective through various tests, but it does not specify concrete, quantifiable acceptance criteria or provide the numerical results of these performance tests. This type of detail is more common in more recent submissions for computational devices or devices with specific performance claims.

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

• Sample Size for Test Set: Not specified.
• Data Provenance (e.g., country of origin, retrospective/prospective): Not specified. The document mentions "practical application tests," which suggests some form of evaluation in a real-world or simulated clinical setting, but details about the size and nature of the dataset are absent.

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

• Not applicable/Not specified. The document mentions "diagnostic images...when interpreted by a trained physician," implying human interpretation, but there's no mention of expert ground truth establishment for a test set to evaluate the coil's diagnostic performance in a comparative manner.

4. Adjudication method for the test set

• Not applicable/Not specified.

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

• Not applicable. This device is a passive MR coil, not an AI or software device that assists human readers. No MRMC study or AI assistance is mentioned.

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

• Not applicable. This is a hardware device (an MR coil), not an algorithm.

7. The type of ground truth used

• Not applicable/Not specified. The document describes the coil's function ("obtaining diagnostic images") and that these images are "interpreted by a trained physician." There is no mention of a ground truth in the context of evaluating a software algorithm or diagnostic aid. The validation likely focused on image quality parameters and safety, not diagnostic accuracy against a specific ground truth.

8. The sample size for the training set

• Not applicable. This is a hardware device and does not involve a training set as understood for AI/ML models.

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

• Not applicable.

Summary of Device and Approval:

The document describes the "Carotid Coil," an 8-channel phased array, receive-only coil for Magnetic Resonance Imaging (MRI) systems. Its intended use is for obtaining diagnostic carotid images (2D, 3D imaging, proton density, T1 and T2 weighted imaging, 2D, 3D time of flight, phase contrast imaging). The device was determined to be substantially equivalent to the Machnet Carotids Coil Array Assembly (K012491), a legally marketed predicate device. The approval (K092962) was based on safety tests, performance tests, bio-compatibility tests, practical application tests, and JEC60601-1 compliance tests, which collectively demonstrated its safety and effectiveness.

This submission predates the need for extensive clinical performance data for AI/ML devices, and therefore, the information requested for such specific studies is not present.

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The Pediatric Body-Cardiac Coil is a receive-only coil, used for obtaining diagnostic images of pediatric cardiac and body in Philips Achieva 1.5T magnetic resonance imaging systems. These images when interpreted by a trained physician, yielding information that may assist in diagnosis.

The Model 0100040201-AP Body Cardiac ArrayCoil1.5T 8ch consists of two parts, bottom part with a cable and a base plate. Bottom part forms an 8-channel phased array, receive-only coil, used for obtaining diagnostic images of body and cardiac of a pediatric body in magnetic resonance imaging systems. Bottom part forms an 8channel phased array, receive-only coil, used for obtaining diagnostic images of the cardiac -body area of a pediatric patient in magnetic resonance imaging systems. These images when interpreted by a trained physician, yield information that may assist in diagnosis.

The provided text describes a 510(k) premarket notification for a medical device: the Shanghai Chenguang Medical Technologies Body Cardiac ArrayCoil1.5T 8ch (Model 0100040201-AP). This device is a receive-only coil used for obtaining diagnostic images of pediatric body and cardiac regions in magnetic resonance imaging systems.

However, the provided text does not contain information about acceptance criteria, a specific study proving the device meets those criteria, or details regarding ground truth establishment, sample sizes for training/test sets, expert qualifications, or adjudication methods. The document is a 510(k) summary for a diagnostic device that is substantially equivalent to predicate devices, and the information provided is focused on regulatory clearance rather than a detailed performance study.

Therefore, for aspects related to acceptance criteria, device performance, study methodology, and ground truth, the answer is that this information is not available in the provided FDA 510(k) document.

Here’s a breakdown of what can be extracted based on the request, with explicit notes about missing information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified. (The 510(k) process often relies on existing data from predicate devices or internal testing, but no details are given).
• Retrospective or Prospective: Not specified.

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

• Number of Experts: Not applicable, as no specific clinical study data is presented to establish ground truth.
• Qualifications of Experts: Not applicable. The document mentions "trained physician" for interpreting images, but not in the context of ground truth establishment for a performance study.

4. Adjudication method for the test set:

• Adjudication Method: Not applicable, as no specific clinical study data requiring adjudication is presented.

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

• MRMC Study: No. This device is a hardware component (MRI coil), not an AI-powered diagnostic algorithm. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this product.

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

• Standalone Performance: No. This device is a hardware component. Standalone performance typically refers to the performance of an AI algorithm without human involvement.

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

• Type of Ground Truth: Not applicable, as no specific performance study requiring ground truth is detailed in this regulatory submission. For an MRI coil, performance is often evaluated through physical and imaging metrics (e.g., SNR, uniformity, image resolution), rather than a diagnostic accuracy relative to a "ground truth" diagnosis.

8. The sample size for the training set:

• Sample Size (Training Set): Not applicable. This is a hardware device (MRI coil), not a machine learning algorithm that requires a training set.

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

• Ground Truth Establishment (Training Set): Not applicable, as this is a hardware device.

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The Pediatric Head-Spine Coil is a receive-only coil, used for obtaining diagnostic images of pediatric head and spine in magnetic resonance imaging systems. This coil is designed to be used in a Philips Achieva MRI 1.5T system. These images, when interpreted by a trained physician, yield information that may assist in diagnosis.

The Model 0100140201 Pediatric Head and Spine Array Coil1.5T 8ch consists is a single unit with eight coils. Four coils are in the head area and four coils reside in the back portion of the device. This forms a 8-channel phased array, receive-only coil, used for obtaining diagnostic images of head and spine of a pediatric body in magnetic resonance imaging systems. Combination of back part and head part forms an 8-channel phased array, receive-only coil, used for obtaining diagnostic images of the head and spine in magnetic resonance imaging systems. These images when interpreted by a trained physician, yielding information that may assist in diagnosis.

The provided text is a 510(k) summary for a medical device (Pediatric Head and Spine Array Coil), which focuses on demonstrating substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria in the way a clinical trial or performance study for a diagnostic AI algorithm would.

Instead, the submission for this type of device (an MRI coil) primarily focuses on:

• Device Description: What the device is and how it works.
• Intended Use: The clinical purpose of the device.
• Substantial Equivalence: Comparing the device to a legally marketed predicate device to show it is as safe and effective. This often means demonstrating similar technical characteristics, materials, and performance specifications (e.g., signal-to-noise ratio, image uniformity), rather than clinical diagnostic accuracy.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this type of 510(k) submission for an MRI coil.

However, I can extract the relevant information from the document as best as possible, focusing on what is available. It's important to note that the "device performance" in this context refers to the coil's technical imaging capabilities rather than diagnostic accuracy.

Here's a breakdown based on the provided text:

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

The document does not explicitly state "acceptance criteria" in the format of a clinical performance study. For a device like an MRI coil, performance is typically evaluated through technical specifications and comparison to a predicate device. The 510(k) summary asserts "substantial equivalence" based on the device's design and intended use being similar to the predicate.

The closest we can infer for "device performance" is its ability to produce diagnostic images.

Study Proving Device Meets Acceptance Criteria:

The "study" proving the device meets the (inferred) acceptance criteria is the 510(k) premarket notification process itself, demonstrating substantial equivalence to the predicate device K003655 (PHS-63 Pediatric Head Spine Coil, manufactured by MRI Devices Corporation). This typically involves providing technical data and comparisons rather than clinical outcome studies of diagnostic accuracy in the way an AI algorithm would.

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

• Not Applicable. This submission is for an MRI coil, not a diagnostic algorithm that processes images. There is no "test set" of patient data in the context of diagnostic performance. Performance is evaluated through engineering and technical testing, and comparison to the predicate device's specifications.

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. See point 2. Ground truth for diagnostic performance is not relevant for an MRI coil's substantial equivalence submission. The images produced by the coil "when interpreted by a trained physician, yielding information that may assist in diagnosis." The interpretation is by experts, but the coil itself is not being evaluated for diagnostic accuracy.

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

• Not Applicable. See point 2 and 3.

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 is not an AI device.

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

• Not Applicable. This is not an AI algorithm. The device is a "receive-only coil" that produces images for interpretation by a "trained physician."

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

• Not Applicable. See point 2 and 3.

8. The sample size for the training set

• Not Applicable. This device does not involve a "training set" in the context of machine learning.

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

• Not Applicable. See point 8.

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The Knee/Foot/Ankle Coil is a receive-only coil, used for obtaining diagnostic images of knee, foot, ankle and lower leg in conjunction with a PHILIPS 1.5T MRI scanner. These images when interpreted by a trained physician, yielding information that may assist in diagnosis.

The Knee/Foot/Ankle Coil consists of three parts, bottom part with a cable and a base plate, a knee part and a foot part. The combination of the bottom part and knee part forms a 4-channel phased array, receive-only coil, used for obtaining diagnostic images of knee, foot, ankle and lower leg in magnetic resonance imaging systems. Combination of bottom part and foot part forms a 4-channel phased array, receive-only coil, used for obtaining diagnostic images of foot and ankle. These images, when interpreted by a trained physician, vields information that may assist in diagnosis.

Acceptance Criteria and Device Performance Study for CG-KFC18-H150-AP

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The provided text does not specify the sample size used for the performance testing.
The data provenance (e.g., country of origin, retrospective or prospective) is also not specified.

3. Number and Qualifications of Experts for Ground Truth

The provided text does not mention the use of experts to establish ground truth for the test set. The stated purpose of the images is "when interpreted by a trained physician, yields information that may assist in diagnosis," implying diagnostic interpretation, but details on ground truth establishment are absent.

4. Adjudication Method

The provided text does not describe any adjudication method used for the test set.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or conducted. The study focused on the technical performance of the MRI coil itself (SNR and uniformity) compared to a predicate device, not on human reader performance with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone (algorithm only without human-in-the-loop performance) study was effectively done. The performance testing focused on the intrinsic characteristics of the device, specifically its Signal-to-Noise Ratio (SNR) and image uniformity in comparison to a predicate device. This evaluates the device's technical capabilities in isolation.

7. Type of Ground Truth Used

The concept of "ground truth" as typically understood in AI/medical device studies (e.g., pathology, expert consensus on disease presence) is not applicable or mentioned in this context. The study assessed the technical image quality metrics (SNR and uniformity) against a predicate device, which serves as the "truth" or benchmark for comparison of physical performance characteristics.

8. Sample Size for Training Set

The concept of a "training set" is not applicable to this device. This is a medical device (an MRI coil), not an AI algorithm that requires training data.

9. How Ground Truth for Training Set was Established

As this is not an AI algorithm, the concept of a training set and its associated ground truth is not relevant.

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The coil is intended to be used in conjunction with a PHILIPS 1.5T MRI scanner as an accessory to produce images of the wrist, hand and elbow.

The Wrist Hand Coil 1.5T 4ch is a 4-channel phased array, receive-only coil, used for obtaining diagnostic images of wrist, hand and elbow in magnetic resonance imaging systems. These images, when interpreted by a trained physician, yields information that may assist in diagnosis. The elements and associated circuitry of the coil are enclosed in a rigid fire rated housing. The sensitive region of the coil offers an approximate 220x117x83 mm3 field of view. With two opening in the coil, patients can bend their wrists at different angles in scanning process.

The provided document is a 510(k) summary for a medical device called the Model CG-WHC18-H150-AP Wrist Hand Coil 1.5T 4ch. This document does not contain information about a study with acceptance criteria for a device with artificial intelligence (AI) or machine learning (ML) components.

This document describes a traditional medical device (an MRI coil) and its substantial equivalence to predicate devices, focusing on technical characteristics, safety, and effectiveness in generating diagnostic images. It does not mention any AI algorithms, human-in-the-loop studies, or specific performance metrics like sensitivity, specificity, or AUC that would be associated with AI evaluations.

Therefore, I cannot fulfill your request for the acceptance criteria and study details as they are explicitly not present in the provided text.

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