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Head Coil - 12 is a 12 channel receive-only RF coil designed for use with UIH 3.0T MRI systems. The coil is indicated for use for head imaging. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.

Head Coil - 32 is a 32 channel receive-only RF coil designed for use with UIH 3.0T MRI systems. The coil is indicated for use for head imaging. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.

Carotid Coil - 8 is an 8 channel receive-only RF coil designed for use with UIH 3.0T MRI systems. The coil is indicated for use for obtaining diagnostic images of carotid. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.

Temporomandibular Joint Coil - 4 is a 4 channel receive-only RF Coil designed for use with UIH 3.0T MRI systems. The coil is indicated for use for diagnostic images of the mandible region. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.

Infant Coil - 24 is a 24 channel receive-only RF coil designed for use for imaging of the infant's brain, spine, heart, torso and extremities. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.

Cardiac Coil - 24 is a 24 channel receive-only RF Coil designed for use with UIH 3.0T MRI systems. The indications for use include imaging of the heart, and mediastinum regions. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.

Foot & Ankle Coil - 24 is a 24 channel receive-only RF coil designed for use with UIH 3.0T MRI systems. The coil is indicated for use for foot and ankle imaging. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.

Head Coil - 12, Head Coil - 32, Carotid Coil - 8, Temporomandibular Joint Coil - 4, Infant Coil - 24, Cardiac Coil - 24, Foot & Ankle Coil - 24 are receive-only multichannel phased array coils designed for use with UIH 3T MRI systems. The suffix number in coil name stands for the receive channel of the resonant nucleus is hydrogen protons (1H). All coil elements are protected from transmit field by both active and passive decoupling circuits. Each coil is designed to provide optimum image quality for its dedicated human anatomy region as defined in intended use.

The provided text is a 510(k) summary for several MRI coils manufactured by Shanghai United Imaging Healthcare Co., Ltd. This document primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical performance data and does not contain detailed information about specific acceptance criteria or an explicit study proving performance against those criteria in the context of diagnostic accuracy.

Here's a breakdown of the requested information based on the provided text, with an acknowledgment of what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list specific quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy) for a given clinical task. Instead, the "performance" demonstrated for these MRI coils relates to their technical imaging capabilities and adherence to safety and image quality standards.

The non-clinical tests performed, and their implied "acceptance criteria" are that the devices perform "as expected" and are "substantially equivalent" to predicate devices. The "reported device performance" is essentially their successful compliance with these standards.

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

The document mentions "Sample clinical images were provided to support the ability of the proposed devices to generate diagnostic quality images." However, it does not specify the sample size of these clinical images, nor does it provide details about their provenance (e.g., country of origin, retrospective or prospective collection).

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

This information is not provided in the document. The text states that images, "When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis." However, it does not detail how ground truth was established for any specific diagnostic performance evaluation.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

No MRMC comparative effectiveness study is mentioned in the provided text. The submission focuses on demonstrating substantial equivalence of the coils themselves, not the impact of AI assistance on human readers.

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

The devices described are MRI coils, which are physical hardware components used to acquire images. They are not AI algorithms. Therefore, a standalone (algorithm only) performance study is not applicable and not mentioned.

7. The Type of Ground Truth Used

The document describes the coils as producing images that, "When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis." This implies that the images are to be used in conjunction with a physician's expertise for diagnosis. For the "sample clinical images" provided, the type of ground truth is not specified. It's generally inferred that for diagnostic imaging devices, the gold standard would be expert clinical diagnosis, possibly correlated with pathology or outcomes where available, but this is not explicitly stated for these coils.

8. The Sample Size for the Training Set

The concept of a "training set" is relevant for machine learning algorithms. Since these devices are MRI coils (hardware), there is no training set in the typical AI/ML sense. The non-clinical tests relate to engineering specifications and image quality measurements, not algorithm training.

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

As there is no training set for these hardware devices, this question is not applicable.

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The Carotid Coil GE1.5T is a receive-only 2-channel diagnostic MR imaging coil designed for use at a static magnetic field strength of 1.5T with the GE Twinspeed HDx 1.5T MRI scanner/system. It is used for obtaining diagnostic images of the carotid arteries in the region of the neck and lower cranium.

The Carotid Coil GE1.5T is a receive-only 2-channel coil for operation at a magnetic field strength of 1.5T with the GE Twinspeed HDx system. The coil is a two-element coil consisting of two independent rectangular loops, each of approximate size 7 cm x 4.5 cm. Coupling of either coil element to the transmitted field is prevented through respective active blocking circuits. The Carotid Coil GE1.5T is specially designed for MR imaging of the carotid arteries in the region of the neck and lower cranium. The coil provides optimum signal to noise ratio and coverage in the area of the carotid arteries, allowing high-resolution imaging, while the sensitive region of the coil covers an approximately 7 cm Field of View.

The provided document is a 510(k) premarket notification for a medical device called "Carotid Coil GE1.5T". This document describes the device, its intended use, and its substantial equivalence to predicate devices, in accordance with FDA regulations.

However, it does not contain information about a study proving the device meets specific acceptance criteria in terms of diagnostic performance or clinical effectiveness. The "Performance Testing & Standards" section and "Safety and Effectiveness" section focus on compliance with electrical, mechanical, flammability, and biocompatibility standards, and a side-by-side comparison for substantial equivalence, rather than a clinical study with outcome-based acceptance criteria regarding diagnostic accuracy.

Therefore, the requested information elements related to diagnostic performance, ground truth, sample sizes for test/training sets, expert involvement, and MRMC studies are not available in this document.

Here's a breakdown of what is available and what is not:

Description of the Acceptance Criteria and Device Performance (Limited to Safety and Equivalence)

The acceptance criteria for the Carotid Coil GE1.5T, as described in this 510(k) summary, are primarily centered around safety and substantial equivalence to legally marketed predicate devices, rather than specific diagnostic accuracy metrics. The device's "performance" in this context refers to its ability to function safely and similarly to existing technology.

Acceptance Criteria for Safety and Effectiveness (as inferred from the document):

1. Compliance with Safety Standards: The device must meet international and national safety standards for medical electrical equipment, flammability, and biocompatibility.
2. Substantial Equivalence in Performance: The device must demonstrate performance that is substantially equivalent to predicate devices in terms of image quality capabilities (e.g., Signal-to-Noise Ratio (SNR), coverage, allowing high-resolution imaging suitable for the intended use).
3. No New Potential Safety Risks: The device should not introduce any new or unacceptable safety risks compared to the predicate devices.

Reported Device Performance (against the inferred criteria):

• Safety Compliance: Tursiop Technologies, LLC states compliance with:
  • IEC 60601-1 (1988) with amendments (Medical electrical equipment safety)
  • IEC 60601-2-33 (2006) (Safety of magnetic resonance equipment)
  • UL 94 (Tests for Flammability of Plastic Materials)
  • ISO 10993-1 (2009) (Biological evaluation of medical devices)
  • NEMA MS-6 (2008) (Characterization of Special Purpose Coils)
  • NEMA MS-9 (2008) (Characterization of Phased Array Coils)
  • ISO 13485-certified for design and manufacture.
  • Risk assessment (FMEA) procedures utilized to mitigate risks.
  • Patient contacting surface material (polycarbonate with biocompatible paint) is safe.
  • "The Carotid Coil GE1.5T does not introduce any new potential safety risks."
• Substantial Equivalence (Performance Aspect):
  • "Side by side comparison testing was conducted with one of the predicate devices, GE 3-inch General Purpose Coil which demonstrated substantially equivalent performance."
  • The Carotid Coil GE1.5T offers "Optimal Signal to Noise Ratio (SNR) and coverage allowing high-resolution imaging, while the sensitive region of the coils covers an approximately 7 cm Field of View." (This is compared to predicate devices also claiming optimal SNR, coverage, and high-resolution imaging, though with slightly different FOV specifications for one predicate).

Table of Acceptance Criteria and Reported Device Performance

Information Not Available / Not Applicable for this Device Type and Submission:

This 510(k) submission primarily addresses the substantial equivalence of a medical device accessory (an MRI coil) based on technical, safety, and performance characteristics compared to existing devices. It is not a clinical study to evaluate diagnostic accuracy outcomes of an AI-powered diagnostic algorithm. Therefore, the following requested information is not present or relevant to this document:

1. Sample size used for the test set and the data provenance: Not applicable. The "testing" referred to is engineering and side-by-side comparison for equivalence, not a clinical diagnostic performance study.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" for diagnostic accuracy was established in this context.
3. Adjudication method for the test set: Not applicable.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size of human readers improve with AI vs without AI assistance: Not applicable. This is an MRI coil, not an AI diagnostic software.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used: Not applicable.
7. The sample size for the training set: Not applicable. No AI model training is described.
8. How the ground truth for the training set was established: Not applicable.

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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 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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