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The Mark 5000 Phased Array Shoulder Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the shoulder and surrounding regions in Magnetic Resonance Imaging systems. The Mark 5000 Phased Array Shoulder Coil is designed for use with the Outlook (.23 Tesla) MRI scanner manufactured by Picker International. The indications for use are the same as for standard imaging: The Picker Outlook system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

The Mark 5000 Phased Array Coil consists of two volume RF coil elements in a quadrature design. The elements and associated circuitry are enclosed in a flexible vinyl enclosure housing. The coil is positioned on the patient's shoulder, by means of straps, during imaging.

The provided text describes the Mark 5000 Phased Array Shoulder Coil, a magnetic resonance imaging accessory. However, it does not contain information about specific acceptance criteria or a study that proves the device meets those criteria in the context of performance metrics like accuracy, sensitivity, or specificity.

The document is a "Summary of Safety and Effectiveness" submitted to the FDA for 510(k) clearance, which means the device is being compared to a legally marketed predicate device to establish substantial equivalence. The focus is on demonstrating that the new device is as safe and effective as existing devices, rather than establishing de novo performance criteria.

Therefore, many of the requested details cannot be extracted from this document. Here's a breakdown of what can and cannot be answered based on the provided text:

Acceptance Criteria and Device Performance

Explanation: The "acceptance criteria" here are largely implied by the comparison to predicate devices, focusing on design, safety features, and functional equivalence rather than specific quantitative performance metrics of image quality or diagnostic accuracy. The "reported device performance" are statements of its design and function that align with the predicates.

Study Details

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

   • Not provided. The document does not describe a clinical study with a test set of patient data. The safety and effectiveness are established through comparison to predicate devices and engineering design rationale.

2. 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. No specific test set with ground truth established by experts is mentioned. The ultimate interpretation of images for diagnosis is stated to be by a "trained physician," but this is for clinical use, not for a performance study of the device itself.

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

   • Not applicable / Not provided. No test set or adjudication process is described.

4. 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 accessory (a shoulder coil), not an AI algorithm. Therefore, an MRMC study related to AI assistance is not relevant to this submission.

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

   • Not applicable. This is a physical hardware device, not an algorithm.

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

   • Not applicable / Not provided. No ground truth data for a performance study is mentioned. The "ground truth" for this type of submission is essentially the proven safety and effectiveness of the existing predicate devices.

7. The sample size for the training set:

   • Not applicable / Not provided. This is not an AI device, so there is no "training set."

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

   • Not applicable / Not provided. As there is no training set, this question is not relevant.

Summary of what the document does provide:

• Intended Use and Indications for Use: Clearly stated, and are identical to routine MRI imaging.
• Device Description: Detailed information about the physical characteristics and components.
• Comparison to Predicate Devices: Extensive comparison of its features and safety aspects to previously cleared devices. This is the primary method of demonstrating safety and effectiveness in a 510(k) submission.
• Safety Features: Emphasizes that it is a receive-only coil, has decoupling to prevent RF burns, and incorporates a non-conductive housing.
• Regulatory Classification: Class II, procode 90 MOS.
• FDA Clearance: The device received 510(k) clearance based on substantial equivalence to predicate devices.

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The Flow 7000 Peripheral Vascular Coil is a receive-only quadrature-phased array RF coil, used for obtaining diagnostic images of the vasculature and soft tissue anatomy, extending from the abdomen to the foot region in Magnetic Resonance Imaging Systems. The indications for use are the same as for standard MR Imaging. The Flow 7000 Peripheral Vascular Coil is designed for use with the 1.5T Signa MRI scanner manufactured by GE Medical Systems.

The Flow 7000 Phased Array Peripheral Vascular Coil is designed to provide Magnetic Resonance Images of the abdominal aorta, peripheral vasculature and soft tissue anatomy. The Premier 7000 Phased Array Spine Coil is designed for use with the GE MR's Signa 1.5T scanner.

Anatomic Regions: Abdominal Vasculature, Peripheral Vasculature and soft tissue Nuclei Excited: Hydrogen

The indications for use are the same as for standard imaging:

The Signa 1.5T system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

The Flow 7000 Peripheral Vascular Coil is a 12 element quadrature, phased array, receive-only coil. The coil consists of two sections: an upper and lower section, which are positioned above and below the patient's body (lower torso and legs). The coil sections which contain the coil elements and accessory coil electronics, is enclosed to prevent any exposure to the patient or environment.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Flow 7000 Peripheral Vascular Coil.

Important Note: The provided document is a 510(k) submission for a medical device (an MRI accessory coil). This type of submission relies on demonstrating substantial equivalence to existing legally marketed devices, rather than a clinical study proving its independent performance against pre-defined acceptance criteria in the way one would for a novel AI algorithm or drug. Therefore, many of the typical acceptance criteria and study elements requested will not be present in this context.

Acceptance Criteria and Device Performance for Flow 7000 Peripheral Vascular Coil (MRI Accessory)

As this is a 510(k) submission for an MRI accessory coil, the "acceptance criteria" are primarily based on demonstrating substantial equivalence to legally marketed predicate devices in terms of intended use, indications for use, safety, and technological characteristics. The "study" proving this involves a direct comparison to these predicates.

1. Table of Acceptance Criteria and Reported Device Performance

Study Details (Relevant to 510(k) Substantial Equivalence)

Given the nature of a 510(k) for an MRI accessory, a "study" in the traditional sense of a clinical trial with specific endpoints and statistical power calculations is not typically performed or required in the document. Instead, the "study" is a comparison and justification of equivalence to predicate devices based on design and safety characteristics.

Here's how the requested information maps to this type of submission:

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

   • Not applicable in the provided text. There is no "test set" of patient data or images described for evaluating the coil's performance in a clinical study. The evaluation is based on engineering design, material specifications, and comparison to already approved predicate devices.

2. 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. No expert review of a test set is documented. The "ground truth" for a 510(k) submission for a device like this is primarily regulatory acceptance of the safety and performance features as equivalent to existing devices.

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

   • Not applicable. No test set or adjudication process is mentioned.

4. 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, an MRMC study related to AI assistance is not relevant.

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

   • Not applicable. This is an MRI coil, not a standalone algorithm.

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

   • For this 510(k), the "ground truth" for demonstrating safety and effectiveness is the established safety and efficacy profile of the identified predicate devices. The new device's design, materials, and functional principles are compared against these predicates to show that it raises no new questions of safety or effectiveness.

7. The sample size for the training set:

   • Not applicable. This device does not involve a "training set" in the context of machine learning or data-driven model development. Its development is based on engineering principles and existing MRI technology.

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

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

Summary of the 510(k) Process for this device:

The "study" for the Flow 7000 Peripheral Vascular Coil is a comparative analysis demonstrating that it is substantially equivalent to legally marketed predicate devices. This is a regulatory pathway that allows new devices to be marketed without requiring entirely new clinical trials if they can be shown to be as safe and effective as existing products.

The key aspects of this demonstration are:

• Identical Intended Use and Indications for Use to the primary predicate (Peripheral Vascular Coil, Medical Advances Inc., K964813).
• Similar (or equivalent safe) Technological Characteristics in terms of coil material, design, decoupling mechanisms, and fundamental safety principles (e.g., receive-only, prevention of RF burns, prevention of resonant loops) as compared to various other predicate MRI coils.

The FDA's letter states: "We have determined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified..." This confirms that the manufacturer successfully demonstrated equivalence, which is the "acceptance criteria" for a 510(k) submission.

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The Picker Outlook system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2)) and 3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

The Large Phased Array Neck Coil is indicated for use in providing coverage of the neck, from the cerebellum to the upper thoracic spine region.

The Large Phased Array Neck Coil is a receive-only coil for the 0.23T Outlook system, and is optimized to image the cervical spine. The sensitive region of the coil covers the base of the cerebellum to the third thoracic vertebra for greater than 98% of patients.

The provided text is a 510(k) premarket notification for a medical device, specifically an MRI coil. It focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing acceptance criteria and performing an in-depth study to prove the device meets these criteria in the way a novel diagnostic AI algorithm might.

Therefore, many of the requested elements for an AI or diagnostic device study are not applicable in this context. The "acceptance criteria" here are essentially the demonstration of equivalent performance and safety characteristics to the predicate devices.

Here's an attempt to address your request based on the provided document, highlighting where the information is not present or not directly applicable:

1. Table of Acceptance Criteria and Reported Device Performance

• Enclosure Material
• Coil Design
• Decoupling
• Prevention of Resonant Loops
• Prevention of RF burns
• Radio Frequency Absorption | Same as predicate devices |
  | Effectiveness (Indications)| Equivalent indications for use as predicate devices. | "The Large Phased Array Neck Coil is indicated for use in providing coverage of the neck, from the cerebellum to the upper thoracic spine region." (Same as predicate) |
  | Intended Use | Equivalent intended use as predicate devices (for NMR imaging for diagnosis by a trained physician). | Same as predicate devices |
  | Compatibility | Compatible with Picker 0.23T Outlook system. | Compatible with Picker 0.23T Outlook system |
  | Tuning Scheme | Automatically tuned for each patient, equivalent to predicate. | Automatically tuned for each patient |
  | Anatomic Regions | Neck, from cerebellum to upper thoracic spine, equivalent to predicate. | Neck |
  | Nuclei Excited | Hydrogen, equivalent to predicate. | Hydrogen |

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

• Not applicable. This submission relies on demonstrating substantial equivalence to existing devices, primarily through comparison of design, materials, and functional specifications, rather than a clinical trial with a "test set" of patient data.

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

• Not applicable. No ground truth in the context of diagnostic interpretation is established for this submission. The "ground truth" for regulatory approval is the established safety and effectiveness of the predicate devices.

4. Adjudication Method for the Test Set

• Not applicable. No test set or human interpretation adjudication was part of this submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. This is not a study comparing human reader performance with and without AI assistance. It's a device comparison for substantial equivalence.

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

• Not applicable. This is a physical medical device (an MRI coil), not a standalone algorithm.

7. The Type of Ground Truth Used

• Substantial Equivalence to Predicate Devices: The "ground truth" for this submission is the regulatory acceptance and established safety/effectiveness of the predicate devices (USAI Quadrature Volume Neck Coil and Picker Phased Array Neck Coil). The manufacturer is asserting that the new device is functionally identical or very similar in all critical aspects affecting safety and efficacy.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of an AI algorithm or a clinical trial for this type of device.

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

• Not applicable. See point 8.

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The Premier 7000 Phased Array CTL Spine Coil is a receiveonly phased array RF coil, used for obtaining diagnostic images of the spine region (cervical, thoracic and lumbar anatomy) in Magnetic Resonance Imaging Systems. The indications for use are the same as for standard MR Imaging. The Premier 7000 Phased Array CTL Spine Coil is designed for use with the 1.5T Signa MRI scanner manufactured by GE Medical Systems.

The Premier 7000 Phased Array Spine Coil is designed to provide Magnetic Resonance Images of the spine anatomy. The Premier 7000 Phased Array Spine Coil is designed for use with the GE MR's Signa 1.5T scanner.

Anatomic Regions: Spine Nuclei Excited: Hydrogen

The indications for use are the same as for standard imaging:

The Signa 1.5T system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

The Premier 7000 Phased Array CTL Spine Coil is a multi-element phased array receive-only coil. The coil is shaped to conform to the contours of the spine and has an removable anterior section for imaging the anterior cervical region. The elements and associated circuitry are enclosed in a housing made of plastic materials which are fire rate and have high impact and tensile strength.

The provided documentation for the K980157 Premier 7000 Phased Array CTL Spine Coil is a 510(k) premarket notification. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data to prove novel performance criteria.

Therefore, the submission does not include a study that proves the device meets specific acceptance criteria in the way a traditional clinical trial or performance study would. Instead, the "acceptance criteria" here are aligned with demonstrating substantial equivalence in terms of intended use, indications for use, materials, design, and safety mechanisms compared to predicate devices.

Here's an analysis based on the provided text, addressing your questions where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the characteristics of the predicate devices. The "Reported Device Performance" for the Premier 7000 Phased Array Spine Coil is its ability to match or be similar in these characteristics.

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

• Sample Size for Test Set: Not applicable in the context of this 510(k) submission. A clinical "test set" with patient data to evaluate performance metrics directly is not described. The evaluation is based on comparing device specifications and technical characteristics to predicates.
• Data Provenance: Not applicable. The submission is a comparison of technical specifications and intended use against existing, cleared devices.

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

• Number of Experts: Not applicable. Ground truth, in the sense of expert consensus on image quality or diagnostic accuracy, is not part of this 510(k) submission.
• Qualifications of Experts: Not applicable.

4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set

• Adjudication Method: Not applicable. No test set involving human interpretation and adjudication 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

• MRMC Study: No. This device is an MRI accessory (a coil), not an AI-powered diagnostic system.
• Effect Size: Not applicable.

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

• Standalone Performance Study: No. This is a hardware component with its performance intrinsically linked to the MRI scanner it integrates with, not a standalone algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: The "ground truth" for this 510(k) submission is the established safety and effectiveness profile of the predicate devices. The applicant asserts that their new device shares the same fundamental scientific technology and intended use, and does not raise new questions of safety or effectiveness compared to these predicates. This is a regulatory "ground truth" rather than a clinical one.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not an AI/machine learning device requiring a training set.

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

• How Ground Truth for Training Set was Established: Not applicable.

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