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The Nova Medical 3T 32 Channel Head Coil is to be used in conjunction with a Magnetic Resonance (MR) Scanner to produce images and/or spectra of the head, that when interpreted by a trained physician yield information that may assist in diagnosis.
Model # 3832016 is used with GE 3T MRI Scanner Discovery MR750.
Model # 38320169 is used with GE 3T MR Scanners Signa Architect, Discovery MR750W and Signa PET/MR.

The Nova Medical 3T 32 Channel Head Coil is receive only MR coil for imaging the human head when used with GE Healthcare 3T MR Systems. The head coil has 32 RF elements that are tuned to 127.75 MHz. The head coil is constructed of a two part rigid plastic housing with an opening for patient viewing and comfort. The 3T 32 Channel Head Coil comprises a split design for easy patient positioning, measures approximately 17.5" long x 12″ high x 15″ wide without the tray and has an approximate weight of 20 lbs. The device comes with optional accessories; Mirror for patient viewing and Foam Cushions for patient comfort and head positioning.

The provided text describes a 510(k) summary for the "3T 32 Channel Head Coils." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove a device meets specific clinical acceptance criteria for diagnostic performance.

Therefore, many of the requested details, such as sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth for training sets, are not applicable to this type of submission.

The acceptance criteria and performance data provided are related to the safety and engineering characteristics of the head coil, ensuring it functions as intended and is safe for use in conjunction with an MRI scanner.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the other requested information:

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

• Test Set Sample Size: Not applicable. The performance testing described relates to engineering and safety standards, not a clinical diagnostic performance test on a specific patient dataset.
• Data Provenance: Not applicable for a clinical diagnostic test set. The clinical images obtained were to demonstrate acceptable image quality.

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 for a diagnostic performance ground truth.
• Qualifications: "A Chief Medical Physicist" certified the acceptable image quality of the clinical images.

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

• Not applicable. There was no diagnostic test set requiring adjudication in this submission.

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 submission is for an MRI head coil, not an AI-powered diagnostic algorithm. Therefore, an MRMC study related to AI assistance is not applicable.

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

• No. This is an MRI head coil, not a standalone diagnostic algorithm.

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

• For the engineering and safety tests, the "ground truth" is adherence to established national and international standards (e.g., ISO, IEC, NEMA).
• For clinical images, the "ground truth" was an assessment of acceptable image quality by a Chief Medical Physicist. This is a technical assessment of image integrity, not a diagnostic accuracy ground truth.

8. The sample size for the training set:

• Not applicable. This device does not involve a "training set" in the context of an AI/machine learning algorithm.

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

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

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The GE Discovery MI is a PET/CT system for producing attenuation corrected PET images. It is intended to be used by qualified health care professionals for imaging the distribution and localization of any positron-emitting radiopharmaceutical in a patient, for the assessment of metabolic (molecular) and physiologic function in patients, with a wide range of sizes and extent of disease, of all ages.

Discovery MI is intended to image the whole body, head, heart, brain, lung, breast, bone, the gastrointestinal and lymphatic systems, and other organs. The images produced by the system may be used by physicians to aid in radiotherapy treatment planning, therapy guidance and monitoring, and in interventional radiology procedures. The images may also be used for precise functional and anatomical mapping (localization, registration, and fusion).

When used with radiopharmaceuticals approved by the regulatory in the country of use, the raw and image data is an aid in; detection, localization, evaluation, diagnosis, staging, monitoring, and/or follow up, of abnormalities, lesions, tumors, inflammation, infection, organ function, disorders, and/or disease, such as, but not limited to, those in oncology, cardiology, and neurology. Examples of which are:

Cardiology:

• Cardiovascular disease
• Myocardial perfusion
• Myocardial viability
• Cardiac inflammation
• Coronary artery disease

Neurology:

• Epilepsy
• Dementia, such as Alzheimer's disease, Lewy body dementia, Parkinson's disease with dementia, and frontotemporal dementia.
• Movement disorders, such as Parkinson's and Huntington's disease
• Tumors
• Inflammation
• Cerebrovascular disease such as acute stroke, chronic and acute ischemia
• Traumatic Brain Injury (TBI)

Oncology/Cancer:

• Non-Small Cell Lung Cancer
• Small Cell Lung Cancer
• Breast Cancer
• Prostate Cancer
• Hodgkin disease
• Non-Hodgkin lymphoma
• Colorectal Cancer
• Melanoma

Discovery MI is also intended for stand-alone, diagnostic CT imaging in accordance with the stand-alone CT system's cleared indications for use.

The Discovery MI system is a PET/CT diagnostic imaging system combining a GE Positron Emission Tomography (PET) System and a GE Computed Tomography (CT) System.

The PET portion of the system uses a Lutetium-based Scintillator (LBS) detector. Scintillator crystal arrays are attached to Silicon Photo Multipliers (SiPM) to form detector units. The detector units are inherited from the reference device Signa PET/MR. Detector units are attached on a common support to form detector modules. The detector modules are arranged in a ring around the patient positioned inside of the PET gantry for detection of gamma rays generated as a result of PET radiopharmaceuticals injected into the patient.

The PET/CT system uses the full-featured multi-slice diagnostic CT subsystem with PET/CT post processing software to generate a map of the non-uniform attenuation in the patient. This attenuation map is then used for attenuation correction of the PET data. The CT image is also used for localization of the PET image in the patient anatomy by means of fusing the PET and CT images.

The Discovery MI system's major components are the PET gantry/detector, Revolution EVO CT system, patient table, operator console/workspace, computing hardware, power distribution unit, system software, and reconstruction software. The operator console and software provide control of the imaging (i.e. setting and confirming conditions of operation), image acquisition, dose display, reconstruction, viewing, post processing analysis, patient management, networking, and filmina. The system may include respiratory and cardiac gating capabilities, signal analysis and display equipment, patient and equipment supports, components and accessories. In addition to being installed as a complete PET/CT system, the Discovery MI may result from an upgrade to a Revolution EVO- based Discovery PET/CT 710.

The Discovery MI system provides scalable axial coverage for the PET detector. All configurations offer reference adult and pediatric protocols for both hybrid PET/CT and CT applications. The PET 3D data acquisition modes include Static, Gated, Dynamic, and Whole Body scanning. All of which can be acquired with List mode data. The system includes standard PET iterative reconstruction alqorithms. Q.Clear full-convergence, reqularized reconstruction is optionally available. Time of Flight (ToF) may be used for all PET reconstruction types.

The CT system is the commercially available 64-detector row Revolution Evo, which may also be used for stand-alone, diagnostic CT imaging. The CT system's acquisition modes include Axial, Cine, Helical (Volumetric), Cardiac, and Gated, for head, whole body, trauma, cardiac and vascular applications.

This document describes the Discovery MI, a PET/CT diagnostic imaging system. No specific acceptance criteria table or a detailed study proving the device meets acceptance criteria in the sense of a clinical trial for diagnostic performance are provided in the extracted text. The document focuses on demonstrating substantial equivalence to a predicate device, as required for a 510(k) premarket notification.

However, the text does mention non-clinical testing to substantiate product performance and claims, which effectively serve as internal performance criteria:

1. Table of Performance Claims Tested (Non-Clinical) and Device Performance (Implicitly Met):

2. Sample Size and Data Provenance for Test Set:

• Test Set (Non-Clinical): "a variety of test methods and phantoms appropriate for the performance metric/claim to be tested and evaluated." No specific sample size (e.g., number of phantoms) is provided, and the data is generated through physics and engineering analysis, not from human subjects.
• Data Provenance: Non-clinical (phantom-based, mathematical, and physics analysis). Not applicable for country of origin or retrospective/prospective as it's not human data.

3. Number of Experts and Qualifications for Ground Truth of Test Set:

• Not applicable as the "ground truth" for the non-clinical performance evaluations (sensitivity, NECR, resolution, lesion detectability) would be based on the known physical properties of the phantoms and the expected performance of the system as designed and measured, rather than expert consensus on clinical images.

4. Adjudication Method for Test Set:

• Not applicable, as this was non-clinical phantom testing.

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

• No MRMC comparative effectiveness study involving human readers and AI assistance is mentioned. The document explicitly states: "Given the above information and the type and scope of the changes, particularly that the new system uses PET detector modules from the cleared Signa PET/MR, and that its 510k included numerous clinical images, clinical testing is not required to demonstrate that the Discovery MI is as safe and as effective as the legally marketed predicate and reference devices."

6. Standalone (Algorithm Only) Performance Study:

• The "lesion detectability evaluation included a model observer study." This implies a standalone computational assessment of lesion detection performance, without human readers. No specific metrics (e.g., AUC, sensitivity, specificity) or detailed results from this model observer study are provided.

7. Type of Ground Truth Used (for Non-Clinical Tests):

• For non-clinical performance evaluation, the ground truth was based on the known physical properties of the phantoms and the expected performance derived from mathematical and physics analysis.

8. Sample Size for Training Set:

• Not applicable. The document does not describe the development of an AI algorithm that would typically require a training set. The "model observer study" mentioned for lesion detectability is unlikely to refer to a machine learning training set in this context but rather a computational model used to assess detectability in phantoms.

9. How Ground Truth for Training Set Was Established:

• Not applicable, as there is no mention of a machine learning training set for an AI algorithm.

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The 18ch T/R Knee Coil is intended for use with GE 3.0T MR systems to produce diagnostic images of the knee that can be interpreted by a trained physician.

The 18ch T/R Knee Coil is a transmit/receive. 18-channel phased array coil designed for magnetic resonance imaging (MRI) using the GE 3T MR systems. The 18ch T/R Knee Coil is intended to be used for imaging the knee.

The 18ch T/R Knee 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 18ch T/R Knee Coil also includes the accessories listed in Table 1. The accessories consist only of patient comfort pads.

The provided text is a 510(k) Summary for a medical device called the "18ch T/R Knee Coil," a transmit/receive, 18-channel phased array coil designed for magnetic resonance imaging (MRI) of the knee. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics typically found for AI/software devices.

Therefore, many of the requested points related to acceptance criteria, sample sizes for test/training sets, ground truth establishment, expert adjudication, and MRMC studies are not applicable or cannot be extracted from this type of regulatory submission for a hardware device like an MRI coil.

However, I can extract the relevant performance data and conclusions regarding the substantial equivalence to the predicate device.

Here's a breakdown of the information that can be extracted and where the requested information is not applicable:

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

For an MRI coil, "acceptance criteria" are typically related to fundamental safety and performance standards rather than diagnostic accuracy metrics. The document references compliance with these standards.

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

This information is not applicable for the type of device and study described. This document pertains to the regulatory clearance of an MRI hardware component based on engineering and bench testing, not a clinical study involving patient data with a "test set" in the context of an algorithm or diagnostic accuracy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. Ground truth for diagnostic interpretation is not relevant for the engineering and safety testing of an MRI coil.

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

This information is not applicable. No adjudication method was used as there was no clinical test set requiring expert interpretation.

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

This information is not applicable. This device is an MRI coil, not an AI, CAD, or software device. No MRMC study was performed.

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

This information is not applicable. This is a hardware device, not an algorithm.

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

This information is not applicable. Ground truth in the context of diagnostic accuracy is not relevant here. The "ground truth" for this device's performance is compliance with established engineering, electrical safety, and imaging standards (e.g., NEMA standards for SNR and uniformity).

8. The sample size for the training set

This information is not applicable. This is not an AI/ML device with a training set.

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

This information is not applicable. This is not an AI/ML device.

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