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The Prima III TotalSENSE Torso Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the abdominal and pelvic anatomy, including the liver, spleen, and renal arteries in Magnetic Resonance Imaging Systems. The Prima III TotalSENSE Torso Coil is designed for use with the Intera 3.0T MRI system manufactured by Philips Medical Systems, Inc. The indications for use are the same as for standard MR Imaging.

The Prima III TotalSENSE Torso Coil is designed to provide Magnetic Resonance Images of the abdominal and pelvic anatomies. The Prima III TotalSENSE Torso Coil is designed for use with the Philips Intera 3.0T MRI scanner manufactured by Philips Medical Systems, Inc.

The 3.0T MRI 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 Prima III TotalSENSE Torso Coil is a six channel receive only phased array coil. The coil is composed of a flexible top and a rigid bottom piece which allow for imaging of patients of different sizes. The open, patient friendly design minimizes claustrophobic effects and maximizes patient comfort. The coil elements and accessory electronics are enclosed in flexible and rigid plastic housings, which are fire rated.

The provided document describes a 510(k) premarket notification for a medical device, the Prima III TotalSENSE Torso Coil for Magnetic Resonance Imaging (MRI). It is a declaration of "substantial equivalence" to predicate devices, rather than a study demonstrating meeting specific acceptance criteria in the way a clinical trial for a novel drug or AI diagnostic would.

Therefore, many of the typical acceptance criteria and study design elements for an AI or diagnostic device are not applicable here. This document pertains to a hardware accessory for an existing medical imaging modality.

However, I will extract what can be inferred about the "acceptance criteria" for a 510(k) submission, which in this context means demonstrating that the new device is as safe and effective as a legally marketed predicate device.

Description of Acceptance Criteria and Device Performance

The "acceptance criteria" for a 510(k) submission like this primarily revolve around demonstrating substantial equivalence to a predicate device in terms of intended use, indications for use, technological characteristics, and safety/effectiveness. There are no explicit quantitative performance metrics like sensitivity/specificity/accuracy with specific thresholds in this type of submission for an MRI coil.

The "study" that proves the device meets these "acceptance criteria" is the 510(k) submission itself, where the manufacturer provides a comparison of their new device to existing predicate devices.

Here's the information structured as requested, with "N/A" where the requested information is not relevant to this type of regulatory submission (an MRI coil, not an AI diagnostic):

1. Table of Acceptance Criteria and Reported Device Performance

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

• N/A. This is a hardware device (MRI coil) submission, not an AI or diagnostic algorithm requiring a test set of patient data for performance evaluation. The "test" is the comparison to predicate devices and the technical specifications provided.

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)

• N/A. Ground truth for patient data is not applicable to an MRI coil submission. The "ground truth" for the submission itself is the existing regulatory framework and the characteristics of predicate devices, assessed by the manufacturer and then reviewed by the FDA.

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

• N/A. Not applicable, as there is no test set of patient data requiring expert adjudication.

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

• N/A. Not applicable. No MRMC or AI component described.

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

• N/A. Not applicable. This is a hardware component.

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

• N/A. For this type of submission, the "ground truth" for demonstrating substantial equivalence relies on:
  • Technical specifications and engineering data proving the coil's physical properties, safety features, and performance within the MRI system.
  • Regulatory precedent (predicate devices cleared by the FDA).
  • Established principles of MRI physics and safety.

8. The sample size for the training set

• N/A. Not applicable. There is no AI component or training set.

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

• N/A. Not applicable. There is no AI component or training set.

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The Prima III TotalSENSE Torso Coil is a receiveonly phased array RF coil, used for obtaining diagnostic images of the abdominal and pelvic anatomy, including the liver, spleen, and renal arteries in Magnetic Resonance Imaging Systems. The Prima III TotalSENSE Torso Coil is designed for use with the Magnetom Trio 3.0T MRI system manufactured by Siemens Medical Solutions, Inc. The indications for use are the same as for standard MR Imaging: The Prima III TotalSENSE Torso Coil is designed to provide Magnetic Resonance Images of the abdominal and pelvic anatomies. The Prima III TotalSENSE Torso Coil is designed for use with the Siemens Magnetom Trio 3,0T MRI scanner manufactured by Siemens Medical Solutions, Inc. Anatomic Regions: the abdominal and pelvic anatomy, including the liver, spleen, and renal arteries Nuclei Excited: Hydrogen The indications for use are the same as for standard imaging: The 3.0T MRI 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 vield information that can be useful in the determination of a diagnosis.

The Prima III TotalSENSE Torso Coil is an eight element receive only phased array coil. The coil is composed of flexible top and bottom pieces which allow for imaging of patients of different sizes. The open, patient friendly design minimizes claustrophobic effects and maximizes patient comfort. The coil elements and accessory electronics are enclosed in flexible plastic housings. which are fire rated.

The provided text is for a 510(k) premarket notification for a medical device, specifically an MRI coil (Prima III TotalSENSE Torso Coil). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical study with acceptance criteria and performance data like one would find for a de novo device or a PMA.

Therefore, the document does not contain the acceptance criteria and the detailed study described in your request.

Here's why and what information can be inferred or is missing:

• Acceptance Criteria and Reported Device Performance: This information is not provided. 510(k) submissions typically demonstrate substantial equivalence through technical characteristics and, if necessary, non-clinical bench testing or phantom studies to show that the new device performs as intended and is as safe and effective as the predicate. Clinical performance data with specific acceptance criteria is generally not required for a device like an MRI coil in a 510(k) unless there's a significant change in intended use or technological characteristics that raises new safety or effectiveness questions.

• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): None of these details are present because a formal clinical study with human subjects, requiring these elements, was not conducted or reported in this 510(k) summary. The "study" here is essentially a comparison to predicate devices and likely involved technical testing of the coil's performance (e.g., signal-to-noise ratio, image uniformity) which are not elaborated upon in a public summary.

In summary, based only on the provided text, I cannot fulfill your request for: a table of acceptance criteria and reported device performance, sample sizes, data provenance, number or qualifications of experts, adjudication methods, MRMC study results, standalone performance, types of ground truth, training set sample size, or how training set ground truth was established.

The document states:

• Device Name: Prima III TotalSENSE Torso Coil
• Intended Use: Obtaining diagnostic images of the abdominal and pelvic anatomy, including the liver, spleen, and renal arteries in Magnetic Resonance Imaging Systems.
• Device Description: An eight-element receive-only phased array RF coil, composed of flexible top and bottom pieces for varied patient sizes, open design to minimize claustrophobia, and enclosed elements in flexible plastic housings. Designed for use with the Magnetom Trio 3.0T MRI system by Siemens Medical Solutions, Inc.
• Safety and Effectiveness: Demonstrated by "Similar to" comparisons with predicate devices (Vision 5000 Torso Coil K013594, Insight Plus 9000 Phased Array Torso and Pelvis Coil K001209, Mark 5000 Quadrature Shoulder coil K013854) across various features like intended use, indications for use, coil enclosure material, coil design, decoupling mechanisms, prevention of RF burns, radio frequency absorption, and formation of resonant loops.

This indicates that the device was cleared based on its equivalence in design and function to previously cleared devices, rather than a clinical trial demonstrating specific performance metrics against pre-defined acceptance criteria.

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