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The Pelvic Array Coil is a receive only phased array RF coil used for obtaining diagnostic images of the pelvis, including the hips, in magnetic resonance imaging systems. The Pelvic Array Coil is designed for use with the GE Signa 1.5T MRI system manufactured by GE Medical Systems.
The Pelvic Array Coil is designed to provide Magnetic Resonance Images of the pelvis, including the hips. The Pelvic Array Coil is designed for use with the GE Signa 1.5T MR scanner.
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 Pelvic Array Coil is a receive-only, quadrature phased array RF coil, used for obtaining diagnostic MR images of the pelvis, including the hips. The elements and associated circuitry are enclosed in a semi-flexible housing that is fire rated and has a high impact and tensile strength.

The provided document is a 510(k) summary for a Magnetic Resonance Imaging Accessory (Pelvic Array Coil), dated December 17, 2003. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a new AI/software-based device.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types is not available in this document.

This document describes a physical medical device (an MRI coil) and its intended use, rather than a diagnostic algorithm or AI product. The safety and effectiveness are established through comparison to a predicate device based on material, design, and function, not through clinical performance metrics against specific diagnostic criteria.

Key areas from your request that are NOT present in the provided document:

• A table of acceptance criteria and the reported device performance: This document does not establish specific performance metrics or acceptance criteria like sensitivity, specificity, accuracy, or image quality scores that would be typical for an AI/software device. Its acceptance is based on substantial equivalence.
• Sample size used for the test set and the data provenance: There is no mention of a test set, human subjects study, or data provenance.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there's no test set or ground truth in the context of an AI/software evaluation.
• Adjudication method for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is for a physical MRI coil, not an AI system.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

What the document does provide regarding safety and effectiveness:

The document establishes safety and effectiveness by demonstrating "substantial equivalence" to a legally marketed predicate device (Insight Plus 9000 Torso and Pelvis Coil manufactured by USA Instruments, Inc. - K001209).

The comparison focuses on:

• Intended Use: Similar for imaging of the pelvis, including hips.
• Indications for Use: Identical to routine MRI imaging.
• Coil Enclosure Material: Similar materials (Delrin Acetal, Flame Retardant PVC, Flame Retardant Polyurethane, Vinyl Coated EVA Foam).
• Coil Design: Receive-only quadrature phased array coil, similar to the predicate.
• Decoupling: Switching diode decoupling, similar to the predicate.
• Prevention of RF Burns: Does not transmit RF power, decoupling isolates elements, and uses a non-conductive housing. These features are similar to the predicate.
• Radio Frequency Absorption: It's a receive-only coil and does not transmit RF power, consistent with the predicate.
• Formation of Resonant Loop: Decoupling isolates elements and the cable design prevents looping, similar to the predicate.

In essence, the "study" demonstrating the device meets acceptance criteria is a technical and functional comparison study against a predicate device, focusing on design, materials, and operational principles to show that it is as safe and effective as the already-cleared device. There are no performance metrics in the sense of diagnostic accuracy or reader improvement for this type of device.

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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 Insight Plus 9000 Phased Array Torso and Pelvis Coil is a receive only phased array RF coil, used for obtaining diagnostic images of the torso and pelvic regions, including the abdomen, chest, and hips, in Magnetic Resonance Imaging Systems. The Insight Plus 9000 Phased Array Torso and Pelvis Coil is designed for use with the Philips Infinion 1.5T MRI system manufactured by Philips Medical Systems, Inc. The indications for use are the same as for standard MR Imaging.

The Insight Plus 9000 Phased Array Torso and Pelvis Coil is designed to provide Magnetic Resonance Images of the torso and pelvic regions, including the abdomen, chest, and hips. The Insight Plus 9000 Phased Array Torso and Pelvis Coil is designed for use with the Philips Intera 1.5T MRI scanner manufactured by Philips Medical Systems, Inc.

The 1.5T 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 Insight Plus 9000 Phased Array Torso and Pelvis Coil is an eight element receive only phased array coil. The coil elements and associated circuitry are enclosed in a semi-flexible housing, which is fire rated and has a high impact and tensile strength.

The provided text is a 510(k) summary for the "Insight Plus 9000 Phased Array Torso and Pelvis Coil," a Magnetic Resonance Imaging Accessory. This document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than presenting a performance study with detailed acceptance criteria and reported device performance metrics in the way that would typically be seen for a new algorithmic device or a device requiring a specific clinical outcome.

Therefore, the requested information, particularly regarding specific numerical acceptance criteria, reported device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, is not present in this document.

The document states that the device's acceptable performance is established through comparison to legally marketed predicate devices, meaning its capabilities are similar to existing devices that have already met safety and effectiveness standards.

Here's an analysis of the provided information in relation to your request:

1. Table of acceptance criteria and reported device performance

Not present in the document. The document establishes substantial equivalence by comparing the features and intended use of the new coil to predicate devices. It does not define specific performance metrics (e.g., signal-to-noise ratio, image quality scores) with corresponding acceptance criteria and then report the device's achievement of those criteria. Instead, it states the new device is "similar" for various features.

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

Not applicable/Not present. This document does not describe a performance study with a test set of data in the context of an AI/ML device. The device is an MRI accessory (a coil), and its safety and effectiveness are established by demonstrating that its technical characteristics are substantially equivalent to existing, legally marketed devices.

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

Not applicable/Not present. As this is not a study requiring diagnostic accuracy assessment of images by experts, there is no mention of ground truth establishment by experts for a test set.

4. Adjudication method for the test set

Not applicable/Not present.

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/Not present. This is not an AI/ML device, and no MRMC study is described.

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

Not applicable/Not present. This is not an algorithmic device.

7. The type of ground truth used

Not applicable/Not present.

8. The sample size for the training set

Not applicable/Not present. This is not an AI/ML device, and no training set is mentioned.

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

Not applicable/Not present.

In summary: The provided 510(k) summary (K023650) for the "Insight Plus 9000 Phased Array Torso and Pelvis Coil" demonstrates substantial equivalence to predicate devices based on its intended use, indications for use, materials, design, and safety features. It does not detail a performance study with specific numerical acceptance criteria, reported performance metrics, or data sets (test or training) in the manner expected for software or AI/ML devices. Therefore, most of the requested information is not available in this document.

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