Search Results

The Premier III Phased Array CTL Spine Coil is a receive- only phased array RF coil, used for obtaining diagnostic images of the cervical, thoracic, and lumbar regions of the spine in Magnetic Resonance Imaging Systems. The Premier III Phased Array CTL Spine 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 Premier III Phased Array CTL Spine Coil is designed to provide Magnetic Resonance Images of the cervical, thoracic, and lumbar regions of the spine. The Premier III Phased Array CTL Spine Coil is designed for use with the Philips 3.0T Intera MR scanner manufactured by Philips Medical Systems, Inc.

Anatomic Regions: cervical, thoracic, and lumbar regions of the spine. 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 yield information that can be useful in the determination of a diagnosis.

The Premier III Phased Array CTL Spine Coil is a twelve element receive only phased array coil. The coil is shaped to conform to the contours of the spine and has been designed to maximize comfort and ease of use. The coil elements and accessory electronics are enclosed in a rigid plastic housing, which is fire rated and has a high impact and tensile strength.

The provided text is a 510(k) summary for a Magnetic Resonance Imaging Accessory, specifically the Premier III Phased Array CTL Spine Coil. The document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study with specific acceptance criteria and detailed performance metrics as would be found in a clinical trial for a novel AI device or a device requiring new clinical evidence.

Therefore, many of the requested sections (2-9), which are typical for studies proving meeting acceptance criteria for AI/diagnostic devices, cannot be directly answered from the provided text. The device described is a hardware component (an MRI coil), and its "performance" is primarily assessed by comparing its features and intended use to existing, legally marketed predicate devices, ensuring it doesn't raise new questions of safety or effectiveness.

Here’s what can be extracted and what cannot:

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

The document doesn't explicitly state "acceptance criteria" in the traditional sense of numerical thresholds for a study. Instead, it presents a comparison of the new device's features and safety aspects against predicate devices to establish substantial equivalence. The "performance" is inferred from these comparisons being "similar."

Regarding the study proving the device meets acceptance criteria:

The provided document describes a 510(k) Premarket Notification process, which is a regulatory pathway to demonstrate that a device is "substantially equivalent" to a legally marketed predicate device. This process typically relies on comparing design, materials, intended use, and safety features rather than extensive clinical studies with specified acceptance criteria as might be seen for novel diagnostic algorithms or drugs.

The "study" described here is essentially a comparison to predicate devices to prove substantial equivalence.

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

• Not applicable / Not provided. The document does not describe a test set, clinical trial, or data of patients. The evaluation is based on design and technical specifications compared to predicate devices.

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. No ground truth establishment by experts for a test set is described.

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

• Not applicable / Not provided. No adjudication method for a test set 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

• No, not done. This device is an MRI hardware component (a coil), not an AI-assisted diagnostic tool.

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

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

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

• Not applicable / Not provided. No specific ground truth type is mentioned as this is a device for substantial equivalence, not a diagnostic accuracy study.

8. The sample size for the training set

• Not applicable / Not provided. The concept of a "training set" is not relevant to the evaluation of this hardware device.

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

• Not applicable / Not provided. The concept of "ground truth for the training set" is not relevant here.

Ask a specific question about this device

The Premier III Linear Phased Array CTL Coil is designed to provide Magnetic Resonance Images of the cervical, thoracic and lumbar regions of the spine. The Premier III Linear Phased Array CTL Coil is designed for use with the GE Signa 3.0T scanner manufactured by GE Medical Systems, Inc.

Anatomic Regions: cervical, thoracic and lumbar regions of the spine 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 yield information that can be useful in the defermination of a diagnosis.

The Premier III Linear CTL Spine Coil is a multi-element phased array receive only coil. The coil has a rigid enclosure. The open, patient friendly design eases patient handling and positioning and maximizes patient comfort. The coil elements and accessory electronics are enclosed in a rigid plastic housing, which is fire rated and has a high impact and tensile strength.

The provided text is a 510(k) premarket notification for a medical device, specifically a Magnetic Resonance Imaging accessory (Premier III Linear Phased Array CTL Spine Coil). This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study of the device's performance against specific acceptance criteria in the manner you've requested.

Therefore, the information required to build the table and answer the study-related questions (sample size, experts, adjudication, MRMC, standalone, ground truth type and training set details) is not present in the provided text. The document is a regulatory submission for a device component, emphasizing its similarity in design and function to previously cleared devices. It does not contain clinical study data or performance metrics in the way a diagnostic AI device submission would.

Here's a breakdown of what could be extracted if such data were present, and why it's missing in this case:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable/Not provided. The document doesn't define specific performance acceptance criteria (e.g., sensitivity, specificity, image quality metrics) for the coil itself. Instead, it relies on demonstrating that the new coil's design and features are "similar to" or "identical to" predicate devices, implying that if the predicate devices meet performance standards (which they are presumed to as legally marketed devices), then this new device, being substantially equivalent, also implicitly meets those standards for its intended use.

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

Not provided. There is no mention of a test set or any performance study involving patient data. This is a device component.

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 provided. No study or ground truth establishment is described.

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

Not provided. No test set or adjudication process is mentioned.

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. This document is for an MRI coil, not an AI-assisted diagnostic tool. No MRMC study was conducted or is relevant here.

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

Not applicable. This is an MRI coil, not an algorithm.

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

Not provided. No ground truth establishment is described.

8. The sample size for the training set

Not provided. No training set is mentioned as this is not an AI/algorithm-based device.

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

Not provided. No training set or ground truth establishment is described.

In summary: The provided document is a 510(k) premarket notification for an MRI coil, which focuses on demonstrating substantial equivalence to existing predicate devices. It does not contain the kind of performance study data (acceptance criteria, test/training sets, expert adjudication, etc.) that would typically be found in a submission for a diagnostic algorithm or a device requiring new clinical performance studies.

Ask a specific question about this device

The Premier III Phased Array CTL Spine Coil is designed to provide Magnetic Resonance Images of the cervical, thoracic, and lumbar regions of the spine. The Premier III Phased Array CTL Spine Coil is designed for use with the Siemens 3.0T Magnetom Trio MR scanner manufactured by Siemens Medical Solutions, Inc.

Anatomic Regions: cervical, thoracic, and lumbar regions of the spine. 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 yield information that can be useful in the determination of a diagnosis.

The Premier III Phased Array CTL Spine Coil is a twelve element receive only phased array coil. The coil is shaped to conform to the contours of the spine and has been designed to maximize comfort and ease of use. The coil elements and accessory electronics are enclosed in a rigid plastic housing, which is fire rated and has a high impact and tensile strength.

The provided text is a 510(k) premarket notification for a medical device: the Premier III Phased Array CTL Spine Coil. This document establishes substantial equivalence to a predicate device, not through a clinical performance study with acceptance criteria, but by demonstrating that its technical characteristics and intended use are similar to a previously cleared device.

Therefore, many of the requested categories (acceptance criteria, study details, sample sizes, expert involvement, ground truth, MRMC study, standalone performance) are not applicable or cannot be extracted from this type of regulatory submission. The document focuses on comparing the new device's features to a predicate device to prove it is equally safe and effective.

Here's a breakdown based on the information available:

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

• Acceptance Criteria: Not explicitly stated as performance metrics in the way one might expect for a diagnostic algorithm. For a device like an MRI coil, "acceptance criteria" are typically related to meeting established engineering and safety standards, and demonstrating performance comparable to a predicate device. The primary "performance" here is its ability to produce diagnostic images.

• Reported Device Performance:

  • Intended Use: Imaging of the spine.
  • Indications for Use: Identical to routine MRI imaging (same as standard MR Imaging).
  • Coil Design: Receive-only phased array design, twelve elements.
  • Safety Features: Switching diode decoupling, additional RF fuses, enclosed in a non-conductive housing, does not transmit RF power, decoupling isolates elements during RF transmission, cable length/stiffness prevents looping.
  • Compatibility: Designed for use with the Magnetom Trio 3.0T MRI system (Siemens Medical Solutions, Inc.).

  The document asserts that these features are "Similar to the Premier 7000 Phased Array C/T/L Spine Coil manufactured by USA Instruments, Inc. (K980157)." This "similarity" is the core of its demonstrated performance and safety for regulatory purposes, implying it performs equivalently to the predicate.

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. This 510(k) notification does not describe a clinical performance study with a test set of patient data. The evaluation is based on technical comparisons to a predicate device.

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. No test set or ground truth established by experts is described in this document for the purpose of a clinical performance evaluation.

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

• Not Applicable. No test set or expert 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

• Not Applicable. This device is an MRI coil, not an AI-powered diagnostic tool, and no MRMC study is mentioned.

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

• Not Applicable. This device is an MRI coil, not an algorithm.

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

• Not Applicable. No ground truth for a clinical performance study is described. The "ground truth" for regulatory clearance is the established safety and effectiveness of the predicate device (Premier 7000 Phased Array C/T/L Spine Coil).

8. The sample size for the training set

• Not Applicable. There is no mention of a training set as this is not an AI/algorithm device.

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

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

Ask a specific question about this device

The Premier III Phased Array CTL Spine Coil is a receive-only 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 III Phased Array CTL Spine Coil is designed for use with the GE Medical Systems 3.0Tesla MRI scanner.

The Premier III Phased Array CTL Spine Coil is designed to provide Magnetic Resonance Images of the spine anatomy. The Premier III Phased Array CTL Spine Coil is designed for use with the GE Medical Systems 3.0Tesla scanner.

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

The GE Medical Systems 3.0Tesla 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 III 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 been designed to maximize comfort and ease of use. The elements and associated circuitry are enclosed in a housing made of plastic materials, which are fire rated and have high impact and tensile strength.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Premier III Phased Array CTL Spine Coil:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel clinical study with explicit performance metrics against predefined acceptance criteria. The "reported device performance" is primarily a statement of similarity to predicate devices already cleared by the FDA.

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

The document does not describe a test set or test data in the way one would for a clinical performance study of a diagnostic algorithm or new technology. The safety and effectiveness information is presented as a comparison to predicate devices. There is no mention of a specific sample size of images or patients used for performance testing.

Therefore:

• Sample size for test set: Not applicable/not provided in this document.
• Data provenance: Not applicable/not provided in this document. The comparison is feature-based against existing cleared devices, not data-driven.

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

There is no mention of experts being used to establish ground truth for a test set. This type of evaluation is characteristic of studies assessing the diagnostic accuracy of AI or interpretive devices, which is not the nature of this 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable, as no test set or ground truth establishment process is described.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in this document. This submission is for an accessory (an RF coil) to an MRI system, not a diagnostic algorithm.

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

No, a standalone performance study was not conducted or described. This device is a passive RF coil; it does not perform any algorithmic analysis or interpretation.

7. The Type of Ground Truth Used

Not applicable, as no ground truth was established for performance testing of this device. The regulatory pathway here is substantial equivalence based on physical and functional characteristics compared to predicate devices.

8. The Sample Size for the Training Set

Not applicable. This device is a hardware accessory; it does not involve machine learning algorithms that require training sets.

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

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

Ask a specific question about this device