Search Results

The Liberty 9000 8-ch Breast Coil with Disposable Biopsy Plate is a receive-only RF coil, used for obtaining MR images of the breast and axillary tissue. The biopsy plates allow access to the breast anatomy during biopsy procedures. No biopsy needles are included with, or packaged with the Liberty 9000 8-ch Breast Coil with Disposable Biopsy Plate. The Liberty 9000 8-ch Breast Coil with Disposable Biopsy Plate is designed for use with the Excite 1.5T system, manufactured by General Electric Healthcare.

The Liberty 9000 8-ch Breast Coil with Disposable Biopsy Plate is designed to provide Magnetic Resonance Images of the breast anatomy. The Liberty 9000 8-ch Breast Coil with Disposable Biopsy Plate is designed for use with the GE MR's Signa Excite 1.5T MRI scanner.

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

The Signa Excite 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 reluxation and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

The Liberty 9000 8-ch Breast Coil with Disposable Biopsy Plate is a phased array, receive-only MRI coil. The coil consists of a main supporting base with a coil chamber in the middle section. A sternum bridge and two lateral wings divide the chamber into two segments, one to receive each breast. Each of the hollow coil segments houses four coil elements that are insulated from the patient by a ridged plastic housing. The coil housing is made of plastic materials, which are fire rated and have high impact and tensile strength. The Liberty 9000 8-ch Breast Coil with Disposable Biopsy Plate is designed to offer optimized imaging capabilities and maximum lateral access to each breast for biopsy procedures.

The provided text is a 510(k) premarket notification for a medical device, specifically a "Liberty 9000 8-ch Breast Coil with Disposable Biopsy Plate" for Magnetic Resonance Imaging. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting novel clinical study data to prove performance against specific acceptance criteria. Therefore, the document does not contain information on acceptance criteria, a study proving device performance against such criteria, sample sizes, expert qualifications, or ground truth establishment in the way typically seen for new diagnostic algorithms or devices requiring extensive clinical validation.

The document primarily focuses on:

• Device Description and Intended Use: Detailing the physical characteristics and purpose of the breast coil.
• Comparison to Predicate Devices: Explicitly stating that the device is "Similar to Liberty 9000 Breast Coil with Disposable Biopsy Plate" (K001582) and other cleared devices, emphasizing similarities in features, intended use, indications for use, and safety aspects.
• Safety Features: Highlighting design aspects that mitigate risks like RF burns and resonant loops (e.g., receive-only coil, decoupling, non-conductive housing).

Given this context, I will address the requested points by explaining why the information is not present in the provided text for a 510(k) submission of this nature.

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

Information Not Available: This document does not present a table of acceptance criteria or reported device performance metrics in the way one would expect for a novel diagnostic algorithm or a device requiring new performance claims. As a 510(k) submission for a medical device accessory (an MRI coil), the focus is on demonstrating that the device is substantially equivalent to a legally marketed predicate device, particularly in terms of safety and functionality. Performance is implicitly demonstrated by showing it functions similarly to the predicate for its intended use (obtaining MR images of the breast).

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

Information Not Available: No specific test set, patient data, or clinical study data (prospective or retrospective) from which performance metrics would be derived is mentioned in this 510(k) summary. The submission relies on a comparison to predicate devices, engineering design specifications, and safety assessments rather than new clinical trials with patient cohorts.

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)

Information Not Available: Since no specific test set or clinical study is described, there is no mention of experts used to establish ground truth or their qualifications.

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

Information Not Available: No test set or clinical study is described, so no adjudication method 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

Information Not Available: This document describes an MRI breast coil, which is a hardware accessory, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not relevant and not mentioned.

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

Information Not Available: This device is an MRI coil, a hardware component, not a standalone algorithm. Thus, this question is not applicable.

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

Information Not Available: As no clinical studies or test sets are described, there is no mention of the type of ground truth used.

8. The sample size for the training set

Information Not Available: This device is an MRI coil, not an AI-driven algorithm, so the concept of a "training set" is not applicable in this context.

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

Information Not Available: As the concept of a "training set" does not apply to this device, the establishment of ground truth for such a set is not mentioned.

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 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 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

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.

Ask a specific question about this device