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The Rapture 11000 a phased array peripheral vascular coil is a multi-element phased array RF coil, used for obtaining diagnostic images of the vasculature and soft tissue anatomy extending from below the knee to the foot region, in Magnetic Resonance Imaging Systems. The Rapture 11000 Peripheral Vascular Coil is designed for use with the Signa 1.5T MRI system manufactured by GE Healthcare Technologies. The indications for use are the same as for standard MR Imaging.

The Rapture 11000 a peripheral vascular coil is a multi-element phased array receive-only coil. The coil consists of four sections: two detachable legs sections, a main base and a pre-amplifier box. The open, patient friendly design 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.

This document describes the Rapture 11000 Phased Array Peripheral Vascular Coil, an MRI accessory. The submission is a Traditional 510(k) Premarket Notification from 2004.

Here's an analysis of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) submission for a medical device cleared in 2004. At that time, acceptance criteria were typically demonstrated by proving substantial equivalence to a predicate device, rather than meeting specific quantifiable performance metrics as might be seen for AI/ML devices today. The "acceptance criteria" here are implicitly satisfied by demonstrating the new device is as safe and effective as existing legally marketed devices.

Therefore, the table below reflects the comparison presented in the document to establish substantial equivalence.

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

The document does not detail a specific test set or data provenance in the way an AI/ML device submission would. For a traditional medical device like an MRI coil, "testing" typically involves:

• Engineering validation and verification (e.g., electrical performance, mechanical integrity, safety tests).
• Clinical evaluation to ensure image quality and compatibility with the MRI system.

The submission does not specify a clinical study with a defined sample size for patients. The focus is on demonstrating equivalence based on design, materials, and intended use, implying that similar clinical performance is expected given the similarity to predicate devices. Therefore,

• Sample Size for Test Set: Not specified in terms of patient data.
• Data Provenance: Not applicable in the context of patient data studies for this submission type.

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

This information is not provided in the document. For a traditional MRI coil, "ground truth" would relate to the physical and functional performance of the coil itself (e.g., signal-to-noise ratio, homogeneity, artifact levels), typically assessed by engineers and MR physicists, not medical experts establishing 'ground truth' for diagnostic findings. Since no clinical studies establishing diagnostic truth are mentioned, no expert panel for ground truth is indicated.

4. Adjudication Method for the Test Set

This is not applicable to this type of device submission. Adjudication methods (like 2+1 or 3+1) are typically used in clinical trials involving subjective interpretation of diagnostic findings, often for AI/ML algorithms or new diagnostic methods where a consensus ground truth needs to be established from multiple expert readers. This submission for an MRI coil focuses on technical equivalence and safety aspects.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done or at least not reported in this summary. This type of study is common for evaluating the impact of AI on human reader performance for diagnostic tasks. For a physical device like an MRI coil, performance is generally evaluated based on image quality metrics and safety, not on how a human reader's diagnostic accuracy improves with the coil.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This device is an MRI hardware component, not an algorithm.

7. The Type of Ground Truth Used

For this device, the "ground truth" would primarily be established through:

• Engineering specifications and tests: Confirming electrical, mechanical, and safety parameters meet design requirements.
• Image quality metrics: Assessing signal-to-noise ratio, image homogeneity, artifact levels, and resolution achievable with the coil.
• Comparison to predicate devices: The primary ground truth for regulatory clearance here is that the new device performs at least as well as or equivalent to legally marketed predicate devices in terms of its intended function and safety.

No specific "pathology," "outcomes data," or "expert consensus" on diagnostic findings is reported as ground truth for this device's performance in the provided summary.

8. The Sample Size for the Training Set

Not applicable. This device is a hardware component (an MRI coil), not a software algorithm that requires a training set.

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

Not applicable. As stated above, this device is hardware and does not have a training set or associated ground truth establishment process for training.

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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.

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