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510(k) Data Aggregation
(56 days)
DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR); DISCOVERY 3T 16 CH BODY ARRAY COIL (POSTERIOR); DISCOVERY
The Discovery 3T 16 Ch Body Array Coil and Discovery 3T 32 Ch Body Array Coil are receive-only RF Coils designed for use with 3.0T MRI systems manufactured by GE Healthcare. The indications for use include chest, cardiac, abdomen, torso, pelvis, prostate, hips, and long bone imaging. The nucleus detected is hydrogen.
The Discovery 3T 16 Ch Body Array Coil and Discovery 3T 32 Ch Body Array Coil are surface coils used for Magnetic Resonance Imaging. They are tuned to image Proton nuclei in a receive-only configuration. They are comprised of 32 individual Phased Array coil elements each utilizing an integrated preamplifier to improve image quality. The geometry is optimized for use with parallel imaging techniques. The 16 Ch version uses multiplexers to allow a 32 channel design to be used on 16 Channel systems.
The GE Healthcare 510(k) Premarket Notification Submission (K103365) describes the Discovery 3T 16 Ch Body Array Coil and Discovery 3T 32 Ch Body Array Coil. The submission asserts that these devices are substantially equivalent to their predicate device, the USA Instruments Prima III TotalSENSE Torso Coil (K030371).
The study provided to demonstrate substantial equivalence and meet acceptance criteria is based on non-clinical voluntary standards, focusing on safety and performance, rather than clinical efficacy.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standards and Performance Metrics) | Reported Device Performance |
|---|---|
| Safety Standards: | Comply with all applicable sections. |
| IEC 60601-1: Electrical Safety | Comply with all applicable sections. |
| IEC 60601-1-2: Electromagnetic Compatibility (e.g., electrostatic discharge) | Comply with all applicable sections. |
| IEC 60601-2-33: Electrical Safety (e.g., documentation requirements) | Determinded to be post market acceptable. |
| ISO 10993-1: Biocompatibility (determination of post market acceptability of materials) | Improved upon the predicate device. |
| Performance Standards: | |
| SNR testing method identified in Section 18 | Increased channel and larger coverage area compared to the predicate. Shares similar high-level phased array, receive-only design. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly mention a specific "test set" in terms of patient data. The evaluation appears to be based on testing of the device hardware against engineering and safety standards. Therefore, information regarding "country of origin of the data" or "retrospective or prospective" is not applicable as it's not a clinical study involving patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The evaluation is against engineering standards rather than expert-derived ground truth on clinical images.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of adjudication for a test set, as the study relies on compliance with technical standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission focuses on device equivalence based on technical specifications and safety standards, not on human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
Not applicable. This device is a receive-only RF coil for an MRI system, not an algorithm. Its performance is evaluated in terms of its ability to acquire high-quality MR signals.
7. Type of Ground Truth Used
The "ground truth" for this submission is established through compliance with recognized electrical, electromagnetic, and biocompatibility safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-33, ISO 10993-1), and performance characteristics like Signal-to-Noise Ratio (SNR) as per a specified method. This is a technical and engineering-based ground truth, not clinical ground truth derived from expert consensus, pathology, or outcomes data.
8. Sample Size for the Training Set
Not applicable. This is a hardware device (MRI coil), not an AI algorithm, so there is no training set in the AI sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of medical device.
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(84 days)
BODY ARRAY COIL
The Body Array Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the abdomen, pelvis and lumbar spine regions in Magnetic Resonance Imaging Systems. The indications for use are the same as for standard MR Imaging. The Body Array Coil is designed for use with the Siemens Rhapsody 1.0Tesla MRI scanner manufactured by Siemens Medical Systems, Inc.
The Body Array Coil is designed to provide Magnetic Resonance Images of the torso region including the abdomen, thoracic, and lumbar spine anatomy. The Body Array Coil is designed for use with the Siemens Rhapsody 1.0Tesla scanner.
Anatomic Regions: Torso, Abdomen and Spine Anatomy Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The Siemens Rhapsody 1.0Tesla 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 Body Array Coil is a four-element receive-only phased array RF coil. The coil consists of two sections: upper and lower sections, which are positioned above and below the patient torso respectively. The upper section is latched on to the former bottom during imaging. The elements and associated circuitry are enclosed in a housing made of plastic materials, which are fire rated and have a high impact and tensile strength.
The provided document is a 510(k) premarket notification for a Medical Device, specifically a "Body Array Coil" for Magnetic Resonance Imaging. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed study with acceptance criteria and performance data in the way a clinical trial for a new therapeutic drug or an AI-powered diagnostic device would.
Therefore, the document does not contain the granular information typically required to answer your specific questions regarding acceptance criteria, study details, and performance metrics for an AI-based device or a device requiring such detailed validation. The information provided is geared towards proving equivalence for a hardware accessory to an MRI system.
Here's a breakdown based on the provided text, indicating what information is present and what is not:
Description of Acceptance Criteria and Study to Prove Device Meets Criteria
The document describes the Body Array Coil as a receive-only phased array RF coil for obtaining diagnostic images of the abdomen, pelvis, and lumbar spine regions in MRI systems. The primary method for proving the device meets acceptance criteria is through demonstrating substantial equivalence to predicate devices, as is typical for 510(k) submissions for medical devices of this nature. The "acceptance criteria" are implicitly met by proving that the device is as safe and effective as existing legally marketed devices.
1. A table of acceptance criteria and the reported device performance
The document provides a table comparing the new device's product features to predicate devices, establishing similarity rather than specific quantitative performance metrics against predefined acceptance criteria.
| Body Array Coil Product Features | Comparison to Predicate or other 510(k) cleared products | Implied "Acceptance Criteria" |
|---|---|---|
| Intended Use: Torso Imaging including abdomen, chest, lumbar and thoracic spine | -Similar to Insight Plus 9000 Torso and Pelvis Coil manufactured by USA Instruments, Inc. (K001209) | |
| -Similar to Vision 5000 Phased Array Torso Coil manufactured by USA Instruments, Inc. (K002482) | Device must perform torso imaging comparable to predicate devices. | |
| Indications for Use: Identical to routine MRI imaging | -Similar to Vision 5000 Phased Array Torso Coil manufactured by USA Instruments, Inc. (K002482) | Device must have the same indications for use as routine MRI. |
| Coil Material: Royalite R59™ ABS Plastic, Polyurethane | -Similar to Vision 5000 Phased Array Torso Coil manufactured by USA Instruments, Inc. (K002482) | Materials used must be comparable and safe. |
| Coil Design: Receive-only phased array design | -Similar to Vision 5000 Phased Array Torso Coil manufactured by USA Instruments, Inc. (K002482) | Design must be a receive-only phased array, similar to predicates. |
| Decoupling: RF Chokes with Switching Diodes | -Similar to Vision 5000 Phased Array Torso Coil manufactured by USA Instruments, Inc. (K002482) | |
| -Similar to Insight Plus 9000 Torso and Pelvis Coil manufactured by USA Instruments, Inc. (K001209) | Decoupling mechanism must be effective and comparable. | |
| Prevention of RF Burns: Does not transmit RF Power, Decoupling isolates the coil elements from RF fields during RF transmission, Coil elements and circuitry are enclosed in a non-conductive housing. | -Similar to Vision 5000 Phased Array Torso Coil manufactured by USA Instruments, Inc. (K002482) | Device must safely prevent RF burns, similar to predicates. |
| Radio Frequency Absorption: Coil is a receive only coil and does not transmit RF power | -Similar to Vision 5000 Phased Array Torso Coil manufactured by USA Instruments, Inc. (K002482) | Device must not transmit RF power, consistent with receive-only design. |
| Formation of Resonant Loops: Decoupling isolates coil elements from RF fields during RF transmission, Length of cable and stiffness does not permit looping | -Similar to Vision 5000 Phased Array Torso Coil manufactured by USA Instruments, Inc. (K002482) | Device design must prevent the formation of resonant loops that could be hazardous. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. As this is an accessory to an MRI system, the "test set" would typically refer to engineering validation or potentially a small set of phantom/volunteer scans for image quality assessment, not a clinical trial with a large patient sample size that would be described in terms of provenance.
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)
This information is not provided. Establishing ground truth by expert consensus is typically associated with diagnostic algorithms or interpretative devices, not a passive MRI coil. The efficacy is assumed to be equivalent to predicate coils, which primarily deliver images for interpretation by a "trained physician" (as mentioned in the Indications for Use for the MRI system itself).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are relevant for studies comparing diagnostic interpretations, which is not the focus of this submission.
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
This information is not provided, and such a study would not be applicable to an MRI coil. MRMC studies are associated with evaluating the impact of AI-assisted diagnostic tools on human reader performance. This device is a hardware component for image acquisition, not an AI-driven interpretation tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided. This device is a hardware component (an MRI coil), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not explicitly stated beyond the general statement that images "yield information that can be useful in the determination of a diagnosis" when interpreted by a trained physician. For an MRI coil, "ground truth" would likely relate to image quality metrics (signal-to-noise ratio, uniformity, artifact levels) or safety parameters, which are often evaluated against engineering specifications and predicate device performance. Specific methodologies for establishing this kind of "ground truth" are not detailed.
8. The sample size for the training set
This information is not provided. The concept of a "training set" is relevant for machine learning algorithms, which this device is not.
9. How the ground truth for the training set was established
This information is not provided for the same reason as point 8.
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