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510(k) Data Aggregation
(76 days)
AIR Anterior Array, AIR Posterior Array
The AIR Anterior Array is a receive-only RF coil designed for use with GE 3.0T MRI Systems. When used with other coils, the indications for use include chest, cardiac, abdomen, torso, pelvis, prostate, hips, peripheral vascular and long bone imaging. The nucleus detected is hydrogen.
The AIR Posterior Array is a receive-only RF coil designed for use with GE 3.0T MRI Systems. The indications for use include spine. When used with other coils, the indications for use also include abdomen, torso, pelvis, prostate, cardiac, hips, and long bone imaging. The nucleus detected is hydrogen.
The AIR Anterior Array is a receive-only coil designed to provide optimum signal-to noise ratio and uniform coverage of the chest, cardiac, abdomen, torso, pelvis, prostate, hips, peripheral vascular and long bone. The AIR Anterior Array contains 30 elements and the housing of the AIR Anterior Array is made of a soft, pliable material that conforms to the patient's anatomy. The coil is padded with a soft material designed to maximize patient comfort.
The AIR Posterior Array is a receive-only coil designed to provide optimum signal-to noise ratio and uniform coverage of the spine, abdomen, torso, pelvis, prostate, cardiac, hips and long bone. The AIR Posterior Array contains 60 elements and is embedded within the patient table of the MR System.
The provided text describes GE Healthcare's AIR Anterior Array and AIR Posterior Array, which are receive-only RF coils for GE 3.0T MRI Systems. The submission focuses on demonstrating substantial equivalence to predicate devices (3.0T AA for Anterior Array and TDI Posterior Array for Posterior Array, both K143345) rather than proving performance against specific acceptance criteria for a new clinical claim. Therefore, much of the requested information regarding acceptance criteria and performance against those criteria as would be found in a study for a new clinical claim is not present.
However, I can extract the information that is available regarding the comparison to predicate devices and the non-clinical testing performed.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission demonstrating substantial equivalence to existing predicate devices, explicit, quantifiable "acceptance criteria" for a new clinical performance claim are not provided in the same way they would be for a de novo device or a device seeking a novel indication. Instead, the "acceptance criteria" are implied by compliance with established standards and comparable performance to the predicate device.
| Acceptance Criterion (Implied) | Reported Device Performance (Summary of Non-Clinical Tests) |
|---|---|
| Safety and Electrical Standards Compliance | The AIR Anterior Array and AIR Posterior Array comply with relevant safety and performance testing, including:AAMI/ANSI ES60601-1IEC 60601-1-2IEC 60601-2-33MS 6-2008MS 9-2008Maximum B1 peakNetwork blocking analysisHeat Testing |
| Biocompatibility | Both predicate and modified devices have a successful biocompatibility track record, as demonstrated by ISO 10993 testing and by their history of use in previously cleared devices. |
| Functional Equivalence (Imaging Quality) | The sample clinical images included in the submission, along with the conclusion of substantial equivalence, implicitly demonstrate comparable imaging quality to the predicate devices for their indicated uses. The statement: "The indications for use of the proposed devices are comparable to the claimed predicate devices. ... Additionally, the results from the above non-clinical tests demonstrate that the devices perform as intended" supports this. |
| Manufacturing Quality Assurance | The following quality assurance measures were applied: Risk Analysis, Requirements Reviews, Design Reviews, Unit-level testing (Module verification), Integration testing (System verification), Performance testing (Verification), Safety testing (Verification), Simulated use testing (Validation). |
2. Sample Size Used for the Test Set and Data Provenance
The submission explicitly states: "The subjects of this premarket submission, the AIR Anterior Array and AIR Posterior Array, do not require clinical studies to support substantial equivalence. Sample clinical images have been included in this submission." This indicates that a formal test set, in the sense of a clinical trial or large-scale evaluation, was not conducted. The "sample clinical images" suggest a limited number of images were used for visual comparison, but the exact number, their provenance, or whether they constituted a formal "test set" for quantitative analysis is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given that formal clinical studies were not required and "sample clinical images" were provided, it is highly unlikely that a formal ground truth establishment process involving multiple experts was undertaken for these images. The evaluation would have likely been internal to GE Healthcare’s regulatory and engineering teams, comparing the images to those obtained with the predicate device. Therefore, this information is not available.
4. Adjudication Method for the Test Set
As a formal test set and expert review for ground truth are not described, an adjudication method is not applicable and not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was performed. The submission explicitly states "do not require clinical studies to support substantial equivalence." The focus is on demonstrating equivalence through technical comparison and non-clinical testing.
6. Standalone (Algorithm Only) Performance Study
These devices are MRI coils, which are hardware components, not algorithms. Therefore, a standalone (algorithm only) performance study is not applicable. The performance is intrinsically linked to the MRI system.
7. Type of Ground Truth Used
For the "sample clinical images," the ground truth implicitly would have been standard clinical interpretation by radiologists, but this was not part of a formal study with documented "ground truth" establishment. For the non-clinical tests, the ground truth was derived from the compliance with engineering standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, etc.) and successful completion of internal verification and validation activities.
8. Sample Size for the Training Set
There are no algorithms or AI described for these devices, so the concept of a "training set" is not applicable. The devices are hardware components (MRI coils).
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for these devices.
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