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1.5T SIGNA Creator and 1.5T SIGNA Explorer is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used.
The images produced by 1.5T SIGNA Creator and 1.5T SIGNA Explorer reflects the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

1.5T SIGNA Creator and 1.5T SIGNA Explorer is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The 1.5T SIGNA Creator and 1.5T SIGNA Explorer features a superconducting magnet operating at 1.5 Tesla. The system uses a combination of time-varying magnetic fields (gradients) and RF transmissions to obtain information regarding the density and position of nuclei exhibiting magnetic resonance. The data acquisition system accommodates 16 independent receive channels and multiple independent coil elements per channel during a single acquisition series.

Here's an analysis of the provided text regarding the acceptance criteria and study for the 1.5T SIGNA Creator and 1.5T SIGNA Explorer:

The provided document is a 510(k) Premarket Notification Summary from the FDA for GE Healthcare's 1.5T SIGNA Creator and 1.5T SIGNA Explorer Magnetic Resonance Imaging (MRI) systems. The primary purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria in a detailed clinical study for a novel device.

Therefore, the information you're requesting regarding explicit acceptance criteria and a dedicated study to prove precise performance metrics is largely not present in this type of regulatory document. Instead, the document focuses on demonstrating that the new device meets the same safety and effectiveness standards as its predicate.

Here's a breakdown of the information that can be extracted and what is not available based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided in this document.

This 510(k) submission does not include a table of quantitative acceptance criteria (e.g., specific sensitivity, specificity, accuracy thresholds for a diagnostic task) and corresponding performance metrics for the 1.5T SIGNA Creator and 1.5T SIGNA Explorer. The acceptance criteria for a 510(k) are generally around demonstrating that the new device is as safe and effective as the predicate device(s).

The document states:

• "The subject of this premarket submission, 1.5T SIGNA Creator and 1.5T SIGNA Explorer did not require clinical studies to support substantial equivalence."
• "Internal scans were conducted as part of validation for workflow and image quality, and sample clinical images are included in the submission."
• "Additionally, the result of the above described testing demonstrates that the device performs as intended."
• "GE Healthcare considers the 1.5T SIGNA Creator and 1.5T SIGNA Explorer to be as safe, as effective, and performance is substantially equivalent to the predicate device(s)."

These statements highlight that the absence of significant differences and the compliance with established standards are the "acceptance criteria" for substantial equivalence.

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

Not applicable/available as a formal "test set" for performance evaluation.

Since no dedicated clinical study was performed to assess diagnostic performance against specific acceptance criteria, there is no "test set" in the traditional sense for diagnostic accuracy. The document mentions "internal scans" as part of validation, but does not specify sample size or data provenance for these (e.g., country of origin, retrospective/prospective). These internal scans would likely be used to evaluate image quality and workflow, not necessarily diagnostic performance against a ground truth.

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

Not applicable.

Because there was no diagnostic performance study with a formal "test set," there's no mention of experts establishing ground truth for such a study.

4. Adjudication Method for the Test Set

Not applicable.

No formal test set or diagnostic performance study means no adjudication method is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done.

The document explicitly states: "The subject of this premarket submission, 1.5T SIGNA Creator and 1.5T SIGNA Explorer did not require clinical studies to support substantial equivalence." This implies that no MRMC study or any other clinical study was deemed necessary to demonstrate the device's functionality beyond substantial equivalence to the predicate. Therefore, no effect size of human reader improvement with/without AI assistance is applicable, as this device is an MRI scanner, 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 an MRI hardware device, not a diagnostic algorithm. Therefore, "standalone" algorithm performance is not relevant.

7. The Type of Ground Truth Used

Not applicable.

Without a diagnostic performance study, the concept of "ground truth" for diagnostic accuracy is not discussed in this document. The "ground truth" underpinning this submission is fundamentally that the new device is technologically equivalent and operates within the same safety and performance parameters as already-approved predicate devices.

8. The Sample Size for the Training Set

Not applicable.

This is not an AI/algorithm-driven device requiring a training set in the machine learning sense.

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

Not applicable.

As it's not an AI/algorithm-driven device, there is no training set or associated ground truth establishment process.

Summary of what the document does provide regarding "performance" and "acceptance criteria":

• Reliance on Substantial Equivalence: The core "acceptance criterion" for this 510(k) approval is demonstrating substantial equivalence to predicate devices (1.5T Brivo MR355 and 1.5T Optima MR360, K123417; and 1.5T Optima MR450w, K142085).
• Technological Equivalence: The document states, "Proposed 1.5T SIGNA Creator and 1.5T SIGNA Explorer Technology employs the same fundamental scientific technology as its predicate device..."
• Compliance with Voluntary and Recognized Standards: The device underwent testing to comply with various standards, which serve as performance benchmarks in lieu of specific clinical performance criteria:
  • IEC60601-1, IEC60601-2-33, IEC60601-1-1, IEC60601-1-2 (Electrical safety and performance for medical devices, specifically MRI)
  • NEMA MS1, MS2, MS3, MS4, MS5, MS8 (Performance standards for MRI systems, defining terms, measurements, and reporting for aspects like image quality, S/N, geometric distortion, etc.)
  • NEMA PS PS3.1-3.20 (DICOM standard for communication interface)
• Quality Assurance Measures: The device applied standard quality assurance measures, including Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level (Module verification), Integration testing (System verification), Performance testing (Verification), Safety testing (Verification), and Simulated use testing (Validation). These indicate that the device meets internal design and quality standards.
• Internal Scans for Validation: "Internal scans were conducted as part of validation for workflow and image quality." While not a formal clinical study, these would demonstrate that the system produces images and operates as expected.

In conclusion, for a 510(k) submission regarding an MRI system like this, the "acceptance criteria" are tied to demonstrating that the device is as safe and effective as a previously approved predicate device, primarily through technological comparison, compliance with recognized performance standards, and internal validation of image quality and workflow, rather than detailed clinical performance metrics from controlled diagnostic studies.

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