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The 0.35T Signa® Ovation with Excite Magnetic Resonance System is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The Signa 0.35T Signa® Ovation with Excite Magnetic Resonance System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the entire body, including, but not limited to, the musculocskeletal, vascular, cardiac, and neuro systems. The images produced by the Signa 0.35T Signa® Ovation with Excite Magnetic Resonance System reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

Due to the 'open' design of the Signa 0.35T Signa® Ovation with Excite may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in-room display and MR safe biopsy needles

The 0.35T Signa® Ovation with Excite Magnetic Resonance System is a modification to the 0.35T Signa® MFO/i Magnetic Resonance System (K033504) which utilizes a permanent magnet to acquire 2D single-slice and multi-slice, and 3D volume images. The 0.35T Signa® Ovation with Excite Magnetic Resonance System features a permanent magnet operating at 0.35T. The system can image in the sagittal, coronal, axial, oblique and double oblique planes, using various pulse sequences. Images are acquired and reconstructed using 2D and 3D Fourier transformation techniques. The system is intended for high-resolution anatomical applications, short scan times, and multinuclear spectroscopy.

The provided text describes a 510(k) premarket notification for a medical device, the GE 0.35T Signa® Ovation with Excite MR System. However, it does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and a study proving device performance.

Here's what can be extracted and what is missing:

Description of Acceptance Criteria and Study Proving Device Performance

The submission focuses primarily on demonstrating substantial equivalence to a predicate device (Signa® 0.35T® Ovation with Excite System, K033504) through engineering modifications and adherence to performance standards, rather than a clinical performance study with defined acceptance criteria for diagnostic efficacy.

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

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

• Not specified. The submission does not describe a clinical test set or data derived from human subjects for performance evaluation in the way you might expect for a diagnostic AI device. The evaluation appears to be based on technical performance and safety testing against established standards, and comparison to existing device specifications.

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. No clinical ground truth establishment is described for a diagnostic performance study. The "trained physician" is mentioned in the indications for use as interpreting the images, but not in the context of creating a test set for the device's performance.

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

• Not applicable. No clinical test set or adjudication method 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:

• Not applicable. This device is an MR system, not an AI-assisted diagnostic tool. No MRMC study is mentioned.

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

• Not applicable. This is an MR system, not an algorithm.

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

• Not applicable for diagnostic accuracy. The "ground truth" for this type of submission relates to compliance with engineering and safety standards (e.g., an MR system must correctly measure field strength, produce images with certain resolution, operate safely). No diagnostic accuracy ground truth is discussed.

8. The sample size for the training set:

• Not applicable. This device is an MR system, not an AI model that requires a training set.

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

• Not applicable. As above, no training set is relevant for this device.

Summary of the Study Discussed:

The actual "study" described in this 510(k) summary is focused on engineering and safety verification of the device's modifications and its adherence to relevant international and national standards.

• Type of Study: Technical evaluation against established performance and safety standards, and a comparison to a predicate device.
• Standards Referenced:
  • NEMA performance standards (specific ones not listed, but implied to be relevant to MR system performance).
  • IEC 601-1 (International Medical Equipment Safety standard).
  • IEC 601-2-33 (Particular Requirements for Safety of Magnetic Resonance Equipment for Medical Diagnosis).
• Purpose: To demonstrate that the GE 0.35T Signa® Ovation with Excite MR System, with the addition of a motorized control circuit for lateral table movement, is substantially equivalent (in terms of safety and effectiveness) to its predicate device (K033504) and meets applicable safety and performance requirements.
• Conclusion: GE concluded that the device is substantially equivalent to the predicate and introduces no new potential hazards. FDA agreed with this determination.

This submission is typical for modifications to existing medical imaging hardware where the fundamental imaging principles and diagnostic capability remain unchanged, and the focus is on maintaining safety and performance characteristics in the face of minor design alterations.

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