(79 days)
Evry is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces axial, sagittal, coronal, and oblique cross-sectional images and displays the internal structure and/or function of the region of interest, contrast agents may be used. These images when interpreted by a trained physician yield information that may assist in diagnosis.
Evry is a magnetic resonance diagnostic device (MRDD) that uses a superconducting magnet to produce axial, sagittal, coronal, and oblique cross-sectional images, and displays the internal structure and/or function of the head. The system features various pulse sequences, imaging techniques and conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).
Integrated into the Magnetic Resonance Imaging system are a set of gradient coils which vary the strength of the applied magnetic field as a function of position and time, and are used to spatially encode the radio signals. Computed image reconstruction algorithms are then able to convert the encoded, digitized signals into images which can then be displayed to the user.
As with the predicate device, Evry includes the following technological components: Magnet scanner unit, gradient system and RF transmit coil, Equipment room containing the equipment needed to support the scanner unit functionality, Patient Transporter, 16-Channel Receive-Only Head Coil, Patient Communication System, Operator Console.
The furnished document describes the FDA 510(k) premarket notification for Evry, a magnetic resonance diagnostic device (MRDD). However, the document does not contain the detailed acceptance criteria or results of a clinical study that proves the device meets specific performance criteria in terms of diagnostic accuracy or comparative effectiveness with human readers.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (GE Medical Systems' 1.5T Signa HDx and 3.0T Signa HDx families) primarily through non-clinical performance data and conformity to recognized standards.
Here's an analysis of the provided text in relation to your request, highlighting what is present and what is missing:
Summary based on the provided document:
The provided document describes the FDA 510(k) premarket notification for Synaptive Medical Inc.'s "Evry" Magnetic Resonance Diagnostic Device (MRDD). The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (GE Medical, 1.5T Signa HDx and 3.0T Signa HDx families).
The document primarily outlines non-clinical performance data and adherence to recognized consensus standards and FDA guidance documents. It does not contain a detailed clinical study demonstrating the device's diagnostic performance against specific acceptance criteria in terms of metrics like sensitivity, specificity, or reader improvement with AI assistance.
Details from the document related to your questions:
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A table of acceptance criteria and the reported device performance:
- Not explicitly provided. The document states that "Non-clinical verification and validation tests have been performed with regards to the intended use, technical claims, requirement specifications and risk management results." It also notes that "The verification and validation test results demonstrate that Evry conforms with the aforementioned FDA-recognized consensus standards and guidance documents and meets the acceptance criteria."
- However, specific quantitative acceptance criteria (e.g., minimum SNR, image quality metrics) and the exact reported values are not listed in a table format within this summary. It implicitly states that the device's performance is sufficient given its compliance with various engineering and safety standards (ISO, IEC, NEMA).
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Sample size used for the test set and the data provenance:
- No specific test set for diagnostic accuracy is described. The document mentions a "direct determination peripheral nerve stimulation (PNS) volunteer study" with 20 subjects to characterize stimulation thresholds for safety purposes. This is a safety study, not a diagnostic performance study.
- Data Provenance: The document does not specify the country of origin for the PNS study data or if it was retrospective or prospective, beyond stating it was a "volunteer study."
- It mentions that "a representative set of clinical images of the proposed subject device have been reviewed by a U.S. Board Certified radiologist attesting that images produced by the device are of sufficient quality for diagnostic use." This implies some form of qualitative assessment of imaging, but not a large-scale test set for diagnostic performance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the qualitative image review, it mentions one U.S. Board Certified radiologist. No specific details about the radiologist's years of experience are provided in this excerpt.
- For the PNS study, ground truth isn't applicable in the same diagnostic sense; it's about physiological response to stimulation.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not described for diagnostic performance, as no such study is detailed. For the single radiologist review, no adjudication method would be necessary.
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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:
- No MRMC or AI assistance study was conducted or described. This device is an MRDD (MRI scanner), not an AI-powered diagnostic algorithm. Its function is to produce images for interpretation by a physician, not to interpret or assist in the interpretation of those images. Therefore, questions regarding AI assistance or human reader improvement are not relevant to the scope of this particular device's submission as described.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. As stated above, this is an imaging device, not a diagnostic algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the limited "clinical images review," the "ground truth" was the attestation by a U.S. Board Certified radiologist regarding the diagnostic quality of the images produced by the device. This is a qualitative assessment of image quality, not a diagnostic accuracy assessment against a confirmed patient condition.
- For the PNS study, the "ground truth" was the direct observation of physiological responses (nerve stimulation) in volunteers.
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The sample size for the training set:
- Not applicable/Not described. This device is a hardware imaging system, not a machine learning algorithm that requires a training set in the typical sense.
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How the ground truth for the training set was established:
- Not applicable/Not described. (See point 8).
Conclusion:
The provided document describes a Class II MRI device (Evry) seeking 510(k) clearance by demonstrating substantial equivalence. The clearance is primarily based on non-clinical performance data, conformance to recognized engineering and safety standards (e.g., ISO, IEC, NEMA, FDA guidance), and qualitative review of image quality by a radiologist. A safety study (PNS) was conducted with 20 subjects.
The document does not contain information related to a clinical study on diagnostic accuracy, sensitivity, specificity, or the comparative effectiveness of human readers with or without AI assistance, because the device itself is an MR scanner, not an AI-driven diagnostic tool. Therefore, many of the questions asked are not addressed by the provided content.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.