(20 days)
The Synq Software is indicated for use in conjunction with Synq, 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 head. Depending on the region of interest, contrast agents may be used. These images when interpreted by a trained physician yield information that may assist in diagnosis.
The Synq Software allows a user to configure and initiate a magnetic resonance scan of a subject. In doing so, the software coordinates the interactions of the magnetic field, gradients, radio frequency (RF) transmitter and receiver coil in Synq (Previously known as EVRY, K200327) to produce axial, sagittal, coronal, and oblique cross-sectional images that represent the spatial distribution of protons with spin. The Synq Software Version 1.3 upgrades the current software version in the Synq system to include additional imaging applications, functionality, and minor bug fixes. The Software should be used only by qualified medical professionals who are trained in magnetic resonance diagnostic devices.
This document describes the Synaptive Medical Inc. Syng Software Version 1.3, a magnetic resonance diagnostic device (MRDD). The 510(k) submission (K232981) asserts its substantial equivalence to the predicate device (Evry, K200327).
Acceptance Criteria and Reported Device Performance
The provided text does not contain a specific table detailing acceptance criteria alongside reported device performance. However, it states:
"As per Bench Testing document attached under Bench Testing the image performance testing and safety testing meet all predefined acceptance criteria. Together, with an attestation from a U.S. Board certified radiologist, demonstrate substantial equivalence to the predicate device (EVRY K200327) by conforming to FDA recognized standards and addressing all requirements in FDA MRDD Guidance."
This indicates that the acceptance criteria were based on FDA recognized standards (NEMA MS 1, 2, 3, 4, 5, 8, 9; IEC 62464-1, IEC-60601-2-33) and FDA MRDD Guidance, focusing on image performance and safety. The reported performance is that the device meets all these predefined acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion Category | Specific Criteria (Inferred from Text) | Reported Device Performance |
|---|---|---|
| Image Performance | Conformance to NEMA MS 1, 2, 3, 4, 5, 8, 9 standards | Met all predefined criteria |
| Conformance to IEC 62464-1 (Medical electrical equipment - Requirements for the safety of MR equipment for medical diagnosis) | Met all predefined criteria | |
| Compliance with FDA MRDD Guidance | Met all requirements | |
| Safety Testing | Conformance to IEC-60601-2-33 (Medical electrical equipment - Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis) | Met all predefined criteria |
| Compliance with FDA MRDD Guidance | Met all requirements |
2. Sample Size Used for the Test Set and Data Provenance
The text states: "A small, representative subset of clinical images are provided along with this 510(k) submission, as per guidance document 'Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices' issued November 18, 2016."
- Sample Size: "A small, representative subset of clinical images." The exact number is not specified in the provided text.
- Data Provenance: The text does not explicitly state the country of origin or whether the data was retrospective or prospective. It refers to "clinical images," which implies human subject data, but further details are absent.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The text mentions: "Together, with an attestation from a U.S. Board certified radiologist, demonstrate substantial equivalence to the predicate device (EVRY K200327) by conforming to FDA recognized standards and addressing all requirements in FDA MRDD Guidance."
- Number of Experts: At least one U.S. Board certified radiologist provided an attestation. It's unclear if more than one was involved for ground truth establishment.
- Qualifications: U.S. Board certified radiologist. The number of years of experience is not specified.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method (like 2+1 or 3+1) for establishing the ground truth of the test set. It mentions an "attestation from a U.S. Board certified radiologist," suggesting a single expert's assessment was used, possibly against benchmarks.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and its Effect Size
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Synq Software Version 1.3 did not require clinical tests since substantial equivalence to the legally marketed predicate device was proven with the verification and validation testing." Therefore, there is no effect size of human readers improving with AI vs. without AI assistance to report.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, a standalone performance assessment was effectively conducted through "image performance testing and safety testing" against predefined acceptance criteria derived from FDA recognized standards. This implies the software's output (images) was evaluated independently as part of the verification and validation. The role of the radiologist was for "attestation" and interpretation of images, rather than as part of a human-in-the-loop performance study.
7. The Type of Ground Truth Used
The ground truth for the verification and validation testing appears to be based on conformance to established technical performance standards and safety requirements (NEMA MS and IEC standards, FDA MRDD Guidance). For the clinical images, the "attestation from a U.S. Board certified radiologist" suggests a form of expert consensus/opinion regarding the quality and diagnostic utility of the images produced by the device, likely assessed against expected clinical standards of MRI imaging. Pathology or outcomes data are not mentioned.
8. The Sample Size for the Training Set
The document does not provide information regarding a training set. The submission focuses on verification and validation testing for an updated software version (1.3) of an already cleared device, implying the device's core algorithms were likely developed and validated previously. This 510(k) is for updates and does not detail the original training data for the base software.
9. How the Ground Truth for the Training Set Was Established
Since no training set information is provided, there is no information on how its ground truth was established.
§ 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.