(146 days)
The Comfort EC710 is a whole-body magnetic resonance imaging (MRI) system intended for general diagnostic use. Transverse, sagittal, coronal and oblique planes may be imaged. MRI images produced by the Comfort EC710 system reflect the spatial distribution for the density of hydrogen nuclei (protons) spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images yield information that can be useful in the determining of a diagnosis.
The Comfort EC710, a 1.5T MRI System, represents a modification to the previously cleared Echostar Comfort 1.5T MRI system (K141945); both utilize a 1.5T superconducting magnet with a 71cm bore, gradients, RF transmission, various sequences and reconstruction algorithms to acquire 2D single slice, multi-slice and 3D volume images, with a data acquisition system supporting multiple coil elements.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Comfort EC710 device by Alltech Medical Systems America, Inc.
Important Note: The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device with extensive new clinical performance studies. As such, many of the typical elements of an acceptance criteria and study description for a new AI-powered diagnostic device will not be present.
Acceptance Criteria and Study for Comfort EC710 MRI System (K163192)
Based on the provided 510(k) summary, the Comfort EC710 is an update to an existing Magnetic Resonance Imaging (MRI) system (Echostar Comfort 1.5T MRI system, K141945), and the primary focus of the submission is to demonstrate that the changes do not alter fundamental scientific technology or raise new safety concerns. Therefore, the "acceptance criteria" and "study" described are mainly focused on verifying that the modified device still meets established safety and performance standards for MRI systems and performs equivalently to its predicate.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Safety and Performance | Conformance to international standards for MRI systems. | Nonclinical testing conducted to applicable portions of: NEMA MS-1 2014, NEMA MS-3 2014, AAMI ANSI ES 60601-1:2005/(R)2012, NEMA MS-4 2010, IEC 60601-2-33:2010, IEC 60601-1-2:2007. Test reports are presented, demonstrating conformance with standards and equivalent performance with the predicate device. |
| Software Functionality | Verification and validation of software changes. | Software verification and validation testing conducted and documentation provided as recommended by FDA guidance ("Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"). Software considered a "moderate" level of concern. |
| Imaging Performance | Confirmation of performance for new features (Knee-Foot coil, software). | Clinical images were obtained to confirm the performance of the knee-foot coil and the new software features. "Sample phantom and clinical images, and test data support the safety of the device." "The intended use, technological characteristics and performance of the Knee-Foot Coil is the same as the predicate Knee Coil." "The enhanced software features do not create a new intended use or alter the fundamental technological characteristics." "Comfort EC710 has the same performance of effectiveness and safety as the predicate Echostar Comfort 1.5T MRI system." |
| Equivalence | Demonstrated substantial equivalence to predicate device. | "Based on the results of the safety and performance testing, it is the opinion of Alltech Medical Systems America, Inc. that the device, Comfort EC710, is substantially equivalent to the Echostar Comfort 1.5T MRI System predicate device." "The Comfort EC710, a 1.5T MRI System, has the same fundamental technological characteristics of the predicate device, does not include any new indications for use and no new or additional safety concerns have been raised." |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions that "clinical images were obtained to confirm the performance of the knee-foot coil and the new software features" and "sample phantom and clinical images, and test data support the safety of the device."
- Test Set Sample Size: Not explicitly stated. The document refers to "clinical images" and "sample phantom images" generically without providing specific numbers of patients, cases, or scans.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study appears to be retrospective in comparison to the predicate and current clinical images were prospectively/concurrently acquired for verification of new features, rather than as a formal clinical trial for validation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified. The document states that "MRI images produced by the Comfort system... When interpreted by a trained physician, these images yield information that can be useful in the determining of a diagnosis." This implies image interpretation by physicians but does not detail how ground truth was established for the specific testing mentioned.
- Qualifications of Experts: Not specified beyond "trained physician."
4. Adjudication Method for the Test Set
Not applicable/Not mentioned. The document primarily focuses on technical safety and performance equivalence, and verification of new features, rather than a diagnostic performance study requiring expert adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Reader Improvement with AI vs. without AI Assistance
- MRMC Study: No. This is not an AI-powered diagnostic device in the sense of providing automated interpretations or assisting human readers for increased diagnostic accuracy or efficiency. It is an MRI imaging system that produces images for human interpretation.
- Effect Size: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The Comfort EC710 is an MRI imaging device, not a standalone diagnostic algorithm. Its output (images) is explicitly intended for interpretation by a "trained physician."
7. The Type of Ground Truth Used
For the safety and performance acceptance criteria:
- Standards and Benchmarks: Conformance to recognized NEMA and IEC standards for MRI systems.
- Equivalence to Predicate: Performance that is "equivalent" to the legally marketed Echostar Comfort 1.5T MRI system (K141945).
- Image Quality: Implied ground truth for "confirming performance" of new features would likely involve assessments of image quality, resolution, contrast, artifact reduction, and homogeneity, likely against established benchmarks for diagnostic utility in MRI. However, the specific "type" of ground truth (e.g., pathology, clinical outcomes, expert consensus on image quality) for the "clinical images" is not detailed.
8. The Sample Size for the Training Set
Not applicable. The Comfort EC710 is an MRI system, not a machine learning algorithm that requires a "training set" in the conventional sense. The "software" mentioned refers to operational software, sequences, and reconstruction algorithms that are developed through engineering and testing, not typically "trained" on data in the way an AI model would be.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" for an AI model in this context.
§ 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.