(90 days)
The ISAAC 1.5 T MR System is a 1.5 T whole-body magnetic resonance imaging (MRI) system intended for general diagnostic use. Sagittal, coronal and oblique planes may be imaged. MRI images produced by the ISAAC system reflect the spatial distribution of 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 provide information that can be useful in determining an diagnosis.
The ISAAC 1.5 T MR System is a new clinical whole-body MR system, utilizing a superconducting magnet operating at 1.5 T. A variety of pulse sequences are available as described in Section II. The system is provided with transmit/receive head and body coils, along with several receive-only specialty coils. The system utilizes an actively shielded gradient coil.
The provided document (K020268) is a 510(k) summary for the ISAAC 1.5 T MR System. Based on the content, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" in the format of a table with specific thresholds for performance metrics. Instead, it refers to compliance with NEMA performance standards as the basis for demonstrating substantial equivalence. The reported "performance" is that the device was tested to and complies with these standards.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Compliance with appropriate NEMA performance standards | "Testing to the appropriate NEMA performance standards was carried out and reported in this 510(k)." |
| Operating in Normal Operating Mode for static field level, dB/dt, and SAR according to proposed revision of IEC 601-2-33 standard | "the system always operates in the Normal Operating Mode for static field level, dB/dt and SAR, according to the proposed revision of the IEC 601-2-33 standard." |
| Acoustic noise within 99 dBA limit specified in IEC standard | "The acoustic noise is well within the 99 dBA limit specified in the IEC standard." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on a "test set" in the context of clinical image data used for algorithm evaluation. The testing referenced is related to NEMA performance standards, which typically involve phantom studies and hardware performance measurements, not clinical image analysis. Therefore, information on sample size, country of origin, or retrospective/prospective nature of a clinical test set is not available.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable and not provided. The submission focuses on demonstrating substantial equivalence to a predicate MR system based on technological characteristics and NEMA performance testing of the hardware, not on the performance of an AI algorithm or a diagnostic interpretation by experts. The "ground truth" for the NEMA standards is the physical correctness of the MR system's output based on defined metrics. The intended use states that "When interpreted by a trained physician, these images provide information that can be useful in determining an diagnosis," but this refers to the end-user interpretation, not a part of the device's substantial equivalence testing for this 510(k).
4. Adjudication Method for the Test Set
This information is not applicable and not provided. No clinical test set requiring expert adjudication is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, an MRMC comparative effectiveness study was not done or reported in this 510(k). This submission is for an MR imaging system itself, not an AI-based diagnostic aid that would improve human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study was not done or reported. The device is a Magnetic Resonance Diagnostic Device, an imaging system, not an algorithm, and it explicitly requires interpretation "by a trained physician."
7. The Type of Ground Truth Used
For the NEMA performance standards testing, the "ground truth" is based on physical and engineering specifications and measurements from the MR system, rather than clinical ground truth like pathology or expert consensus. The device's output (images) is evaluated against these engineering and physics-based criteria.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The ISAAC 1.5 T MR System is a hardware imaging device, not an AI algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided, as there is no training set for an AI algorithm.
§ 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.