(493 days)
i Space 1.5T Superconducting Magnetic Resonance Imaging device, which is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MRI System produces transverse, sagittal, coronal, and oblique images that display the internal structure of the head, body, or extremities. The images produced by the MRI 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 diagnosis determination.
i Space 1.5T Superconducting Magnetic Resonance Imaging System utilizes a 1.5 Tesla superconducting magnet in an open gantry design. i Space 1.5T Superconducting Magnetic Resonance Imaging System has been designed to enhance clinical utility as compared to the HHF1 by taking advantage of the imaging properties of the 1.5T magnet.
The provided text describes the 510(k) summary for the i Space 1.5T Superconducting Magnetic Resonance Imaging System, establishing substantial equivalence to a predicate device (HHF1 Magnetic Resonance Imaging System, K052172).
However, the document does not contain specific acceptance criteria, reported device performance metrics against those criteria, or details of a study that directly proves the device meets specific performance acceptance criteria for image quality or diagnostic accuracy in the way described by the prompt's request (e.g., in terms of clinical sensitivity, specificity, accuracy, or reader performance).
Instead, the submission focuses on demonstrating substantial equivalence by comparing technological characteristics and adherence to recognized standards. The "study" mentioned refers to non-clinical tests verifying design specifications and compliance with safety and performance standards.
Therefore, I cannot fulfill all parts of your request with the provided information. I will extract the relevant information that is present and indicate where information is missing.
Description of Acceptance Criteria and Proving Study for i Space 1.5T Superconducting Magnetic Resonance Imaging System
The provided 510(k) summary focuses on demonstrating "substantial equivalence" of the i Space 1.5T Superconducting Magnetic Resonance Imaging System to a predicate device rather than providing a detailed clinical study with diagnostic performance acceptance criteria. The "study" referenced in the document is a series of non-clinical tests to verify compliance with design specifications and recognized standards.
1. Table of Acceptance Criteria and Reported Device Performance
The document lists "safety parameters with action levels" and "performance levels" that will be evaluated according to FDA guidance and NEMA/IEC standards. However, actual numerical acceptance criteria (e.g., specific SNR thresholds, uniformity percentages) are not explicitly stated in the provided text, nor are specific numerical results of the device's performance against such criteria. The document only confirms that "Non clinical tests were conducted to verify that the proposed device met all design specifications" and "The test results demonstrated that the proposed device complies with the following standards."
| Aspect | Acceptance Criteria (Not explicitly quantified in document) | Reported Device Performance (Implied as compliant with standards) |
|---|---|---|
| Maximum Static Field | Conforms to FDA guidance | Tested and found compliant with relevant standards. |
| Rate of Change of Magnetic Field | Conforms to FDA guidance | Tested and found compliant with relevant standards. |
| RF Power Deposition | Conforms to FDA guidance | Tested and found compliant with relevant standards. |
| Acoustic Noise Levels | Conforms to FDA guidance and NEMA MS 4-2010 | Tested and found compliant with relevant standards. |
| Specification Volume | Conforms to FDA guidance | Tested and found compliant with relevant standards. |
| Signal to Noise | Conforms to FDA guidance and NEMA MS 1-2008 (R2014) | Tested and found compliant with relevant standards. |
| Image Uniformity | Conforms to FDA guidance and NEMA MS 3-2008 (R2014) | Tested and found compliant with relevant standards. |
| Geometric Distortion | Conforms to FDA guidance and NEMA MS 2-2008 (R2014), NEMA MS 12-2016 | Tested and found compliant with relevant standards. |
| Slice Profile, Thickness, and Gap | Conforms to FDA guidance and NEMA MS 5-2018 | Tested and found compliant with relevant standards. |
| High Contrast Spatial Resolution | Conforms to FDA guidance | Tested and found compliant with relevant standards. |
2. Sample size used for the test set and the data provenance
The document refers to "non-clinical tests" and "test results" but does not specify a "test set" in terms of patient data, nor does it provide information on sample size, country of origin of data, or whether it was retrospective or prospective. The testing described is intrinsic device performance testing against engineering specifications and standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. The non-clinical tests described would typically involve engineering measurements and phantom studies rather than expert-established ground truth from clinical cases.
4. Adjudication method for the test set
This information is not provided, as the nature of the test set is non-clinical device performance measurements.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not described or referenced in the provided text. The device is an MRI system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
A standalone performance study of an algorithm was not described or referenced. The device is a whole MRI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests, the "ground truth" would be established physical or engineering properties and reference standards (e.g., phantom measurements, calibrated equipment). There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for these tests.
8. The sample size for the training set
This information is not applicable and not provided. The submission describes an MRI hardware system, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable and not provided.
§ 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.