(60 days)
The Machnet Bilateral Open Breast Coil, Catalog Number MICS-GSXX, is for use in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the breast and axillary tissues that can be interpreted by a trained physician.
The Machnet Bilateral Open Breast Coil is designed as a bilateral open breast coil which allows clinical imaging combined with very precise multiple localizations of breast lesions and subsequently small interventional breast procedures. Features: Dual channel phased array configuration. Allows bilateral and unilateral imaging of the breast and surrounding tissues. Minimal variation of contrast across images. The design allows adequate reception of signals from chest wall and axilla Ergonomic design minimizes motion artifacts. Open coil design allows virtually all sizes of breasts to be imaged. Breast support and positioning devices allow controlled positioning. High sensitivity allows thin slices. Interventional MRI possible with optional device (MICS-MIA). Accurate (2 to 3 mm) multiple computer-assisted localizations of breast lesions (with MICS-MIAS). Compatibility: GE Signa® (3X-LX) 1.5T, 1.0T, 0.5T MR scanners.
The provided text does not contain information about acceptance criteria or a study proving the device meets them in the way a typical AI/ML medical device submission would. This document is a 510(k) summary for a medical device (a breast coil for MRI) from 2002, which predates the widespread use of AI/ML in medical devices and the specific reporting requirements for such devices.
Instead, the document details the device's substantial equivalence to a predicate device based on design, function, and intended use. The "Testing information and Conclusion" section broadly states that "Testing was performed according to internal company procedures. Test results support the conclusion that actual device performance satisfies the design intent." This is a general statement and does not provide specific acceptance criteria or details of a study with performance metrics, sample sizes, or ground truth establishment relevant to an AI/ML device.
Therefore, I cannot populate the requested table or answer the specific questions about AI/ML device study design from the provided text.
Based on the document, here's what can be extracted, acknowledging the absence of AI/ML specific information:
Acceptance Criteria and Device Performance (Not applicable for AI/ML criteria):
| Acceptance Criteria (Not explicitly stated for AI/ML) | Reported Device Performance (General) |
|---|---|
| Substantial Equivalence to Predicate Device | "In all material respects, the 'Machnet Bilateral Open Breast Coil' (Catalog # MICS-GSXX) is substantially equivalent to MRI Devices Model OBC-149 (K003340)." |
| Satisfy design intent | "Test results support the conclusion that actual device performance satisfies the design intent." |
| Produce diagnostic images | "Produce diagnostic images of the breast and axillary tissues that can be interpreted by a trained physician." |
| Features/Capabilities | Dual channel phased array, bilateral/unilateral imaging, minimal contrast variation, adequate signal reception (chest wall/axilla), ergonomic, open coil, breast support, high sensitivity (thin slices), interventional MRI possible (with optional device), accurate multiple computer-assisted localizations (with MICS-MIAS). |
| Compatibility | GE Signa® (3X-LX) 1.5T, 1.0T, 0.5T MR scanners. |
Specific Questions (Answers based on the provided text, indicating "Not Applicable" or "Not Provided" for AI/ML specific criteria):
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A table of acceptance criteria and the reported device performance: See table above. It is important to note these are functional and equivalence criteria, not performance metrics for an AI/ML diagnostic output.
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Sample size used for the test set and the data provenance: Not provided. The text mentions "Testing was performed according to internal company procedures," but gives no details on the sample size or provenance of data used in those tests. This would typically involve physical testing of the coil, not a dataset in the AI/ML sense.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For a physical device like an MRI coil, "ground truth" would relate to its physical properties (e.g., signal-to-noise ratio, image uniformity) rather than diagnostic interpretations of images requiring expert consensus.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This concept is for diagnostic agreement on image interpretation, which is not described for the testing of this MRI coil.
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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: Not applicable. This document is for a non-AI medical device.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This document is for a non-AI medical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided, and likely not applicable in the AI/ML sense. The "ground truth" for a physical device would relate to engineering specifications and performance measurements.
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The sample size for the training set: Not applicable. This is not an AI/ML device.
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How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
§ 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.