(70 days)
The coil is indicated for use on the order of a physician, in conjunction with GE 1.5T MR scanners as an accessory to produce images of the wrist and hand regions, as an aid to diagnosis.
The design of the 1.5T 16-channel Hand-Wrist Coil is based on design features of the predicate device. · 1.5T 8-Channel Hand-Wrist Coil. The 16-Channel Hand-Wrist Coil is designed as receive only for high resolution diagnostic imaging of regional structures of the wrist and hand. The 16-Channel Hand-Wrist Coil is manufactured of materials that are similar to those used to manufacture the predicate device.
This submission is a 510(k) premarket notification for a 1.5T 16-Channel Hand-Wrist Coil. It describes the device, its intended use, and its substantial equivalence to a predicate device.
Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:
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A table of acceptance criteria and the reported device performance
The provided document does not contain explicit acceptance criteria or reported device performance metrics in a tabular or descriptive format. This is typical for a 510(k) summary for a medical device accessory like an MR coil, where the substantial equivalence argument relies on comparing the new device to a legally marketed predicate device rather than presenting performance metrics against predefined criteria.
The primary "acceptance criterion" for a 510(k) submission is demonstrating substantial equivalence to a predicate device. The document states: "When compared to the predicate device, 1.5T 8-Channel Hand-Wrist Coil - K050622, cleared 04/08/05, substantial equivalence is based on similarities in design features, overall indications for use, and technological characteristics."
Therefore, the "reported device performance" is essentially that it functions similarly to the predicate device for imaging the wrist and hand, as an aid to diagnosis, with the implication of improved performance due to the higher channel count (16 vs 8), though specific metrics are not provided.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a specific clinical "test set" or associated data provenance. As this is a 510(k) for an MRI coil, the "testing" would primarily focus on engineering verification and validation (e.g., signal-to-noise ratio, image uniformity, SAR compliance) rather than a clinical trial with a patient test set for diagnostic accuracy. Such technical verification data is typically included in the full 510(k) submission but summarized only for substantial equivalence in the public summary.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Since there is no described clinical "test set" requiring ground truth establishment, this information is not applicable and not provided in the document.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
Similar to point 3, as no clinical "test set" with diagnostic outcomes is described, an adjudication method is not applicable and not provided.
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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
This device is an MRI coil, which is a hardware accessory, not an AI software intended for diagnostic aid. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not discussed in the document.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device is a hardware accessory (MRI coil), not an algorithm or AI system. Therefore, standalone algorithm performance is not applicable and not discussed.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
No clinical "ground truth" is discussed for this device, as it's a hardware component rather than a diagnostic algorithm requiring performance evaluation against known disease states. The focus is on the technical performance of the coil itself (e.g., image quality, safety).
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The sample size for the training set
This document pertains to a hardware device (MRI coil), not a software algorithm that requires a training set. Therefore, a "training set" and its sample size are not applicable and not mentioned.
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How the ground truth for the training set was established
As there is no training set for this hardware device, this question is not applicable and not addressed.
In summary:
The provided 510(k) summary for the 1.5T 16-Channel Hand-Wrist Coil focuses on demonstrating substantial equivalence to a predicate device based on design, indications for use, and technological characteristics. It does not contain information typically found in submissions for diagnostic AI algorithms or other devices requiring extensive clinical performance studies with patient data and expert interpretations. The "study" proving the device meets criteria is the argument for substantial equivalence supported by (unspecified in this summary) engineering verification and validation testing, which is typical for such hardware accessories.
§ 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.