(21 days)
The dS Wrist Coil 8ch 1.5T is intended to be used in conjunction with Philips 1.5T Magnetic Resonance Scanner to produce diagnostic images of the wrist that can be interpreted by a trained physician.
The dS Wrist Coil 8ch 1.5T is an 8-channel phased-array coil with rigid volume coils of 8 elements that closely encircle the wrist for high SNR. This coil for Prodiva and MR5300 is a one-piece, hinged design for easy patient set-up. To reduce patient motion artifacts, the dS Wrist coil includes one rigid base plate to fixate the coil & allowing for overhead and at the side examinations. This coil is only available in 1.5T. This coil is used independently and cannot be combined with any other coils
This FDA 510(k) summary describes a new medical device, the Philips dS Wrist Coil 8ch 1.5T, which is a magnetic resonance (MR) receive-only coil for wrist imaging. The document claims the device is substantially equivalent to a predicate device (8ch Wrist Coil, K222325). However, it does not provide a table of acceptance criteria and reported device performance, nor details of a study proving the device meets specific acceptance criteria related to diagnostic performance for image quality.
Instead, it lists non-clinical and clinical performance testing performed to demonstrate safety and effectiveness. The clinical testing merely states that "Acquired Image quality was assessed by U.S. Board Certified radiologist to confirm that images produced on the subject coil have sufficient quality for diagnostic use." This is a very high-level statement and lacks the specificity required to answer your questions regarding acceptance criteria, study details, and quantifiable performance.
Therefore, many of your questions cannot be answered from the provided text. Below, I will answer what is inferable from the document and explicitly state where information is missing.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from clinical testing description) | Reported Device Performance |
|---|---|
| Images produced on the subject coil have sufficient quality for diagnostic use. | Achieved (as confirmed by U.S. Board Certified radiologist review) |
Missing Information: The document does not provide specific quantifiable acceptance criteria (e.g., SNR values, image uniformity metrics thresholds) or detailed reported performance against such criteria. The statement is qualitative.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Missing Information: The document does not specify the sample size for the clinical test set, the country of origin of the data, or whether it was retrospective or prospective.
3. 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)
Inferred Information: The ground truth (or assessment of image quality for diagnostic use) was established by "U.S. Board Certified radiologist."
Missing Information: The exact number of radiologists, their specific years of experience, or any further specific qualifications are not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Missing Information: The document does not mention any adjudication method for the radiologists' assessments.
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
Missing Information: The device described is a medical imaging coil, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study regarding "human readers improve with AI vs without AI assistance" is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Missing Information: The device is a hardware component (an MR coil), not an algorithm. Therefore, a standalone algorithm performance study is not applicable and not mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Inferred Information: For the clinical performance assessment, the "ground truth" for sufficient image quality was based on the qualitative assessment of "U.S. Board Certified radiologist." This can be considered a form of expert consensus or expert review.
8. The sample size for the training set
Missing Information: The document does not describe any machine learning or AI component that would require a "training set." This question is not applicable to an MR coil.
9. How the ground truth for the training set was established
Missing Information: As there is no mention of a training set or AI/ML components, this question is not applicable to the device described.
§ 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.