(22 days)
The dS FootAnkle 16ch 1.5T and 3.0T MR Coils are intended to be used in conjunction with Philips 1.5T/3.0T Magnetic Resonance Scanners to produce diagnostic images of the foot and ankle anatomy that can be interpreted by a trained physician.
The dS HiRes Hand/Wrist 16ch 1.5T and 3.0T MR Coils are intended to be used in conjunction with Philips 1.5T/3.0T Magnetic Resonance Scanners to produce diagnostic images of the hand and wrist anatomy that can be interpreted by a trained physician.
The dS Small Extremity 16ch 1.5T and 3.0T MR Coils are intended to be used in conjunction with Philips 1.5T/3.0T Magnetic Resonance Scanners to produce diagnostic images of the small extremities anatomy on adult and pediatric patients that can be interpreted by a trained physician.
The Philips Orthopedic MR Coils are designed for use with Magnetic Resonance Imaging (MRI) systems. The coils are designed to work in unison with the Body Coil of the MRI system, which will transmit the radio frequency (RF) signals, so that the coil may receive the resultant RF signal from the excited nuclei.
The subject devices have 16-elements and are for use with Philips Ingenia 1.5T and 3.0T MR Systems with dStream interface (K193215). The devices are designed for optimum coverage and high-resolution visualization of detailed cartilage structures of the body anatomy (foot/ankle, hand/wrist, small extremity). The coil is used independently and cannot be combined with any other coils. The coils are available in both 1.5T and 3.0T magnetic strengths.
The provided text outlines the performance testing for the Philips Orthopedic MR Coils, but it does not contain details on acceptance criteria or performance data as would be found in a study proving a device meets specific acceptance criteria in the context of an AI/ML diagnostic device regulatory submission. The document is a 510(k) summary for magnetic resonance coils, which are hardware components, not artificial intelligence software.
Therefore, I cannot fulfill your request for details regarding:
- A table of acceptance criteria and reported device performance (in the context of AI/ML diagnostic output).
- Sample sizes for test sets or data provenance (as there's no AI algorithm being tested).
- Number of experts or their qualifications, or adjudication methods (as this pertains to evaluating AI output against ground truth).
- MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used.
- Training set information.
The document focuses on the substantial equivalence of the MR coils to predicate devices based on:
- Physical characteristics (design, material, chemical composition, energy source).
- Adherence to recognized standards for MR coil performance (e.g., NEMA MS 1, 3, 9, IEC 62464-1 for image quality; ANSI/AAMI ES 60601-1, NEMA MS 14 for surface heating).
- General electrical/mechanical safety (IEC 60601-2-33, AAMI/ANSI ES 60601-1).
- Biocompatibility (ISO 10993 series).
The closest mention of "image quality assessment by a U.S. Board Certified radiologist" just confirms that the images produced were "sufficient quality for diagnostic use," but this is a general statement and not a quantitative performance metric against specific acceptance criteria for a diagnostic 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.