(41 days)
The dS FootAnkle 16ch 1.5T Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the foot and ankle that can be interpreted by a trained physician.
The proposed dS FootAnkle 16ch 1.5T Coil is designed for use with Magnetic Resonance Imaging (MRI) systems. The coil is 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 proposed dS FootAnkle 16ch 1.5T Coil is a volume phased array receive-only coil for high resolution diagnostic imaging of foot and ankle with coil housing dimensions to be 14.46x8.13x12.65 inches. The coil is constructed on molded polycarbonate (Lexan 925) former using Kapton rigid-Flex PCB (loop elements) and FR-4 PCB (feedboard, interface boards) and urethane-jacketed cable to connect to MR system. The coils provide unilateral images (Left and Right) of the anatomy of interest. The coil is designed for high resolution diagnostic imaging of the foot and ankle anatomical regions.
The coil pads are made of Urethane foam with Polyscan coating with one of the Base Plate Pad to comfort other foot (not being imaged) have PolyDry Healthcare Fabric Exterior.
Variations between the proposed dS FootAnkle 16ch 1.5T Coil and currently marketed and predicate device FAC-63 Foot and Ankle Coil include MR system compatibility and a 16channel connection to the MRI system. Mechanical design changes include modifications to the connector to permit the 16-channel connection and the specified MR system compatibility. In addition, modifications to the overall dimensions improve workflow as well as meet customer requirements.
Proposed changes to the device
- Coil housing material changed from Lexan 950 to Lexan 925 for ease of availability with ● no impact to device safety and effectiveness
- Coil pad coating changed from Guardian MPGX to Polyscan coating for ease of availability with no impact to device safety or effectiveness.
- Channel count was increased from 8 channels to 16 channels to meet the customer/market needs with no impact on device to safety and effectiveness.
- The overall coil dimensions were changed from 12.75" x 7.04" x 11.23" to 14.46" x 8.13" x 12.65" to accommodate more channels with no impact to device safety and effectiveness.
The proposed Model dS FootAnkle 16ch 1.5T Coil will operate with the Philips 1.5T MRI Scanners with dStream capabilities. The proposed Model dS FootAnkle 16ch 1.5T Coil is a 16-channel receive-only coil.
Unfortunately, the provided document does not contain the specific details required to fully address your request. The document is a 510(k) summary for a medical device (a foot and ankle MRI coil) and primarily focuses on demonstrating substantial equivalence to a predicate device.
Here's what I can extract and what's missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states: "Non-clinical verification and validation test results demonstrate that the proposed dS FootAnkle 16ch 1.5T Coil... Meets the acceptance criteria and is adequate for its intended use."
It also mentions characterizing:
- Signal-to-Noise Ratio (SNR)
- Image Quality
- Special purpose of the RF receive-only coil
However, it does not provide a specific table with numerical acceptance criteria (e.g., "SNR > X") or the reported numerical device performance results. It indicates that these results "were reviewed by a clinical radiologist to confirm the image quality is adequate," but specific metrics and their corresponding acceptance thresholds are not presented in this summary.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document mentions "clinical demonstration DICOM images" but does not give a number of cases or patients.
- Data Provenance: Not explicitly stated (e.g., country of origin). It's implied to be Philips 1.5T MRI scanners, but no further details on the source of the human images. The study is described as "clinical demonstration" and "non-clinical performance testing," suggesting it was prospective data collection for this submission rather than retrospective, but this is not definitively stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: "a clinical radiologist" (singular)
- Qualifications: "a clinical radiologist" - no further details on years of experience, subspecialty, etc., are provided in this summary.
4. Adjudication method for the test set:
Not mentioned. Since only one radiologist is cited, there wouldn't be an adjudication method in the traditional sense of resolving discrepancies between multiple readers.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study:
- Was it done?: No. The document states, "The proposed dS FootAnkle 16ch 1.5T Coil does not require clinical study since substantial equivalence to the predicate device was demonstrated with the following attributes: ...Non-clinical performance testing;". This implies no formal MRMC comparative effectiveness study was conducted with human readers comparing the new device to the predicate for diagnostic performance.
- Effect Size of human readers improve with AI vs without AI assistance: Not applicable, as this device is an MRI coil, not an AI-based diagnostic tool.
6. Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is an MRI coil, not an algorithm. The "performance" refers to the image quality produced by the coil, which is then interpreted by a human.
7. Type of ground truth used:
"The clinical demonstration DICOM images were reviewed by a clinical radiologist to confirm the image quality is adequate." This indicates expert consensus (from a single expert) on image quality adequacy. There is no mention of pathology or outcomes data for ground truth.
8. Sample size for the training set:
Not applicable. This device is an MRI coil, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. This device is an MRI coil.
§ 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.