(77 days)
The coil is indicated for use by the order of a physician to be used as an accessory to a Siemens 3.0T magnetic resonance scanner for general human anatomy imaging as supported by the scanner. These images, when interpreted by a trained physician, may assist in medical diagnosis.
The Siemens 3.0T PROCURE™ Array Coil interfaces with a 3.0T 16-channel Siemens MRI scanner and provides high-quality images of the reproductive and urological anatomies in an easy-to-position, wearable, and very flexible design. This lightweight SemiFlex™ design facilitates effortless and accurate positioning similar to wearing a diaper and positions the multiple antenna elements as close as possible to the target anatomies regardless of patient size. The enclosure for the antenna set is made of flexible liquid impermeable, biocompatible materials, and the coil is accompanied by disposable liners (USP Class 6 PET) easily changed between patients, should scanning without clothing be desired. The coil design and materials used for manufacture are identical to standard MRI coil technology that has existed for several years. The coil uses similar blocking networks and impedance matching circuits, and it does not transmit energy into the patient, neither predicate nor current submission.
This phased-array coil also accommodates popular biopsy systems, both delivered via an opening near the anus and/or vagina, neither included in the scope of this submission as they are independently operated and cleared by the FDA.
This document describes the Siemens 3.0T PROCURE Array Coil, an MRI accessory, and its substantial equivalence to a predicate device. It does not contain information about the acceptance criteria or a study proving that a device meets those criteria in the way typically seen for AI/ML-based medical devices.
The document is a 510(k) premarket notification from the FDA, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than defining new performance acceptance criteria and proving them through a specific study for a novel device.
Therefore, many of the requested elements for an AI/ML-based device evaluation are not applicable or cannot be extracted from this document.
However, based on the provided text, I can infer some aspects related to the assessment performed for this device:
1. A table of acceptance criteria and the reported device performance:
This document does not present explicit numerical acceptance criteria for diagnostic performance or reported performance results in a table. The evaluation focuses on demonstrating "substantial equivalence" to a predicate device, meaning it performs as safely and effectively as the predicate, rather than meeting specific quantifiable performance thresholds.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Diagnostic image quality for reproductive and urological anatomies comparable to predicate. | "Provides high-quality images of the reproductive and urological anatomies" |
| Safe operation (e.g., no excessive heat, electrical safety). | Subject to similar risk management studies as predicate; compliant with IEC60601-1 3rd Edition. |
| Biocompatibility comparable to predicate device. | Biocompatibility track record demonstrated by cytotoxicity testing and history of use for similar materials. |
| Mechanical and electrical safety. | Tested for mechanical and electrical safety using IEC60601-1 3rd Edition. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document mentions "Analyses in all 3 planes (sagittal, coronal, and axial) were run on the Siemens 3.0T PROCURE™ Array Coil to show that the anatomies of the submitted and predicate coils have substantial equivalence." This implies a clinical evaluation, but:
- Sample size: Not specified.
- Data provenance: Not specified (e.g., country of origin, 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):
Not specified. The document states images "when interpreted by a trained physician, may assist in medical diagnosis," but does not detail the process of expert review for establishing ground truth in a structured study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not specified.
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:
Not applicable. This device is an MRI coil, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is an MRI coil.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The document does not explicitly define how ground truth was established for "analyses". Given it's an imaging device, the "high-quality images" would likely be judged by expert clinical interpretation, but the specific standard for ground truth is not detailed.
8. The sample size for the training set:
Not applicable. This device is an MRI coil and does not use a training set in the context of machine learning.
9. How the ground truth for the training set was established:
Not applicable.
Summary of what is present in the document:
- Device Type: An MRI coil, an accessory to an MRI scanner.
- Purpose of Evaluation: To demonstrate "substantial equivalence" to a predicate device (1.5T and 3.0T GE PROCURE™ Array Coil, K140606).
- Non-Clinical Tests: Blocking network analysis, SNR and uniformity analysis, risk management (hazard analysis and FMEA), heat testing, compliance testing to IEC60601-1 3rd Edition.
- Clinical Tests: Analyses in all 3 planes (sagittal, coronal, and axial) to show substantial equivalence of anatomies imaged by the submitted and predicate coils.
- Intended Use/Indications for Use: To provide high-quality images of reproductive and urological anatomies to assist in medical diagnosis when interpreted by a trained physician.
- Key Argument for Equivalence: Identical scientific principles of operation, similar design (with minor modification for Siemens scanner compatibility), same materials, and successful biocompatibility track record for materials.
This information aligns with the typical process for 510(k) clearance of hardware devices where the emphasis is on safety, performance characteristics (like image quality assessed qualitatively), and comparability to an existing device, rather than explicit numerical performance metrics and detailed study designs for AI/ML algorithms.
§ 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.