(64 days)
The coil is indicated for use on the order of a physician, in conjunction with Philips 1.5T and 3.0T MR scanners as an accessory to produce images of the breast, chest wall and axillary tissue, as an aid to diagnosis. The coil permits MR-guided breast biopsy and localization of lesions.
The dS Breast 16ch I/T 1.5T and dS Breast 16ch I/T 3.0T coils are designed for use with a Magnetic Resonance Imaging (MRI) system. 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 coils are designed as receive only coil for high resolution diagnostic imaging and intervention of breast. The coil provides both unilateral and bilateral images (Left, Right and Both) of the anatomy of interest and permits MR-guided biopsy and localization of lesions.
This K122646 submission for the dS Breast 16ch I/T MRI coils is a pivotal study concerning a Class II medical device. However, the provided documentation focuses on substantial equivalence to existing predicate devices rather than directly providing a detailed study with acceptance criteria and performance metrics in the format usually expected for AI/ML device evaluations.
Here's a breakdown of what can be extracted and what is missing, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the "acceptance criteria" and "reported device performance" are primarily framed within the context of demonstrating substantial equivalence to predicate devices rather than a direct quantitative clinical trial.
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (from K122646) |
|---|---|
| Intended Use: Similar to predicate devices (aid to diagnosis, MR-guided biopsy/localization of breast lesions). | Coil indicated for use on order of a physician, with Philips 1.5T/3.0T MR scanners, to produce images of breast, chest wall, and axillary tissue as an aid to diagnosis. Permits MR-guided biopsy/localization. |
| Design Features: Similar to predicate devices (receive-only coil for high-resolution diagnostic imaging and intervention of breast, unilateral/bilateral imaging capability). | Designed to work with Body Coil of MRI system (transmitter), receive RF signals, receive-only coil for high resolution diagnostic imaging and intervention. Provides unilateral/bilateral images. |
| Technological Characteristics: Similar to predicate devices (receives RF signals from tissue of interest). | Fundamental scientific technology is receiving RF signals from tissue of interest. |
| Performance Metrics: Comparable Signal-to-Noise (SNR) ratio to predicate devices. | Supporting product evaluations included Signal-to-Noise (SNR) ratio assessment. |
| Performance Metrics: Comparable Image Uniformity to predicate devices. | Supporting product evaluations included Image Uniformity assessment. |
| Performance Metrics: Comparable clinical image quality to predicate devices. | Supporting product evaluations included assessment of clinical images. |
| Safety: Device passes electrical safety testing. | Device passed electrical safety testing in accordance with IEC standards. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a distinct "test set" sample size in terms of patient numbers or images. The clinical image assessment mentioned is described generally.
- Data Provenance: Not specified. It's listed as "clinical images," without details on country of origin, or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The document only mentions "assessment of clinical images" without detailing who performed this assessment or their qualifications.
4. Adjudication Method for the Test Set
- Not specified. There is no mention of a formal adjudication method (e.g., 2+1, 3+1, none) for the assessment of clinical images.
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
- No, an MRMC comparative effectiveness study was not done. This device is an MRI coil, not an AI/ML diagnostic software. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an MRI coil, a hardware component, not an algorithm or AI software. Therefore, "standalone performance" in the context of an algorithm is not relevant.
7. The Type of Ground Truth Used
- The ground truth for evaluating the coil's performance appears to be based on:
- Technical measurements: Signal-to-Noise (SNR) ratio and Image Uniformity.
- Qualitative assessment of clinical images: Comparing the images produced by the new coil against those of predicate devices in terms of diagnostic quality.
- Electrical safety standards: Verification against IEC standards.
- Design and technological similarity: Comparison of features and operating principles to predicate devices.
8. The Sample Size for the Training Set
- Not applicable / Not specified. As this is an MRI coil and not an AI/ML model, there is no "training set" in the conventional sense for algorithm development. The device design and validation would rely on engineering principles, testing, and clinical evaluations rather than algorithm training.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See point 8.
§ 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.