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510(k) Data Aggregation
(25 days)
The dS Breast Coil 7ch 1.5T is intended to be used in conjunction with a Philips Prodiva 1.5T CX and a MR 5300 1.5T Magnetic Resonance Scanner to produce diagnostic images of the breast, chest wall, and axillary tissues that can be interpreted by a trained physician.
The dS Breast Coil 7ch 1.5T is a 7-element phased array receive only coil to be used on a 70cm bore Philips 1.5T MR 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 subject coil is designed to be used in conjunction with Philips Prodiva 1.5T CS and 1.5T CX MR System (K173507) and with Philips MR 5300 System (K212673) with dStream interfaces. The subject coil is designed for optimum coverage and high-resolution visualization of detailed cartilage structures of the breast anatomy. The coil is used independently and cannot be combined with any other coils. The coil is only available in 1.5T version. The open coil housing design of the dS Breast Coil 7ch 1.5T allows for lateral-medial and cranial-caudal access to the breast for both diagnostic breast imaging and interventional exams.
The device in question is the dS Breast Coil 7ch 1.5T.
Based on the provided text, the acceptance criteria and the study that proves the device meets them are outlined as follows:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Non-Clinical Performance Testing (aligned with FDA-recognized consensus standards and FDA guidance documents): | The device underwent and met standards for: |
| - Electrical/Mechanical Safety (IEC 60601-1) | Testing conducted. |
| - EMC Immunity, Electrostatic Discharge Testing (IEC 60601-1-2) | Testing conducted. |
| - Basic Safety and Essential Performance of Magnetic Resonance Equipment (IEC 60601-2-33) | Testing conducted. |
| - Image Uniformity and Signal-to-Noise Ratio (NEMA-MS-1.3.9.14) | Testing conducted. Acknowledged as sufficient quality for diagnostic use by clinical experts (see below). |
| - Determination of Essential Image Quality Parameters (IEC62464-1) | Testing conducted. Acknowledged as sufficient quality for diagnostic use by clinical experts (see below). |
| - Biological Safety Evaluation (ISO 10993-1) | Testing conducted. |
| - Cleaning and Disinfection Validations (ISO 17664) | Testing conducted to support reprocessing instructions. |
| Clinical Performance Testing (Acquired Image Quality): | Images produced on the subject coil were confirmed to be of sufficient quality for diagnostic use. |
| Substantial Equivalence (Safety and Performance Based Pathway) as outlined in the guidance "Magnetic Resonance (MR) Receive-only Coil - Performance Criteria for Safety and Performance Based Pathway" (December 11, 2020). | All criteria in the guidance were met, demonstrating that the device is as safe, as effective, and performs as well as or better than the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated in terms of the number of patient images or specific cases. The clinical performance testing mentions "images produced on the subject coil."
- Data Provenance: Not explicitly stated as retrospective or prospective, nor the country of origin. However, the clinicians involved were "U.S. Board Certified radiologists."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: Two.
- Qualifications of Experts: U.S. Board Certified radiologists. No specific years of experience are mentioned.
4. Adjudication Method for the Test Set:
- The text states, "Acquired Image quality was assessed by two U.S. Board Certified radiologists to confirm images produced on the subject coil are sufficient quality for diagnostic use." This implies a consensus or agreement was reached between the two readers, but the explicit adjudication method (e.g., 2+1, 3+1, majority vote, etc.) is not detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a MRMC comparative effectiveness study was not done. The study focuses on confirming the diagnostic quality of images produced by the new coil, rather than comparing human reader performance with and without AI assistance, or comparing human readers with another device. This is a breast coil, not an AI diagnostic software.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Not applicable. The dS Breast Coil 7ch 1.5T is a hardware device for image acquisition, not an algorithm or AI software for interpretation. Its performance is evaluated on the quality of the images it produces for human interpretation.
7. Type of Ground Truth Used:
- For the clinical performance assessment, the "ground truth" was established by expert consensus (assessment by two U.S. Board Certified radiologists) on the "sufficient quality for diagnostic use" of the images produced by the coil. This is effectively expert opinion regarding image quality for diagnostic purposes.
8. Sample Size for the Training Set:
- Not applicable. The dS Breast Coil 7ch 1.5T is a passive hardware device (receive-only coil) and does not involve AI or machine learning algorithms that require a "training set" in the conventional sense. The "training" for the device would be its engineering design and manufacturing process.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for this type of device.
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