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510(k) Data Aggregation
(66 days)
The NeoCoil 16ch Breast Coils are Magnetic Resonance Imaging (MRI) RF Receive-Only Coils intended for use by trained medical professionals, in combination with and controlled by compatible 1.5T or 3T/3.0T MRI system software.
The NeoCoil 16ch Breast Coils can be used with compatible ancillary components, accessories, and/or devices to provide access to breast anatomy for diagnostic or interventional planning/procedures.
When used as intended, the 16ch Breast Coil provides information used by the MRI system to produce diagnostic and/or interventional planning images of the breast, axilla, and chest wall. The images produced are interpreted by medical professionals as part of clinical decision making.
The NeoCoil 3.0T 16ch Breast Coil is a phased array coil for imaging structures of the breast, axilla and chest wall. The 3.0T 16ch Breast Coil is a three part receive-only coil designed to provide high resolution imaging. The.3.0T 16ch Breast Coil includes a coil support structure, patient support structure, biopsy components, accessories and comfort pads.
The NeoCoil 3.0T 16ch Breast Coil is tuned to receive RF frequency corresponding to the proton precession in a 3 tesla magnetic field, which is governed by the Larmor equation.
The 16ch Breast Coils are intended for use in a manner that is identical to the predicate device and reference device described in this submission 3.0T 16ch Breast Coil, K173377, cleared on 11/28/2017 and 1.5T 16ch Breast Coil, K182958, cleared on 11/16/2018. The 16ch Breast Coil consists of the following arrays available in 1.5T, 3.0T and 3T field strengths:
- Medial Array, Breast Coil
- . Lateral Array Left, Breast Coil
- Lateral Array Right, Breast Coil ●
- . Baseplate Assembly, Breast Coil
- Biopsy Array Left, Breast Coil ●
- Biopsy Array Right, Breast Coil ●
The coils receive magnetic resonance signals generated in hydrogen nuclei (protons) in the Head. Neck and Brachial Plexus anatomy while blocking the high-frequency magnetic field applied by the MRI scanner at specified timings. The received signals are amplified before being transferred to the MRI scanner through the coil's system cable. The amplified signals are processed into tomographic images of the breast, axilla and chest wall anatomy by the MRI scanner. Images are typically generated as axial, sagittal, coronal oblique slices. Accessories associated with the 16ch Breast Coils include biopsy grids and biopsy drapes.
The 1.5T Breast Coil, the 3T 16ch Breast Coil, and the 3.0T 16ch Breast Coil are tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla and 3.0 tesla magnetic field (respectively), which is governed by the Larmor equation.
The 16ch Breast Coil is intended for use in a manner that is identical to the predicate device described in this submission.
Proposed labeling is documented in the Instructions for Use manual for the 16ch Breast Coil (NC149IFU-en).
The provided text describes the regulatory clearance of NeoCoil's 16ch Breast Coils (K222407) and outlines the testing performed to demonstrate its substantial equivalence to predicate devices. However, the document does not contain information related to an AI/ML powered medical device or a study involving human readers or expert consensus for ground truth establishment. Instead, it focuses on the performance and safety of a physical medical device (an MRI coil).
Therefore, I cannot extract the information required to answer your questions about AI device acceptance criteria, human reader studies, or ground truth establishment based on the provided text. The questions you've asked are typically relevant to the evaluation of AI/ML-driven diagnostic or interpretative tools, which is not what this document addresses.
The document primarily covers non-clinical bench testing for a physical MRI coil, ensuring it meets safety and performance standards comparable to an existing device.
Here's what the document does cover regarding "acceptance criteria" and "study" for the physical device:
1. A table of acceptance criteria and the reported device performance
The document provides a table of "Test Performed" (which serves as acceptance criteria) and the "Results Summary" (reported performance).
| Test Performed | Objective(s) of the Test | Test Method Description | Pre-defined pass/fail criteria | Results Summary | Discussions / Conclusions |
|---|---|---|---|---|---|
| Biocompatibility Assessment | Assess potential biological risks | Evaluation of data; historical use, biologic testing, where warranted | Acceptable level of risk | Pass | No identified significant risks. |
| Electrical Safety (60601-1) | Basic electrical safety/essential performance | Test Lab | Pre-defined performance standards | Pass | Applicable requirements for basic electrical safety and essential performance met. |
| Electrical Safety (60601-2-33) | Particular electrical requirements: MR equipment | Test Lab | Pre-defined performance standards | Pass | Applicable requirements of the particular standard were met. |
| Electrical Safety (60601-1-2) | Collateral electrical safety/essential performance | Test Lab / Bench Testing | Pre-defined performance standards | Pass | Applicable requirements of the collateral standard were met. |
| Usability Assessment | Devices meet customer, end user and patient needs | Actual, simulated or retrospective evaluation of the device and/or data | Pre-defined requirements | Pass | The devices met the needs of the customer, end user and patient. |
| Entrapment, Trapping Zone and Cable Looping (assessment w/ scanner) | Assess the device for pinch points, entrapment, cable looping - interfacing with MRI scanner | Evaluation of coil-to-scanner entrapment, trapping and cable looping not covered by test lab assessments. | Requirements based on pre-defined requirements in 60601-1 and customer requirements | Pass | Requirements were met. |
| Surface Temperature | Surface temperatures do not exceed limits | MRI scanner test | Pre-defined performance standards | Pass | Surface temperatures were within IEC limits. |
| Unplugged Surface Temperature | Devices remain safe in first fault condition | MRI scanner test | Acceptable level of risk | Pass | Surface temperatures were within IEC limits when the coil is left unplugged in the MRI scanner. |
| Blocking Network Analysis | Ensures devices are designed with adequate active and passive transmit decoupling | Theoretical calculations | Adequate transmit decoupling | Pass | Blocking network demonstrates adequate active and passive transmit decoupling. |
| B1 Field Distortion | Measure amount of distortion produced due to presence of an RF coil in the scanner | MRI scanner test | Pre-defined performance standards | Pass | B1 field inhomogeneity meets performance requirements and demonstrates adequate active and passive transmit decoupling. |
| B0 Field Distortion | Measure amount of distortion produced due to presence of an RF coil in the scanner | MRI scanner test | Pre-defined performance standards | Pass | B0 field inhomogeneity meets performance requirements and demonstrates adequate active and passive transmit decoupling. |
| NEMA MS 6-2008 | Evaluate single-channel non-volume special purpose radiofrequency (RF) coils for use with magnetic resonance (MR) imaging (MRI) systems | MRI scanner test | Pre-defined performance standards | Pass | SNR and Image Uniformity are consistent with the requirements for indications for use. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Bench Testing" and "MRI scanner test" but does not specify sample sizes for these tests (e.g., number of coils tested, number of scans performed). It also does not provide information on data provenance like country of origin or whether the data was retrospective or prospective, as these are typically considerations for clinical data, which was not gathered for this 510(k).
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)
This is not applicable as the study involves the performance of a physical device against engineering and safety standards, not an AI model requiring human ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not relevant to the described device. The tests performed are on the physical MRI coil itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the physical device, the "ground truth" for the bench tests are the established engineering standards, pre-defined performance criteria (e.g., for electrical safety, temperature limits, B0/B1 field homogeneity), and consensus standards like NEMA MS 6-2008. There is no biological or diagnostic "ground truth" in the way an AI model would require.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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