(31 days)
The intended use of Breast BI 7 MR Coil 1.5T Mammavention is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the female breast. It is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the female breast. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.
The included Breast Biopsy Unit permits MR guided breast biopsy and wire localization of lesions can be performed by a trained physician.
The coil system Breast BI 7 MR Coil 1.5T Mammavention can be used with the following MRI systems:
1.5T: Siemens 1.5T:
Avanto fit, Aera, Amira
The Breast BI 7 MR Coil 1.5T Mammavention described in this document has been designed, depending upon model type, for use with a SIEMENS MRI system with field strength of 3 T. The coil system serves solely as a receiving coil for the reception of high frequency signals from the hydrogen -(1-H) nuclei. The hydrogen nuclei are induced into precession by the transmitting coil of the MRT device. The processing magnetization induces potential differences in the Breast Bl 7 MR Coil 1.5T Mammavention which are digitized and further processed in the MRT system
The provided text describes a 510(k) summary for the NORAS Breast BI 7 MR Coil 1.5T Mammavention. It does not present a study or acceptance criteria for device performance, particularly in terms of diagnostic accuracy or a clinical evaluation with human subjects.
Instead, the summary focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and compliance with recognized safety and performance standards for MR coils.
Here's the breakdown of why the requested information cannot be found in the provided text:
- Acceptance Criteria and Reported Device Performance (Table): This document does not define specific clinical acceptance criteria (e.g., sensitivity, specificity, image quality metrics beyond general "high resolution") or corresponding performance results from a clinical study. The "performance" mentioned refers to compliance with NEMA and IEC standards for MR coils.
- Sample size, data provenance, expert ground truth, adjudication, MRMC study, standalone performance, type of ground truth for test set: No clinical test set is described, because no clinical performance study was conducted or presented to compare the diagnostic output of the device. The 510(k) process for this type of device (an MR coil) primarily focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than a de novo clinical validation study of its diagnostic efficacy in patients.
- Training set sample size and ground truth establishment: Since no machine learning or AI component is mentioned or evaluated in this submission, there is no discussion of a training set or how ground truth for such a set would be established.
Based on the provided information, the answers to your questions are as follows:
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A table of acceptance criteria and the reported device performance:
The document does not explicitly define acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity). Instead, the acceptance criteria are implicitly related to safety and technological equivalence based on compliance with recognized standards.- Acceptance Criteria (Implicit):
- Conformity with NEMA Standards for measurement of performance and safety parameters.
- Conformity with IEC standards (IEC 60601-2-33:2011) for safety issues with Magnetic Resonance Imaging Devices.
- Technological characteristics are substantially equivalent to the predicate device (Breast BI 7 MR Coil 3T Mammavention, K162651).
- Successful completion of all device testing.
- Reported Device Performance:
- "All device testing have been completed successfully before device clearance."
- "The power tests which have been done by MRI manufacturer for the whole system can be found in 076 Third Party Power Test Breast Bl 7 MR Coil 1.5T.pdf." (The details of these power tests are not provided in this document).
- "Proton imaging" and "High resolution of breast anatomic regions" are listed as comparable properties to the predicate device.
- Acceptance Criteria (Implicit):
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Sample size used for the test set and the data provenance: Not applicable. No clinical test set or data from human subjects is mentioned for performance evaluation in this 510(k) summary. The evaluation focuses on engineering new coil and its compatibility to existing MR scanners and equivalence to a predicate device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set requiring expert ground truth establishment is described.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical test set is described.
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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 MR coil, not an AI-assisted diagnostic tool, and no MRMC study is mentioned.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an MR coil, not a standalone diagnostic algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a clinical performance study. The "ground truth" here is the adherence to engineering standards and technical specifications.
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The sample size for the training set: Not applicable. There is no mention of a training set as this is an MR coil, not an AI or machine learning device.
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How the ground truth for the training set was established: Not applicable. There is no mention of a training set.
§ 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.