(117 days)
The intended use of Breast Bl 7 MR Coil 3T 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 transverse, sagittal, coronal ad 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 Bl 7 MR Coil Mammavention can be used with the following MRI systems:
- 3T: Siemens 3T: Skyra, Skyra fit, Prisma, Prisma fit, Spectra
The Breast BI 7 MR Coil 3T 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 -('-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 3T Mammavention which are digitized and further processed in the MRT system
The provided document is a 510(k) summary for the NORAS MRI products GmbH's Breast BI 7 MR Coil Mammavention 3T. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria and a comprehensive evaluation of device performance against those criteria in a standalone or comparative effectiveness study.
Therefore, the information required to fully answer your request regarding acceptance criteria and a study proving the device meets them is largely absent from this document. The document describes the device's technical specifications and intended use, and asserts its safety and effectiveness through conformity with recognized standards, but it does not detail specific performance acceptance criteria or a study designed to demonstrate them in a quantitative clinical setting.
Here's what can be extracted and what is missing:
Acceptance Criteria and Device Performance
Based on the provided text, there are no explicit quantitative acceptance criteria listed for the device's performance in a clinical context (e.g., sensitivity, specificity, accuracy for a specific diagnostic task). The document instead focuses on demonstrating substantial equivalence to a predicate device through comparable technological characteristics and adherence to safety standards.
| Acceptance Criteria (Explicit or Implied from Equivalence) | Reported Device Performance (as described in the document) |
|---|---|
| Safety: | |
| - Conformity with NEMA Standards for safety parameters | "conform with the FDA recognized NEMA Standards for the measurement of performance and safety parameters" |
| - Conformity with IEC standards for safety (IEC 60601-2-33:2002) | "conform with... the IEC standards for safety issues with the Magnetic Resonance Imaging Devices, IEC 60601-2-33:2002" |
| - Successful completion of all device testing before clearance | "All device testing have been completed successfully before device clearance." |
| - Compatibility with specified MRI systems without issues | "power tests which have been done by MRI manufacturer for the whole system can be found in 017 20160728 Prisma Third Party Power Test Breast Bl 7." |
| Performance (Implied from predicate device): | |
| - Proton imaging capability | "Proton imaging" (listed as comparable property of predicate) |
| - High resolution of breast anatomic regions | "High resolution of breast anatomic regions" (listed as comparable property of predicate) |
| - Ability to produce transverse, sagittal, coronal, and oblique images of the female breast | "produce transverse, sagittal, coronal ad oblique images of the internal structures of the female breast." |
| - Functionality for MR-guided breast biopsy and wire localization | "The included Breast Biopsy Unit permits MR guided breast biopsy and wire localization of lesions can be performed by a trained physician." |
| Technological Characteristics: | |
| - Substantial equivalence to predicate device | "Summary of technological characteristics of the Breast Bl 7 MR Coil 3T Mammavention are the same as for the predicate device Breast Biopsy 4-Ch Coil MR-BI320-PA 3T" |
Missing Information:
The following information is not available in the provided document:
- Sample size used for the test set: No specific clinical test set data is presented. The document refers to "all device testing" but does not quantify it in terms of patient samples.
- Data provenance: Not specified, as clinical test set details are absent.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no human-read clinical test set is described.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned or implied. The focus is on the device's physical and technical performance and its equivalence to a predicate, not on how it changes human reader performance.
- Standalone (i.e., algorithm only without human-in-the-loop performance) study: This device is an MRI coil, a hardware component for imaging, not an AI algorithm. Therefore, "standalone performance" in the context of an algorithm is not applicable. Its performance is evaluated within the context of an MRI system.
- Type of ground truth used: Not applicable, as no clinical performance study requiring ground truth is detailed. The "ground truth" for the device's technical specifications would be engineering measurements and adherence to standards.
- Sample size for the training set: Not applicable, as this is a hardware device, not a machine learning model that requires a training set.
- How the ground truth for the training set was established: Not applicable for the same reason as above.
Conclusion based on the provided text:
The document serves as a 510(k) premarket notification, demonstrating substantial equivalence for a medical device (an MRI coil). It asserts the device's safety and effectiveness by claiming conformity to recognized standards (NEMA, IEC) and stating that its technical characteristics are the same as a cleared predicate device. It does not present a clinical study with specific acceptance criteria related to diagnostic performance or patient outcomes, nor does it involve the kind of data, experts, or methodologies typically associated with evaluating AI/software performance as requested in your prompt. The "acceptance criteria" here are primarily about meeting technical specifications and safety standards, and proving substantial equivalence.
§ 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.