(30 days)
The Breast SPEEDER CX is intended for use with Toshiba 1.5T MRI systems to produce diagnostic images of the breast anatomy that can be interpreted by a trained physician.
The Grid Holder CX kit is intended for use with the Breast SPEEDER CX to permit access to the breast anatomy for biopsy and lesion localization procedures.
The Breast SPEEDER CX is a receive-only, eight-channel phased array coil designed for magnetic resonance imaging (MRI) using the Toshiba 1.5T MR systems. The Breast SPEEDER CX is intended to be used for imaging the breast anatomy. Similar to other breast coils, the Breast SPEEDER CX includes apertures through which the breasts are admitted. The Breast SPEEDER CX includes compression plates which allow compression and immobilization of the breast. Breasts may be imaged individually or simultaneously. The Breast SPEEDER CX also includes the accessories listed in Table 0-1. The accessories consist of pads and a head rest intended to increase patient comfort during scanning.
The Grid Holder CX Kit is an optional kit offered separately and is intended to be used to allow access to the breast for interventional procedures, such as biopsy and lesion localization. When the Grid Holder CX is used with the Breast SPEEDER CX, the lateral coils are replaced with the biopsy adaptor, which is fitted with either a grid or a post and pillar device, both commercially available. Compatible biopsy grids and post and pillar biopsy devices are available from NORAS MRI Products GmbH and include the items listed in Table 0-2. The breast can be accessed and interventional procedures performed from either the lateral or medial directions.
The Breast SPEEDER CX and Grid Holder CX Kit are reusable, noninvasive devices with limited exposure with regard to duration of contact with the body. All coil elements are enclosed in a rigid plastic housing which is fire-rated, has impact and tensile strength, and has been tested for biocompatibility.
The provided text is a 510(k) summary for the Breast SPEEDER CX and Grid Holder CX Kit. It describes the device, its intended use, and the testing performed to demonstrate substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, comprehensive study details, or detailed performance metrics for the device in the way requested by the prompt.
The document primarily focuses on establishing safety and function through general compliance with standards, rather than detailing clinical performance metrics or reader studies.
Here's a breakdown of what can and cannot be extracted from the provided text according to your request:
1. A table of acceptance criteria and the reported device performance:
Based on the provided text, specific numerical acceptance criteria and corresponding reported device performance for clinical efficacy (e.g., sensitivity, specificity, accuracy) are not available. The document mentions general compliance with standards and comparable performance to a predicate device, but without quantifying it against specific targets.
| Acceptance Criteria (If mentioned) | Reported Device Performance (If mentioned) |
|---|---|
| Max surface temperature (according to AAMI/ANSI ES60601-1) | Never exceeded 41°C |
| Compliance with AAMI/ANSI ES60601-1 | Found compliant |
| Compliance with IEC 60601-2-33 | Found compliant |
| SNR and Uniformity per NEMA MS 9-2008 | Analyzed per and found to conform to NEMA MS 9-2008 |
| Biocompatibility (Lexan 940A polycarbonate & Polane S polyurethane enamel) | History of use in MR applications and other medical devices; materials cleared through K122638 and K140998. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not provided. The document describes bench testing and electrical safety tests, but there is no mention of a human-subject "test set" for performance evaluation, nor any information about data provenance.
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):
Not applicable/Not provided. Since no human-subject clinical performance study (test set) is described, there's no mention of experts for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable/Not provided. As there is no described clinical test set, there is no adjudication method mentioned.
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. The document does not describe an MRMC study, nor does it involve an AI component. This device is a passive coil and a biopsy guide kit, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a physical medical imaging accessory, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable/Not provided. For the physical and electrical testing described, ground truth would be defined by engineering specifications and direct measurements (e.g., temperature probes for surface heating, signal measurement equipment for SNR). There is no clinical "ground truth" mentioned for diagnostic accuracy.
8. The sample size for the training set:
Not applicable/Not provided. This device is hardware (an MRI coil and biopsy kit), not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable/Not provided. As above, no training set for an algorithm is relevant here.
In summary:
The 510(k) summary for the Breast SPEEDER CX and Grid Holder CX Kit focuses on demonstrating substantial equivalence through:
- Bench Testing: SNR and uniformity per NEMA MS 9-2008.
- Electrical Safety & Electromagnetic Compatibility: Compliance with AAMI/ANSI ES60601-1 and IEC 60601-2-33, and surface heating measurements.
- Biocompatibility Testing: Focusing on material history of use and prior clearances.
The document does not contain information about clinical performance studies involving human subjects, statistical metrics like sensitivity or specificity, or any artificial intelligence components that would require a "test set" or "training set" with expert-established ground truths. The nature of this device (a passive MRI coil and biopsy kit) means its clearance relies more on demonstrating safe and effective hardware operation rather than diagnostic accuracy as one would expect from a software device or a contrast agent.
§ 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.