(183 days)
The Signa Horizon Cx System is indicated for use as a diagnostic imaging device to produce transverse, sagital, coronal and oblique images of the internal structures of the head or body. The images produced by the Signa Horizon Cx System reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
The Signa Horizon Cx System utilizes a superconducting maanet to acquire 2D single-slice and multi-slice, and 3D volume images. A wide variety of pulse sequences is provided to the operator, including inversion recovery, spin echo, gradient echo, gradient recalled, and steady state, free precession acquisitions. Imaging options such as cardiac gating, peripheral gating, flow compensation and fat/water suppression are provided to suppress artifacts due to physiological motion and improve image quality. The system can be used as a stationary or mobile svstem.
The provided document does not contain information about acceptance criteria, device performance, or a study proving that the device meets specific acceptance criteria in the manner described by the prompt's request for detailed study design elements (sample size, ground truth, expert consensus, etc.).
This document is a 510(k) Summary of Safety and Effectiveness for the Signa Horizon Cx Magnetic Resonance System. Its purpose is to demonstrate substantial equivalence to a predicate device, not to detail performance against a set of acceptance criteria based on clinical outcomes or diagnostic accuracy.
Here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in terms of diagnostic accuracy or clinical utility. The document focuses on equivalence to NEMA performance standards and IEC safety standards.
- Reported Device Performance: No specific performance metrics like sensitivity, specificity, or inter-reader variability are provided. The "performance" mentioned refers to compliance with established engineering and safety standards.
2. Sample size used for the test set and the data provenance: Not applicable. This document does not describe a clinical study with a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set is described.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, an MRMC study is not mentioned. The comparison is between the new device and a predicate device in terms of design and compliance with standards.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is an MR imaging system, not an AI algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
Summary of Information from the Document:
The document states:
- The Signa Horizon Cx System was "evaluated to the appropriate NEMA performance standards as well as the IEC 601-1 International medical equipment safety standard."
- It is "comparable to the Signa Horizon MR Systems."
- "The Signa Horizon Cx does not include any new indications for use, nor does use of this device result in any new potential hazards."
- The comparison with the predicate device focuses on physical and technical characteristics: the new magnets are 2 tons lighter, have a lower cryogen boil-off rate, and are 68 cm shorter. The software and electronics are "substantially equivalent" to the currently marketed Signa Horizon System.
Conclusion based on the provided text:
This document demonstrates substantial equivalence to a predicate device based on engineering and safety standards, not through clinical performance studies against specific acceptance criteria for diagnostic accuracy or clinical outcomes. Therefore, the detailed information requested regarding study design and performance metrics is not available in this document.
§ 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.