(85 days)
The Signa SP System optional accessories are indicated for use as follows:
- The Scan Plane Pointer facilitates localization of the scanning planes. .
- . The side entry patient support access feature and the Patient Imaging Chair allows multiple patient positions enabling imaging exams of dynamic joints (such as knees and shoulders) and loaded spine studies.
- . The use of MR Imaging during interventional procedures using common devices such as fine needles and suction.
The Signa SP System employs an open magnet configuration which helps to reduce patient anxiety. increases patient positioning options and allows easy access to the patient. The Scan Plane Pointer accessory is useful in acquiring MR images relative to the physical orientation of the patient. The images may then be displayed to the operator and on a screen at table side.
The provided text describes a 510(k) summary for the GE Signa SP Magnetic Resonance System with optional accessories. It focuses on demonstrating substantial equivalence to a predicate device and safety and effectiveness, rather than providing a detailed study that proves the device meets specific acceptance criteria in the way a clinical study for a new diagnostic or therapeutic device would.
Therefore, much of the requested information cannot be directly extracted from the provided text because it describes regulatory submission for accessory features, not a performance study for a novel algorithm or diagnostic tool.
However, I can extract what is present and indicate what is not.
Here's an attempt to answer based on the provided text:
Acceptance Criteria and Study for GE Signa SP Magnetic Resonance System - Optional Accessories
The document describes a regulatory submission for optional accessories to an existing Magnetic Resonance (MR) system, focusing on its safety and effectiveness and substantial equivalence to a predicate device. It does not present a clinical study with detailed performance metrics and acceptance criteria as would be typical for a new diagnostic algorithm. Instead, it refers to compliance with industry standards and internal evaluation.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Compliance with NEMA performance standards | Evaluated to appropriate NEMA performance standards. |
| Compliance with IEC 601-1 International medical equipment safety standard | Evaluated to IEC 601-1 International medical equipment safety standard. |
| Accuracy statements in User Manual validated | Evaluation testing confirmed accuracy statements in the User Manual. |
| Substantially equivalent to predicate device (Signa SP System) | It is the opinion of GE that the Signa SP optional accessories is substantially equivalent to the Signa SP Systems. |
| No new potential hazards introduced | The optional accessories do not result in any new potential hazards. |
| Facilitates localization of scanning planes | The Scan Plane Pointer facilitates localization of the scanning planes. |
| Enables imaging exams of dynamic joints and loaded spine studies | The side entry patient support access feature and the Patient Imaging Chair allows multiple patient positions enabling imaging exams of dynamic joints (such as knees and shoulders) and loaded spine studies. |
| Supports MR Imaging during interventional procedures | Supports the use of MR Imaging during interventional procedures using common devices such as fine needles and suction. |
Regarding the study that "proves" the device meets acceptance criteria:
The document states: "The Signa SP optional accessories was evaluated to the appropriate NEMA performance standards as well as the IEC 601-1 International medical equipment safety standard. Evaluation testing confirmed accuracy statements in the User Manual." This indicates internal testing and compliance checks rather than a formal clinical study designed to meet specific performance endpoints for a diagnostic.
Here are answers to the specific questions, where applicable based on the provided text:
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample size: Not specified. The "evaluation testing" mentioned likely refers to engineering and performance verification tests of the accessory hardware, not a data set of patient cases.
- Data provenance: Not applicable in the context of diagnostic data. The evaluation would be on the performance of the hardware itself.
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. This is not a study requiring expert-established ground truth for diagnostic accuracy.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. This is not a study requiring adjudication of diagnostic outcomes.
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. This is not an AI-assisted diagnostic device; it describes hardware accessories for an MR system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm, but hardware accessories.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable for a diagnostic performance ground truth. For hardware, "ground truth" would be established by engineering specifications, calibration standards, and physical measurements.
8. The sample size for the training set
- Not applicable. This is not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable. This is not a machine learning model.
§ 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.