(279 days)
The intended medical use of the OR Head Holder LUCY and Head Coil Set 1.57/3T is, in conjunction with a Magnetic Resonance Scanner, intra-operative MR imaging during an open-skull neurosurgery.
The OR Head Holder LUCY is used for safe securing the patient's head during a surgical intervention at the head. It is possible to make an intraoperative assessment during the intervention to determine its progress. In the MR area the Head Coils enable the diagnostic imaging. Using Computed Tomography or C-arm Fluoroscopy, it is mandatory to remove the Head Coils and the device serves as a skull clamp only.
The OR Head Holder LUCY can be used for intra-operative MR Imaging, CT Imaging and C-arm Imaging. In use with the NORAS OR Head Coils 1.5T or 3T, the OR Head Holder LUCY can be applied for intra operative MR imaging during an open skull neurosurgery at human patients.
The NORAS OR Head Holder LUCY is used for safe fixation of the patient's head during neurosurgical procedures on the patient's skull with planning and resection aid for MRI, CT and C-arm Imaging.
One additional feature of the OR Head Holder LUCY is the ability of height adjustment providing an ideal patient positioning in 70 cm MRI (Siemens Magnetom Aera and Skyra and Philips Ingenia 1.5T/3T, Ingenia Ambition 1.5T and Ingenia Elition 3.0T) and in CT- Scanners. Furthermore, the whole set up can be moved parallel to the bore direction (in Z- direction).
The configuration allows comfortable positioning of the patient in prone, lateral or supine position on the transfer board and allows an exact adjustment of the Head Holder during the positioning of the patient´s head. The system supports awake craniotomy.
Mechanical, the model of the Head Holder allows a slight movement of both posts of the three-point fixation at the Arc with a stable geometry, which minimizes unwanted movements. The patients head will be fixed by three skull pins.
The provided text is a 510(k) summary for the NORAS OR Head Holder LUCY with HeadCoilSet. This document primarily focuses on establishing substantial equivalence to predicate devices based on design, materials, and intended use, rather than presenting a performance study with acceptance criteria in the manner typically seen for AI/ML devices or diagnostic tools.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be fully extracted from the provided text. The document details non-clinical bench testing to demonstrate that "technological changes do not raise any new issues of safety or effectiveness over the predicate," implying a focus on engineering validation rather than clinical performance metrics against specific acceptance thresholds for diagnostic accuracy.
The closest information available pertains to the general safety and effectiveness concerns and non-clinical tests.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
-
Cannot be fully provided as requested for diagnostic/performance metrics. The document states that "Testing and analysis have been conducted to show that the verification, validation, and safety requirements have been met per the FDA as established standards." It also mentions adherence to NEMA Standards and DIN EN standards (DIN EN 60601-2-33:2017) for safety parameters related to MRI devices. However, specific acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy) are not listed, nor are numerical results for such performance. The reported "performance" focuses on mechanical and electrical safety, and compatibility with MRI scanners.
Acceptance Criterion (Inferred from text) Reported Device Performance (Inferred from text) Compliance with NEMA Standards Met Compliance with DIN EN 60601-2-33:2017 (Safety for MRI devices) Met Risk mitigation per DIN EN ISO 14971:2013 Risks controlled via measures in development, testing, and product labeling No new issues of safety or effectiveness compared to predicates Achieved through non-clinical bench testing Compatibility with specified MR systems (Siemens 1.5T/3T, Philips 1.5T/3T) Confirmed through testing
2. Sample size used for the test set and the data provenance:
- Cannot be provided. The document describes "non-clinical bench testing" and "testing and analysis" but does not specify sample sizes or types of data (e.g., patient images). It does not mention clinical test sets or data provenance (country of origin, retrospective/prospective) in the context of device performance evaluation. The "data" refers to engineering test results, not clinical patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Cannot be provided. Since this is a non-AI/ML device primarily focused on mechanical and electrical safety and physical compatibility, there is no mention of "experts" establishing a "ground truth" for a test set in the diagnostic sense. The expertise involved would be in engineering and regulatory compliance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Cannot be provided. This concept is relevant for studies involving human readers and complex diagnostic interpretations, which is not the type of study described for this device.
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:
- Not applicable/Not done. This device is a medical accessory (head holder and coil set) for MRI, not an AI/ML diagnostic tool. Therefore, MRMC studies and human-in-the-loop performance metrics are not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not done. This is not an algorithm or AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.):
- Not applicable. For this device, "ground truth" would relate to the physical and electrical properties meeting specified engineering tolerances and safety standards. It does not involve clinical diagnostic ground truth like pathology or outcomes data.
8. The sample size for the training set:
- Not applicable/Cannot be provided. This device is not an AI/ML model that requires a training set of data.
9. How the ground truth for the training set was established:
- Not applicable/Cannot be provided. As above, no training set information is present.
§ 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.