(265 days)
For Siemens:
The NORAS OR Head Holder Flexibility and the NORAS OR Head Coils 1.5T / 3.0T are used for intra-operative MR imaging during open-skull neurosurgery.
The NORAS OR Head Holder is used for safely securing the patient's head during the intervention.
The NORAS OR Head Holder Flexibility together with the NORAS OR Head Coil 1.5T / 3.0T are suitable for use with the MR system MAGNETOM Aera / Skyra and the Combi-Dockable-Table together with Trumpf OR Tables TrueSystem 7500 (EU/US Version) and as well as together with Maquet OR Tables Magnus (EU/US Version) and Alpha Maquet Plus (EU/US Version).
For Philips:
The NORAS OR Head Holder Flexibility and the NORAS OR Head Coils 1.5T / 3.0T are used for intra-operative MR imaging during open-skull neurosurgery.
The NORAS OR Head Holder is used for safely securing the patient's head during the intervention.
The NORAS OR Head Holder Flexibility together with the NORAS OR Head Coil 1.5T / 3.0T are suitable for Philips MR system Ingenia 1.5T/3T in combination with Maquet Transfer Board together with Maquet OR table.
The NORAS OR Head Holder and the NORAS OR Head Coil 1.5T / 3.0T combine the functions of a head holder for neurosurgical interventions and an MR receiving coil for intra-operative surgery.
The NORAS OR Head Holder without the NORAS OR Head Coil 1.5T / 3.0T can be used for stabilizing the patient's head. It can also be used in combination with the body coil.
The Head Frame of the NORAS OR Head Holder allows adjustment to heads varying in size. For optimal access to the area of intervention, the Head Frame can be swiveled and rotated.
The provided document pertains to the 510(k) premarket notification for the NORAS OR Head Holder Flexibility. The device is a "Magnetic Resonance Diagnostic Device" and is intended for use in intra-operative MR imaging during open-skull neurosurgery, primarily for safely securing the patient's head.
Based on the document, here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria in terms of specific performance metrics (e.g., accuracy, sensitivity, specificity) that a diagnostic device would typically have, nor does it report specific performance values for the device in such a format. This is because the NORAS OR Head Holder Flexibility is primarily a support and positioning device for MR imaging, rather than an active diagnostic algorithm.
Instead, the acceptance criteria are implicitly related to:
- Safety and Mechanical Integrity: Ensuring the device can safely secure a patient's head and function properly within an MR environment without posing new risks.
- Compatibility: Ensuring it works as intended with specified MR systems and operating tables.
- Substantial Equivalence: Demonstrating that it is as safe and effective as a legally marketed predicate device.
Here's an interpretation of the implied acceptance criteria and the device's reported performance based on the provided text:
| Acceptance Criteria (Implied) | Reported Device Performance (Summary of Evidence) |
|---|---|
| Mechanical Safety and Integrity (e.g., ability to securely hold a patient's head, structural soundness in the OR/MR environment) | "According to our internal evaluations as well the external tests done by VDE the new components such as Z-joint meet the requirements of IEC 60601-1 3.ed (clause 9.8) and do not adversely affect the safety of the design." |
| Electrical Safety and Electromagnetic Compatibility (EMC) (relevant for MR environment) | "The NORAS OR Head Holder Flexibility combined with the NORAS OR Head Coil 1.5T / 3T will conform to the FDA recognized NEMA Standards for the measurement of performance and safety parameters and the IEC standards for safety issues with the Magnetic Resonance Imaging Devices, IEC 60601-2-33:2002." |
| Functional Compatibility with specific MR systems & OR tables | The device is suitable for use with:Siemens: MR system MAGNETOM Aera / Skyra, Combi-Dockable-Table, Trumpf OR Tables TrueSystem 7500, Maquet OR Tables Magnus, Alpha Maquet Plus.Philips: MR system Ingenia 1.5T/3T, Maquet Transfer Board, Maquet OR table. |
| Substantial Equivalence (to a predicate device regarding safety and effectiveness) | Manufacturer believes the device is substantially equivalent to the predicate device: NORAS OR Head Holder (K071179). The new device includes "only some minor mechanical changes which contribute to more flexibility in patient positioning" compared to the predicate, and these changes "do not adversely affect the safety of the design." Its comparable property to the predicate is "Fixation of the patient's head." |
| Intended Use (ability to perform the specified function) | "The NORAS OR Head Holder is used for safely securing the patient's head during the intervention." (This is the core function, and the device is presented as meeting this function through its design and safety testing). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "sample size" in terms of patient data or a "test set" in the context of diagnostic algorithm validation. The testing described is primarily focused on engineering and safety standards conformance for the device's mechanical and electrical properties.
- The testing involves "external tests done by VDE" and "internal evaluations" concerning mechanical aspects (e.g., Z-joint meeting IEC 60601-1 clause 9.8).
- Conformance to NEMA and IEC 60601-2-33:2002 standards is stated for safety and performance in an MR environment.
These types of tests are typically conducted in a laboratory or engineering testing facility setting rather than with a "test set" of patient data. Therefore, concepts like data provenance (country of origin, retrospective/prospective) are not applicable in the usual sense for this type of device.
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)
This information is not applicable to this device. As explained above, the device is a piece of hardware for patient positioning, not an AI/diagnostic algorithm that requires ground truth established by medical experts on patient data. The "ground truth" here is adherence to engineering and safety standards, verified by testing bodies and internal evaluations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable to this device, as there is no "test set" of medical images or patient data requiring expert adjudication.
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
This information is not applicable to this device. An MRMC study is relevant for evaluating the impact of an AI-powered diagnostic tool on human reader performance, which the NORAS OR Head Holder Flexibility is not.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable to this device. It is a hardware device, not a standalone AI algorithm. It acts as a component within a human-in-the-loop imaging workflow (neurosurgeon, MR technologist, radiologist, etc.).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically used in diagnostic algorithm validation (e.g., pathology, clinical outcomes) is not applicable here. The "ground truth" for this device's acceptance is its conformance to established international and FDA-recognized engineering and medical device safety standards (e.g., IEC 60601-1, IEC 60601-2-33, NEMA standards). The truth is established by meeting these pre-defined technical and safety requirements through testing.
8. The sample size for the training set
This information is not applicable to this device. There is no AI algorithm being trained, so there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable to this device, as there is no training set or AI algorithm involved.
§ 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.