(47 days)
The intended use of the Noras OR Head Holder is the fixation of the human skull just before, during and at the end of the intervention in the operating room. The head holder enables prone, supine and lateral patient positioning.
The Noras OR Head Coil 1.5T(K060758) can be adopted to the OR Head Holder in conjunction with a Siemens Magnetom System 1.5T to provide MR images before, during and at the end of the intervention. The head holder can be adjusted from adult use down to use for a new born child.
The intended use of the Noras OR Head Holder, in conjunction with a Magnetic Resonance Scanner, is to stabilize patient's head during neurosurgical procedures,
Used in conjunction with Siemens MAGNETOM Systems and the Noras OR Head Coil, it is indication with Olemens MAGNE I OM Systems and
Special Accessories are available for use with the head holder for awake cranic and becomes are available for use with the head holder for aw craniotomies, pediatric patients and minimally invasive interventions.
The OR Head Holder is a fixation unit for the human head before, during and after an intervention at the human brain. The head holder will come with two versions of table adapters, depending on the OR table top used.
The Noras Part Numbers are: SI7000 for use with the Symphony, and Sonata Table top and the Miyabi transport system; and Part Number SI7300 for use with the table top for Espree or TIM Trio.
The OR Head Holder is a fixation unit for the human skull. It can be mounted on the Symphony/Sonata/Espree/Trio table top or the Miyabi Shell.
The OR Head holder provides the possibility to adopt the 1.5T Noras OR Head Coil and in conjunction with a 1.5T Magnetic Resonance Scanner, the MR examination of the human brain just before, during and at the end of brain surgery in the operating room.
The provided document describes a 510(k) premarket notification for the "OR Head Holder" device by Siemens Medical Solutions USA, Inc. The purpose of this submission is to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
However, the submission does not include an acceptance criteria table, a study explicitly designed to show the device meets specific performance criteria with reported device performance metrics, or information about AI assistance. The document focuses on showing substantial equivalence to an existing device through comparison of intended use and technological characteristics, rather than reporting on a new performance study with acceptance criteria.
Therefore, many of the requested details cannot be extracted from this document as they are not present in a 510(k) submission for this type of medical device where substantial equivalence is the primary pathway.
Here's a breakdown of what can and cannot be answered based on the provided text:
Acceptance Criteria and Device Performance Study Information:
| Information Requested | Details from Document |
|---|---|
| 1. Table of acceptance criteria and the reported device performance | NOT APPLICABLE/NOT PROVIDED. The 510(k) submission for this device (an OR Head Holder) focuses on substantial equivalence to a predicate device, not on specific performance acceptance criteria or a clinical study with reported performance metrics. The submission asserts the device is "substantially equivalent" to an existing device (SIEMENS Neurosurgical OR Head Holder, Catalog #7548204, K012495) because both are designed to fix a human skull in the OR environment and work in an MR magnetic field. |
| 2. Sample size used for the test set and the data provenance | NOT APPLICABLE/NOT PROVIDED. No test set or associated data provenance (country of origin, retrospective/prospective) is described. The submission relies on a comparison to a predicate device. |
| 3. Number of experts used to establish the ground truth for the test set and their qualifications | NOT APPLICABLE/NOT PROVIDED. No test set or ground truth establishment by experts is detailed in this type of 510(k) submission for this device. |
| 4. Adjudication method for the test set | NOT APPLICABLE/NOT PROVIDED. No test set or adjudication method is described. |
| 5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done |
- Effect size of human readers improvement with AI vs without AI assistance | NOT APPLICABLE/NOT PROVIDED. The device is an "OR Head Holder," a physical fixation unit. It does not involve AI or human reader interpretation, so an MRMC study related to AI assistance is irrelevant and was not performed. |
| 6. If a standalone (algorithm only without human-in-the-loop performance) was done | NOT APPLICABLE/NOT PROVIDED. The device is a physical head holder; there is no "algorithm only" performance to evaluate. |
| 7. The type of ground truth used | NOT APPLICABLE/NOT PROVIDED. As no performance study with a test set is described, there is no mention of ground truth types (e.g., expert consensus, pathology, outcomes data). The basis for clearance is substantial equivalence to a predicate device's established safety and effectiveness. |
| 8. The sample size for the training set | NOT APPLICABLE/NOT PROVIDED. This device is a physical medical device, not an AI/machine learning algorithm. Therefore, there is no concept of a "training set" in the context of this 510(k) submission. |
| 9. How the ground truth for the training set was established | NOT APPLICABLE/NOT PROVIDED. As there is no training set for an algorithm, there is no ground truth establishment for a training set. The safety and effectiveness of the device are implied by its substantial equivalence to a predicate device, which would have undergone its own clearance/approval process based on its design, materials, and intended use as a physical medical device for fixation during neurosurgical procedures and MR imaging compatibility. |
Summary regarding the 510(k) Submission:
The 510(k) submission for the Noras OR Head Holder sought to demonstrate substantial equivalence to an existing cleared device, the SIEMENS Neurosurgical OR Head Holder (K012495). The core argument for substantial equivalence is that both devices:
- Are designed to fix a human skull in an operating room (OR) environment.
- Are designed to work directly in the magnetic field of an MR scanner.
- Have the same intended use: fixation of the human skull before, during, and at the end of intervention in the operating room, enabling prone, supine, and lateral patient positioning.
This type of submission relies on comparing the new device's technological characteristics and intended use to a predicate device, rather than providing new clinical study data with specific acceptance criteria and performance metrics.
§ 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.