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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:

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.

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The intended use of the Noras OR Head Coil 3T 7230-PH is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the human brain just before, during and at the end of the brain surgery in the operating room. The coil can also be used as a standard diagnostic head coil for diagnostic examinations and fMRI (Functional Magnetic Resonance Imaging).

Used in the 3T Philips Achieva Systems, it is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head.

When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA to Moras MRI Products GmbH for their Noras OR Head Coil 3T. This document is a regulatory approval letter and does not contain the results of a study or detailed acceptance criteria for a device.

Therefore, I cannot extract the information required by your request about acceptance criteria and the study proving the device meets them, because this information is not present in the provided text.

The document states that the FDA reviewed the 510(k) premarket notification and determined the device to be "substantially equivalent" to legally marketed predicate devices. This regulatory pathway typically relies on demonstrating equivalence to an already approved device rather than presenting new clinical study data with specific acceptance criteria and performance metrics in the same way a Premarket Approval (PMA) application might.

The indications for use are provided, but these are not the acceptance criteria or device performance data.

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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:

• 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.

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