(235 days)
The DORO LUCENT radiolucent/MRI Compatible Headrest System with Skull Pins are components of a mechanical support system, which is used in cranial and spine surgery when rigid skeletal fixation is required for cranial stabilization and when intra-operative imaging is used.
The DORO LUCENT radiolucent/MRI Compatible Headrest System with noninvasive head positioning or noninvasive cranial stabilization device are components of a mechanical support system, which is used in cranial and spine surgery when noninvasive head positioning or noninvasive cranial stabilization is required and when intra-operative imaging is used.
The DORO LUCENT Headrest System provides an interface for accessories like retractor systems, navigation adaptors or other items.
The DORO LUCENT® iXI and iMRI Headrest System ensures an adequate positioning of a patient's head for neurosurgery. Additional intra-operative imaging can be performed.
The DORO LUCENT® iXI and iMRI Headrest System consists of the following: Skull Clamp, Skull Pins, Parallelogram Adaptor and Headplate. The Parallelogram Adaptor is used to connect the Skull Clamp (including Skull Pins) or the Headplate to the OR-Table/ Transfer Board.
Additional accessories like the Adjusting wrench and Transfer Collision Indicator supports the performance of the Headrest System.
These special Headrest Systems are developed for selected OR-Table/ MRI scanner combinations. They are separated in following sets:
- . 4003.200 DORO LUCENT® Headrest System TRUMPF for SIEMENS Aera/Skyra MRI Systems
- 4003.300 DORO LUCENT® iMRI Headrest System MAQUET for SIEMENS/PHILIPS/GE ●
- . 4003.500 DORO LUCENT® iXI Headrest System
By the use of the Navigation Adaptors the performance of the Headrest System is supplemented. The intra-operative navigation is feasible because of the provided interface to the navigation device.
The provided FDA 510(k) summary describes a medical device, the DORO LUCENT® iXI and iMRI Headrest System. This document focuses on the substantial equivalence of the new device to a predicate device rather than presenting a clinical study to evaluate diagnostic performance with a human-in-the-loop or standalone algorithm. Therefore, many of the requested criteria related to AI/algorithm performance and clinical study details are not applicable or not present in this submission.
Here's the information that can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally demonstrated through "Pass" results in various performance tests.
| Acceptance Criteria (Test) | Reported Device Performance |
|---|---|
| DORO LUCENT® iXI and iMRI Headrest System | |
| Static load: Ability to sustain a certain load with an additional safety factor. | Pass |
| MR-Compatibility: Does not impair the function of the MRI system. | Pass |
| CT/Angio-Compatibility: No new or additional shadowing on the image. | Pass |
| X-Ray-Compatibility: No new or additional shadowing on the image. | Pass |
| DORO LUCENT® Skull Clamp | |
| Static load (Latching teeth mechanism): Ability to sustain a certain load with an additional safety factor without damage/malfunction. | Pass |
| Torque (Rocker Arm): Ability to resist applied torque without damaging, opening, or malfunction of the Open-Lock mechanism. | Pass |
| DORO LUCENT® Skull Pins | |
| Mechanical stability (scratch test): Withstands an applied radial force when an axial force is applied. | Pass |
| MR-Compatibility: MR conditional. | Pass |
| Sterility: Packaged sterile and stays sterile for shelf life. | Pass |
| Biocompatibility: Biocompatible. | Pass |
| DORO LUCENT® Headplate | |
| Static load: Ability to sustain a certain load with an additional safety factor without mechanical failure. | Pass |
| Biocompatibility: Biocompatible. | Pass |
2. Sample size used for the test set and the data provenance
This is a physical medical device (headrest system), not an AI/software device. The "test set" here refers to the physical units of the device and its components undergoing engineering and materials testing. The document does not specify the exact number of units or components tested for each criterion. The provenance of the data is from pro med instruments GmbH, the manufacturer, and the tests were likely conducted internally or by accredited third-party labs. The study is a prospective testing of manufactured devices against pre-defined engineering and safety standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for a physical device's performance often relates to instrumented measurements (e.g., force, torque, imaging artifacts) and material properties, not expert consensus as would be used for diagnostic imaging algorithms.
4. Adjudication method for the test set
Not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies for diagnostic accuracy, where expert opinions need to be reconciled. For device performance testing, results are quantitative or pass/fail based on pre-defined specifications.
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. This device is not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used
The ground truth for this device's performance is based on engineering specifications, material science, sterility standards, and regulatory requirements (e.g., MRI compatibility standards). For example, "MR-Compatibility" is verified against established standards for how metallic or non-metallic objects interact with MRI fields. "Static load" is verified against a specified weight with a safety factor.
8. The sample size for the training set
Not applicable. This is a physical medical device and does not involve AI/machine learning training sets.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI algorithm, no ground truth needs to be established for it.
§ 882.4460 Neurosurgical head holder (skull clamp).
(a)
Identification. A neurosurgical head holder (skull clamp) is a device used to clamp the patient's skull to hold head and neck in a particular position during surgical procedures.(b)
Classification. Class II (performance standards).