Search Results

The DORO LUCENT® Skull clamp is part of a mechanical support system, which is used during head or neck surgery. The product can be used in an intra-operative setting for CT and X-ray imaging.

The DORO LUCENT® Skull clamp Pediatric Set is part of a mechanical support system, which is used during head or neck surgery. The product can be used in an intra-operative setting for CT and X-ray imaging. The target patient population includes children over 5 years of age.

Device Description

The DORO LUCENT® Skull Clamp ensures an adequate positioning of a patient's head and provides rigid fixation for neurosurgery. The device is suitable for intra-operative X-ray and CT based imaging procedures.

The DORO LUCENT® Skull Clamp consists of a fixed arm, an adjustable arm and modular pin holders. Thus, using the DORO LUCENT® Skull Clamp Pediatric Set, the skull clamp can be configured as three-pin or four-pin pediatric set up.

AI/ML Overview

The provided text describes the 510(k) clearance for the DORO LUCENT® Skull Clamp and DORO LUCENT® Skull Clamp Pediatric Set. However, it does not contain information about a study based on AI/ML or any performance testing related to software or AI. The tests mentioned are for mechanical performance, usability, and reprocessing of the physical device.

Therefore, for aspects related to AI/ML device performance, such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training, the information is not available in the provided document.

Here's a breakdown of what is available based on the mechanical device performance testing:

Device: DORO LUCENT® Skull Clamp (1101.001) and DORO LUCENT® Skull Clamp Pediatric Set (1101.040)

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria / Benchmark (Implicit)	Reported Device Performance
Maximum Load Test (System Test)	The skull clamp must be capable of resisting the forces imposed by the patient and surgeon when in use and in locked position without movement in any connection, joint and/or plastic deformation.	Pass. The skull clamp is capable of withstanding the given force without movement in any connection, joint and/or plastic deformation.
Usability	The usability of the skull clamp must be given.	Pass. The usability of the skull clamp is given.
Static load (Latching teeth mechanism)	The skull clamp must be able to withstand a maximum static load for a given duration without signs of permanent deformation, fracture, or breakage.	Pass. The skull clamp withstands a static load for the given duration without signs of permanent deformation, fracture, or breakage.
Creep	The skull clamp must maintain the applied maximum force without a force deviation from the initially applied load by a defined value.	Pass. The skull clamp can maintain the applied maximum force without a force deviation from the initially applied load by a defined value.
Pin force accuracy	The skull clamp force delivery component must be verified at each force level throughout its range to deliver the stated force within the actual setting.	Pass. The skull clamp force delivery component is verified at each force level throughout its range to deliver the stated force within the actual setting.
Torque load resistance	The skull clamp must withstand a defined torque for a given amount of time without deformation or any structural failures.	Pass. The skull clamp withstands a defined torque for a given amount of time without deformation or any structural failures.
CT Evaluation	The skull clamp must produce fewer artifacts than the set benchmark for adequate imaging results.	Pass. The skull clamp produces fewer artifacts than the set benchmark as defined in the test report.
Reprocessing	Reprocessing must be validated according to specified standards (ANSI/AAMI ST98:2022, DIN EN ISO 17664-1:2021, DIN EN ISO 17664-2:2021, AAMI TIR 12: 2020) including accumulation of residue, cleaning effectiveness, and disinfection effectiveness.	Pass. The test data shows the reprocessing of DORO LUCENT® Skull Clamp is validated and a test report in support of the statement is provided.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not explicitly stated for each test. For mechanical/physical performance tests, the "sample size" typically refers to the number of units tested. The document indicates "Tests were performed and the results are shown in the table below," implying a sufficient number of tests were conducted to confirm performance.
Data Provenance: Not specified in terms of country of origin or retrospective/prospective for these physical device tests. These are likely internal laboratory tests conducted by the manufacturer.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Not applicable. This device is a mechanical skull clamp, not an AI/ML diagnostic device requiring expert interpretation for ground truth. The "ground truth" for these tests is the physical measurement and observation of the device's performance against defined engineering and safety standards.

4. Adjudication Method for the Test Set:

Not applicable. See point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This type of study is relevant for AI/ML diagnostic tools being compared to human performance, which is not the case for this mechanical device.

6. Standalone (Algorithm Only) Performance:

Not applicable. There is no algorithm or software for standalone performance in this mechanical device.

7. Type of Ground Truth Used:

Engineering and Safety Standards/Specifications: The ground truth for these tests is established by the device's design specifications and compliance with relevant industry standards (e.g., for mechanical strength, CT compatibility, and reprocessing).

8. Sample Size for the Training Set:

Not applicable. This is a mechanical device, not an AI/ML product developed through a training process with a data set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. See point 8.

Ask a Question

Ask a specific question about this device

Page 1 of 1