(119 days)
The DORO QR3 Headrest System is placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid skeletal fixation is necessary.
DORO® QR3 Headrest System consists of 3 components: 1. Skull clamp, 2. Swivel Adapter, 3. Adjustable Base Unit. DORO® QR3 Headrest System (Aluminum) is a cranial stabilization device, designed to provide rigid skeletal fixation. The DORO Headrest System is placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid skeletal fixation is necessary. The Swivel Adaptor connects the Base Unit (by means of the Transitional Member) with the Skull Clamp. The Swivel Adaptor provides 360 degrees rotation. This allows a fully flexible adjustment of the DORO® Headrest System to the patient's position. The Base Unit is designed for patient positioning in prone or supine, lateral and sitting positions.
The provided document is a 510(k) premarket notification for a medical device called the DORO QR3 Headrest System (Aluminum). This document primarily focuses on establishing substantial equivalence to a predicate device and outlines performance testing for safety and effectiveness, rather than detailing clinical study results for an AI/algorithm-based device.
Therefore, many of the requested categories related to AI/algorithm performance (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this submission.
Here's the information that can be extracted relevant to acceptance criteria and device performance based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the "Pass" results of the performance tests, indicating that the device met the established benchmarks for each test. The study performed is a series of engineering and usability tests.
| Acceptance Criteria (Test) | Reported Device Performance (Result) |
|---|---|
| System Test (in accordance with ASTM F3395 / F3395M-19) | Pass |
| Torque Load Resistance Test (in accordance with ASTM F3395 / F3395M-19) | Pass |
| Force Delivery Verification (in accordance with ASTM F3395 / F3395M-19) | Pass |
| Creep Test (in accordance with ASTM F3395 / F3395M-19) | Pass |
| Static Load Test (in accordance with ASTM F3395 / F3395M-19) | Pass |
| Fourfold Load - Skull Clamp (in accordance with DIN EN 60601-2-46) | Pass |
| Fourfold Load - Interface Skull Clamp to Swivel Adaptor (in accordance with DIN EN 60601-2-46) | Pass |
| Usability Test (in accordance with IEC 62366 as well as FDA-2011-D-0469) | Pass |
| Automated cleaning including disinfection (in accordance with EN ISO 15883-1:2014 – 10, RKI Guideline: 2012, AAMI TIR 30: 2011, Guideline DGKH, DGSV, AKI: 2014) | Pass |
Additional Information:
- Sample size used for the test set and the data provenance: Not applicable. These were engineering performance tests of the physical device, not a test set of medical data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for engineering tests is typically based on established physical standards and measurements, not expert human interpretation.
- Adjudication method for the test set: Not applicable.
- 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 document is for a physical medical device, not an AI/algorithm.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used:
- For engineering tests (Load, Torque, Creep, System Tests): The ground truth is the performance specified by the referenced ASTM and DIN EN standards. The "Pass" results indicate the device met these engineering specifications.
- For Usability Test: The ground truth would be adherence to the usability requirements outlined in IEC 62366 and FDA-2011-D-0469.
- For Cleaning and Disinfection Test: The ground truth is compliance with the referenced ISO, RKI, AAMI, and DGKH/DGSV/AKI guidelines for reprocessing medical devices.
- The sample size for the training set: Not applicable. This is for a physical device, not an AI/algorithm.
- How the ground truth for the training set was established: Not applicable.
§ 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).