(114 days)
The DORO Radiolucent Headrest System is used in open and percutaneous craniotomies and spinal surgeries for rigid cranial fixation and when intraoperative CT imaging is used.
The DORO® J-ARM Retractor Accessory is used to fix tissue retractor during neurosurgical procedures.
The DORO® Radiolucent Headrest System is a device system used as a support during head and neck surgery. It is composed of several components which are fabricated of materials that allow it to be radiolucent on x-ray. These components are:
-
- the adjustable Base Unit,
-
- the Skull Clamp, and
-
- the Swivel Adaptor,
-
- Horseshoe Headrest Adult and Children
It is suitable for use in adults and children when the appropriate components are selected.
The DORO System uses a three-point fixation of the head during surgery in the prone, supine, lateral, and sitting positions. The double clamping of the Adjustable Base unit provides simultaneous fixation of the lateral and vertical positions. The Crossbar is used for connection to the side rails of standard operating tables for fixation in a sitting position. The Swivel Adaptor is used in the base unit to provide 360 degree rotation.
The DORO Headrest System, except for the disposable Skull Pins, is sold non-sterile. The Base Unit, Swivel Adaptor and Skull Clamp are intended to be cleaned by the user between uses. It is intended to be used with Disposable, Skull Pins which were cleared with the DORO Headrest System (K001808).
The components of the DORO Headrest System are made of the following materials:
Skull Clamp is made of NOVOTEX laminated fabric with phenolic resin (GRP) colored with BASANTOL black X82 liqu1d and POM (Delrin), PEEK and Polyurethan.
The Swivel Adaptor and the Horseshoe Headrest in adult and pediatric versions, made of Novotex, PEEK and POM
The Base is made of Novotex, PEEK, POM and aluminum.
The J-Arm Retractor System is made of aluminum alloy and is not radiolucent.
The DORO Radiolucent Headrest System can also be used with accessories from the predicate DORO Headrest System (K001808) with Elastic Pads for adults, Headrest supports with one or two Elastic Pads, single Pin Holders, dual Pin Holders for adults, dual Pin Holders for children, a Multi-Purpose Skull Clamp with six Pin fixation or three Elastic Pads).
The DORO Radiolucent Headrest System can also be used with the J-Arm Retractor and Halo Retractor Assembly (K001808) which allows for use as a support and retraction device during neurosurgical procedures where retraction of the brain tissue and handrest are needed.
The provided 510(k) summary for the DORO® Radiolucent Headrest System does not contain information about specific acceptance criteria, device performance metrics, or any detailed studies demonstrating the device meets such criteria.
The document primarily focuses on demonstrating substantial equivalence to predicate devices based on design, construction, intended use, and performance characteristics, as required for a 510(k) submission. It briefly mentions materials and intended use but does not present quantitative performance data or a study design.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: No specific acceptance criteria or performance metrics are listed. The submission asserts "similar performance characteristics" to predicate devices without providing explicit data.
- Sample size used for the test set and the data provenance: No test set is described, and thus no sample size or data provenance is available.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No test set or ground truth establishment process is described.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as no test set is described.
- 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. The device is a physical medical instrument (surgical head holder), not an AI-powered diagnostic or assistive tool for human readers.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no ground truth is discussed for a study.
- The sample size for the training set: Not applicable as there is no training set for a study of this nature.
- How the ground truth for the training set was established: Not applicable.
The document states that "Performance standards for sheath introducers have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act." This implies that the submission relies on substantial equivalence rather than meeting specific pre-defined performance standards or conducting extensive performance studies beyond what's needed for safety and equivalence claims.
§ 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).