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The Radiolucent / MRI Compatible Skull Clamp Headrest System with Skull Pins are components of a mechanical support system which is used in head and neck surgery when rigid skeletal fixation is required for cranial stabilization and when intra-operative CT or MR Imaging is used.

The DORO® Radiolucent / MRI Compatible Horseshoe Headrest System are components of a mechanical support system which is used in head and neck surgery when non-invasive head support is required and when intra-operative CT or MR Imaging is used.

The DORO® Radiolucent / MRI Compatible Halo System is a system of radiolucent halo rings of varying size and styles that may be used in neurosurgical applications as an arm rest during head and neck surgery when intra-operative CT or MR Imaging is required.

The DORO® Radiolucent / MRI Compatible Cranial Stabilization and Halo Systems are for use in open and percutaneous craniotomies and spinal surgeries when rigid skeletal fixation is necessary (Skull Clamp with Skull Pins) or when secured noninvasive cranial stabilization (Horseshoe Headrest System) is required and when Intra-Operative CT or MR Imaging is used.

Main components:

• DORO® Radiolucent / MRI Compatible Skull Clamp Headrest System with Skull Pins
• DORO® Radiolucent / MRI Compatible Horseshoe Headrest Systems
• DORO® Radiolucent / MRI Compatible Halo System

The DORO® Radiolucent / MRI Compatible Skull Clamp Headrest System uses a three-point fixation of the head during surgery in the prone, supine, lateral, and sitting positions via the radiolucent Skull Clamp with Skull Pins. The DORO® Radiolucent / MRI Compatible Horseshoe Headrest System is an alternative noninvasive gel-pad cranial stabilization system for prone and supine positioning. The Skull Clamp or Horseshoe Headrests can be connected to Swivel Adaptor which in turn can be connected to the appropriate Transitional Members (of varying lengths). These are all MR-Safe.

The Radiolucent Halo System is a series of radiolucent rings (full, half and quarter rings) with fixation rods to attach to the radiolucent skull clamp described above. It provides a hand rest for the Surgeon and a mounting place for a variety of surgeon tools, such as brain Retractor and a holding tray. The Halo Rings and the Rod Fixation Assembly are all MR-Safe.

The DORO® Radiolucent / MRI Compatible Cranial Stabilization and Halo Systems are sold non-sterile. The Swivel Adaptor, Skull Clamp and Horseshoe Headrests are intended to be cleaned by the user between uses. For rigid skeletal fixation, the Skull Clamp uses the disposable single-use ceramic (Yttried Zirconium) or Titanium Skull Pins, which are both x-ray and MRI-compatible.

The components of the DORO® Headrest Systems are made of the following materials:

• The Skull Clamp is made of NOVOTEX laminated fabric with phenolic resin (GRP) colored with BASANTOL black X82 liquid and POM (Delrin), PEEK and Polyurethan. MR-Safe.
• The Swivel Adaptor and the Horseshoe Headrest in adult and pediatric versions, the Transitional Members and the Halo Systems are made of Novotex, PEEK and POM. MR-Safe.
• DORO® Radiolucent Disposable Single-Use Skull Pins of Yttried Zirconium or Titanium are X-ray and MRI compatible. MR-Safe.

The DORO® Radiolucent / MRI Compatible Cranial Stabilization and Halo Systems can be used with accessories from the predicate DORO® Headrest System (K001808) with Gel Pads for adults, Headrest supports with one or two Gel 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 Gel Pads.

The provided text is a 510(k) summary for a medical device (DORO® Radiolucent / MRI Compatible Cranial Stabilization and Halo Systems). This document is a regulatory submission for premarket notification to the FDA, demonstrating that a new device is substantially equivalent to a legally marketed predicate device.

It does not contain the acceptance criteria and study information typically found in a clinical performance study report for a diagnostic or AI-driven device. The document focuses on showing substantial equivalence based on design, construction, intended use, and performance characteristics compared to existing devices, particularly concerning its MRI compatibility.

Therefore, many of the requested categories (such as reported device performance, sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, and ground truth for training set) are not applicable to this type of regulatory submission for this device.

The "performance" aspect here refers more to the functional performance and safety of a mechanical device, rather than the accuracy of a diagnostic algorithm.

Here's a breakdown of what can be extracted and what is not available from the provided text:

Acceptance Criteria and Study for DORO® Radiolucent / MRI Compatible Cranial Stabilization and Halo Systems

This 510(k) summary (K063494) for the DORO® Radiolucent / MRI Compatible Cranial Stabilization and Halo Systems focuses on establishing substantial equivalence to predicate devices, rather than presenting a clinical study with acceptance criteria for diagnostic performance. The "performance" discussed primarily relates to the device's mechanical integrity, radiolucency, and MRI compatibility.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Not Applicable. This is a 510(k) for a mechanical device, not a diagnostic algorithm that requires a "test set" in the context of diagnostic accuracy. Data provenance would refer to where clinical data for performance assessment came from, which is not relevant here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. No ground truth for a diagnostic test set is established. This device's performance is assessed through material properties, mechanical testing, and comparison of design features, not expert interpretation of outputs.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. No test set or adjudication process as defined for diagnostic performance is mentioned.

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 is a mechanical surgical device, not an AI-powered diagnostic tool. MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This device does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Applicable. The "ground truth" for this device's regulatory review would be adherence to material specifications, engineering standards, biocompatibility testing results (implied), and demonstration of functional equivalence (e.g., rigid fixation, MRI safety) to predicate devices rather than a medical "truth" like disease presence.

8. The sample size for the training set

• Not Applicable. No training set for an algorithm exists for a mechanical device.

9. How the ground truth for the training set was established

• Not Applicable. No training set for an algorithm exists for a mechanical device.

In summary: The provided document is a 510(k) summary for a mechanical neurosurgical device. It addresses regulatory requirements by demonstrating substantial equivalence to previously cleared devices, primarily focusing on materials, construction, intended use, and functional properties like MRI compatibility. The questions regarding acceptance criteria, sample sizes, expert ground truth, and AI/algorithm performance are not applicable to the information contained within this type of submission for this device.

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