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.

Device Description

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.

AI/ML Overview

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

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance (from document)
Material Composition	Use of specific materials for radiolucency and MRI compatibility.	Skull Clamp: NOVOTEX (laminated fabric with phenolic resin, colored with BASANTOL black X82 liquid), POM (Delrin), PEEK, and Polyurethane. MR-Safe. Swivel Adaptor, Horseshoe Headrest, Transitional Members, Halo Systems: Novotex, PEEK, and POM. MR-Safe. Skull Pins: Yttried Zirconium or Titanium. X-ray and MRI compatible. MR-Safe.
Intended Use Equivalence	Similar use cases as predicate devices for cranial stabilization and support during neurosurgery.	Used for rigid skeletal fixation (Skull Clamp with Skull Pins) or non-invasive cranial stabilization (Horseshoe Headrest System) and as an armrest/tool mount (Halo System) in head and neck surgery, specifically when intra-operative CT or MR Imaging is used. This is an additional application compared to some predicates, enabled by the device's MRI compatibility.
Biocompatibility (for contacting parts)	No biocompatibility issues should be raised for patient-contacting components.	Radiolucent components (non-sterile): Do not contact the patient. Materials: NOVOTEX colored with BASF Basantal, POM, and Polyurethane. DORO® Radiolucent Disposable Single-Use Skull Pins: Contact the patient, but "there is no biocompatibility issues raised." (This implies a review and satisfaction of biocompatibility, often through adherence to ISO 10993 or similar standards, though specific data is not provided in this summary).
MRI Compatibility	Device components must be MR-Safe.	All specified components (Skull Clamp, Swivel Adaptor, Horseshoe Headrest, Transitional Members, Halo Systems, Skull Pins of Yttried Zirconium or Titanium) are explicitly stated as "MR-Safe."
Cleaning/Sterilization	Information on cleaning/sterilization status.	Sold non-sterile. Swivel Adaptor, Skull Clamp, and Horseshoe Headrests are "intended to be cleaned by the user between uses." Skull Pins are "disposable single-use."
Compatibility with existing systems	Ability to integrate with predicate accessories.	Can be used with accessories from the predicate DORO® Headrest System (K001808), including Gel Pads, Headrest supports, Pin Holders, and a Multi-Purpose Skull Clamp.
General Equivalence	"Similar in design, construction, intended use and performance characteristics to the predicate devices." (K032331, K001808, K051501xc for specific materials).	The summary states: "This device is almost similar in design, construction, intended use and performance characteristics to the predicate devices."

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.

Summary

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063494

Appendix 1 510(k) Summary

MAY 2 1 2007

Summary of Safety and Effectiveness Compliance with 513 (i) of the Federal Food, Drug and Cosmetic Act

1. General Provisions

Date Prepared:

Classification Name:

Common/Usual Name

Proprietary Name

Applicant Address

Applicant Name

October 31, 2006

Neurological Surgical Device

Neurosurgical Head Holder (Skull Clamp)

DORO® Radiolucent / MRI Compatible Cranial Stabilization and Halo Systems (including DORO® Radiolucent / MRI Compatible Skull Clamp Headrest System with Skull Pins, DORO® Radiolucent / MRI Compatible Horseshoe Headrest Systems and DORO® Radiolucent / MRI Compatible Halo System)

pro med instruments GmbH Bötzinger Str. 38 D79111 Freiburg / Germany

Edgar Schuele, Managing Director

P. 1 of 5

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Predicate

Table – Predicate Devices

Applicant	Product	Clearance Number
pro med instrumentsGmbH	DORO® Radiolucent / MRICompatible Skull Clamp HeadrestSystem, including DisposableSkull Pins	K032331, K001808Acucera, Inc.K051501xc
pro med instrumentsGmbH	DORO® Radiolucent / MRICompatible Horseshoe HeadrestSystems	K032331, K001808
pro med instrumentsGmbH	DORO® Radiolucent / MRICompatible Halo Systems	K032331, K001808

Table - Predicate Materials

Materials	Applicant	Device	ClearanceNumber
Laminated linen phenoliccomposite	SpinalConcepts, Inc.	SC-Acufix ThinlineAnterior PlateSystem	K013979
Laminated linen phenoliccomposite	Buxton 77-1042	Mallet System	Class 1
PEEK coating is used onpro med instrument's.laminated linen phenolic	Aesculap	ModularMonopolarElectrodes	K970541
zirconium stabilized withyttrium	ACUCERA, INC.	ZIRACE	K051501xc

. 2 of 5

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2. Device Description

Main components (see also Appendix 2):

DORO® Radiolucent / MRI Compatible Cranial Stabilization and Halo Systems:

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 components of the DORO® Headrest Systems are made of the following materials (see also Appendix 2):

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.

A1-4

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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.

Classification 4.

DORO® Radiolucent / MRI Compatible Cranial Stabilization (Skull Clamp and Skull Pins) are classified as class II devices according to 21 CFR 882.4460 (HBL). These devices are reviewed by the Neurological device panel.

A neurosurgical head holder (skull clamp with skull pins) is a device used to clamp the patient's skull to hold head and neck in a particular position during surgical procedures. A Horseshoe Headrest is a non-invasive method for cranial stabilization using Gel Pads. A Halo System is an arm rest for the surgeon or a mounting place for surgeons' tools.

5. Performance Standards

Performance standards for sheath introducers have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act.

Intended Use and Device Description 6.

The Radiolucent / MRI Compatible Skull Clamp Headrest System with Skull Pins

The DORO® 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 Radiolucent / MRI Compatible Horseshoe Headrest System

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The Radiolucent / MRI Compatible Halo System

The intended use of this device is similar to the predicate pro med instruments GmbH DORO® Headrest System (K001808 and K032331), Ohio Medical Instrument Company, Inc.'s (OHIO medical Instrument Co., Inc.) "MAYFIELD Radiolucent 2000 Skull Clamp" (K953124) with the additional application of MRI-compatibility.

7. Biocompatibility

The Radiolucent components of the system are intended to be used non sterile. They do not contact the patient. These materials are NOVOTEX colored with BASF Basantal, POM and Polyurethan.

The DORO® Radiolucent Disposable Single-Use Skull Pins, Ceramic (Yttried Zirconium) and Titanium have contact with the patient, but there is no biocompatibility issues raised.

Summary of Substantial Equivalence 8.

The DORO® Radiolucent / MRI Compatible Cranial Stabilization and Halo Systems and components are used as a head and neck support top stabilize a patient's head during neurosurgical operative procedures. It's the same use as the previous predicates of PMI.

This device is almost similar in design, construction, intended use and performance characteristics to the predicate devices.

P.S.d S

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract human form or a caduceus, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Pro-Med Instruments GMBH % Pro Med Instruments, Inc. Mr. Edgar Schuele 5450 Lee Street, Suite 1 Lehigh Acres, FL 33971

MAY 2 1 2007

Re: K063494

Trade/Device Name: DORO® Radiolucent/MRI Compatible Cranial Stabilization and Halo Systems and accessories Regulation Number: 21 CFR 882.4260 Regulation Name: Neurosurgical head holder (skull clamp) Regulatory Class: II Product Code: HBL Dated: May 4, 2007 Received: May 7, 2007

Dear Mr. Schuele:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

for Pedro Ramirez

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: K063494

Device Names:

The DORO® Radiolucent / MRI Compatible Cranial Stabilization and Halo Systems includes:

DORO® Radiolucent / MRI Compatible Skull Clamp Headrest System with Skull . Pins.
DORO® Radiolucent / MRI Compatible Horseshoe Headrest Systems, ●
DORO® Radiolucent / MRI Compatible Halo System .

Indications for Use:

The Radiolucent / MRI Compatible Skull Clamp Headrest System with Skull Pins

The Radiolucent / MRI Compatible Horseshoe Headrest System

The Radiolucent / MRI Compatible Halo System

Prescription Use: × (Part 21 CFR 801 Subpart D)

and /or Over-The Counter Use: NO (21 CFR 807 Subpart (C)

(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of(DMSIon Sign Offe Evaluation (ODE)
Division of General, Restorative
and Neurological Devices
510(k) Number LoL3494

Page 1 of 1

Regulation Number and Section

§ 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).