The EasyGuide Standard Workstation is intended for planning neurosurgery and for localizing and navigating during neurosurgery. The Easyguide Neuro (Release 2) option and the EasyTaxis option are used for support in neurosurgical procedures such as:

Frameless stereotactic procedures .
Intra-operative resection of brain tumors .
Biopsies .
Endoscopic procedures .

The EasyGuide Neuro (Release 2) option is used for instrument pointing, instrument learning, 3D marker visualization and image rendering when used with the EasyGuide Standard Workstation.

Device Description

The EasyGuide Neuro (Release 1) Image Guided Surgery Workstation was cleared for marketing via 510(k) 961834. Since then the product structure for EasyGuide has been reconfigured into a basic version known as EasyGuide Standard and options to this version. EasyGuide Standard has also been called EasyGuide Neuro Basic. The EasyGuide Standard Workstation is the same as the EasyGuide Neuro Image Guided Surgery Workstation which was cleared for marketing as noted above. A Neuro (Release 2) option and an EasyTaxis option, which are the subjects of this premarket notification, are options for the Philips EasyGuide Standard Workstation. The Neuro (Release 2) option and the EasyTaxis option extend the functionality and application areas of the EasyGuide Standard Workstation.

AI/ML Overview

The provided document is a 510(k) summary for the Philips EasyGuide Neuro (Release 2) and EasyTaxis options, which are enhancements to an existing Image Guided Surgery System. This type of submission focuses on demonstrating substantial equivalence to previously cleared devices rather than providing detailed performance studies with acceptance criteria, sample sizes, and ground truth methodologies.

Therefore, the document does not contain the specific information requested regarding acceptance criteria, device performance from a study, sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or specific ground truth methodologies.

The document primarily states that the device complies with electrical safety standards (UL-2601), electromagnetic compatibility standards (IEC-601-1-2), and digital imaging communication standards (ACR/NEMA DICOM Version 3). These are not performance metrics in the way you might expect for diagnostic or AI-driven devices but rather safety and interoperability compliance.

Here's a summary of what is available in the document, framed against your request, and why other information is absent:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Compliance Statements):
  - Compliance with UL-2601 (electrical safety)
  - Compliance with IEC-601-1-2 (electromagnetic compatibility)
  - Compliance with ACR/NEMA DICOM Version 3 (digital imaging communication)
  - Compliance with Title 21 CFR Part 1040.10 (position digitizer laser)
- Reported Device Performance: No quantitative performance metrics are provided in the context of clinical accuracy or efficacy studies. The "performance" described is its adherence to the aforementioned safety and communication standards. This is typical for a 510(k) focused on substantial equivalence for a surgical navigation system, where the efficacy is largely tied to predicate devices and the system's ability to accurately track instruments.
Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not applicable / Not provided. The document describes a substantial equivalence submission, which doesn't typically require such detailed clinical study data for device clearance unless significant new claims or technologies are involved that differ substantially from predicates.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable / Not provided. No test set or related ground truth establishment is described.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not provided.
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 / Not provided. This device is a surgical navigation system, not an AI diagnostic tool involving "human readers" in the typical sense.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable / Not provided. The device is inherently-human-in-the-loop as it assists surgeons.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable / Not provided.
The sample size for the training set:
- Not applicable / Not provided.
How the ground truth for the training set was established:
- Not applicable / Not provided.

In conclusion, this 510(k) document establishes substantial equivalence based on safety, interoperability, and functional similarity to predicate devices, rather than detailed performance studies with acceptance criteria based on clinical outcomes or accuracy metrics for a new, novel technology.

Summary

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OCT 13 1998

Philips Medical Systems

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K980926

February 24, 1998

510(K) Summary

In accordance with the requirements of the Safe Medical Device Act, Philips Medical Systems North America Company herewith submits a 510(K) summary of safety and effectiveness for the following device.

CLASSIFICATION NAME:	Stereotaxic Instrument(Class II; Tier 2; 84HAW, 21CFR 882.4560)
COMMON/USUAL NAME:	Image Guided Surgery System
TRADE/PROPRIETARY NAME:	Philips EasyGuide
ESTABLISHMENT NO.:	1217116
CONTACT PERSON:	Peter Altman, Director of Regulatory Affairs

PERFORMANCE STANDARDS:

This device complies with electrical safety standard UL-2601, electromagnetic compatibility standard IEC-601-1-2 and the ACR/NEMA DICOM Version 3 digital imaging communication standard.

SYSTEM DESCRIPTION:

INTENDED USE:

Frameless stereotactic procedures .
Intra-operative resection of brain tumors .
Biopsies .
Endoscopic procedures .

The EasyGuide Neuro (Release 2) option is used for instrument pointing, instrument learning, 3D marker visualization and image rendering when used with the EasyGuide Standard Workstation.

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Image /page/1/Picture/1 description: The image shows the Philips logo. The logo consists of the word "PHILIPS" in bold, uppercase letters above a circular emblem. The emblem features a globe-like design with wavy lines and stars, enclosed within a shield-like shape. The logo is black and white.

Image /page/1/Picture/2 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The letters are all capitalized and evenly spaced. The word is presented in black against a white background, creating a high contrast and making the text easily readable. The overall impression is clean and professional, typical of a brand logo.

SUBSTANTIAL EQUIVALENCE INFORMATION:

The Philips EasyGuide Standard Workstation with the Neuro (Release 2) option and the EasyTaxis option is considered substantially equivalent to the BrainLab VectorVision (K962939), the Zeiss Surgical Microscope Navigator (SMN) (K965139) and the Sofamor Danek StealthStation (K954276). A comparison matrix is provided in Appendix 5 along with commercial brochures for the predicate devices.

SAFETY INFORMATION:

The Philips EasyGuide Standard Workstation with Neuro (Release 2) option and EasyTaxis option is designed to comply with applicable requirements of the Underwriters Laboratories Standard for Safety, X-ray Equipment (UL 2601) and be classified by Underwriters Laboratories. Additionally, the EasyGuide Standard Workstation with Neuro (Release 2) option and EasyTaxis option is in compliance with the ACR/NEMA Digital Imaging Communication (DICOM) standard. The position digitizer laser complies with Title 21 CFR Part 1040.10.

The results of the hazard analysis, combined with the appropriate preventive measures taken indicate that the device is of minor level of concern as per the August 29, 1991 issue of the "Reviewer's Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review".

Additionally, the Philips EasyGuide Standard Workstation with Neuro (Release 2) option and EasyTaxis option is designed to comply with international standard IEC-601-1-2 for electromagnetic compatibility.

Philips Medical Systems North America Company feels that sufficient information and data are contained in this submission to enable CDRH to reach a determination of substantial equivalence.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 13 1998

Mr. Frank Gianelli Senior Requlatory Affairs Specialist Philips Medical Systems, Inc. 710 Bridgeport Avenue P.O. Box 860 Shelton, Conneticut 06484-4708

Re: K980820 Philips Neuro (Release 2) Option and Trade Name: EasyTaxis Option for the EasyGuide Standard Workstation Regulatory Class: II Product Code: HAW Dated: July 14, 1998 Received: July 15, 1998,

Dear Mr. Gianelli:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

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Page 2 - Mr. Frank Gianelli

not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to......................................................................................................................... information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Philips Neuro (Release 2) Option and EasyTaxis Option Device Name : for the EasyGuide Standard Workstation

Indications For Use :

The EasyGuide Neuro (Release 2) option is used for instrument pointing, instrument learning, 3D marker visualization and image rendering when used with the EasyGuide Standard Workstation which is indicated for use in planning neurosurgical procedures and for localizing and navigating during neurosurgical procedures.

The EasyTaxis option is used to assist the surgeon in the positioning of instruments and in guiding an instrument to its targeted position during a surgical procedure when used with the EasyGuide Standard Workstation which is indicated for use in planning neurosurgical procedures and for localizing and navigating during neurosurgical procedures.

The Easyguide Neuro (Release 2) option and the EasyTaxis option are used for support in neurosurgical procedures such as:

. Frameless stereotactic procedures
. Intra-operative resection of brain tumors
Biopsies ●
Endoscopic procedures .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number

Prescription Use (Per 21 CFR 801.109	X
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OR Over-The-Counter Use ______(Optional Format 1-2-96)

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).