The ViewPoint is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-operative procedures.

The ViewPoint is indicated for use in:

Intra-cranial surgical procedures involving space occupying lesions or malformations (including soft tissue, vascular and osseous)
Spinal surgical procedures involving spinal stabilization, neural decompression, or resection of spinal neoplasms.

Device Description

The Microscope Option for the ViewPoint system allows for optical tracking of a surgical microscope. The tip of the tool in this case is the focal point of the Microscope instead of the physical end of the instrument. This option gives the user the ability to see crosssectional images that correspond with the anatomy viewed through the microscope.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the ViewPoint Microscope Option, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Predicate Device)	Reported Device Performance (ViewPoint Microscope Option)
Average Tool Accuracy	2.0 - 5.0 mm	Same (implies 2.0 - 5.0 mm)

Note: The provided document is a 510(k) submission summary focusing on demonstrating substantial equivalence to a predicate device (ViewPoint 3.0 Software K970604). Therefore, the "acceptance criteria" for the ViewPoint Microscope Option is simply that its performance parameters are "Same" as the predicate device. It doesn't explicitly state new, distinct acceptance criteria for the Microscope Option itself, but rather indicates it maintains the performance of the established system.

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify a test set sample size or data provenance (e.g., country of origin, retrospective/prospective) for the ViewPoint Microscope Option.

This submission relies on demonstrating substantial equivalence to a previously cleared device. It effectively states that the Microscope Option does not change the core functionality or performance characteristics (like tool accuracy) of the existing ViewPoint system.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

The provided document does not mention a specific test set requiring ground truth established by experts for this 510(k) submission. The submission is a comparison to a predicate device, not a de novo study with novel performance claims requiring expert-labeled ground truth for an independent test set.

4. Adjudication Method for the Test Set

The provided document does not mention any adjudication method for a test set, as no specific test set requiring expert adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The provided document does not mention a multi-reader, multi-case (MRMC) comparative effectiveness study. The submission centers on technological equivalence rather than human reader performance with or without AI assistance.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

The ViewPoint Microscope Option is an "Image Assisted Surgery Device" that provides "orientation and reference information during intra-operative procedures." It is inherently a device that assists a human (the surgeon). Therefore, a purely standalone algorithm only performance as might be seen in diagnostic AI would not be directly applicable or tested in this context. The document does not describe such a study.

7. Type of Ground Truth Used

The concept of "ground truth" as typically defined in diagnostic AI studies (e.g., pathology, outcomes data) is not directly applicable or explicitly mentioned in this 510(k) submission. This device aids surgery, and its metrics (like tool accuracy) would typically be validated against physical measurements and engineering specifications, often using phantoms or established calibration methods, rather than clinical ground truth diagnoses. The core ground truth for equivalence is the proven performance specifications of the predicate device.

8. Sample Size for the Training Set

The provided document does not mention a training set sample size. This device is not an AI/ML algorithm in the modern sense that undergoes supervised training on a dataset. It's a system (software and hardware) designed to perform specific tracking and display functions for surgical navigation.

9. How the Ground Truth for the Training Set Was Established

Given that this is not an AI/ML device that requires a "training set" in the conventional sense, the establishment of "ground truth for the training set" is not applicable and therefore not described in the document.

Summary

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3/30/99

K990860

SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92)

General Information 1.

Classification:	Class IIImage Assisted Surgery Device
Common/Usual Name:	Image Assisted Surgery Device Option
Proprietary Name:	ViewPoint Microscope Option
Establishment Registration:	Picker International, Inc.World Headquarters595 Miner RoadHighland Heights, Ohio 44143Contact: Elaine K. Keeler, Ph.D.Phone Number: (440) 473-3000FDA Owner Number: #1580240FDA Registration Number: #1525965
Performance Standards:	No applicable performance standards have beenissued under section 514 of the Food, Drug andCosmetic Act.

2. Intended Uses

The ViewPoint Microscope Option does not change the existing intended use and indications for use for the ViewPoint as defined below.

The ViewPoint is indicated for use in:

Intra-cranial surgical procedures involving space occupying lesions or malformations (including soft tissue, vascular and osseous)
Spinal surgical procedures involving spinal stabilization, neural decompression, or resection of spinal neoplasms.

PICKER INTERNATIONAL, INC.	(MICRO)	03/11/99	I-1
----------------------------	---------	----------	-----

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Device Description 3.

Safety and Effectiveness 4.

The ViewPoint system with the Microscope Option is substantially equivalent to the ViewPoint system described in the 510(k) submission K970604. The following chart has been compiled to demonstrate this substantial equivalency.

Parameter	ViewPoint Microscope Option	Predicate Device - View Point 3.0Software (K970604)
Tools and Accessories	Same tools as previoussubmission with the additionalcapability of using a surgicalmicroscope.	Probe with various length tips, drillguide, tracking device (head andspine), and phantoms. Each trackabletool has a minimum of four IREDs.
Average Tool Accuracy	Same.	2.0 - 5.0 mm
Type of Detector	Same.	Infrared signals emitted from diodeson a tool are detected by a PositionSensor Assembly with two opticaldetectors. The assembly is either on amobile pedestal, mounted to the ORtable or mounted to the ceiling.
Active Digitizer Volume	Same.	Silo shape comprised of 0.5m radiushemisphere and a cylinder with 0.5mradius and 0.5m length. DetectorPositioning Feature added to guideuser in finding center of activedigitizer volume.
Registration Technique	Same.	Scanned Fiducials and AnatomicalFiducials.

Substantial Equivalence Chart

PICKER INTERNATIONAL, INC.

(MICRO) 03/11/99

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Parameter	ViewPoint Microscope Option	Predicate Device - ViewPoint 3.0Software (K970604)
Operating SoftwareStructure	Same with some additions to theSurgery Application toaccommodate the MicroscopeOption.	UNIX environment with three majorprocesses: Import, SurgeryApplication and Foot Switch. Uses aGraphical User Interface to facilitateinteraction with user.
Image Manipulation	Same.	MPR and surface rendering.
Other Features	Same.	Detector Positioning Feature.
Intended Use	Same.	The ViewPoint is intended for use as adevice which uses diagnostic images ofthe patient acquired specifically toassist the physician with presurgicalplanning and to provide orientationand reference information during intra-operative procedures.
Indications for Use	Same.	The ViewPoint is indicated for use in:- Intra-cranial surgical proceduresinvolving space occupying lesionsor malformations (including softtissue, vascular and osseous)- Spinal surgical proceduresinvolving spinal stabilization,neural decompression, or resectionof spinal neoplasms.

PICKER INTERNATIONAL, INC.

(MICRO) 03/11/99

I - 3

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with flowing lines above them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 0 1999

Elaine K. Keeler, Ph.D. Manager, Clinical Science Picker International, Inc. 595 Miner Road Highland Heights, Ohio 44143

K990860 Re: Trade Name: ViewPoint Microscope Option Regulatory Class: II Product Code: HAW Dated: March 12, 1999 Received: March 16, 1999

Dear Dr. Keeler:

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 action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does 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.

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Page 2 - Elaine K. Keeler, Ph.D.

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 premarket notification" (21 CFR 807.97). Other general 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.gov/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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Page 1 of 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

ViewPoint Microscope Option Device Name:

Indications for Use:

The ViewPoint Microscope Option does not change the existing intended use and indications for use for the ViewPoint as defined below.

The ViewPoint is indicated for use in:

Intra-cranial surgical procedures involving space occupying lesions or malformations (including soft tissue, vascular and osseous)
cluding soll though varial and observinal stabilization, neural decompression, or resection of spinal neoplasms.

(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	K990860
Prescription Use(Per 21 CFR 801.109)	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).