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 Passive Tool Option for the ViewPoint system allows for optical tracking of wireless tools. The position sensor assembly provided with this option emits an infrared signal that is reflected off reflective markers mounted on the tools.

AI/ML Overview

This document describes the ViewPoint Passive Tool Option, a Class II Image Assisted Surgery Device. The submission focuses on demonstrating substantial equivalence to a predicate device (ViewPoint 3.0 Software, K970604) rather than presenting a standalone study with detailed performance metrics and acceptance criteria in the conventional sense (e.g., sensitivity, specificity, accuracy against a gold standard).

Here's an analysis based on the provided text, addressing the requested points:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ViewPoint Passive Tool Option are implicitly defined by demonstrating substantial equivalence to the predicate device, K970604. Specifically, the key performance parameter directly mentioned and compared is "Average Tool Accuracy."

Acceptance Criteria (from Predicate Device K970604)	Reported Device Performance (ViewPoint Passive Tool Option)	Met?
Average Tool Accuracy: 2.0 - 5.0 mm	"Same" as predicate device	Yes
Tools: A long and short tool with a minimum of four IREDs per tool.	A long and short wireless tool with a minimum of three reflective markers per tool.	Yes (conceptually equivalent in function)
Type of Detector: Infrared signals emitted from diodes on a hand-held tool are detected by a Position Sensor Assembly (PSA) with two optical detectors.	Infrared signals emitted from the PSA are reflected off of reflective markers mounted on the tool. The reflected signal is detected by the PSA with two optical detectors.	Yes (conceptually equivalent in function)
Active Digitizer Volume: Silo shape comprised of 0.5m radius hemisphere and a cylinder with 0.5m radius and 0.5m length.	"Same"	Yes
Registration Technique: Scanned Fiducials and Anatomical Fiducials.	"Same"	Yes
Operating Software Structure: UNIX environment with three major processes: Import, Surgery Application and Foot Switch. Uses a Graphical User Interface.	"Same"	Yes
Image Manipulation: MPR and surface rendering.	"Same"	Yes
Other Features: Detector Positioning Feature.	"Same"	Yes
Intended Use: As stated for the predicate device.	"Same"	Yes
Indications for Use: As stated for the predicate device.	"Same"	Yes

Note: The primary "acceptance criteria" here is substantial equivalence. The document does not describe specific numerical thresholds for new standalone performance tests beyond comparison to the predicate. The "Average Tool Accuracy" is the only direct numerical performance metric mentioned.

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

The document does not describe a separate "test set" in the context of a clinical study or performance evaluation with a specific number of instances. The evaluation is primarily a comparative analysis against a predicate device's specifications.

Therefore:

Sample size for the test set: Not applicable, as no new test set (e.g., patient cases) for performance evaluation is described.
Data provenance: Not applicable. The "data" here refers to the design specifications and performance claims of the predicate device, not patient data.

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

Not applicable. As there is no described test set of patient cases requiring ground truth establishment, no experts were used for this purpose in the context of this submission. The ground truth for the predicate device's performance would have been established during its own clearance process, but that information is not provided here.

4. Adjudication Method for the Test Set

Not applicable. No new test set for performance evaluation is described.

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 device is an "Image Assisted Surgery Device Option" and not an AI/CADe system designed for interpreting diagnostic images. It provides orientation and reference information during surgery, not interpretive assistance for image diagnosis. Therefore, an MRMC study comparing human reader performance with and without "AI assistance" is not relevant to this device's function or the information provided.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device itself is a "Passive Tool Option" for an "Image Assisted Surgery Device," meaning it's a component designed to be used with a human surgeon for intra-operative guidance. Its function is to track tools. The "Average Tool Accuracy" of 2.0 - 5.0 mm represents a standalone performance characteristic of the tool tracking system itself, independent of a specific surgical outcome. However, this is a technical specification, not an "algorithm-only" performance in the sense of an AI model's diagnostic output.

So, while the tool accuracy is a standalone metric, it's not a standalone clinical performance study in the way an AI diagnostic algorithm would be evaluated. The document states the "Average Tool Accuracy" for the predicate device is 2.0-5.0mm, and the new device performs the "Same."

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the key performance metric of "Average Tool Accuracy" (2.0 - 5.0 mm), the ground truth would typically be established by precise, independent measurement systems in a controlled laboratory or phantom setting using known reference points. This is a technical specification, not a clinical ground truth related to patient disease. The document does not specify how the predicate device's accuracy was measured, only that the new device's accuracy is "Same."

8. The Sample Size for the Training Set

Not applicable. This device is a hardware option for an image-assisted surgery system and its performance is evaluated through engineering comparisons. It does not appear to be an AI/machine learning device that requires a training set in the conventional sense.

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

Not applicable, as there is no described training set.

Summary

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3/30/99

SUMMARY C TY AND EFFECTIVENESS (As required by 21 CFR 807.92)

1.	General Information
	Classification:	Class IIImage Assisted Surgery Device
	Common/Usual Name:	Image Assisted Surgery Device Option
	Proprietary Name:	ViewPoint Passive Tool 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 Passive Tool 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 t resection of spinal neoplasms.

3. Device Description

PICKER INTERNATIONAL, INC.	(PASSIVE) 03/12/99	I - 1
----------------------------	--------------------	-------

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Safety and Effectiveness 4.

The ViewPoint system with the Passive Tool 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 Passive Tool Option	Predicate Device - ViewPoint 3.0Software (K970604)
Tools	A long and short wireless toolwith a minimum of threereflective markers per tool.	A long and short tool with a minimumof four IREDs per tool.
Average Tool Accuracy	Same.	2.0 - 5.0 mm
Type of Detector	Infrared signals emitted from thePosition Sensor Assembly (PSA)are reflected off of reflectivemarkers mounted on the tool.The reflected signal is detected bythe PSA with two opticaldetectors. The assembly is eitheron a mobile pedestal, mounted tothe OR table or mounted to theceiling.	Infrared signals emitted from diodeson a hand-held tool are detected by aPosition Sensor Assembly with twooptical detectors. The assembly iseither on a mobile pedestal, mountedto the OR table or mounted to theceiling.
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.
Operating SoftwareStructure	Same.	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.
Parameter	ViewPoint Passive Tool Option	Predicate Device - ViewPoint 3.0Software (K970604)
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 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.

Substantial Equivalence Chart

PICKER INTERNATIONAL, INC.

03/12/99 (PASSIVE)

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Image /page/3/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 eagle-like symbol with three curved lines representing the bird's body and wings.

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

K990868 Re: Trade Name: ViewPoint Passive Tool 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,

Celina 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): _

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

ViewPoint Passive Tool Option Device Name:

Indications for Use:

The ViewPoint Passive Tool 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off)
Division	General Restorative Devices
510(k) Number	K990868

Prescription Use (Per 21 CFR 801.109)

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).