The intended use of the ViewPoint is unchanged by the 3.0 software, but the indications for use have been expanded to include spinal surgical procedures. The intended use and indications for use are as follows:

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 new features in the 3.0 Software include a detector positioning feature and support for the following optional hardware accessories: a tracking device, drill guides and a CT spine phantom. The indications for use of the ViewPoint have also been expanded to include use in spinal surgeries.

AI/ML Overview

The provided text describes a 510(k) submission for the ViewPoint - 3.0 Operating Software, focusing on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with specific acceptance criteria and performance data. Therefore, many of the requested details about acceptance criteria, study design parameters (like sample size, number of experts, adjudication methods), and specific performance metrics for the device itself are not explicitly stated within the provided document.

The document highlights the substantial equivalence of the ViewPoint 3.0 software to its predicate device (ViewPoint & Optical Digitizer Option - K961168, K963221). The "Acceptance Criteria" here are implicitly linked to demonstrating that the new software maintains the safety and effectiveness characteristics of the predicate device, particularly its accuracy and intended use, while expanding its indications to include spinal surgery.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, measurable form for the ViewPoint 3.0 software as if it were a new device proving its efficacy. Instead, it demonstrates substantial equivalence to a predicate device. The "performance" is primarily described in terms of matching or improving upon the predicate device's specifications.

Parameter	Predicate Device Performance / Acceptance (Implicit)	ViewPoint with 3.0 Software Performance	Device Meets Acceptance Criteria?
Average Tool Accuracy	2.0 - 5.0 mm (from K961168)	Same (2.0 - 5.0 mm)	Yes (Matches predicate)
Active Digitizer Volume	Silo shape, with 1 meter diameter and 1 meter length (from K963221)	Same (Silo shape, 1m diameter, 1m length) with Detector Positioning Feature added	Yes (Matches predicate, with enhancement)
Intended Use	Uses diagnostic images to assist presurgical planning and intra-operative orientation (from K961168)	Same	Yes (Matches predicate)
Indications for Use	Intra-cranial surgical procedures (K961168)	Expanded to include Intra-cranial and Spinal Surgical procedures	Yes (Expands on predicate)
Tools	A long and short tool with a minimum of four IREDs per tool (K963221)	Same	Yes (Matches predicate)
Type of Detector	Infrared signals from diodes detected by a Position Sensor Assembly (K963221)	Same	Yes (Matches predicate)
Accessories	MR/CT Head Phantoms (K961168)	Expanded to include MR/CT Head Phantoms, CT Spine Phantom, Tracking device, Drill Guide	Yes (Expands on predicate)
Registration Technique	Scanned Fiducials (K961168)	Expanded to include Scanned Fiducials and Anatomical Fiducials	Yes (Expands on predicate)
Operating Software Structure	UNIX environment with three processes (Import, Surgery Application, Foot Switch), Graphical User Interface	Same structure. Modified Graphical User Interface with similar functionality	Yes (Matches predicate, with similar functionality)
Image Manipulation	MPR and surface rendering	Same	Yes (Matches predicate)
Other Features	None (K961168)	Detector Positioning Feature	Yes (New feature, presumably beneficial)

2. Sample Size for the Test Set and Data Provenance

The document does not describe a specific test set or clinical study for the ViewPoint 3.0 software in this submission. Its approach is to demonstrate substantial equivalence to previously cleared predicate devices. Therefore, details like sample size, country of origin, or retrospective/prospective nature of a test set are not provided for the 3.0 software itself. The basis for "Average Tool Accuracy" (2.0 - 5.0 mm) would have been established in the predicate device’s 510(k) (K961168), but the specifics of that study are not included here.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

Not applicable, as no new test set study for the 3.0 software is described in this submission. The ground truth for the predicate device's accuracy would have been established during its clearance.

4. Adjudication Method (Test Set)

Not applicable, as no new test set study for the 3.0 software is described.

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

No MRMC study is mentioned. This submission focuses on hardware and software feature equivalence and expansion of indications rather than comparative effectiveness with or without AI assistance for human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

The ViewPoint system is an "Image Assisted Surgery Device," meaning it is inherently designed for "human-in-the-loop" use to assist the physician. Therefore, a standalone (algorithm only) performance assessment would not be applicable or relevant to its intended use. The "Average Tool Accuracy" is a standalone technical specification of the device's measurement capabilities.

7. Type of Ground Truth Used

For the predicate device's accuracy, the ground truth would likely be established by precise physical measurements (e.g., using a coordinate measuring machine or similar high-precision measurement system on phantoms) to verify the tool's reported position against its true physical position. For the 3.0 software, the ground truth for its new features (like Detector Positioning Feature, support for CT Spine Phantom, Anatomical Fiducials) would be centered around functional verification and validation that these features operate as intended and maintain the previously established accuracy.

8. Sample Size for the Training Set

The document does not describe the development or training of an AI algorithm in the contemporary sense. This device (from 1997) is an early image-assisted surgery system, not a machine learning-based AI device that typically relies on "training sets." Its "operating software" refers to conventional programming.

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

Not applicable, as there is no mention of a training set for a machine learning model.

Summary

{0}------------------------------------------------

K970604

SUMMARY OF SAFETY AND EFFECTIVENESS

(As required by 21 CFR 807.92)

MAY 1 9 1997

General Information 1.

Classification:	Class IIImage Assisted Surgery Device
Common/Usual Name:	Image Assisted Surgery Device Option
Proprietary Name:	ViewPoint - 3.0 Operating Software
Establishment Registration:	Picker International, Inc.World Headquarters595 Miner RoadHighland Heights, Ohio 44143FDA Owner Number: #1580240FDA Registration Number: #1525965
Performance Standards:	No applicable performance standards have beenissued under section 514 of the Food, Drug andCosmetic Act.
	The device does comply with the draft voluntaryindustry standard titled "Neurological Standard foImage-Interactive Stereotactic and LocalizationSystems (ASTM 10th Draft 9/94)."

2. Intended Use and Indications for Use

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.	(VIEW30)	2/11/97	I-1
----------------------------	----------	---------	-----

{1}------------------------------------------------

3. Device Description

Safety and Effectiveness 4.

The ViewPoint System operating with the 3.0 software is substantially equivalent to the ViewPoint System described in the 510(k) submissions K961168 and K963221. The following chart has been compiled to demonstrate the substantial equivalence of the ViewPoint operating with the 3.0 software to the predicate device.

Parameter	Predicate DeviceViewPoint & Optical DigitizerOption (K961168, K963221)	ViewPoint with 3.0 Software
Tools	A long and short tool with aminimum of four IREDs per tool.(See K963221)	Same.
Average Tool Accuracy	2.0 - 5.0 mm (See K961168)	Same.
Type of Detector	Infrared signals emitted fromdiodes on a hand-held tool aredetected by a Position SensorAssembly with two opticaldetectors. The assembly is eitheron a mobile pedestal, mounted tothe OR table or mounted to theceiling. (See K963221)	Same.
Active Digitizer Volume	Silo shape, with 1 meter diameterand 1 meter length.(See K963221)	Same, Detector PositioningFeature added to guide user infinding center of active digitizervolume.
Accessories	MR/CT Head Phantoms.(See K961168)	MR/CT Head Phantoms, CTSpine Phantom, Trackingdevice, Drill Guide.
Parameter	Predicate DeviceViewPoint & Optical DigitizerOption (K961168, K963221)	ViewPoint with 3.0 Software
Registration Technique	Scanned Fiducials.(See K961168)	Scanned Fiducials andAnatomical Fiducials.
Operating SoftwareStructure	UNIX environment with threemajor processes: Import, SurgeryApplication and Foot Switch.Uses a Graphical User Interface tofacilitate interaction with user.	Same structure. ModifiedGraphical User Interface withsimilar functionality.
Image Manipulation	MPR and surface rendering.	Same.
Other Features	None.(See K961168)	Detector Positioning Feature.
Intended Use	The ViewPoint is intended for useas a device which uses diagnosticimages of the patient acquiredspecifically to assist the physicianwith presurgical planning and toprovide orientation and referenceinformation during intra-operativeprocedures. (See K961168)	Same.
Indications for Use	The ViewPoint is indicated foruse in intra-cranial surgicalprocedures involving spaceoccupying lesions ormalformations (including softtissue, vascular and osseous).(See K961168)	The ViewPoint is indicated foruse in:• Intra-cranial surgicalprocedures involving spaceoccupying lesions ormalformations (including softtissue, vascular and osseous)• Spinal surgical proceduresinvolving spinal stabilization,neural decompression, orresection of spinal neoplasms.

SUBSTANTIAL EQUIVALENCE CHART

PICKER INTERNATIONAL, INC.

(VIEW30)

2/11/97

I - 2

{2}------------------------------------------------

PICKER INTERNATIONAL, INC.

(VEW30)

2/11/97

I - 3

قوب سابق

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of a caduceus, a symbol often associated with medicine and healthcare.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 9 1997

Elaine K. Keeler, Ph.D. Manager, Clinical Science Picker International, Inc ... . . . 5500 Avion Park Drive Highland Heights, Ohio 44143

Re : K970604 ViewPoint - 3.0 Operating Software Trade Name: Requlatory Class: II Product Code: 84HAW Dated: February 14, 1997 Received: February 18, 1997

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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 requlations.

{4}------------------------------------------------

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological 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): ____________________________________________________________________________________________________________________________________________________

Device Name: ViewPoint - 3.0 Operating Software

Indications for Use: ..... .... .... .... . . ... . . . . .

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)

Thomas J. Callahan

(on-Off)
Cardiovascular, Respiratory,
Devices

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).