VIRTUOSO is a software-based planning system used to create treatment plans for radiation therapy with high-energetic phontons. It is used for patients which are selected for a precise radiation therapeutical treatment according to medical diagnosis. It may be used only by radiation therapeutical experts under medical supervision in rooms which are suitable for the operation of computers.

Device Description

The VIRTUOSO Stereotaxic Planning Software is a software-based planning system intended for the creation of treatment plans for radiation therapy with high-onergetic phontons.

AI/ML Overview

The provided documentation for VIRTUOSO Stereotaxic Planning Software (K991706) is very limited and primarily focuses on establishing substantial equivalence to a predicate device (STP treatment planning software K892425D) rather than detailing a specific study with acceptance criteria and performance metrics.

Based only on the provided text, the device's acceptance is based on its substantial equivalence to a previously marketed device, due to it not raising "any new safety and efficacy concerns." There is no detailed study described in the provided text that outlines specific acceptance criteria, performance metrics, or a rigorous validation against a ground truth dataset with expert input.

Therefore, many of the requested details about a specific performance study cannot be answered from the provided document.

Here's a breakdown of what can be inferred and what cannot:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Inferred from Substantial Equivalence Basis)	Reported Device Performance (Inferred)
Does not raise any new safety concerns compared to predicate.	Met
Does not raise any new efficacy concerns compared to predicate.	Met
Functions as a software-based planning system for radiation therapy with high-energetic photons.	Met (as per description and intended use)
Used by radiation therapeutical experts under medical supervision.	Met (as per intended use)
Used in rooms suitable for computer operation.	Met (as per intended use)

2. Sample size used for the test set and the data provenance:

Not explicitly stated. The document does not describe a performance study with a test set. The basis for equivalence is the lack of new safety/efficacy concerns compared to a predicate, not a direct performance measurement on a patient dataset.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not explicitly stated. No test set or ground truth establishment process is described in the provided document for this device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable/Not explicitly stated. The document does not describe a performance study that would involve adjudication.

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:

No. The document does not mention an MRMC study or any comparison of human readers with or without AI assistance. This device is described as a "planning software," implying direct use by experts rather than an AI assistance tool for human interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not explicitly stated as a formal study. The device is a "planning software," which by definition is an algorithm used by experts. Its performance is implicitly tied to its function for experts, but a formal "standalone" performance study of the algorithm independent of human use/review is not described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not explicitly stated. No specific ground truth methodology is mentioned as part of a performance study for this device.

8. The sample size for the training set:

Not applicable/Not explicitly stated. The document does not indicate that this device utilizes machine learning or requires a training set in the modern sense. It is described as planning software, implying rule-based or calculational processes rather than AI learning from data.

9. How the ground truth for the training set was established:

Not applicable/Not explicitly stated. As there is no mention of a training set, the establishment of ground truth for such a set is also not discussed.

Summary

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

K 99 1706

VIRTUOSO Summary of Safety and Effectiveness

Device Name:

Classification Name:	Instrument, Stereotaxic: 21 CFR 882.4560, Class II
Common/Usual Name:	Stereotaxic Planning Software
Proprietary Name:	VIRTUOSO – Stereotaxic Planning Software

Device Sponsor:

Manufacturer:	Stryker CorporationStryker Leibinger GmbH and Co. KGBotzinger Straße 41D-79111 Freiburg GermanyRegistration No.: 8010177
Distributor:	Stryker CorporationStryker Leibinger4100 E. Milham AvenueKalamazoo, MI 49001Registration No.: 1811755
Regulatory Class:	Class II

Summary of Safety and Effectiveness:

The VIRTUOSO Stereotaxic Planning Software is a software-based planning system intended for the creation of treatment plans for radiation therapy with high-onergetic phontons. It is used for patients which are selected for a precise radiation therapeutical treatment according to medical diagnosis. It may be used only by radiation therapeutical experts under medical supervision in rooms which are suitable for the operation of computers.

The VIRTUOSO Stereotaxic Planning Software is equivalent to the STP treatment planning software K892425D. The VIRTUOSO Stereotaxic Planning Software does not raise any new safety and efficacy concerns when compared to this similar legally marketed software. Therefore, the VIRTUOSO Stereotaxic Planning Software is substantially equivalent to this existing software.

By: Nicole Petty

Nicole Petty Regulatory Affairs Representative Stryker Instruments

Dated: 5-18-99

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

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 7 1999

Ms. Nicole Petty Regulatory Affairs Analyst Stryker Corporation 4100 East Milham Avenue Kalamazoo, Michigan 49001

Re: K991706 Trade Name: VIRTUOSO Stereotactic Planning Software Regulatory Class: II Product Code: HAW Dated: September 20, 1999 Received: September 21, 1999

Dear Ms. Petty:

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 (OS) 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.

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

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 vour 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,

pcollyer

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use Statement

510(k) K 99/706
Number

Number

VIRTUOSO - Stereotaxic Planning Software Device Name

VIRTUOSO is a software-based planning system used to create treatment plans Indications for radiation therapy with high-energetic phontons. It is used for patients which are selected for a precise radiation therapeutical treatment according to medical diagnosis. It may be used only by radiation therapeutical experts under medical supervision in rooms which are suitable for the operation of computers.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)
------------------------------------------	--

Over-The-Counter Use
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K991706

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).