The Leksell® Image Guidance Surgical System (LIGS) is intended for use in cranial and spinal neurosurgical procedures to provide image guidance based on preoperative images which are visualized interactively with the aid of surgical tools. The LIGS System was cleared for commercial distribution under K973684 on March 31, 1998. The purpose of this special premarket 510(k) notification is to describe the changes in product specifications and system modifications. The LIGS System has not changed in its functionality or its indications for use. Technological enhancements have been made to the ViewScope/Elekta Insight Localization System and Surgical Tools. As a result of these enhancements, the software and instruction manuals have also been updated.

AI/ML Overview

Here’s an analysis of the acceptance criteria and the study information based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Product Accuracy and Repeatability	Found to be acceptable
Performed as intended	Performed as intended

Note: The document provides very generalized statements regarding acceptance criteria and performance. Specific numerical criteria or detailed performance metrics are not given.

Study Details

Sample size used for the test set and data provenance:
- Sample Size: Not specified. The study involved "simulated cranial and spinal models," but the number of models or tests conducted is not mentioned.
- Data Provenance: The study was conducted on "simulated cranial and spinal models," indicating it's an in-house performance test rather than using patient data (retrospective or prospective). The country of origin for the data is implicitly Sweden, as the company Elekta Instruments, AB, is based in Stockholm, Sweden, and likely conducted their own testing.
Number of experts used to establish the ground truth for the test set and their qualifications:
- This information is not provided in the document. The study was a technical performance test on simulated models, not a diagnostic study requiring expert human interpretation of images to establish ground truth.
Adjudication method for the test set:
- This information is not provided. Given it was a technical performance test on simulated models, an adjudication method for human experts is not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, an effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. The device in question is a surgical image guidance system, not an AI diagnostic tool that assists human readers in interpreting images. Therefore, the concept of improving human reader performance with AI assistance is not applicable to this device and its reported study.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance test was done. The "performance testing on simulated cranial and spinal models was conducted for product accuracy and repeatability" describes the standalone performance of the Leksell® Image Guidance Surgical System itself, without necessarily involving a human operator beyond initiating the tests and collecting data. The system's ability to provide image guidance and its localization technology were evaluated directly.
The type of ground truth used:
- The ground truth for the performance test would have been engineering specifications or known measurements on the simulated cranial and spinal models. For example, for "accuracy," the system's measurements would be compared against the precisely known real-world coordinates or distances within the simulated models.
The sample size for the training set:
- This information is not applicable/not provided. The Leksell® Image Guidance Surgical System is a navigation system, not an AI/machine learning algorithm that requires a "training set" in the conventional sense for image recognition or diagnostic tasks. Its functionality is based on established physics principles for localization and display, not learned patterns from data.
How the ground truth for the training set was established:
- This information is not applicable/not provided for the same reasons as #7.

Summary

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Leksell® Image Guidance Surgical System Special Premarket 510(k) Notification: Device Modifications

K992ff2

SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 18:

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.

SUBMITTER INFORMATION 18.1

a.	Company Name:	Elekta Instruments, AB
	b. Company Address:	Birger Jarlsgatan 53, S-103 93Stockholm, Sweden
	c. Company Phone:Company Facsimile:	(011) 46 8 5872 54 00(011) 46 8 5872 55 00
	d. Contact Person:	Sverker GlansVice PresidentQuality and Regulatory Affairs
	e. Date Summary Prepared:	August 24, 1999

DEVICE IDENTIFICATION 18.2.

a. Trade/Proprietary Name:	Leksell® Image Guidance Surgical System
b. Classification Name:	Stereotaxic Instrument21 CFR 882.4560

IDENTIFICATION OF PREDICATE DEVICES 18.3

Company	Device	510(k) No.	Date Cleared
ElektaInstruments, AB	Leksell® Image GuidanceSurgical System	K973684	03/31/98
BrainLAB	Vector Vision2	K983831	05/19/99

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DEVICE DESCRIPTION 18.4

SUBSTANTIAL EQUIVALENCE 18.5

The Leksell® Image Guidance Surgical System with its proposed modifications, is substantially equivalent to the current Leksell Image Guidance Surgical System and the BrainLAB Vector Vision2.

The fundamental technical characteristics of the LIGS System are similar to those of the predicate devices. The functionality and the indications for use have not changed with the proposed modifications. The addition of the wireless probe feature and use of illuminator infrared camera and universal instrument adapter is equivalent to the features found in the BrainLAB Vector Vision2 predicate device. The Indications for Use for the LIGS System is also is equivalent to the BrainLAB Vector Vision2 predicate device.

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18.6 INDICATIONS FOR USE

The Leksell® Image Guidance Surgical System (LIGS) is indicated for use in cranial and spinal neurosurgical procedures to provide image guidance based on preoperative images which are visualized interactively with the aid of surgical tools.

TECHNOLOGICAL CHARACTERISTICS 18.7

Modifications have been made to the Leksell® Image Guidance Surgical System in regards to the Elekta Insight/ViewScope models. The localization technology has been enhanced to include an illuminator infrared camera and reflective spheres on the instruments, allowing for wireless probe options. In addition, the surgical tools have been enhanced to include a Universal Instrument Adapter for fixation to the user's instruments. Comparison of the technological characteristics to those of the predicate devices has been provided in this submission.

18.8 PERFORMANCE DATA

Performance testing was conducted on the Elekta Insight/ViewScope 2.5. System and component testing was completed based on product specifications and hazard effects determined from the risk analysis. Performance testing on simulated cranial and spinal models was conducted for product accuracy and repeatability. All results of testing was found to be acceptable. The Leksell® Image Guidance Surgical System with the proposed modifications performed as intended.

18.9 510(K) CHECKLIST

This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewer's Checklist is provided in this submission.

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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 image of an eagle with its wings spread, facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 4 1999

Elekta Instruments, AB C/o Ms. Carol Patterson Consultant Patterson Consulting Group, Inc. 21911 Erie Lane Lake Forest, California 92630

Re: K992882 Trade Name: Leksell® Image Guidance Surgical System Regulatory Class: II Product Code: HAW Dated: August 24, 1999 Received: August 26, 1999

Dear Ms. Patterson:

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 Ouality 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.

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Page 2 - Ms. Carol Patterson

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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K992FF2

INDICATION FOR USE

To Be Assigned By FDA 510(k) Number:

Leksell® Image Guidance Surgical System Device Name:

Indications for Use: The Leksell® Image Guidance Surgical System (LIGS) is intended for use in cranial and spinal neurosurgical procedures to provide image guidance based on preoperative images which are visualized interactively with the aid of surgical tools.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Pallez

(Division Sign-Off) of General Restorative Devices K992882 510(k) Number

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

CONFIDENTIAL

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).