The Leksell Stereotactic System is a stereotaxic instrument and accessories which functions on the center-of-the-arc principle. The basic components of the system are a cartcsian coordinate frame and a semi-circular arc. The system has been developed as a modular design with dedicated components and a range of optional accessories. Accessories are available for stereotactic micro-surgery and functional interventions, target localization, diagnostic and therapeutic procedures, and Gamma Knife surgery.

AI/ML Overview

The provided text describes a 510(k) submission for the Elekta Leksell Stereotactic System, where the device is demonstrated to be substantially equivalent to predicate devices. The submission focuses on product characteristics and performance relative to existing, cleared devices, rather than a standalone clinical study with specific acceptance criteria in the manner of a novel AI/software medical device.

Therefore, much of the requested information (such as specific performance metrics, sample sizes, expert qualifications, and ground truth methodologies often associated with AI/ML evaluations) is not present in this type of traditional medical device submission.

Here's an analysis based on the provided text, highlighting what can be extracted and what information is not available:

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

Acceptance Criteria (Implied)	Reported Device Performance
Accuracy and Repeatability in performing its intended function.	"The Leksell Stereotactic System has been demonstrated to perform as intended with accuracy and repeatability."
Material Compatibility with MR scanners of low frequencies.	"The system have been shown to be compatible when used in MR scanners of low frequencies."
Technological Equivalence to predicate devices.	"[Fundamental technical characteristics are] similar to those of the predicate devices and are listed on the comparison charts provided in this 510(k) submission."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Available. The document states "Complete results of performance testing of the Leksell Stereotactic System have been included the 510(k) submission," but the specific details of the test set, including sample size or data provenance, are not provided in this summary. This generally pertains to engineering bench testing rather than clinical study data for this type of device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable/Not Available. For a stereotactic system, "ground truth" would typically refer to physical measurements or engineering precision rather than expert human interpretation of medical images to establish a diagnosis or finding. The document does not describe the use of human experts in this manner.

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

Not Applicable/Not Available. Adjudication methods are typically used in studies involving human interpretation or subjective assessments. The performance testing for this device would likely involve objective physical measurements and engineering specifications, where adjudication is not typically relevant.

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. This is not an AI/software device. It is a physical stereotactic system. Therefore, an MRMC study and effects on human readers with/without AI assistance are not relevant to this submission.

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

Not Applicable. This is a physical medical device, not an algorithm. Its performance is inherent to its mechanical and functional design, often evaluated in a standalone bench-testing environment.

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

Implied: For a stereotactic system, the "ground truth" would be established through precision engineering measurements and physical accuracy standards. This would involve comparing the system's calculated coordinates and physical targeting capabilities against known, independently verified reference points or specifications. However, the specific methodology is not detailed.

8. The sample size for the training set

Not Applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not Applicable. This device is not an AI/ML algorithm that requires a training set.

Summary

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Elekta Instruments AB Elexanse to $10(k) #K972324 Deficiencies February 16, 1998

MAR - 2 1998

K972324

SUMMARY OF SAFETY AND EFFECTIVENESS

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, AB
b.	Company Address:	Birger Jarlsgatan 53, S-103, 93Stockholm, Sweden
c.	Company Phone:Company Fax:	(011) 46 8402 5400(011) 46 8402 5500
d.	Contact Person:	Sverker GlansVice PresidentQuality and Regulatory AffairsElekta, AB
e.	Date Summary Prepared:	April 14, 1997

18.2. DEVICE IDENTIFICATION

a.	Trade/Proprietary Name:	Leksell Stercotactic System
b.	Classification Name:	Stereotaxic Instrument and Accessories

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Elekta Instruments AB Response to 510(k) #K972324 Deficiencies February 16, 1998

IDENTIFICATION OF PREDICATE DEVICE 18.3

Company	Device	510(k) No.	Date Cleared
Radionics	Cosman-Robert-WellsStereotactic System	K934523	February 8, 1995
Leibinger &F.L. Fischer	ZD NeurosurgicalLocalizing Unit	K892425	March 23, 1990

DEVICE DESCRIPTION 18.4

18.5 SUBSTANTIAL EQUIVALENCE

The Leksell Stereotactic System is substantially equivalent to other stereotactic systems currently in commercial distribution by Radionics and Leibinger & Fischer in terms of intended use for localization (spatial reference) for cranial surgery using X-Ray, or CT and MRI image data.

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Elekta Instruments AB Response to 510(k) #K972324 Deficiencies February 16, 1998

The fundamental technical characteristics are similar to those of the predicate devices and are listed on the comparison charts provided in this 510(k) submission.

18.6 INTENDED USE

The Elekta Leksell Stereotactic System and Accessories is intended for localization (spatial reference) for cranial surgery using X-Ray, or CT and MRI image data.

18.7 TECHNOLOGICAL CHARACTERISTICS

A comparison of the technological characteristics of the predicate and legally marketed devices is provided within this submission.

18.8 PERFORMANCE DATA

The Leksell Stereotactic System has been demonstrated to perform as intended with accuracy and repeatability. The system have been shown to be compatibile when used in MR scanners of low frequencies. Complete results of performance testing of the Leksell Stereotactic System have been included the 510(k) 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" around the perimeter. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Carol Patterson Consultant for Elekta Instruments AB Patterson Consulting Group, Inc. 18140 Smokesignal Drive San Diego, California 92127

K972324 Re: Leksell® Stereotactic System Trade Name: Regulatory Class: II Product Code: HAW December 1, 1997 Dated: December 2, 1997 Received:

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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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. ਉ 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 requlation may result in requlatory In addition, FDA may publish further announcements action. 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.

MAR - 2 1998

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Page 2 - Ms. 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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Elekta Instruments AB Response to 510(k) #K972324 Deficiencies February 16, 1998

INDICATIONS FOR USE

510(k) Number:	To Be Assigned By FDA K972324
Device Name:	Elckta Leksell® Stereotactic System
Indications For Use:	The Leksell Stereotactic System is a system intended for localization (spatial reference) for cranial surgery using X-

Ray, or CT and MRI image data.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use Prescription Use OR (Per 21 CFR 801.109)

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).