The Leksell® Gamma Knife Target System Model 24001 is a teletherapy device indicated for use in the stereotactic irradiation of intracranial structures

Device Description

The Leksell® Gamma Knife Target System is an upgraded version of the currently available Leksell® Gamma Knife device. The device is intended for the stereotactic irradiation of intracranial structures and is composed of seven basic components. The Leksell® Gamma Knife Target System receives data from the Leksell Gamma Plan software. The Target System is composed of a Computerized Control System, Automatic Positioning System, Couch, Radiation Unit and Patient Surveillance System. The patient's head is fixated by the Leksell Stereotactic Coordinate Frame.

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a specific study that proves the device meets those criteria in the way typically expected for medical device performance studies (e.g., clinical trials with specific endpoints, statistical analyses, and a defined patient cohort).

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics and general performance testing.

Here's an analysis of the provided information, addressing your points where possible:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not explicitly defined as quantitative criteria (e.g., sensitivity, specificity, accuracy).	"The Leksell® Gamma Knife Target System has been demonstrated to perform as intended with accuracy and repeatability."
Implicitly: Performance matching or exceeding the predicate device in terms of "stereotactic irradiation of intracranial structures."	"The fundamental technical characteristics are similar to those of the predicate devices..."
Implicitly: Software and hardware functionality.	"Testing of the software and hardware components of the device have also been completed."
Implicitly: System integration.	"Integration testing and complete system testing have also been performed."

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

The document does not specify a "test set" in terms of patient data or clinical cases. The performance data mentioned relates to system-level technical testing rather than clinical study data. Therefore, there's no information on sample size, country of origin, or whether it was retrospective or prospective.

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

Not applicable. As no clinical "test set" is described, there's no mention of experts establishing ground truth for such a set. The performance testing appears to be technical validation.

4. Adjudication method for the test set

Not applicable. No clinical test set or adjudication process 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 a radiation therapy system, not an AI-assisted diagnostic or treatment planning tool that would involve human readers or AI assistance in that context. The "Target System" receives data from "Leksell Gamma Plan software," but the submission does not describe it as an AI system requiring an MRMC study.

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

Not applicable. This is not an AI algorithm. The performance testing mentioned refers to the functionality and accuracy of the device's hardware and software components.

7. The type of ground truth used

For the technical performance testing, the "ground truth" would likely be based on engineering specifications, known physical properties (e.g., radiation dose distribution accuracy), and comparison to the predicate device's established performance. The document doesn't specify how this technical "ground truth" was established beyond "testing of the software and hardware components."

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. No training set is involved.

Summary of the Study:

The "study" presented in this 510(k) summary is not a clinical trial or a performance study in the sense of evaluating diagnostic accuracy or treatment efficacy on patient data. Instead, it's a technical performance evaluation and a demonstration of substantial equivalence to a previously cleared device (Leksell® Gamma Unit Model 23004, Type B).

The 510(k) submission primarily relies on the following to demonstrate that the device performs as intended:

Comparison of Technological Characteristics: The new device (Leksell® Gamma Knife Target System Model 24001) shares fundamental technical characteristics with its predicate, including the same radiation unit (Cobalt 60 through 201 collimator sources), receiving treatment planning data from Leksell® Gamma Plan software, and patient head fixation with the Leksell® Stereotactic Coordinate Frame.
System-level Performance Testing: The document states that the device has undergone testing at the system and subsystem levels, including software and hardware components, integration testing, and complete system testing. The results of these tests are stated to have been included in other sections of the submission (Sections 13, 15, and 16), which are not provided here. The conclusion drawn from these tests is that the device "has been demonstrated to perform as intended with accuracy and repeatability."

This type of submission often focuses on demonstrating that changes introduced in a new model do not raise new questions of safety or effectiveness and that the device performs equivalently to an already-cleared device. Specific quantitative clinical performance metrics (like sensitivity, specificity, or survival rates) are typically not required for this type of substantial equivalence submission unless significant changes impacting clinical outcomes are introduced.

Summary

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

MAY 2 1 1999

K984328

SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 19:

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 19.1

a.	Company Name:	Elekta Instruments, AB
b.	Company Address:	Birger Jarlsgatan 53, S-103, 97Stockholm, Sweden
c.	Company Phone:Company Fax:	(011) 46 8 5872 54 00(011) 46 8 5872 55 00
d.	Contact Person:	Sverker GlansVice PresidentQuality and Regulatory AffairsElekta Instruments, AB
e.	Date Summary Prepared:	November 20, 1998

19.2. DEVICE IDENTIFICATION

a.	Trade/Proprietary Name:	Leksell® Gamma Knife Target SystemModel 24001
b.	Classification Name:	Radionuclide Radiation Therapy Device21 CFR 892.5750

IDENTIFICATION OF PREDICATE DEVICE 19.3

Company	Device	510(k) No.	Date Cleared
Elekta Instruments	Leksell Gamma UnitModel 23004, Type B	K924849	November 20, 1995

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

19.4 DEVICE DESCRIPTION

19.5 SUBSTANTIAL EQUIVALENCE

The Leksell® Gamma Knife Target System Model 24001 is substantially equivalent to previous version of the Leksell® Gamma Knife Model 23004 currently in commercial distribution by Elekta Instruments. The Leksell® Gamma Knife Target System and the predicate device are both indicated for the stereotactic irradiation of intracranial structures.

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.

19.6 INTENDED USE

The Elekta Instruments Leksell® Gamma Knife Target System Model 24001 is intended for the stereotactic irradiation of intracranial structures.

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

19.7 TECHNOLOGICAL CHARACTERISTICS

A complete comparison of the technological characteristics of the predicate is provided within this submission. Both the predicate and Target System are composed of the same radiation unit using Cobalt 60 through 201 collimator sources. The Target System and the predicate receive treatment planning data from the Leksell® Gamma Plan software program. In both devices, the patient's head is fixated by the Leksell® Stereotactic Coordinate Frame.

19.8 PERFORMANCE DATA

The Leksell® Gamma Knife Target System has been demonstrated to perform as intended with accuracy and repeatability. The Leksell® Gamma Knife Target System has been tested on the system and subsystem level. Through testing of the software and hardware components of the device have also been completed. Integration testing and complete system testing have also been performed. Results of performance testing, software and hardware testing of the Leksell® Gamma Knife Target System have been included in Sections 13, 15, and 16 of this submission.

19.9 510(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.

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

Rockville MD 20850

Food and Drug Administration 9200 Corporate Boulevard

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human figures or birds in flight.

MAY 2 1 1999

Elektra Instruments AB C/O Carol Patterson Consultant 18140 Smokesignal Drive San Diego, California 92127 RE:

K984328 Gamma Knife: Dated: May 17, 1999 Received: May 18, 1999 Regulatory Class: II 21 CFR 892.5750/Procode: 90 IWB

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 legally marketed predicate 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 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 requirements, 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 oblication 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.

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) 594-4613. 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/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

INDICATIONS FOR USE

510(k) Number:	K984328
Device Name:	Elekta Leksell® Gamma Knife Target System Model 24001
Indications for Use:	The Leksell® Gamma Knife Target System Model 24001 isa teletherapy device indicated for use in the stereotacticirradiation of intracranial structures
To Be Assigned By FDA

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David h. Segerson

(Division Sign-Off) (Division of Reproductive, Abdominal, ENT, and Radiological Deyig 510(k) Number

Prescription Use

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)

Regulation Number and Section

§ 892.5750 Radionuclide radiation therapy system.

(a)
Identification. A radionuclide radiation therapy system is a device intended to permit an operator to administer gamma radiation therapy, with the radiation source located at a distance from the patient's body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts (including beam-limiting devices), and accessories.(b)
Classification. Class II.