Leksell Gamma Knife® PERFEXION ™ is a radiosurgery system for use in the stereotactic Lessen Gamilia Nime Fire - Fire Erivery is achieved by delivering a prescribed dose as one or more shots of ionizing radiation to the exact site of the target.

The system consists basically of the radiation unit with patient positioning system and the operator console (with control panel and system computer).

AI/ML Overview

This document is a 510(k) summary for the Leksell Gamma Knife® PERFEXION™ and does not contain detailed information about acceptance criteria or specific study results to prove meeting those criteria.

The document primarily focuses on:

Identifying the device and its manufacturer.
Classifying the device and its regulation number.
Identifying predicate devices for substantial equivalence.
Stating the intended use of the device.
Confirming its regulatory clearance by the FDA.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, or MRMC studies from this document.

However, based on the provided text, here is what can be inferred and what is missing:

1. Table of acceptance criteria and the reported device performance:

Missing. The document explicitly states: "The functionality for the Leksell Gamma Knife® PERFEXION ™ is equivalent to its predicate device... The fundamental technical characteristics are similar to those of its predicate device(s) and are listed on the comparison charts provided in this 510(k) submission." This implies that acceptance criteria and performance are likely demonstrated through a comparison to the predicate device's established performance, rather than a separate, detailed performance study with explicit acceptance criteria laid out in this summary. The actual comparison charts are not included in this extract.

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

Missing. No information on a specific "test set" or data provenance (country of origin, retrospective/prospective) is provided. The submission relies on demonstrating substantial equivalence to a predicate device.

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

Missing. No information on "ground truth" establishment or expert involvement for a test set is provided.

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

Missing. No information on an adjudication method is provided.

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:

Missing. This device is a "Radionuclide radiation therapy system" (a hardware system for radiosurgery), not an AI-based diagnostic or assistive software. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.

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

Missing. This is a physical radiosurgery device, not an algorithm, so a standalone algorithm performance study is not applicable.

7. The type of ground truth used:

Missing. As no specific performance study is detailed, no ground truth type is mentioned.

8. The sample size for the training set:

Missing. As this is a hardware device submission, not a machine learning algorithm submission, there is no concept of a "training set" in the context of device performance as described here.

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

Missing. Not applicable.

In summary, this 510(k) document is a regulatory submission for a physical medical device (Leksell Gamma Knife® PERFEXION™) seeking substantial equivalence to a predicate device. It confirms the device's classification, intended use, and substantial equivalence, but it does not include the detailed performance study data, acceptance criteria, or ground truth methodologies that would typically be found in a submission for, for example, a novel diagnostic AI algorithm.

Summary

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Image /page/0/Picture/0 description: The image shows a series of handwritten numbers and letters. The characters appear to be 'K061941'. The writing is in black ink and the background is white.

ELEKTA INSTRUMENT AB

Dokumentnamn/Name of document

AUG 2 1 2006

Traditional 510(k)

Utfärdare/Issuer	Ref nr/Dok nr/Ref no/Doc no	Utgåva /Edition
Anders Skoglund	-	-
Avser/Regarding	-	Directory
Leksell Gamma Knife® PERFEXION ™		-

Section 4- 510(k) Summary

As Required by 21 CFR 807.87(k)510 (k) Summary

Subscribers Name & Address 1.

Elekta Instrument AB Kungstensgatan 18, P.O Box 7593 SE-103 93 Stockholm, Sweden Tel: (011) 46 8 587 254 00 Fax: (011) 46 8 587 255 00 Contact Person for this submission: Mr Anders Skoglund Official Correspondent: Mr Peter Löwendahl

Trade Name 2.

Leksell Gamma Knife® PERFEXION тм

Device Classification 3.

Common Name	Product Code	Class	Regulation Number
Radionuclide radiation therapy system.	FWB	II	21 CFR 892.5750

Predicate Device Identification 4.

Legally marketed devices to which equivalence is being claimed	510(k) #
Leksell Gamma Knife Target System, Model 24001	K984328

Other relevant submissions 5.

Devices	510(k) #
Leksell Stereotactic System	K972324

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ELEKTA INSTRUMENT AB

Dokumentnamn/Name of docur Traditional 510(k)

Utfärdare/Issuer	Ref nr/Dok nr/Ref no/Doc no	Utgåva /Edition
Anders Skoglund	-	-
Avser/Regarding		Directory
Leksell Gamma Knife® PERFEXION ™	-	-

Device Description (for detailed description see Section "Device Description") 6.

The system consists basically of the radiation unit with patient positioning system and the operator console (with control panel and system computer).

7. Intended Use

Leksell Gamma Knife® PERFEXION ™ is a teletherapy device intended for use in the stereotactic irradiation of intra-cranial structures.

Substantial Equivalence 8

The functionality for the Leksell Gamma Knife® PERFEXION ™ is equivalent to its Fire Tanetionality for the Lettorma Knife Target System, Model 24001 (K984328) in predicate deffectiveness. The fundamental technical characteristics are similar to those of sates) and enversion and are listed on the comparison charts provided in this 510(k) submission.

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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

AUG 2 1 2006

Mr. Peter Löwendahl Director Group Regulatory Affairs Elekta Instrument AB P.O. Box 7593 SE-103 93 Stockholm SWEDEN

Re: K061941

K001941
Trade/Device Name: Leksell Gamma Knife® PERFEXION™ Regulation Number: 21 CFR 892.5750 Regulation Name: Radionuclide radiation therapy system Regulatory Class: II Product Code: IWB Dated: July 6, 2006 Received: July 10, 2006

Dear Mr. Löwendahl:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaused the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass sunce in the encready to regain date of the Medical Device Amendments, or to devices that proof to May 26, 1770, and marked with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general ancerors, mailier and abrilor, salejove excirements for annual registration, listing of devices, good controls provisions or alsocing, 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 Apploval), It thay be subject to back aderal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/2/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top and "Centennial" at the bottom. The letters "FDA" are prominently displayed in the center of the logo. Three stars are located below the word "Centennial".

Protecting and Promoting Public Health

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Page 2 -

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualies of a sudential requirements of the Act
that FDA has made a determination that your device of a Force onerains. You must that FDA has made a delechniation that Jour St. Co., St. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. L. or any Federal statutes and regulations daminents but not limited to: registration and listing (21 comply with all the Act Stequirements, monamal manufacturing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing the dectronic CFR Part 807); labeling (21 CFR Part 601); good fixed 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicabl forth in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin makemig your antial equivalence of your device to a legally premarket notification. The PDA midning of basination 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), please If you desire specific advice for your decided on one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" Also, please note the regulation chittics, "Thistanation on your responsibilities under (21CFR Part 807.97). 100 may obtain other general and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150

or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C Hodgon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ELEKTA INSTRUMENT AB

Utfärdare/Issuer	Ref nr/Dok nr/Ref no/Doc no	Utgåva /Edition
Anders Skoglund	-	-
Avser/Regarding	Directory
Leksell Gamma Knife® PERFEXION ™	-	-

Section 7- Indications for Use Statement

510(k) Number	To be defined K061941
Device Name	Leksell Gamma Knife® PERFEXION TM
Indications for Use	Leksell Gamma Knife® PERFEXION ™ is a teletherapy device intended for use in the stereotactic irradiation of intra-cranial structures.

Prescription X Use (Part 21 CFR 801 Subpart D)

ADDIOR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David R. Lynn

(Division Sign-Off Division of Reprodu and Radiological De 510(k) Number

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.