Leksell Gamma Knife® PERFEXION ™ is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters e.g. metastatic tumors.

Device Description

Leksell Gamma Knife® PERFEXION ™ is a radiosurgery system for use in the stereotactic irradiation of intra-cranial structures. Surgery 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™. It is a Traditional 510(k) submission.

Analysis of Acceptance Criteria and Study Details:

Based on the provided text, the submission is a Traditional 510(k) for a medical device (Radionuclide radiation therapy system), specifically the Leksell Gamma Knife® PERFEXION ™. The purpose of this type of submission is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to establish novel performance criteria or conduct studies proving the device meets new acceptance criteria in the same way an AI/ML device might.

Therefore, many of the requested details regarding acceptance criteria, performance metrics, sample sizes for test/training sets, expert involvement, and ground truth establishment, which are typical for an AI/ML device study, are not applicable or not explicitly detailed in the provided 510(k) summary.

The primary "acceptance criterion" for a Traditional 510(k) is substantial equivalence to a predicate device in terms of safety and effectiveness. The "study" that proves this is the comparison to the predicate device itself.

Here's a breakdown based on your requested information, highlighting what is present and what is not applicable/detailed:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied for 510(k) Substantial Equivalence)	Reported Device Performance (as stated in 510(k) Summary)
Safety and Effectiveness equivalent to predicate device.	"The functionality for the Leksell Gamma Knife® PERFEXION ™ is equivalent to its predicate device the Leksell Gamma Knife® PERFEXION ™ (K061941) in safety and effectiveness."
Fundamental Technical Characteristics similar to predicate device.	"The fundamental technical characteristics are the same to those of the predicate device and are listed on the comparison charts provided in this 510 k submission." (Comparison charts are not provided in this extract).
Intended Use matching predicate or well-understood clinical application.	"Leksell Gamma Knife® PERFEXION ™ is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeter e.g. metastatic tumors." (This matches the predicate's intended use and the general use of Gamma Knife systems).

Note: For a medical device like a radiation therapy system, specific performance metrics (e.g., radiation dose accuracy, positional accuracy, treatment time) would be detailed in the underlying engineering and validation studies, but these are summarized by the claim of substantial equivalence in the 510(k) document.

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

Not Applicable/Not detailed. This 510(k) submission does not describe a clinical performance study with a "test set" in the context of an AI/ML device performing diagnostic or prognostic tasks. The "test" for a Traditional 510(k) is the demonstration of substantial equivalence through comparison of design, materials, and intended use, often supported by engineering verification and validation (V&V) tests rather than clinical studies with "test sets" of patient data for algorithm performance.

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

Not Applicable. No "ground truth" for a test set is discussed, as this is not an AI/ML diagnostic device submission.

4. Adjudication method for the test set

Not Applicable. No clinical test set requiring adjudication 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 is a hardware/software system for radiation therapy delivery, not an AI-assisted diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

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

Not Applicable. This is not an algorithm-only device. It's a complete radiation therapy system. While it contains algorithms for dose calculation and positioning, the 510(k) focuses on the system as a whole and its equivalence to a predicate, not isolated algorithm performance.

7. The type of ground truth used

Not Applicable. The concept of "ground truth" as typically applied to image analysis or diagnostic AI is not present in this 510(k) summary. The "truth" for a radiation therapy system relates to its ability to accurately deliver radiation as intended, which is verified through engineering tests, phantom studies, and quality assurance protocols (not detailed in this summary, but inherent to the device type).

8. The sample size for the training set

Not Applicable. This is not an AI/ML device where a "training set" is used to develop a model.

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

Not Applicable.

Summary Regarding the Study(ies) for K063512:

The "study" that proves the device meets (the implied) acceptance criteria for this Traditional 510(k) is the comparison to its predicate device, Leksell Gamma Knife® PERFEXION ™ (K061941). The manufacturer asserts that:

"The functionality for the Leksell Gamma Knife® PERFEXION ™ is equivalent to its predicate device... in safety and effectiveness."
"The fundamental technical characteristics are the same to those of the predicate device and are listed on the comparison charts provided in this 510 k submission."

The 510(k) process for this type of device does not typically require new clinical studies with patient test sets, expert ground truth, or training sets as would be seen for a novel diagnostic AI/ML algorithm. Instead, it relies on demonstrating that the new device is as safe and effective as a device already on the market through engineering specifications, design comparisons, and adherence to recognized standards. The provided text doesn't offer details on specific engineering verification/validation studies, such as phantom measurements or simulation results, which would underpin the claim of equivalent technical characteristics.

Summary

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Ka6351/2

ELEKTA INSTRUMENT AB

Dokumentnamn/Name of docume Traditional 510/k)

Traditional 510(k)

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

Section 4- 510(k) Summary

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

MAR 0 5 2007

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 ™

Device Classification 3.

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

Predicate Device Identification 4.

Legally marketed devices to which equivalence is being claimed	510(k) #
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Leksell Gamma Knife® PERFEXION TM	K061941

Other relevant submissions 5.

Devices	510(k) #
Leksell Stereotactic System	K972324
Leksell GammaPlan® PFX	K061540

Elekta Instrument AB, P.O. Box 7593, SE-103 93 Stockholm, Sweden Tel +46 8 587 255 00

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K063512

Page2f2

Dokumentnamn/Nome of doe

Traditional 51016

ELEKTA INSTRUMENT AB

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

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).

Intended Use 7.

Substantial Equivalence 8

The functionality for the Leksell Gamma Knife® PERFEXION ™ is equivalent to its predicate device the Leksell Gamma Knife® PERFEXION ™ (K061941) in safety and effectiveness. The fundamental technical characteristics are the same to those of the predicate device and are listed on the comparison charts provided in this 510 k submission.

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Mr. Anders Skoglund Regulatory Affairs Elekta Instrument AB Kungstensgatan 18, P.O. Box 7593 SE-103 93 Stockholm SWEDEN

MAR C 5 2007

Re: K063512

Rooss12
Trade/Device Name: Leksell Gamma Knife® PERFEXION™ System Regulation Number: 21 CFR §892.5750 Regulation Name: Radionuclide radiation therapy system Regulatory Class: II Product Code: IWB Dated: February 15, 2007 Received: February 20, 2007

Dear Mr. Skoglund:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) 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 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/2/Picture/9 description: The image shows a circular logo with the text "1906-2006" at the top. The letters "FDA" are in the center of the logo, with the word "Centennial" underneath. Three stars are below the word "Centennial". The text "Growth & Innovation in Consumer Protection" is around the top of the circle, and the text "In the Service of Food" is around the bottom of the circle.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (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) 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Nancy C. Brogdon

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

Dokumentnamn/Name of document Traditional 510(k)

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

Section 7- Indications for Use Statement

510(k) Number	K063512
Device Name	Leksell Gamma Knife® PERFEXION ™
Indications for Use	Leksell Gamma Knife® PERFEXION ™ is a teletherapy deviceintended for stereotactic irradiation of head structures rangingfrom very small target sizes of a few millimeters to severalcentimeters e.g. metastatic tumors.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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) T

Nancy C. Brogdon

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 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.