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, arteriovenous malformations, trigeminal neuralgia, meningiomas and vestibular schwannomas.

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.

Based on preoperative radiological examinations, the Leksell Gamma Knife Perfexion unit provides highly accurate external irradiation of intra-cranial structures using collimated beams of ionizing radiation.

Each unit contains 192 sealed sources of Cobalt 60.

Leksell Gamma Knife Perfexion systems consists of several units, physically separated in an Office side in the control room and a Medical side in the treatment room.

. The medical side consists basically of the radiation unit with a patient positioning system. The system control and power units are placed inside the cover of the radiation unit.
The office side consists of the operator console with control panel and office computer. .

AI/ML Overview

The provided text is a 510(k) summary for the Leksell Gamma Knife Perfexion. This document primarily focuses on establishing substantial equivalence to a predicate device and regulatory information. It does not contain a study that demonstrates the device meets specific acceptance criteria in the way a clinical performance study for an AI/ML device would.

The "acceptance criteria" here would be the regulatory requirements for showing substantial equivalence for a medical device that performs radiation therapy, not a set of performance metrics for an AI algorithm.

Therefore, many of the requested sections about acceptance criteria, device performance, sample sizes, ground truth, and expert adjudication are not applicable to the information provided in this 510(k) submission.

Here's a breakdown of what can be extracted and what cannot, based on the provided text:

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

Acceptance Criteria: Not explicitly stated as performance metrics in the context of a clinical study demonstrating AI/ML performance. The "acceptance criteria" for this 510(k) are implicitly the requirements for showing substantial equivalence (same intended use, similar technical characteristics, safety, and effectiveness) to the predicate device.
Reported Device Performance: Not presented as a results table from a performance study. The document states that the device's functionality is "equivalent" to its predicate in safety and effectiveness.

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

Not Applicable: This document does not describe a clinical performance study with a test set. There is no information on sample size or data provenance in this context.

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

Not Applicable: No test set or ground truth in the context of an AI/ML performance study is mentioned.

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

Not Applicable: No test set or adjudication method is mentioned.

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 not a study for an AI-assisted device, nor does it describe a comparative effectiveness study.

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

Not Applicable: This is a physical radiation therapy device, not an algorithm, so the concept of standalone performance does not apply in the manner typically asked for AI/ML devices.

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

Not Applicable: No ground truth in the context of an AI/ML performance study is mentioned.

8. The sample size for the training set

Not Applicable: No training set is mentioned as this is not an AI/ML device.

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

Not Applicable: No training set or ground truth establishment is mentioned.

Summary of Relevant Information from the Provided Text:

Device Name: Leksell Gamma Knife® Perfexion™
Intended Use: Stereotactic irradiation of head structures (e.g., metastatic tumors, arteriovenous malformations, trigeminal neuralgia, meningiomas, vestibular schwannomas).
Device Type: Teletherapy device (radiation therapy system)
Predicate Device: Leksell Gamma Knife® Perfexion™ (K063512)
Basis for Substantial Equivalence: "The functionality for the Leksell Gamma Knife Perfexion is equivalent to its predicate device K063512 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." (These comparison charts are not provided in the snippet.)

In conclusion, this 510(k) submission is for a physical radiation therapy device establishing substantial equivalence to a prior version, not an AI/ML device that would typically undergo a performance study with specific acceptance criteria, test sets, and ground truth as described in your prompt.

Summary

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K120811

ELEKTA INSTRUMENT AB

Dokumentnamn/Name of document 13 Traditional 510(k)

Utfärdare//ssuer	Viveka Wretman
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

1. Subscribers Name & Address

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 Official Correspondent: Mr Anders Skoglund

MAY 2 4 2012

Trade Name 2.

Leksell Gamma Knife® Perfexion™

3. Device Classification

Common Name	Product Code	Class	Regulation Number
Leksell Gamma Knife® Perfexion™	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™	K063512

5. Other relevant submissions

Devices	510(k) #
Leksell Steretocatic System	K080355
Leksell GammaPlan® PFX	K103093

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ELEKTA INSTRUMENT AB

Dokumentnamn/Name of document Traditional 510(k)

Utfärdare/Issuer	Ref nr/Dok nr/Ref no/Doc no	Utgåva /Edition
Viveka Wretman	--	--
Avser/Regarding
Leksell Gamma Knife Perfexion	--	Directory

Device Description 6.

Each unit contains 192 sealed sources of Cobalt 60.

Leksell Gamma Knife Perfexion systems consists of several units, physically separated in an Office side in the control room and a Medical side in the treatment room.

. The medical side consists basically of the radiation unit with a patient positioning system. The system control and power units are placed inside the cover of the radiation unit.
The office side consists of the operator console with control panel and office computer. .

7. Intended Use

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 turnors, arteriovenous malformations, trigeminal neuralgia, meningiomas and vestibular schwannomas.

8 Substantial Equivalence

The functionality for the Leksell Gamma Knife Perfexion is equivalent to its predicate device K063512 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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Image /page/2/Picture/0 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 symbol resembling an abstract human figure or bird in flight, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Ms. Viveka Wretman Regulatory Affairs Engineer Elekta Instrument AB Kungstensgatan 18 STOCKHOLM 10393 SWEDEN

2 4 2012 MAY

Re: K120811

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: March 14, 2012 Received: March 16, 2012

Dear Ms. Wretman:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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 Parts 801 and 809); medical device reporting (reporting of

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Page 2

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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ELEKTA INSTRUMENT AB

Dokumentnamn/Name of document

ELEKTA INSTRUMENT AB
Traditional 510(k) K1205118

Utfärdare/Issuer	Viveka Wretman
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	To be defined
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, arteriovenousmalformations, trigeminal neuralgia, meningiomas andvestibular schwannomas.

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)

(Division Sign Off)

Division of Radiological Devices Diagnostic Device Evaluation and Safety Office of In Vitro

Kla0811
510K

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.