The Leksell GammaPlan 4C with MultiView is a computer-based dose planning system specifically designed for use with the Leksell Gamma Knife®. The Leksell GammaPlan 4C with MultiView is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgey and stereotactic radio therapy. It processes the inputs from the healt care professionals such that the desired radiation dose is provided by the Leksell Gamma Knife® to a precisely defined target area within the cranium.

Device Description

The Leksell GammaPlan 4C with MultiView adds support for frameless images by means of co-registration of image series. This simplifies stereotactic radiosurgery procedures as only one image series needs to be acquired with the Leksell stereotactic frame. Leksell GammaPlan 4C with MultiView also adds support for brain altas structures and visualization of color mapped PET images for use in preoperative planning.

AI/ML Overview

The provided text describes a Special 510(k) submission for the "Leksell GammaPlan 4C with MultiView" device. This submission focuses on demonstrating substantial equivalence to a predicate device ("Leksell GammaPlan", K973441) and highlights new features like support for frameless images via co-registration and visualization of color-mapped PET images.

However, the document does not contain specific acceptance criteria or details of a study designed to prove the device meets such criteria. It primarily details the device description, intended use, and substantial equivalence claim, which is a regulatory pathway for devices that are similar to already legally marketed devices.

Therefore, I cannot provide the requested table or answer most of the questions because the information is not present in the provided text.

Here's an assessment based on the available information:

Table of acceptance criteria and the reported device performance:
- N/A. The document does not specify acceptance criteria or report performance against such criteria. The submission is a "Special 510(k)" which usually relies on demonstrating substantial equivalence to a predicate device, often without a detailed performance study like a traditional 510(k) might require for novel features.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. No information on a test set or data provenance is provided.
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):
- N/A. No information on experts or ground truth establishment for a test set is provided.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No information on adjudication methods for a test set is provided.
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:
- N/A. This device is a dose planning system, not an AI-assisted diagnostic tool for human readers. No MRMC study is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document implies the device is a "computer-based dose planning system" for "health care professionals," indicating human-in-the-loop operation. No standalone performance study details are provided.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- N/A. No information on the type of ground truth is provided.
The sample size for the training set:
- N/A. This document describes a software update for a medical device; it does not detail a machine learning model that would typically have a "training set."
How the ground truth for the training set was established:
- N/A. As above, no training set is described in the context of a machine learning model.

Summary

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ELEKTA INSTRUMENT AB

Dokumentnamn/Nome of document Special 510(k)

Utfärdare/IssuerAnders Skoglund	Ref nr/Dok nr/Ref no/Doc no	Utgava / Edition
Avser/RegardingLeksell GammaPlan 4C with MultiView		Directory

GammaPlan 4C with MultiView

Kø4 2269

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 GammaPlan 4C with MultiView

Device Classification 3.

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

Regulatory History (Unmodified Predicate Device) 4.

Devices	510(k) #
Leksell GammaPlan	K973441

5. Other relevant submissions

Devices	510(K) #
Leksell Surgiplan with Atlaspace	K013861
Leksell Surgiplan with Imagemerge	K033340

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ELEKTA INSTRUMENT AB	Ky4 2264	Dokumentnamn/Name of document
Special 510(k)
Utfärdare/Issuer	Ref nr/Dok nr/Ref no/Doc no	Utgåva /Edition
Anders Skoglund	-	1

Avser/Regarding Leksell GammaPlan 4C with MultiView

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

Intended Use 7.

Substantial Equivalence 8

The functionality for the Lekscll GammaPlan 4C with MultiView is equivalent to its predicate device Leksell GammaPlan (K973441) in safety and effectiveness. The fundamental technical characteristics are similar to those of the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 8 2004

Mr. Peter Löwendahl Quality and Regulatory Affairs Manager Elekta Instrument AB P.O. Box 7593 SE-103 93 Stockholm SWEDEN

Re: K042269 Trade/Device Name: Leksell GammaPlan 4C with MultiView Regulation Number: 21 CFR 892.5750 Regulation Name: Radionuclide radiation therapy system Regulatory Class: II

Product Code: 90 MUJ Dated: August 20, 2004 Received: August 23, 2004

Dear Mr. Löwendahl:

We have reviewed your Section 510(k) premarket notification of intent to market the device we neve roviewed your coreemined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated 9776, the enactment date of the Medical Device Amendments, or to eoniner of process that have been recordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Oosmotion For (100) the ) the device, subject to the general controls provisions of the Act. The r ou may, the crowisions 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can may or subject to Sateral Regulations, Title 21, Parts 800 to 898. 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 that I Dr. I has had 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to oght hands.org of substantial equivalence of your device to a legally premarket notification. The PDA maily gour 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 de to the following numbers, based on the regulation number at the top of the letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on and personation entitled, "Miso, please note the regulation entitled, "Misbranding Other of Complanos at (201) 22ation" (21CFR Part 807.97) you may obtain. Other general by relection on your responsibilities under the Act may be obtained from the Division of Small mornation on your responsionities 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/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brydon

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

ELEKTA INSTRUMENT AB
Special 510(k)

Utfärdare/Issuer	Anders Skoglund	Utgåva /Edition	1
Ref nr/Dok nr/Ref no/Doc no	-	Directory
Avser/Regarding	Leksell GammaPlan 4C with MultiView

Section 7- Indications for Use Statement

510(k) Number	To be definedK$\phi$42269
Device Name	Leksell GammaPlan 4C with MultiView
Indications for Use	The Leksell GammaPlan 4C with MultiView is a computer-based doseplanning system specifically designed for use with the Leksell GammaKnife®. The Leksell GammaPlan 4C with MultiView is intended to beused for planning the dosimetry of treatments in stereotacticradiosurgey and stereotactic radio therapy. It processes the inputsfrom the healt care professionals such that the desired radiation doseis provided by the Leksell Gamma Knife® to a precisely defined targetarea within the cranium.

510(k) Number

To be definedK$\phi$42269

Device Name

Leksell GammaPlan 4C with MultiView

Indications for Use

The Leksell GammaPlan 4C with MultiView is a computer-based doseplanning system specifically designed for use with the Leksell GammaKnife®. The Leksell GammaPlan 4C with MultiView is intended to beused for planning the dosimetry of treatments in stereotacticradiosurgey and stereotactic radio therapy. It processes the inputsfrom the healt care professionals such that the desired radiation doseis provided by the Leksell Gamma Knife® to a precisely defined targetarea within the cranium.

X Prescription Use (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)

David A. Layman
(Division Sign-Off)

Division of Reproductive, Abdomis and Radiological Devices 510(k) Number J

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.