GammaPlan® is a computer-based dose planning system specifically designed for use with the Gamma Knife®. Gamma Plan® is intended to be used for planning the dosimetry of treatments, in stereotactic radiosurgery and stereotactic radiotherapy.

AI/ML Overview

The provided text does not contain detailed information about acceptance criteria or specific studies to prove device performance. It primarily focuses on regulatory approval (510(k) summary) rather than scientific validation studies. Therefore, much of the requested information cannot be extracted from this document.

However, based on the provided text, here's what can be gathered and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not present in the provided document. The document states that GammaPlan® is "substantially equivalent" to its predicate devices in safety and effectiveness, but it does not specify any quantitative acceptance criteria or report on specific performance metrics of the new device.

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

This information is not present. The document doesn't describe any specific "test set" or data used for performance evaluation beyond asserting substantial equivalence to predicate devices.

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

This information is not present. No details about ground truth establishment or expert involvement are mentioned.

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

This information is not present. There is no description of an adjudication method, as no specific test set evaluation is detailed.

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:

This information is not present. The document does not describe an MRMC study or any assessment of human reader improvement with or without AI (though GammaPlan® itself is a dose planning system, not an AI for human readers in the traditional sense).

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

This information is not present. While GammaPlan® is a computer-based system, the document does not detail specific standalone performance evaluations. It focuses on its role in "planning the dosimetry of treatments" and being "equivalent to its predicate device."

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

This information is not present. No ground truth definition is provided.

8. The sample size for the training set:

This information is not present. There is no mention of a training set or the methodology for developing the device.

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

This information is not present. As there's no mention of a training set, the ground truth establishment for it is also not discussed.

Summary of what is available from the document:

Device Name: GammaPlan®
Intended Use: GammaPlan® is a computer-based system designed for Gamma Knife® treatment planning. It is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiotherapy.
Regulatory Pathway: 510(k) Premarket Notification, based on substantial equivalence.
Predicate Devices: Leksell GammaPlan® (K973441) and Leksell GammaPlan® 4C with MultiView (K042269).
Claim of Performance: The functionality for the GammaPlan® is equivalent to its predicate device in safety and effectiveness. The fundamental technical characteristics are similar to those of the predicate device.

To get the information requested, a more technical performance report or a validation study document would be necessary, which is typically separate from a 510(k) summary. The 510(k) summary mainly demonstrates that a new device is "substantially equivalent" to an existing legally marketed device, often by showing it performs as well or better than the predicate, but it doesn't always detail the full scientific validation studies with specific performance metrics and acceptance criteria for the new device as a standalone product.

Summary

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ELEKTA INSTRUMENT AB

JUN 1 - 2005

Dokumentnamn/Name of document Traditional 510(k)

Utfärdare/Issuer	Louise Lindblad
Avser/Regarding	GammaPlan®
Ref nr/Dok nr/Ref no/Doc no
Utgåva /Edition	1
	Directory

Section 4- 510(k) Summary

Kosiolzz

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: Ms Louise Lindblad Official Correspondent: Mr Peter Löwendahl

Trade Name 2.

GammaPlan®

Device Classification 3.

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

Regulatory History (Unmodificd Predicate Device) 4.

Devices	510(k) #
Leksell GammaPlan®	K973441
Leksell GammaPlan® 4C with MultiView	K042269

5. Other relevant submissions

Devices	510(k) #
Leksell Gamma Knife® Target System, Model 24001	K984328

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ELEKTA INSTRUMENT AB

Kos 1022

Dokumentnamn/Name of document Traditional 510(k)

Utfärdare/Issuer	Louise Lindblad
Ref nr/Dok nr/Ref no/Doc no
Utgåva /Edition	1
Avser/Regarding	GammaPlan®
	Directory

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

Intended Use 7.

GammaPlan® is a computer-based system designed for Gamma Knife® treatment planning.

Substantial Equivalence 8

The functionality for the GammaPlan® is equivalent to its predicate device Leksell GammaPlan® (K973441) and Leksell GammaPlan® 4C with MultiView (K042269) in safety and effectiveness. The fundamental technical characteristics are similar to those of the predicate device.

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JUN 1 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Peter Löwendahl Manager Quality & Regulatory Affairs Elekta Instrument AB Kunsgstensgatan 18, P.O. Box 7593 Stockholm, SE-10393 SWEDEN

Re: K051022 Trade/Device Name: GammaPlan® Regulation Number: 21 CFR 892.5750 Regulation Name: Radionuclide radiation therapy system Regulatory Class: II Product Code: IWB and MUJ Dated: April 13, 2005 Received: April 22, 2005

Dear Mr. Löwendahl:

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.

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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter with and w Jourse organ inding of substantial equivalence of your device to a legally prematice notification: - The PDF maces
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 If you done sportive at no af 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 Also, prease note the regulation on your responsibilities under the Act from the 601:57). I ou may orders, 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. Hodgdon

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	Louise Lindblad
Ref nr/Dok nr/Ref no/Doc no
Utgåva /Edition	1
Avser/Regarding	GammaPlan®
Directory

Section 7- Indications for Use Statement

510(k) Number	KOSIDZZTo be defined
Device Name	GammaPlan®
Indications for Use	GammaPlan® is a computer-based system designed for Gamma Knife®treatment planning.

Prescription Use X (Part 21 CFR 801 Subpart D)

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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)

Ra-E. Phillips

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

Elekta Instrument AB, P.O. Box 7593, SE-103 93 Stockholm, Sweden Tel +46 8 587 254 00 Fax +46 8 587 255 00

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.