Leksell GammaPlan® is a computer-based dose planning system specifically designed for use with the Leksell Gamma Knife". Leksell 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 describes a 510(k) summary for the Elekta Instrument AB's Leksell GammaPlan® system. This document is a premarket notification for a medical device and primarily focuses on establishing "substantial equivalence" to a predicate device, rather than presenting a detailed clinical study with acceptance criteria and performance data in the way a diagnostic AI device submission might.

Therefore, many of the requested elements for acceptance criteria and study design are not present in this 510(k) summary because this type of submission typically demonstrates equivalence through technical specifications rather than extensive clinical performance studies.

Here's an analysis based on the provided text, highlighting what is present and what is absent:

Acceptance Criteria and Device Performance Study (as per the provided document)

1. Table of Acceptance Criteria and Reported Device Performance

This document does not contain a specific table of acceptance criteria or reported device performance in the sense of accuracy, sensitivity, specificity, or other performance metrics for a diagnostic or AI-driven device.

Instead, the "acceptance criteria" for a 510(k) submission like this are generally satisfied by demonstrating substantial equivalence to predicate devices. This means showing that the new device has the same intended use, technological characteristics, and safety/effectiveness profiles as devices already legally marketed.

The key "performance" claimed in this document is:

Acceptance Criterion (Implicit)	Reported Device Performance (Claim)
Substantial Equivalence	"The functionality for Leksell GammaPlan® is equivalent to its predicate devices Leksell GammaPlan® (K061540) and Leksell GammaPlan® (K051022) in safety and effectiveness. The fundamental technical characteristics are similar to those of the predicate devices."
Intended Use	"Leksell GammaPlan® is a computer-based dose planning system specifically designed for use with Leksell Gamma Knife®."
Device Classification	Radionuclide radiation therapy system (Class II, Product Code IWB, Regulation Number 892.5750)

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

Not applicable/Not provided. This submission does not describe a clinical performance study with a test set of patient data to evaluate the device's diagnostic or predictive performance. The assessment is based on technical equivalence to predicate devices, not on a new clinical data evaluation.

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

Not applicable/Not provided. There is no mention of experts or ground truth establishment because a clinical performance study on a test set is not detailed.

4. Adjudication method for the test set

Not applicable/Not provided. No test set or adjudication method 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 device is a dose planning system for radiation therapy, not a diagnostic AI system intended to assist human readers. Thus, an MRMC study comparing human readers with and without AI assistance is not relevant to this device's function or the information provided in this 510(k) summary.

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

Not applicable/Not explicitly detailed as a 'standalone performance study'. The Leksell GammaPlan is itself a computer-based dose planning system, used by human operators. Its performance is inherent in its functionality for dose planning, which is being compared for equivalence to existing versions of the same system (predicate devices). The submission focuses on its technical characteristics being similar, implying its standalone function is equivalent.

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

Not applicable/Not provided in the context of a performance study. The "ground truth" for this 510(k) submission implicitly lies in the established safety and effectiveness of the predicate devices. The new device is deemed acceptable because it is substantially equivalent to these already-approved devices, whose 'ground truth' in terms of clinical utility and safety has already been accepted by the FDA.

8. The sample size for the training set

Not applicable/Not provided. This is not an AI/ML-driven device that underwent a distinct "training" phase with a dataset. It is a software system for dose planning.

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

Not applicable/Not provided. As there is no stated training set for an AI/ML model, the concept of establishing ground truth for it is not relevant to this document.

Summary

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K090972

510(k) Summary

JUL 2 0 2009

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 Contact Person for this submission: Mrs Anna Keck Official Correspondent: Mr Anders Skoglund

2. Trade Name

Leksell GammaPlan®

3. . Device Classification

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

Predicate Device Identification 4.

Legally marketed devices to which equivalence is being claimed	510(k) #
Leksell GammaPlan®	K061540
Leksell GammaPlan®	K051022
Leksell GammaPlan® 4C with Multiview	K042269
Leksell Gamma Plan®	K973441
Leksell GammaPlan®	K914808

5. Other relevant submissions

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Device Description (for detailed description see Section "Device Description") 6. Leksell GammaPlan® is a computer-based dose planning system specifically designed for use with the Leksell Gamma Knife". Leksell Gamma Plan® is intended to be used for planning the dosimetry of treatments, in stereotactic radiosurgery and stereotactic radiotherapy.

Intended Use 7.

Leksell GammaPlan® is a computer-based dose planning system specifically designed for use with Leksell Gamma Knife®.

Substantial Equivalence 8

The functionality for Leksell GammaPlan® is equivalent to its predicate devices Leksell GammaPlan® (K061540) and Leksell GammaPlan® (K051022) in safety and effectiveness. The fundamental technical characteristics are similar to those of the predicate devices.

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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 image of an eagle or bird-like figure with three curved lines representing its wings or feathers.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2009

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

Re: K090972

Trade/Device Name: Leksell GammaPlan® Regulation Number: 21 CFR 892.5750 Regulation Name: Radionuclide radiation therapy system Regulatory Class: II Product Code: MUJ Dated: June 2, 2009 Received: June 4, 2009

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 (PMA), it may be subject to 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); medical device reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/cdrl/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number	K0909072
Device Name	Leksell GammaPlan®
Indications for Use	Leksell GammaPlan® is a computer-based dose planning systemspecifically designed for use with Leksell Gamma Knife®.

Prescription X Over-The-Counter Use Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

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Heidi Reimer
(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Devices 09/972 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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.