The provided text for K080250 is a 510(k) summary for the Leksell SurgiPlan® device. This document focuses on demonstrating substantial equivalence to a predicate device (an earlier version of Leksell SurgiPlan® with 510(k) # K033340).

The 510(k) summary does not contain information about acceptance criteria or a specific study proving the device meets those criteria in the way a clinical performance study would. The primary mechanism for clearance in this case is a demonstration of substantial equivalence, meaning the new device is as safe and effective as a legally marketed predicate device.

Therefore, many of the requested details (sample sizes for test and training sets, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are generally not part of a 510(k) submission based on substantial equivalence to a previously cleared similar device, unless significant changes in technology or indications warrant a new clinical study.

Based on the provided text, here's what can be extracted and what cannot:

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

The document does not explicitly state "acceptance criteria" and "reported device performance" in the context of a clinical study or performance testing with specific metrics. The device's "performance" is implicitly deemed equivalent to the predicate device.

2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

None of the above information is present in the provided 510(k) summary.

The document states:

"The functionality for the Leksell SurgiPlan® is equivalent to its predicate device the Leksell SurgiPlan® (K033340) in safety and effectiveness. The fundamental technical characteristics are the same to those of the predicate device."

This statement is the core of the submission, asserting that because the new device is fundamentally the same as its cleared predecessor, it is also safe and effective without requiring new clinical performance data to demonstrate this. For a software device, "technical characteristics" often refer to aspects like software architecture, algorithms, user interface, and overall system design. The implication is that since these are the same, or negligibly different, the performance is also considered equivalent.

In summary, this 510(k) submission for Leksell SurgiPlan® relies on substantial equivalence to a predicate device (K033340) rather than presenting new performance data from a specific study with defined acceptance criteria and detailed methodology as requested in your prompt.

Summary

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ELEKTA INSTRUMENT AB

Dokumentnamn/Name of document

Special 510(k)

Utfärdare/Issuer	Anders Skoglund
Ref nr/Dok nr/Ref no/Doc no	--
Utgåva /Edition	--
Avser/Regarding	Leksell SurgiPlan®
Directory

K080250

Section 4- 510(k) Summary

MAY 1 3 2008

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 SurgiPlan®

3. Device Classification

Common Name	Product Code	Class	Regulation Number
Stereotaxic instrument	HAW	II	21 CFR 882.4560

4. Predicate Device Identification

Legally marketed devices to which equivalence is being claimed	510(k) #
Leksell SurgiPlan®	K033340

1. 2

5. Other relevant submissions

Devices	And Archive of the state of the state of the comments of the comments of the comments of the with the with the with the with and the with the with and the world to the with a510(k)
100PICAL1118111	---------------KO1286
ekselStereotactic System	K031980ﻟﻤﺴﺎﺣﺔ ﺍﻟﻤ

Elekta Instrument AB, P.O. Box 7593, SE-103 93 Stockholm, Sweden Tel +46 8 587 254 00 Fax +46 8 587 255 08

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Dokumentnamn/Name of document Conciol E10/L)

ELEKTA INSTRUMENT AB

Utfärdare/Issuer	Ref nr/Dok nr/Ref no/Doc no	Utgåva /Edition
Anders Skoglund	--	--
Avser/Regarding	Directory
Leksell SurgiPlan®

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

Leksell SurgiPlan® is an advanced image-based neurosurgical planning software, specifically designed for Leksell Stereotactic System®.

7. Intended Use

100 100 100

Leksell SurgiPlan® is intended for use in planning invasive intracranial stereotactic surgical procedures.

Substantial Equivalence 8

The functionality for the Leksell SurgiPlan® is equivalent to its predicate device the Leksell SurgiPlan® (K033340) in safety and effectiveness. The fundamental technical characteristics are the same to those of the predicate device.

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

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized stripes forming its wing.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 13 2008

Elekta Instrument AB % Mr. Anders Skoglund Regulatory Affairs P.O. Box 7593 SE-103 93 Stockholm, Sweden

Re: K080250

Trade/Device Name: Leksell SurgiPlan® Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: April 24, 2008 Received: April 28, 2008

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 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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Page 2 - Mr. Anders Skoglund

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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,

Mark M Millerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ELEKTA INSTRUMENT AB

Dokumentnamn/Name of document

Utfärdare/issuer	Ref nr/Dok nr/Ref no/Doc no	Utgåva /Edition
Anders Skoglund	--	--
Avser/Regarding		Directory
Leksell SurgiPlan®

Section 7- Indications for Use Statement

510(k) Number	To be defined K080250
Device Name	Leksell SurgiPlan®
Indications for Use	Leksell SurgiPlan® is intended for use in planning invasive intra-cranial stereotactic surgical procedures.

Prescription x Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nil Re dgl formxm

(Division Sign-Off (Division of General, Restorative, and Neurological Devices

510(k) Number K 080250

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

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).