The Elekta Stereotactic Guide is indicated for the guidance and stereotactic instrument positioning in open cranial procedures and surgeries normally performed with traditional stereotactic apparatus.

Device Description

The Elekta Stereotactic Guide is an accessory to the Leksell Image Guidance Surgical (LIGS) System. The device consists of a base ring, targeting swivel with instrument channel, and locking ring. The guide and the LIGS are used for guidance and stereotactic instrument positioning during open cranial procedures and surgeries normally performed with traditional stereotactic apparatus. Once the target and entry point is determined during the presurgical planning phase, the craniotomy is made and the Elekta Stereotactic Guide is screwed into the patient's skull at the point of entry. The LIGS probe is placed into the guide and the orientation toward the target is determined using the intra-operative images. The guide is then locked into place and classic stereotactic instruments may then be placed into the channel of the guide for the surgical procedure.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the Elekta Stereotactic Guide, based on the provided document:

The submission does not explicitly state quantitative acceptance criteria or a specific study designed to prove the device meets those criteria in a formal way (e.g., a hypothesis test against a predefined delta). Instead, it describes performance evaluations that show the device performs as intended.

1. Table of Acceptance Criteria and Reported Device Performance:

Criteria/Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
Mechanical Accuracy	Comparable to stereotactic frames for biopsy needle measurements	Performed on a phantom model with biopsy needle measurements, compared to stereotactic frames. Studies show the device "performs as intended."
Clinical Performance	Guide and LIGS system perform as intended for guidance and stereotactic instrument positioning in open cranial procedures.	A clinical evaluation of 31 procedures documented "performs as intended."

Explanation of "Implicit" Acceptance Criteria:
The document does not explicitly state specific quantitative acceptance criteria such as "accuracy must be within X mm" or "clinical success rate must be Y%." Instead, the studies aim to demonstrate that the device "performs as intended" and is equivalent to predicate devices. For mechanical accuracy, this implicitly means the accuracy achieved should be comparable to the established accuracy of traditional stereotactic frames. For clinical performance, it implies that the device successfully facilitates guidance and instrument positioning in actual surgical settings without adverse events or significant deviations from expected outcomes.

2. Sample Size Used for the Test Set and Data Provenance:

Mechanical Accuracy Study:
- Sample Size: Not explicitly stated regarding the number of measurements or phantom tests. It mentions "a phantom model" and "biopsy needle measurements" but not the quantity.
- Data Provenance: Not specified, but generally, phantom studies are conducted in a controlled lab setting and are not tied to specific countries or retrospective/prospective designations.
Clinical Evaluation:
- Sample Size: 31 procedures.
- Data Provenance: Not specified, but "clinical evaluation" typically implies prospective or retrospective collection of real-world patient data. The country of origin is not mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document for either the mechanical accuracy study or the clinical evaluation.

4. Adjudication Method for the Test Set:

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The document describes mechanical and clinical evaluations, but not a study comparing human readers with and without AI assistance. The device is a physical stereotactic guide, not an AI-assisted diagnostic or therapeutic tool for human reader interpretation.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

Yes, a standalone evaluation was performed in essence, for the mechanical accuracy. The "mechanical accuracy study" on a phantom model can be considered a standalone evaluation of the device's physical precision, independent of direct human judgment during the measurement process, assuming automated or objective measurement techniques were used.
The clinical evaluation involved human surgeons, but it's not framed as an algorithm-only test; rather, it assesses the device's function in a real-world surgical context.

7. The type of ground truth used:

Mechanical Accuracy Study: The ground truth would likely be the known, precisely measured targets within the phantom model, against which the biopsy needle measurements guided by the device were compared. This is a form of objective physical measurement.
Clinical Evaluation: The ground truth is implicit in the "procedures" themselves, reflecting the intended surgical outcome or successful instrument positioning as determined by the surgical team and confirmed through intra-operative imaging and post-procedure assessment. This would likely be clinical success and potentially patient outcomes, though specific metrics are not detailed.

8. The sample size for the training set:

This information is not applicable/not provided. The device is a mechanical accessory, not a machine learning or AI algorithm that requires a training set.

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

This information is not applicable/not provided for the same reason as point 8.

Summary

{0}------------------------------------------------

UUL 20 1999

K991636

Elekta Stereotactic Guide Original Premarket 510(k) Notification

SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 16:

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.

SUBMITTER INFORMATION 16.1

	a. Company Name:	Elekta Instruments, AB
	b. Company Address:	Birger Jarlsgatan 53, S-103 93Stockholm, Sweden
	c. Company Phone:Company Facsimile:	(011) 46 8 5872 54 00(011) 46 8 5872 55 00
	d. Contact Person:	Sverker GlansVice PresidentQuality and Regulatory Affairs
	e. Date Summary Prepared:	May 7, 1999

DEVICE IDENTIFICATION 16.2.

a. Trade/Proprietary Name:	Elekta Stereotactic GuideAccessory to the Leksell Image GuidanceSurgical System
b. Classification Name:	Stereotaxic Instrument
	21 CFR 882.4560

16.3 IDENTIFICATION OF PREDICATE DEVICES

Company	Device	510(k) No.	Date Cleared
Ohio Medical	Mayfield-ACCISS Workstation	K955397	04/30/96
Ad-Tech	DAP II Biopsy Guide	K830999	07/12/83
Elekta, AB	Leksell Stereotactic System	K972324	03/02/98

{1}------------------------------------------------

11991636

Elekta Stereotactic Guide Original Premarket 510(k) Notification

DEVICE DESCRIPTION 16.4

16.5 SUBSTANTIAL EQUIVALENCE

The Elekta Stereotactic Guide, as an Accessory to the Leksell Image Guidance Surgical System, is substantially equivalent to Ohio Medical Instruments Mayfield-ACCISS Workstation, Ad-Tech's DAP II Biopsy Guide and Elekta Instruments' Leksell Stereotactic System.

The fundamental technical characteristics of the Elekta Stereotactic Guide are similar to those of the predicate devices. The design of guide and affixation to the patient is equivalent to the Ad-Tech predicate device. The materials used in the Elekta Stereotactic Guide is equivalent to those used in all three predicate devices. The image guidance capabilities are equivalent to that of the Ohio Medical Instruments predicate device.

The Indications for Use for the Elekta Stereotactic Guide is equivalent to the

{2}------------------------------------------------

predicate devices in terms of precise stereotactic instrument positioning and image guidance capabilities.

16.6 INTENDED USE

16.7 TECHNOLOGICAL CHARACTERISTICS

The Elekta Stereotactic Guide is affixed to the patient's cranium. The device consists of a base ring, targeting swivel with instrument channel and locking ring. The base ring provides a rigid fixation for the locking ring and targeting swivel. The instrument channel can accommodate Elekta stereotactic instruments and an Leksell Image Guidance Surgical System probe. A navigational probe is used for determination of the orientation of the target using the intra-operative images of the LIGS system. The guide is locked into place when the correct orientation is obtained. A stop is attached to the stereotactic instrument prior to insertion into the channel. Comparison of the technological characteristics to those of the predicate devices has been provided in this submission.

16.8 PERFORMANCE DATA

The Elekta Stereotactic Guide has been evaluated for performance characteristics using a mechanical accuracy study and a clinical evaluation. Mechanical accuracy was performed on a phantom model with biopsy needle measurements and compared to stereotactic frames. A clinical evaluation of 31 procedures, using the Elekta Stereotactic Guide as an accessory to the Leksell Image

{3}------------------------------------------------

K99/636

Guidance Surgical System was documented. Both studies show that the Elekta Stereotactic Guide performs as intended.

510(K) CHECKLIST 16.9

This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewer ls Checklist is provided in this submission.

{4}------------------------------------------------

Image /page/4/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure with three overlapping profiles, representing health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 20 1999

Elekta Instruments, AB c/o Ms. Carol Patterson Patterson Consulting Group, Inc. 18140 Smokesignal Drive San Diego, California 92127

Re: K991636 Trade Name: Elekta Stereotactic Guide Regulatory Class: II Product Code: HAW Dated: May 7, 1999 Received: May 12, 1999

Dear Ms. Patterson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{5}------------------------------------------------

Page 2 - Ms. Carol Patterson

This letter will allow you to begin marketing your device as described in your 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 vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

|<991636

INDICATION FOR USE

To Be Assigned By FDA 510(k) Number:

Elekta Stereotactic Guide Device Name: Accessory to the Leksell® Image Guidance Surgical System

The Elekta Stereotactic Guide is indicated for use in guidance Indications for Use: and stereotactic instrument positioning in open cranial procedures and surgeries normally performed with traditional stereotactic apparatus.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Deeds

an-Off) (Division Division of General Restorative D 510(k) Number

Prescription Use

(Per 21 CFR 801.109)

Over-The-Counter Use

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).