The AIS S4 Cervical Navigation Instruments are intended to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures. They are indicated for use in surgical spinal procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure , such as the pelvis or a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. These procedures include but are not limited to spinal fusion during the navigation of pedicle screws (T1-T3).

Device Description

The AIS S4 Cervical Navigation Instruments are manual surgical instruments which are designed to interface with BrainLAB's already cleared surgical navigation systems. Instruments in this system may be pre-calibrated or manually calibrated to already cleared systems using manufacturers' instructions. These instruments are intended to be used in spine applications to perform general or manual functions within the orthopedic surgical environment.

AI/ML Overview

The provided text describes the Aesculap S4 Cervical Navigation Instrumentation, which is a set of manual surgical instruments designed to interface with BrainLAB's surgical navigation systems. The submission is a Traditional 510(k) Premarket Notification.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list specific quantitative acceptance criteria for the device's performance (e.g., a certain level of accuracy in millimeters). Instead, it describes a more qualitative assessment.

Acceptance Criteria (Implied)	Reported Device Performance
Device functions as intended for surgical navigation.	AIS Navigation Instruments met the performance requirements.
No safety issues are raised by performance testing.	No safety issues were raised by the performance testing.
No effectiveness issues are raised by performance testing.	No effectiveness issues were raised by the performance testing.
Substantially equivalent to predicate devices for intended use.	Found substantially equivalent.

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

Sample Size: The document states that "BrainLAB conducted validation activities including usability testing with the AIS Navigation Instruments." However, it does not specify the sample size (e.g., number of users, number of cases tested) for this usability testing or any other performance testing.
Data Provenance: The document does not specify the country of origin of the data. The testing appears to be conducted by BrainLAB, a company with international operations, but the specific location of the testing is not mentioned. It is also not explicitly stated whether the data was retrospective or prospective, though usability testing typically involves prospective data collection.

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

The document mentions "usability testing with the AIS Navigation Instruments." Usability testing typically involves end-users (surgeons) but does not specify the number or qualifications of these experts for establishing ground truth related to navigational accuracy or effectiveness. The study relies on the outcome of the usability testing and performance testing rather than expert-established ground truth in a clinical or imaging sense.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method for the test set. Given the nature of the testing described (usability and performance requirements), it's unlikely a formal adjudication process (like 2+1 or 3+1 consensus) would be used as it would be in an imaging diagnostic study. The assessment would likely be based on whether the instruments appropriately facilitated the surgical steps and met performance specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC comparative effectiveness study was done. The document states, "Clinical data was not needed for the AIS Navigation Instruments." The submission focuses on substantial equivalence based on technological characteristics and performance testing.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable as the device (AIS S4 Cervical Navigation Instruments) is a set of manual surgical instruments designed to interface with surgical navigation systems. It is not an AI algorithm or a standalone software. The performance testing would inherently involve human interaction with the instruments and the navigation system.

7. The Type of Ground Truth Used

The document implies that the ground truth for "performance requirements" would be established by the functional specifications and design requirements of the instruments when used with the BrainLAB navigation systems. For usability testing, the "ground truth" would be whether the instruments are usable and meet the functional needs of the surgeons. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this submission, as clinical data was not required.

8. The Sample Size for the Training Set

This question is not applicable. The device is a set of manual surgical instruments; it is not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as there is no AI algorithm or training set involved.

Summary

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Traditional 510(k) Premarket Notification

Aesculap S4 Cervical Navigation Instrumentation

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2012

B. 510(k) SUMMARY (as required by 21 CFR 807.92)

Aesculap® Implant Systems (AIS) S4 Spinal System Auqust 6, 2013

COMPANY:	Aesculap®Implant Systems (AIS), LLC.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 3005673311
CONTACT:	Lisa M. Boyle, Sr Regulatory Affairs Specialist610-984-9274 (phone)610-791-6882 (fax)lisa.boyle@aesculap.com
TRADE NAME:	AIS S4 Cervical Navigation Instruments
COMMON NAME:	Stereotaxic Instrument
REGULATION NUMBER:	882.4560 - Instrument, Stereotaxic

PRODUCT CODE:	OLO and HAW
REVIEW PANEL:	Orthopedics

INDICATIONS FOR USE

DEVICE DESCRIPTION

TECHNOLIGICAL CHARACTERISTICS(compared to Predicate(s)}

The AIS S4 Cervical Navigation Instruments have similar design features, materials, and indications for use as the current AIS manual instruments (class I instrumentation)

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and are substantially equivalent to the instruments used with the BrainLAB's various navigation systems. The use of the navigated polyaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine.

PERFORMANCE DATA

BrainLAB conducted validation activities including usability testing with the AIS Navigation Instruments. The AIS Navigation Instruments met the performance requirements. No safety or effectiveness issues were raised by the performance testing. Clinical data was not needed for the AIS Navigation Instruments.

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Spine & Trauma 2D / Fluro Express K110204 .
Aesculap S4C Spinal System (K050797, K060152, K062327) .

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles an abstract caduceus or a stylized representation of human figures.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 13, 2013

Ms. Lisa M. Boyle Senior Regulatory Affairs Specialist Aesculap Implant Systems, LLC 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K130887

Trade/Device Name: Aesculap S4 Cervical Navigation Instrumentation Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO, HAW Dated: June 13, 2013 Received: June 14, 2013

Dear Ms. Boyle:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Lisa M. Boyle

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Erini Meith

For

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT A.

K130887 510(k) Number:

Device Name: Aesculap S4 Cervical Navigation Instrumentation

Indications for Use:

The Aesculap S4 Cervical Navigation Instruments are intended to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures. They are indicated for use in surgical spinal procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure , such as the pelvis or a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. These procedures include but are not limited to spinal fusion during the navigation of pedicle screws (T1-T3).

Prescription Use	X
(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 NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth L. Frank -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K130887

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).