BrainLAB ACL is intended to be used as an intraoperative image-guided navigation system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system, to a virtual computer image space on the model of a bone, overlaid with individually acquired patient landmarks.

The system is indicated for any surgical anterior cruciate ligament procedure in which the use of stereotactic surgery for the planning and navigation of interosseous canals may be appropriate, and where a reference to a rigid anatomical structure can be established.

Device Description

ACL is an image quided surgery system for the replacement of torn ligaments in the knee joint. It is based on intra-operatively acquired landmarks that are used for planning and navigation. It supports the surgeon in the planning and drilling of transplants canals in the position to regain the stability of the knee joint.

AI/ML Overview

This 510(k) summary for the BrainLAB ACL device does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a specific study proving device performance against those criteria. The provided document is a regulatory submission for substantial equivalence rather than a detailed scientific study report.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the document. The 510(k) summary focuses on verifying and validating the device in general terms and establishing substantial equivalence to predicate devices, rather than presenting specific quantitative performance criteria and results from a singular study.

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

This information is not provided. The document mentions "Subsystem & System Verification using Xtool," "Non-Xtool tests," "License group tests," "Installer tests," and "Startup tests," as well as "Testing and evaluation under real world conditions" and "Preclinical and clinical validation." However, no specific sample sizes for test data, or details on whether this data was retrospective or prospective, or its country of origin, are given.

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

This information is not provided. While "Evaluation at special sites" and "Preclinical and clinical validation" imply expert involvement, the document does not specify the number or qualifications of any experts involved in establishing ground truth for testing.

4. Adjudication Method for the Test Set:

This information is not provided.

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

This information is not provided. The document mentions "Comparison with a previously marketed medical device" as part of the validation process, but it does not describe an MRMC study or any effect size related to human readers improving with or without AI assistance. The BrainLAB ACL is an image-guided surgery system, not an AI diagnostic tool, so an MRMC study in the typical sense for AI might not apply directly.

6. If a Standalone Performance Study Was Done:

The document broadly states:

"Subsystem & System Verification using Xtool."
"Non-Xtool tests."
"Preclinical and clinical validation."

However, it does not provide details of specific standalone performance metrics or results for the algorithm or system without human interaction, in the way a diagnostic AI would. The device is intended as an intraoperative image-guided navigation system, inherently involving a human surgeon.

7. The Type of Ground Truth Used:

This information is not explicitly stated or detailed. Given the nature of an image-guided surgery system, ground truth would likely refer to the accuracy of instrument tracking, alignment, and navigation relative to anatomical landmarks or surgical plans. This would probably be established through direct measurement, imaging correlation, and expert assessment of surgical outcomes or accuracy in phantom/cadaver studies. The document mentions "intra-operatively acquired landmarks that are used for planning and navigation," suggesting that anatomical landmarks form a key part of the "ground truth" for the system's function.

8. The Sample Size for the Training Set:

This information is not provided. The BrainLAB ACL is described as linking a probe to a virtual computer image space "overlaid with individually acquired patient landmarks." This suggests a system that relies on patient-specific imaging and real-time intraoperative data rather than a large, pre-trained machine learning model in the modern sense. Therefore, the concept of a "training set" for a machine learning algorithm might not be directly applicable in the conventional way.

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

This information is not provided, and as noted in point 8, the concept of a "training set" might not fully apply to this type of device in the same way it would for a contemporary AI diagnostic system. The system uses "individually acquired patient landmarks" for its function, which are established intraoperatively.

Summary of what is present:

The document focuses on establishing substantial equivalence to predicate devices (VectorVision® ACL (K042512) and BrainLAB Knee (K073615)) through a series of general verification and validation activities. These include design reviews, software validation, literature research, and comparison with previously marketed devices. The FDA's 510(k) clearance confirms this substantial equivalence based on the provided information.

However, the specific quantitative acceptance criteria and detailed study results you are asking for, which would typically be found in a detailed clinical or performance study report, are not included in this 510(k) summary. These summaries are regulatory documents intended to demonstrate that a new device is as safe and effective as a legally marketed predicate, not comprehensive scientific publications of specific performance trials.

Summary

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1093118 510 (k) Summary of Safety and Effectiveness for BrainLAB ACL

Manufacturer:

Address:

BrainLAB AG Kapellenstrasse 12 85622 Feldkirchen Germany Phone: +49 89 99 15 68 0 Fax: +49 89 99 15 68 33

Contact Person: Mr. Alexander Schwiersch

May 21, 2010 Summary Date:

Device Name:

Trade name:

BrainLAB ACL

Common/Classification Name:

BrainLAB Image Guided Surgery System / Instrument, Stereotaxic

Predicate Device:

VectorVision® ACL (K042512) BrainLAB Knee (K073615)

Device Classification Name: Instrument, Stereotaxic Regulatory Class: Class II

Intended Use:

Indications For Use:

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Device Description:

Substantial equivalence:

BrainLAB ACL has been verified and validated according to BrainLAB's procedures for product design and development.

To conclude the substantial equivalence, the following verification aspects were performed:

. Design review meetings
Evaluation at special sites t
Tracking of software versions .
Subsystem & System Verification using Xtool .
Non-Xtool tests .
License group tests .
Installer tests .
Startup tests .

To conclude the substantial equivalence, the following validation aspects were performed:

Testing and evaluation under real world conditions .
Desian reviews .
Software validation .
Literature research .
Literature evaluation ◆
Comparison with a previously marketed medical device .
Indications for use/Changed indications for use .
. Non-clinical validation
Preclinical and clinical validation .
Side effects .

The information provided by BrainLAB in this 510 (k) application was found to be substantially equivalent with the predicate device VectorVision® ACL (K042512) and BrainLAB Knee (K073615)

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the seal is a stylized image of an eagle with its wings spread.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

BrainLAB AG % Mr. Stefan Wimmer Kapellenstrasse 12 85622 Feldkirchen Germanv

JUN 1 1 2010

Re: K093118

Trade/Device Name: BrainLAB ACL Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: June 04, 2010 Received: June 09, 2010

Dear Mr. Wimmer:

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

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Page 2 - Mr. Stefan Wimmer

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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/MedicalDevices/Safety/ReportalProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark A. Milliken

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

Enclosure

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Indications for Use

510(k) Number (if known): K09318

Device Name: ACL

Indications For Use:

BrainLAB ACL is intended to be used as an intraoperative image-guided navigation system to enable minimally invasive surgery. It links a freehand probe, tracked by a bystein to enable minimal computer image space on the model of a bone, overlaid with individually acquired patient landmarks.

Prescription Use × (Per 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)

Nilses. Ryden Loc. mnr

(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices

510(k) Number K093118

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).