Ci TKR/UKR is intended to be an intraoperative image guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. The system is indicated for any medical condition in which the use of stereo tactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT, X-ray, MR based model of the anatomy. The system aids the surgeon to accurately navigate a knee prosthesis to the intraoperatively planned position. Ligament balancing and measurements of bone alignment are provided by Ci TKR/UKR.

Example orthopedic surgical procedures include but are not limited to:

Knee Procedures: Total Knee Replacement Unicondylar Knee Replacement Ligament Balancing Range of Motion Analysis Cruciate Ligament Surgery Patella Tracking

Device Description

Ci TKR/UKR is intended to enable operational planning and navigation in orthopedic surgery. It links a surgical instrument, tracked by flexible passive markers to virtual computer image space on an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. Ci TKR/UKR uses the registered landmarks to navigate the femoral and tibial cutting guides and the implant to the planned optimally position.

Ci TKR/UKR allows 3-dimensional reconstruction of the mechanical axis and alignment of the implants. Ci TKR/UKR software registers the patient data needed for planning and navigating the surgery intraoperatively. No preoperative CT-scanning is necessary.

Ci TKR/UKR software has been designed to read in implant data from DePuy and offers to individually choose the prosthesis during each surgery.

AI/ML Overview

The provided text describes the Ci TKR/UKR (Kolibri Knee) image-guided surgical system, but it does not contain information about the acceptance criteria or a specific study proving the device meets those criteria, nor any performance metrics.

The document is a 510(k) summary and FDA clearance letter, which focuses on establishing substantial equivalence to predicate devices rather than detailing performance studies with specific statistical outcomes or acceptance criteria.

Therefore, I cannot populate the requested table or answer most of the questions as the information is not present in the provided text.

Here's what can be extracted based on the document:

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

No specific acceptance criteria or reported device performance metrics are provided in this document. The document states "The validation proves the safety and effectiveness of the information provided by BrainLAB in this 510 (k) application was found to be substantially equivalent with predicate devices..." indicating that validation was performed, but the details of that validation (criteria, results) are not included here.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not specified in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not specified in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not specified in the document.

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 an image-guided surgical system, not an AI or diagnostic imaging device that involves human "readers" or "interpreters" in the context of MRMC studies. Its purpose is to assist surgeons in navigation.

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

This device is inherently "human-in-the-loop" as it's an image-guided surgical system designed to assist a surgeon. The document does not describe standalone algorithm performance for tasks like diagnosis or prediction. Its function is to provide real-time navigation assistance.

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

Not specified in the document. Given the nature of a navigation system, ground truth would likely relate to the accuracy of instrument positioning relative to planned positions or actual anatomical landmarks, but the method for establishing this is not detailed.

8. The sample size for the training set:

Not applicable/Not specified. This document does not describe a machine learning model with a distinct "training set." The system uses 3D models generated from patient bone landmarks intraoperatively.

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

Not applicable/Not specified.

Summary of what is known from the provided text:

Manufacturer: BrainLAB AG
Device Name: Ci TKR/UKR (Kolibri Knee)
Intended Use: Intraoperative image-guided localization system to enable minimally invasive surgery, aiding surgeons to accurately navigate knee prostheses, provide ligament balancing, and measure bone alignment.
Mechanism: Links a freehand probe (tracked by passive markers) to a virtual computer image space on an individual 3D-model of the patient's bone, generated through acquiring multiple landmarks on the bone surface.
Key Feature: No preoperative CT-scanning is necessary.
Regulatory Status: Cleared via 510(k) process based on substantial equivalence to predicate devices (BrainLAB Vector Vision® CT-free knee and BrainLAB Kolibri™ Image Guided Surgery System).
Validation: The text states, "The validation proves the safety and effectiveness of the information provided by BrainLAB in this 510(k) application was found to be substantially equivalent with predicate devices..."

To answer the detailed questions, a more comprehensive technical report or validation study document would be required, rather than just the 510(k) summary and FDA clearance letter.

Summary

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K03/170

AUG 1 2 2003

510 (k) Summary of Safety and Effectiveness for Ci TKR/UKR (Kolibri Knee)

Manufacturer:	BrainLAB AG
Address:	Ammerthalstrasse 885551 HeimstettenGermanyPhone: +49 89 99 15 68 0Fax: +49 89 99 15 68 33
Contact Person:	Mr. Rainer Birkenbach
Summary Date:	June 2, 2003
Device Name:
Trade name:	Ci TKR/UKR
Common/Classification Name:	Ci TKR/UKR (Kolibri Knee), BrainLAB Image Guided Surgery System /Instrument, Stereotaxic

Predicate Devices:

BrainLAB Vector Vision® CT-free knee (K 021306)

BrainLAB Kolibri™ Image Guided Surgery System (K014256)

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

Intended Use:

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Example orthopedic surgical procedures include but are not limited to:

Knee Procedures: Total Knee Replacement Unicondylar Knee Replacement Ligament Balancing Range of Motion Analysis Cruciate Ligament Surgery Patella Tracking

Device Description:

Ci TKR/UKR software has been designed to read in implant data from DePuy and offers to individually choose the prosthesis during each surgery.

Substantial equivalence:

Ci TKR/UKR has been verified and validated according to BrainLAB's procedures for product design and development. The validation proves the safety and effectiveness of the information provided by BrainLAB in this 510 (k) application was found to be substantially equivalent with predicate devices such as the 510(k)-clearance of VectorVision® CT-free knee (K 021306) and of the Kolibri IGS System (K014256).

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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 features a stylized eagle or bird-like figure with three curved lines representing its body and wings. The bird is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" in capital letters. The text is arranged around the circumference of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 2 2003

Mr. Rainer Birkenbach Executive Vice President BrainLAB AG Ammerthalstrasse 8 85551 Heimstetten Germany

Re: K031770

Trade/Device Name: Ci TKR/ÜKR (Kolibri Knee) Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: June 2, 2003 Received: June 9, 2003

Dear Mr. Birkenbach :

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. Rainer Birkenbach

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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Wily Witt

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name:

Ci TKR/UKR (Kolibri Knee)

Ko31770

Indications For Use:

Example orthopedic surgical procedures include but are not limited to:

Knee Procedures: Total Knee Replacement Unicondylar Knee Replacement Ligament Balancing Range of Motion Analysis Cruciate Ligament Surgery Patella Tracking

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

Wla Witt
(Division Sign-Off)

510(k) Number K03177

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).