The PiGalileo™ TKR System is intended to be used in computer-assisted orthopedic surgery to aid the surgeon with bone cuts and implant positioning during joint replacement. It provides information to the surgeon that is utilized to place surgical instruments during surgery utilizing anatomical landmarks and other data specifically obtained intra-operatively (e.g., ligament tension, limb alignment, etc.).

Examples of some surgical procedures include but are not limited to:

Total knee replacement supporting both bone referencing and ligament balancing techniques
Minimally invasive total knee replacement

Device Description

The PiGalileo™ Navigation (NAV) Total Knee Replacement (TKR) Computer Assisted Surgical (CAS) System (PiGalileo™ TKR System) is a softwarecontrolled electromechanical sterotaxic device for computer-aided navigation of PI Galileo surgical instruments with the purpose of assisting the surgeon in optimally positioning prostheses of the TC-PLUS and VKS knee systems.

The PiGalileo™ TKR System is based on common stereotaxic technology in which Infrared (IF) LED (light emitting diodes) or passive markers on the surgical instruments allow the instruments to be tracked in real time in the surgical field.

In the case of PiGalileo™ TKR System, patient data that is required to navigate the surgical instruments is collected during the procedure. The system utilizes this data to establish a connection between passive locaters, i.e., Infrared (IF) light, and the system's IF camera as previously described tracks the surgical instruments in real time in the surgical field.

Two passive locators are attached to the tibia and distal femur during surgery, where one locater is mobile to determine specific landmarks, known as Bone Referencing (BR) on the tibia and femur. Once the system has collected the information, the system positions a motorized cutting guide on the femur to support the surgeon during surgery and provides information to position or "navigate" additional instruments.

The surgeon maintains control of the operation and any decisions required with regard to the surgery at all times. Positions of the motorized cutting guide may also be adjusted manually. Risk mitigations were implemented under Design Controls to ensure that sufficient fail safe mechanisms allow the surgeon to convert to non-navigated conventional surgical techniques at any time.

The PiGalileo™ TKR System consists of three main elements:

System Cart which houses:
- System electronics and cabling
- Monitor
- User Interface
- IF Camera and Camera Stand
- Optional printer
Software:
- PiGalileo System Software
- Application Software
  - a) PiGalileo TKR BR
  - b) PiGalileo TKR Ligament Balancing (LB)
  - c) PiGalileo TKR Light
  - d) PiGalileo TKR Minimally Invasive Surgery (MIS)
Standard Surgical Instruments and application-specific surgical instruments

AI/ML Overview

The provided document for K061362, concerning the PiGalileo™ Total Knee Replacement (TKR) System, does not include specific acceptance criteria or an explicit study proving the device meets performance criteria in the format requested. The submission focuses on substantial equivalence to predicate devices and adherence to recognized standards for safety and software.

Here's a breakdown of the available information based on your request, with "Not applicable" or "Not specified" where the document does not provide the information:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified	Not specified

Explanation: The document does not define explicit acceptance criteria in terms of accuracy, precision, or other performance metrics for the PiGalileo™ TKR System itself. Instead, it refers to conformity with general standards for electromagnetic compatibility, thermal/electrical/mechanical safety, and software.

2. Sample size used for the test set and the data provenance

The document states: "Neither bench, animal nor clinical testing were assessed." This implies that no specific test set of cases (patients or cadavers) was used for performance evaluation to demonstrate substantial equivalence, as the focus was on comparing technical characteristics and indications for use. Therefore, sample size and data provenance are Not applicable for this type of submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As no specific performance testing was assessed for substantial equivalence, there was no test set requiring ground truth establishment by experts.

4. Adjudication method for the test set

Not applicable.

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. The PiGalileo™ TKR System is a computer-assisted surgical navigation system, not an AI-driven diagnostic or interpretative tool that would involve human "readers" in the context of an MRMC study.

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

The document mentions "Design verification and design validation, e.g., bench testing was performed according to FDA's Design Control Requirements," which is a general statement. However, it explicitly states "Neither bench, animal nor clinical testing were assessed" in the context of the substantial equivalence comparison. Therefore, specific standalone performance data was not provided or assessed in this 510(k) summary. The device's nature as a surgical assistance system inherently involves "human-in-the-loop" at all times as the surgeon maintains control.

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

Not applicable. No specific ground truth was established for performance testing as it was not assessed as part of the substantial equivalence submission.

8. The sample size for the training set

The document states "Neither bench, animal nor clinical testing were assessed." and refers to "Design Control documentation". While the system utilizes patient data collected intra-operatively, this refers to data used during the procedure for real-time navigation, not a "training set" in the machine learning sense to develop the algorithm. Therefore, "training set" sample size is Not applicable in the context of this submission.

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

Not applicable.

Summary

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K061362

E.0 Premarket Notification 510(k) Summary

E.1 Submitter Information

OCT - 6 2006

Company Name and Address:

PLUS ORTHOPEDICS AG Erlenstraße 4a CH-6343 Rotkreuz Switzerland

Contact Name:

Pamela J. Weagraff, Principal Consultant Quintiles Consulting 18 Bridie Lane Norfolk, MA 02056

Telephone: 508-528-1745 Facsimile: 978-752-1225

Date Prepared: May 8, 2006

E.2 Name of Device

Trade Name: PiGalileo™ Total Knee Replacement (TKR) System 2.1 (PiGalileo™ Navigation (NAV) TKR Computer-Assisted Surgery (CAS) System)
Common Name: Navigation System 2.2
Classification Name: Stereotaxic instrument 2.3

E.3 Substantial Equivalence Claimed to Predicate Devices

Galileo CAS/NAV TKR System, K020298, cleared May 2, 2002 3.1
OrthoPilot® 2 Navigation Platform, K003347, cleared February 23, 2001, 3.2 and K013569, cleared April 4, 2002
Navitrack™ System -- Optical TKR CT-Less, K021760, cleared August 27, 3.3 2002, and K 043536, cleared January 14, 2005

E.4 Device Description

Company Confidential Page 120 of 123

1/4

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The PiGalileo™ TKR System consists of three main elements:

System Cart which houses: 4.1
- 프 System electronics and cabling
- 프 Monitor
- 동 User Interface
- IF Camera and Camera Stand 를
- I Optional printer
4.2 Software:
- . PiGalileo System Software
- 原 Application Software
  - a) PiGalileo TKR BR
    - b) PiGalileo TKR Ligament Balancing (LB)
    - c) PiGalileo TKR Light
    - d) PiGalileo TKR Minimally Invasive Surgery (MIS)
4.3 Standard Surgical Instruments and application-specific surgical instruments

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E.5 Intended Use

Examples of some surgical procedures include but are not limited to:

I Total knee replacement supporting both bone referencing and ligament balancing techniques
모 Minimally invasive total knee replacement

E.6 Predicate Device Comparison of Indications for Use / Intended Use and Technical Characteristics

The comparison of the PiGalileo™ TKR System was based on a review of the Design Control documentation for the system, relevant aspects of which are included in the company's 510(k) Premarket Notification, and information concerning the predicate devices that was available to the company internally, i.e., Galileo CAS/NAV TKR System, K020298, and for the other predicate devices via the respective company web sites. Copies of this reviewed information are included at the end of this section. The comparison considered technological characteristics and the indications for use / intended use. Neither bench, animal nor clinical testing were assessed.

E.7 Performance Data

7.1 Performance Standards (Section 514 Compliance): no applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act, for sterotaxic instruments. The PiGalileo™ TKR System does conform to the following FDA recognized standards:
- 7.1.1 Electromagnetic Compatibility:

IEC 60601-1-2:01: Emissions - Class A Limit

IEC 61000-3-2:01: Harmonics

IEC 61000-3-3:94+A1:01: Voltage Fluctuations

IEC 60601-1-2:01: Immunity

7.1.2 Thermal, Electrical and Mechanical Safety
UL 60601-1: Medical Electrical Equipment Part 1

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7 1.3 Software

IEC 60601-1-4:1996. Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems

FDA's "Reviewer Guidance for the Content of Premarket Submission for Software Contained in Medical Devices", May 11, 2005

FDA's "Guidance for Off-The-Shelf Software Use in Medical Devices"

7.1.4 Sterilization

AAMI TIR12:1994, "Designing, testing and labeling reusable medical devices for reprocessing in healthcare facilities".

7.1.5 Risk Analysis
ISO 14971:2000, Application of risk management to medical devices
Biocompatibility (Note: applies only to surgical tools, i.e., materials 7.1.6 for system and software applications do not come into contact with the patient.)
ASTM/ISO standards for materials that are suitable for surgically invasive devices for transient to short term use.
7.1.7 Performance Testing: Design verification and design validation, e.g., bench testing was performed according to FDA's Design Control Requirements, Title 21 Code of Federal Regulations, Part 820.30.

E.8 Conclusion:

The information and data provided in this 510(k) Premarket Notification establish that the PiGalileo ™ TKR System is substantially equivalent to the aforementioned predicate devices with respect to indications for use/intended use, and technical characteristics.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized eagle with three curved lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 6 - 2006

Plus Orthopedics AG % Quintiles Consulting Ms. Pamela J. Weagraff, MBA, RAC Principal Consultant 18 Bridie Lane Norfolk, Massachusetts 02056

Re: K061362

Trade/Device Name: PiGalileo™ Total Knee Replacement (TKR) System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: September 29, 2006 Received: October 2, 2006

Dear Ms. Weagraff:

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 - Ms. Pamela J. Weagraff, MBA, RAC

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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Barbara Mueller

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

Enclosure

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ODE Indications Statement

K061362 510(k) Number (if known): Unknown

Device Name: PiGalileo™ Total Knee Replacement (TKR) System

Indications for Use:

Examples of some surgical procedures include but are not limited to:

Total knee replacement supporting both bone referencing and ligament 해 balancing techniques
I Minimally invasive total knee replacement

Prescription Use: __ X

AND/OR

Over-the-Counter Use:

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Buchner

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

510(k) Number K061362

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).