The PiGalileo™ Total Hip Replacement (THR) 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. hip center, pelvic plane etc.).

Examples of some surgical procedures include but are not limited to: Primary total hip replacement Revision hip surgery Minimally invasive hip arthroplasty

Device Description

The PiGalileo™ Total Hip Replacement (THR) software application when provided with the PiGalileo™ system cart results in the PiGalileo™ THR System, a softwarecontrolled electromechanical stereotaxic device for computer-aided navigation of PiGalileo™ surgical instruments with the purpose of assisting the surgeon in optimally positioning hip prostheses. Refer to Section 11.0 for an in depth description of the PiGalileo™ THR System.

The PiGalileo™ THR 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.

The PiGalileo™ THR 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™ THR 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.

The precision of navigation-assisted surgery depends on accurate scanning of skeletal landmarks. Scanned morphological data represents the basis for calculating the position of the hip cup and hip stem. Scanned points must represent unique anatomic landmarks so that they can be located in a safe and reproducible manner throughout surgery. For cup navigation, the spinae, left/ right are scanned as well as the symphysis. Each point is scanned three times to enhance precision and used for inclination and anteversion alignment. For stem navigation, the sagital plane is determined from the tibialis anterior and the intersection point on the femur. The position and alignment of the proximal stem axis are determined with a probe which provides the basis of the varus/valgus alignment.

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

The navigation platform for the PiGalileo™ THR System is the same as the navigation platform cleared under PiGalileo™ TKR System, K061362, and includes the following elements:

(a) System Cart housing the following items; there are no changes to the system cart as compared to K061362.
1 System electronics such as CPU and connection box
Monitor
User Interface consisting of keyboard, touch pad and hard controls, e.g., "ON / OFF", footswitch
Infrared (IF) Camera and Camera Stand/Tripod
Optional printer
System cabling
(b) PiGalileo™ THR Software refers to the PiGalileo™ System Software and the THR software application:
PiGalileo™ System Software: this software is the same as that of the PiGalileo™ TKR System; there are no changes to either the system software or the calculations or the landmark technique as compared to K061362.
PiGalileo™ THR software application consists of two applets, PiGalileo™ Hip Cup and PiGalileo™ Hip Stem. Each applet consists of a collection of software modules that support the surgeon in hip cup and hip stem replacement. Each module is designed specifically for an implant in which the software calculates the values provided on screen differently for each implant, the specific implant geometry and the implant specific instruments.
(c) Surgical Instruments: include universal instruments such as hemispheres, and various locators; navigated instruments are equipped with markers that are tracked by the stereotaxic camera.

The POLARCUP® Dual Mobility System consists of two components: a thin press fit shell and a liner component.

AI/ML Overview

The provided text describes the PiGalileo™ Total Hip Replacement (THR) System and its premarket notification (510(k)) to the FDA. However, the document does not contain specific acceptance criteria or a study detailing device performance against such criteria in terms of clinical accuracy or effectiveness.

Instead, the document focuses on:

Device Description: What the PiGalileo™ THR System is and how it functions as a navigation system for hip replacement surgery.
Intended Use/Indications for Use: The surgical procedures and assistance it provides.
Predicate Device Comparison: How it compares to previously cleared navigation systems.
Performance Standards (Regulatory Compliance): Conformance to various FDA-recognized standards for safety (electrical, mechanical, thermal), electromagnetic compatibility, software, sterilization, risk analysis, and biocompatibility of surgical tools.
Design Control Performance Testing: A general statement about design verification and validation (bench testing) performed under FDA's Design Control Requirements.

Therefore, I cannot populate the table or answer most of your detailed questions regarding acceptance criteria, specific performance measures, sample sizes for test/training sets, ground truth establishment, expert qualifications, or MRMC studies. The document does not provide this type of detailed performance study information.

Here's a summary of what can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not explicitly stated in terms of clinical accuracy (e.g., X mm accuracy for implant placement). The "acceptance criteria" here are largely met through adherence to recognized regulatory and design control standards.
Reported Device Performance: No specific clinical or quantitative performance metrics (e.g., accuracy in degrees or millimeters, success rates, complication rates) are reported in this summary.

Acceptance Criteria Category	Specific Criteria (as inferred/stated)	Reported Device Performance
Regulatory Compliance	FDA's "Design Control Requirements, Title 21 Code of Federal Regulations, Part 820.30"	"Design verification and design validation, e.g., bench testing, was performed according to FDA's Design Control Requirements."
Electrical, Thermal, Mechanical Safety	IEC 60601-1: Medical Electrical Equipment Part 1: General Requirements for Safety	"PiGalileo™ Total Hip Replacement (THR) System does conform to the following FDA recognized standards." (Implied successful conformance)
Electromagnetic Compatibility (EMC)	IEC 60601-1-2:01, IEC 61000-3-2:01, IEC 61000-3-3:94+A1:01	"PiGalileo™ Total Hip Replacement (THR) System does conform to the following FDA recognized standards." (Implied successful conformance)
Software	IEC 60601-1-4:1996, FDA's "Reviewer Guidance for the Content of Premarket Submission for Software Contained in Medical Devices" (2005), FDA's "Guidance for Off-The-Shelf Software Use in Medical Devices"	"PiGalileo™ Total Hip Replacement (THR) System does conform to the following FDA recognized standards." (Implied successful conformance)
Sterilization (for reusable components)	AAMI TIR 12-1994, ISO 17664, AINSI/AAMI/ISO 11134, EN 556-1, AINSI/AAMI ST 67, LM P 2-11-04, LM SOP 2-11-04	"Cleaning, disinfection and sterilization testing was performed according to the following test protocols." (Implied successful conformance)
Risk Analysis	ISO 14971:2000, Application of risk management to medical devices.	"PiGalileo™ Total Hip Replacement (THR) System does conform to the following FDA recognized standards." (Implied successful conformance)
Biocompatibility (surgical tools)	ASTM/ISO standards for surgically invasive devices for transient to short term use.	"Applies only to surgical tools, i.e., materials for system and THR software application do not come into contact with the patient." (Implied successful conformance)
Substantial Equivalence	To predicate devices (VectorVision Hip, Orthopilot® 2 THA V 2.0, Stryker Navigation System, PiGalileo™ TKR System) in indications for use/intended use and technical characteristics.	"The information and data provided in this 510(k) Premarket Notification establish that the PiGalileo™ Total Hip Replacement (THR) System is substantially equivalent to the afore-mentioned predicate devices."

2. Sample size used for the test set and the data provenance: Not mentioned. The document refers to "bench testing" for design verification and validation, but no details on sample size, type of data, or provenance are provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. Given the nature of the device (a surgical navigation system) and the timeframe (2007), the 'ground truth' for bench testing would likely involve highly precise measurements by engineers or technical experts rather than clinical experts establishing a ground truth in diagnostic interpretation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.

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 mentioned. This document is for a surgical navigation system, not a diagnostic AI tool, so an MRMC study in the context of "human readers" is not applicable. The device assists surgeons, but the document doesn't quantify improvement in surgeon performance with the device versus without.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not explicitly stated regarding specific numerical performance of the algorithm. The system is designed with human-in-the-loop (the surgeon) and explicitly states, "The surgeon maintains control of the operation and any decisions required with regard to the surgery at all times." Standalone performance (algorithm only) would pertain to the accuracy of its tracking and calculation systems, which is generally covered under design verification/bench testing, but no specific metrics are given.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated. For a navigation system, ground truth during verification testing would likely involve highly accurate physical measurements of instrument position and spatial relationships in a controlled environment, possibly using precision measurement tools.

8. The sample size for the training set: Not mentioned. The system is a rule-based or model-based navigation system, not a machine learning/AI diagnostic system trained on large datasets in the modern sense. It relies on mathematical algorithms and optical tracking.

9. How the ground truth for the training set was established: Not applicable in the context of modern machine learning training sets. The "ground truth" for the device's development would be engineering specifications and anatomical models used to program its navigational calculations.

Summary

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|070731

JUL 3 1 2007

Attachment B - Revised Premarket Notification 510(k) Summary

Attachment B July 26, 2007

Company Confidential

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K070731

Premarket Notification 510(k) Summary

1. Submitter Information

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 E-mail: pamela.weagraff@quintiles.com

Date Prepared: July 26, 2007

2. Name of Device

Trade Name: PiGalileo™ Total Hip Replacement (THR) System (a)
(b) Common Name: Navigation System
(c) Classification Name and Reference:

Title 21 Code of Federal Regulation (CFR), Part 882.4560 Stereotaxic instrument, Product Code: HAW

3. Substantial Equivalence Claimed to Predicate Device

VectorVision Hip, K060468, manufactured by BrainLAB AG Orthopilot® 2 THA V 2.0, K050752, manufactured by Aescular®, Inc. Stryker Navigation System, K022365, manufactured by Stryker Corporation PiGalileo™ Total Knee Replacement (TKR) System, K061362, manufactured by Plus Orthopedics AG

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4. Device Description

The navigation platform for the PiGalileo™ THR System is the same as the navigation platform cleared under PiGalileo™ TKR System, K061362, and includes the following elements:

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(a) System Cart housing the following items; there are no changes to the system cart as compared to K061362.
- 1 System electronics such as CPU and connection box
- 트 Monitor
- I User Interface consisting of keyboard, touch pad and hard controls, e.g., "ON / OFF", footswitch
- Infrared (IF) Camera and Camera Stand/Tripod
- l Optional printer
- . System cabling
(b) PiGalileo™ THR Software refers to the PiGalileo™ System Software and the THR software application:
- . PiGalileo™ System Software: this software is the same as that of the PiGalileo™ TKR System; there are no changes to either the system software or the calculations or the landmark technique as compared to K061362.
- 지 PiGalileo™ THR software application consists of two applets, PiGalileo™ Hip Cup and PiGalileo™ Hip Stem. Each applet consists of a collection of software modules that support the surgeon in hip cup and hip stem replacement. Each module is designed specifically for an implant in which the software calculates the values provided on screen differently for each implant, the specific implant geometry and the implant specific instruments.
(c) Surgical Instruments: include universal instruments such as hemispheres, and various locators; navigated instruments are equipped with markers that are tracked by the stereotaxic camera.

The POLARCUP® Dual Mobility System consists of two components: a thin press fit shell and a liner component.

5. Intended Use / Indication for Use

Examples of some surgical procedures include but are not limited to: Primary total hip replacement Revision hip surgery Minimally invasive hip arthroplasty

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

The comparison of the PiGalileo™ Total Hip Replacement (THR) System to the predicate devices was based on a review of the Design Control documentation, relevant aspects of which are included in the company's 510(k) Premarket Notification, and information concerning the predicate device, PiGalileo™ TKR System, K061362, that was available to the company internally, information concerning the predicate device that was obtained from the predicate device manufacturer's web site. The comparison considered technical characteristics and the indications for use / intended use.

7. Performance Data

(a) Performance Standards (Section 514 Compliance): No performance standards applicable to this device, 882.4580, stereotaxic instrument, have been adopted under Section 514 of the Food Drug and Cosmetic Act.
(b) PiGalileo™ Total Hip Replacement (THR) System does conform to the following FDA recognized standards:
- Thermal, Electrical and Mechanical Safety i) IEC 60601-1: Medical Electrical Equipment Part 1: General Requirements for Safety
- ii) Electromagnetic Compatibility: IEC 60601-1-2:01: Electromagnetic Compatibility, Requirements and Tests, Emissions - Class A Limit, and Immunity IEC 61000-3-2:01: Electromagnetic Compatibility - Part 3-2 Limits for Harmonic Current Emissions IEC 61000-3-3:94+A1:01: Electromagnetic Compatibility -- Part 3-3 Limitation of Voltage Changes, Voltage Fluctuations
- iii) 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"

iv) Sterilization
Cleaning, disinfection and sterilization testing was performed according to the following test protocols:

"Microbiological Efficiency Control of the Automated Cleaning and Disinfection Method", AAMI TIR 12-1994, ISO 17664, LM SOP 2-11-01

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"Microbiological Efficiency Control of Steam Sterilization (Fractionated Vacuum Procedure)", AAMI TIR 12-1994, ISO 17664, (half-cycle method), AINSI/AAMI/ISO 11134, EN 556-1, AINSI/AAMI ST 67, LM P 2-11-04, LM SOP 2-11-04

v) Risk Analysis: ISO 14971:2000, Application of risk management to medical devices.
vi) Biocompatibility (Note: applies only to surgical tools, i.e., materials for system and THR software application do not come into contact with the patient.) ASTM/ISO standards, i.e., suitable for surgically invasive devices for transient to short term use.
vii) General: FDA's "Deciding When to Submit a 510(k) for a Change to an Existing Device", January 10, 1997 FDA's "Premarket Notification 510(k): Regulatory Requirements for Medical Devices", August, 1995 FDA's Updated 510(k) Sterility Review Guidance K90-1, August 30, 2002
viii) 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.

8. Conclusion:

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

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 1 2007

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

Re: K070731

Trade/Device Name: PiGalileo™ Total Hip Replacement (THR) System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: July 11, 2007 Received: July 16, 2007

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

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Page 2 - Pamela J. Weagraff, MBA, RAC

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.

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,
Mark A. Millerson

Mark N. Melkerson 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

510(k) Number (if known): Unknown

Device Name: PiGalileo™ Total Hip Replacement (THR) System

Indications for Use:

Examples of some surgical procedures include but are not limited to: Primary total hip replacement Revision hip surgery Minimally invasive hip arthroplasty

Prescription Use: X (21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use: (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)

Mark A. Milliken

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

510(k) Number K070731

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).