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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

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

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

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.

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