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The pari-path surgical navigation system is a stereotactic accessory for Computed Tomography(CT) and Ultrasound imaging systems.

It displays the simulated image of an interventional instrument ( a tracked insertion tool), such as a biopsy needle,an ablation needle ,or probe,on a computer monitor screen that shows an image model of the target organs and the current and the projected future path of the interventional instrument. Ultrasound imaging is incorporated with the pari-path surgical navigation system for the situation in which the target organs may move because of palients's respiratory.

It is intended for treatment planning and intra-operative guidance for surgical procedures. It is intended for use in clinical interventionals and for anatomical structures where imaging is currently used for visualizing such procedures.

The pari-path surgical navigation system is a stereotactic accessory for Computed Tomography(CT) and Ultrasound (US).

It utilizes electromagnetic tracking technology to locate and navigate instruments relative to an image model of the patient anatomy.

It displays the simulated image of an interventional instrument (a tracked insertion tool). such as a biopsy needle, an ablation needle, or probe, on a computer monitor screen that shows the image model of the patient anatomical target organs and the current and the projected future path of the interventional instrument.

The image model of patient anatomical organs is derived from two-dimensional patient images (scan sets) via the navigation system.

The interventional instrument can be located and navigated on the image model. Ultrasound imaging is incorporated with the system for the situation in which the target organs may move because of patient's respiratory.

The system performs spatial mapping from CT image space to physical space ("registration") to correlate scan sets to the patient.

It consists of a magnetic field transmitter, tracking sensors, system unit, monitor, keyboard, mouse, software, and an "off the shelf" ultrasound device (an optional, not supplied with the system).

Here's a breakdown of the acceptance criteria and study information for the Pari-path Surgical Navigation System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly list quantitative acceptance criteria for the Pari-path surgical navigation system. Instead, it describes a more general approach to demonstrating substantial equivalence to predicate devices through various tests.

The reported device performance is also described in general terms, emphasizing that the device "performs according to its specifications" and is "substantially equivalent to its predicate devices." No specific numerical performance metrics (e.g., accuracy, precision) are provided in this summary.

Table (Based on implied criteria and general performance statements):

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

• Sample Size for Test Set: The document does not specify a sample size for any of the tests (software verification, electrical safety, or bench testing).
• Data Provenance: The document does not provide information regarding the country of origin of data or whether it was retrospective or prospective. It only states that the testing was "performed."

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

The document does not mention using experts to establish ground truth for any test set. The testing described appears to be internal validation (e.g., against specifications, electrical standards, or through bench testing).

4. Adjudication Method for the Test Set

The document does not mention any adjudication method for a test set. This suggests that the testing likely involved objective measurements against established standards or internal specifications, rather than subjective expert review that would require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. Therefore, there is no information on the effect size of human readers improving with AI vs. without AI assistance. The focus of this 510(k) summary is on the substantial equivalence of the device itself, not on comparative human performance with or without the device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The primary testing described appears to be standalone testing of the device's components and overall system functionality (e.g., electrical safety, software validation, bench testing). The document does not describe "human-in-the-loop" studies in the context of performance metrics for the device for its 510(k) submission. Its purpose is to guide human operators, so a standalone performance of "algorithm only" in a clinical decision-making sense would not be directly applicable for this device type.

7. Type of Ground Truth Used

The ground truth used for the described testing appears to be based on:

• Industry Standards: For electrical safety and electromagnetic compatibility (IEC 60601-1 and IEC 60601-1-2).
• Internal Specifications: For software performance (Software Requirements Specifications (SRS) and Software Design Specifications (SDS)).
• Engineering Benchmarks: For bench testing to demonstrate performance and accuracy.

There is no mention of expert consensus, pathology, or outcomes data being used as ground truth in this document.

8. Sample Size for the Training Set

The document does not specify a sample size for a training set. This device is a surgical navigation system that utilizes electromagnetic tracking and displays instruments relative to an image model; it is not described as an AI/ML algorithm that requires a traditional "training set" for model development. The software validation mentioned refers to verifying its performance against specifications, not training an AI model.

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

Since no training set is mentioned as part of the device's development or validation process in this document, there is no information on how ground truth for a training set was established.

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