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The Pilot TLS is indicated for use in positioning of PICCs. The Pilot TLS provides real-time catheter tip location information by displaying changes in the patient's cardiac electrical activity. Pilot TLS is indicated for use as an alternative method to chest X-ray or fluoroscopy confirmation of PICC tip placement in adult patients.

Note: Limited, but not contraindicated, situations for this technique are patients where cardiac rhythms may change presentation of the P-wave:

• Atrial fibrillation
• Atrial flutter
• Severe tachycardia
• Pacemaker-Driven Rhythm
• Chronic obstructive pulmonary disease (COPD)

Such patients are easily identified prior to PICC insertion. Use of additional method is necessary to confirm catheter tip location.

Pilot TLS is designed to support quidance and tip positioning of Peripherally Inserted Central Catheters (PICCs) of at least 3 Fr in size. Pilot TLS provides real-time catheter tip location information by using the patient's cardiac electrical activity and is indicated for use as an alternative method to chest X-ray and fluoroscopy for PICC tip placement confirmation for adults. The device includes a medical tablet preloaded with Pilot software, a Pilot TLS module, an ECG cable accessory, and a Vygocard accessory.

The device is only provided in one configuration, and non-sterile. The system is composed of:

• . A medical tablet with a kickstand attached on the back
• . The medical tablet's power supply
• . A Pilot TLS module attached to a USB-A cable
• A stabilization base (option to maintain the black ECG lead for its connection to Vygocard saline connector
• An ECG cable with 4 leads (red, white, green, black)
• 2 USB flash drives

Vygocard is an accessory provided sterile.

This document, a 510(k) Premarket Notification for the "Pilot TLS" device, primarily focuses on demonstrating substantial equivalence to a predicate device, the "C3 Wave," rather than presenting a standalone study with detailed acceptance criteria and performance data in the format requested.

However, based on the provided text, here's what can be extracted and inferred regarding performance and testing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics. Instead, it lists various non-clinical tests conducted to verify performance requirements. These tests are generally designed to ensure compliance with standards and safety, not necessarily to quantify specific performance metrics against a defined acceptance criterion for a clinical study.

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

The document does not provide details on a specific test set size for clinical performance evaluation. It explicitly states: "No human clinical data was provided to support substantial equivalence."

The "human factors study" mentioned could be considered a usability test set, but details about its size or provenance (country, retrospective/prospective) are not disclosed in this document.

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

As "No human clinical data was provided," there is no information about experts used to establish ground truth for a clinical test set. For the human factors study, the participants are referred to as "independent clinician participants," but their number or specific qualifications (e.g., years of experience) are not provided.

4. Adjudication Method for the Test Set

Not applicable, as "No human clinical data was provided" for a clinical test set that would require ground truth adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

No, the document explicitly states: "No human clinical data was provided to support substantial equivalence." Therefore, no MRMC study or effect size for AI assistance is reported.

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

The document describes the "Pilot TLS" as a device providing "real-time catheter tip location information by displaying changes in the patient's cardiac electrical activity." This implies human interaction as "displaying" information requires interpretation by a user. The software verification and validation would test the algorithm's functionality, but a formal "standalone" performance study in a clinical context (without human interaction) is not described. The device is intended as an "alternative method to chest X-ray or fluoroscopy confirmation," which inherently involves a human interpreting the device's output.

7. The Type of Ground Truth Used

Given the statement "No human clinical data was provided to support substantial equivalence," there is no mention of ground truth established through expert consensus, pathology, or outcomes data for clinical performance. The comparison to chest X-ray or fluoroscopy implies these are the traditional "ground truth" methods for PICC tip placement confirmation, but no data is presented where the Pilot TLS's output is validated against these.

8. The Sample Size for the Training Set

Not applicable. The document does not describe the development or training of a machine learning algorithm, and thus no training set sample size is mentioned. This device relies on "identification of a maximum P-wave in the patient's intravascular ECG signal," which is a known physiological principle, not a machine learning model requiring a training set in the typical sense.

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

Not applicable, as no training set for a machine learning model is mentioned.

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