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The Sapiens™ Tip Location System (TLS) is indicated for guidance and positioning of central venous catheters such as PICCs, CVCs, implantable ports, and hemodialysis catheters. The Sapiens™ TLS provides real-time catheter tip location information by using the patient's cardiac electrical activity. Sapiens™ TLS is indicated for use as an alternative method to chest X-ray and fluoroscopy for central venous catheter tip placement confirmation in adult patients.

Limiting but not contraindicated situations for this technique are in patients where alterations of cardiac rhythm change the presentation of the P wave as in atrial fibrillation, atrial flutter, severe tachycardia, and pacemaker driven rhythm, and in central venous catheterization procedures performed through femoral or saphaneous vein access which change the presentation of the P wave. In such patients, who are easily identifiable prior to central venous catheter insertion, the use of an additional method is required to confirm catheter tip location.

The Sapiens™ TLS consists of the following clements: sterile electrical adaptor, ECG module and cable, laptop running Sapiens™ TLS software, label printer (optional), and remote control (optional). A stylet or a guidewire inserted in a central venous catheter can be connected to the Sapiens™ TLS system via the Sapiens™ TLS Electrical Adaptor establishing a direct electrical connection to the catheter distal tip for ECG signal measurement. A different ECG signal measurement method - the column of saline method - can be used by connecting the Sapiens™ TLS Electrical Adaptor to the Arrow- Johans Adaptor, by connecting the Arrow-Johans Adaptor to any central venous catheter and by injecting saline solution into the catheter lumen through the Arrow-Johans Adaptor, thus establishing electrical conductivity to the distal tip of the catheter. When the central venous catheter or its associated stylet or guidewire is connected to Sapiens™ TLS, the Sapiens™ TLS laptop screen displays skin ECG signals and endovascular electrograms acquired at the location of the distal tip of the catheter. The waveforms provided by Sapiens™ TLS can be used for guiding and positioning of the central venous catheter. These ECG waveforms can be printed using an optional label printer to document the catheter tip location for the patient's file.

This 510(k) summary describes the Sapiens™ Tip Location System (TLS), intended for guiding and positioning central venous catheters. The study primarily focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and clinical performance.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" for the Sapiens™ TLS in the way that specific quantitative thresholds (e.g., sensitivity, specificity, accuracy) are typically defined for AI/CADe devices. Instead, the performance is reported as a success rate for catheter tip placement confirmation.

Note: The acceptance criteria are inferred from the context of a 510(k) submission, which aims to demonstrate "substantial equivalence" rather than set de novo performance standards. The primary criterion here is that the device performs comparably to the predicate devices and existing methods (chest X-ray/fluoroscopy) for its intended use.

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

• Test Set Sample Size:
  • Clinical Study: 332 patients (from a prospective, multicenter, non-controlled study).
  • Human Factors/Usability Study: 30 patients.
  • Total analyzed subsets: 362 patients.
• Data Provenance: Europe (five major hospital centers). The study was described as "prospective" and "multicenter."

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

The document states that the catheter tip placement using Sapiens™ TLS was confirmed with "chest X-ray or fluoroscopy." This implies that the ground truth was established by clinical imaging, interpreted by relevant medical professionals (e.g., radiologists, interventionalists), as standard clinical practice dictates for these imaging modalities. However, the exact number of experts and their specific qualifications (e.g., "radiologist with 10 years of experience") are not specified in the provided text.

4. Adjudication Method for the Test Set

The adjudication method is implicitly through the standard clinical interpretation of "chest X-ray or fluoroscopy" to confirm catheter tip location. The document does not specify a formal adjudication process like "2+1" or "3+1" for comparing the device's output to the imaging results. It only states that the imaging "confirmed" the placement.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not explicitly mentioned. The clinical study was a "prospective, multicenter, non-controlled study" where Sapiens™ TLS was used, and its results were confirmed by X-ray/fluoroscopy. The document does not describe a scenario where different human readers interpreted cases with and without AI assistance to measure an "effect size" of improvement.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The Sapiens™ TLS is described as providing "real-time catheter tip location information" using cardiac electrical activity for "guidance and positioning." This implies that the device is providing a standalone measurement or assessment, which is then clinically confirmed by X-ray/fluoroscopy. The reported 97% success rate reflects this standalone performance in guiding placement that was subsequently confirmed. It functions as an alternative method to chest X-ray and fluoroscopy, suggesting a standalone use case that is then verified post-procedure.

7. The Type of Ground Truth Used

The ground truth used for confirming the Sapiens™ TLS's performance was clinical imaging: chest X-ray or fluoroscopy.

8. The Sample Size for the Training Set

The document does not mention a training set or any deep learning/AI model training, as this submission is from 2010 and describes a system based on cardiac electrical activity principles, not explicitly a machine learning algorithm that requires a dedicated training set. The clinical data reported is for performance evaluation, not for training.

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

As no training set is mentioned in the context of an AI/ML model, this question is not applicable based on the provided text. The device's operation is based on real-time cardiac electrical activity rather than a learned model from a dataset.

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