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Nautilus Delta is indicated for navigation and positioning of central venous access devices (CVADs) of at least 3 Fr in size. Nautilus Delta provides real-time catheter tip location by using the patient's cardiac electrical activity and is indicated for use as an alternative method to chest X-ray and fluoroscopy for CVAD tip placement confirmation. In adult patients and in adolescents (greater than 12 through 21 years of age), Nautilus Delta can be used with CVADs such as peripherally inserted central catheters (PICCs), central venous catheters (CVCs), implantable ports, and hemodialysis catheters; in children (greater than 2 to 12 years of age), Nautilus Delta can be used with PICCs and with centrally inserted central catheters (CICCs); in infants (greater than 1 month to 2 years of age) and in neonates (from birth to 1 month of age), Nautilus Delta can be used with CICCs. In each specific age group, the CVAD type and size must be chosen and the CVAD must be used according to the CVAD's indications and instructions for use. Limiting but not contraindicated situations for this method 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. 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 Nautilus Delta™ system consists of the following elements: single use sterile ECG extension cable (also known as Nautilus Electrical Adaptor also known as NautilusE), non-sterile ECG cable, patient module (ECG data acquisition and processing and integrated remote control), and mobile medical application running on any mobile platform which complies with the minimum requirements. Nautilus Delta™ provides real-time catheter tip location information by using the patient's cardiac electrical activity (ECG). This information can be used to position any central venous access devices (CVADs) at or around the cavo-atrial junction (CAJ). Nautilus Delta supports navigation of central venous catheters from the vascular access point towards the CAJ by computing and displaying a navigation signal. Nautilus Delta also displays on its graphical user interface the surface (skin) ECG signal, a marker identifying the R-peak, and the patient's heart rate. In order to obtain intravascular ECG information at the tip (distal end) of a catheter, a stylet or a guidewire inserted in the catheter can be connected to Nautilus Delta patient module via the sterile Nautilus Delta ECG extension cable. Nautilus Delta and NautilusE do not have any direct or indirect contact with the patient.

The provided text is a 510(k) Summary for the Nautilus Delta™ device, which is an accessory to percutaneous, implanted, long-term intravascular catheters. Its intended use is to support navigation and tip positioning of central venous access devices (CVADs) by using the patient's cardiac electrical activity (intracardiac ECG) as an alternative to chest X-ray and fluoroscopy for CVAD tip placement confirmation.

The document states that Romedex International SRL submitted this 510(k) after obtaining CE mark approval, and that the device "was successfully used in Europe in hundreds of patients in several hospitals in several countries by many different users of different backgrounds and experience levels. No adverse events were reported. Side-by-side comparisons with legally marketed similar devices, including the predicate devices, were performed in clinical settings to demonstrated substantial equivalence of Nautilus Delta with the predicate devices."

However, the document does NOT contain explicit acceptance criteria (e.g., target accuracy, sensitivity, specificity values) for device performance, nor does it detail a specific study proving the device meets quantified acceptance criteria. The submission focuses on demonstrating substantial equivalence to predicate devices (Epidural Catheter Connector K973371 and Sherlock 3CG Tip Confirmation System K113808) through a comparison of technological characteristics, performance testing against various standards (ES60601-1, IEC 60601-1-2, IEC 60601-2-27, IEC 62304, IEC 62366, ISO 11737-1, ISO 11135-1, ISO 11135-2, EN 55022, and EN 300328), and post-market clinical experience from Europe.

Since the input document does not contain the specific information requested, I will state that the information is not provided.

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

• A table of acceptance criteria and the reported device performance:
  • Not provided. The document states that "Romedex has performed extensive testing in order to demonstrate that the new characteristics do not affect safety and effectiveness when compared to the predicate devices and to demonstrate compliance with the following standards: ES60601-1, IEC 60601-1-2, IEC 60601-2-27, IEC 62304, IEC 62366, ISO 11737-1, ISO 11135-1, ISO 11135-2, EN 55022, and EN 300328." It does not, however, list specific performance metrics (e.g., accuracy, sensitivity, specificity for tip placement) or their corresponding acceptance thresholds.
• Sample size used for the test set and the data provenance:
  • The document states: "Since obtaining the CE mark, Nautilus Delta also known as Handy Nautilus was successfully used in Europe in hundreds of patients in several hospitals in several countries..." This indicates a retrospective collection of real-world use data from Europe. A precise sample size for a formal "test set" demonstrating performance is not explicitly provided, beyond "hundreds of patients."
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
  • Not provided. The document mentions "many different users of different backgrounds and experience levels" using the device, but it does not specify how ground truth was established for these "hundreds of patients" for comparison purposes (e.g., if chest X-ray or fluoroscopy was used as ground truth for tip placement confirmation and adjudicated by experts).
• Adjudication method (e.g. 2+1, 3+1, none) for the test set:
  • Not provided.
• 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 provided. The device is not an AI/ML algorithm that assists human readers; it's a device that provides real-time catheter tip location information using cardiac electrical activity as an alternative method to chest X-ray and fluoroscopy. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable in the typical sense for this device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
  • The device provides real-time information to a human operator. The document describes it as a system with a patient module, cables, and a mobile application for display. Performance would inherently involve the device generating a "navigation signal" and displaying information for a human to interpret and act upon. The text does not describe a "standalone algorithm-only" performance evaluation independent of human interaction or interpretation of the displayed information for tip placement confirmation.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
  • Not explicitly stated for the "hundreds of patients" data. For CVAD tip placement, the common ground truth methods are chest X-ray or fluoroscopy. The device is indicated as an alternative to these. While "side-by-side comparisons with legally marketed similar devices" (which would presumably use standard confirmation methods) were performed, the specific type of ground truth used to validate the Nautilus Delta's performance in terms of tip placement accuracy is not detailed.
• The sample size for the training set:
  • Not applicable / Not provided. The Nautilus Delta as described is a medical device that measures and processes ECG signals to determine catheter tip location using established physiological principles. It is not an AI/ML device that requires a "training set" in the context of machine learning model development.
• How the ground truth for the training set was established:
  • Not applicable / Not provided. As it's not an AI/ML device in the sense of needing a training set, the methodology for establishing ground truth for a training set is not pertinent here.

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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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