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Neonav is indicated for navigation and positioning of central venous access devices (CVADs) of at least 1Fr in size. Neonav provides real-time catheter tip location information by using the patient's cardiac electrical activity. Neonav is indicated for use as an alternative method to chest X-ray and fluoroscopy for all central venous access device tip placement confirmation.

In adult patients and in adolescents (greater than 12 through 21 years of age), Neonav can be used with CVADs such as peripherally inserted central catheters (PICCs), centrally inserted central catheters (CICCs), implantable ports, and hemodialysis catheters; in children (greater than 2 to 12 years of age), Neonav can be used with CICCs; in infants (greater than 1 month to 2 years of age) and in neonates (from birth to 1 month of age), Neonav can be used with PICCs and 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 use of the Neonav are in patients where alterations of cardiac rhythm change the presentation of the P wave as in atrial flutter, severe tachycardia, and pacemaker driven rhythm. In such patients, who are easily identifiable prior to central venous access device insertion, the use of an additional method is required to confirm catheter tip location.

The Neonav ECG Tip Location System (Neonav) is a non-invasive medical device that analyzes electrocardiographic signals (ECG) to track the location of central venous access devices (CVADs) in patients' blood vessels during placement in real time via a display.

Catheter position in the vasculature is analyzed based on the patient's intravascular ECG (I-ECG). An I-ECG is recorded via the catheter tip from within the blood vessels of a patient. For the conductive fluid method, the sterile Neonav ECG Adapter Cable are used whereas for guidewire/stylet method, the sterile Neonav ECG clip cable is used. These components allow the electrical impulses detected at the catheter tip to be recorded by a non-sterile Acquisition Unit and analyzed by the Neonav Console to assist in determining the catheter tip position. The Neonav Controlled via a touch screen interface or a Remote enclosed in a sterile cover. The Neonav Console displays real-time surface ECG and I-ECG signals, highlighted QRS complex, max measured P-wave, the patient's heart rate, and other device performance indicators. A surface electrode is placed on the subject to act as a reference electrode. A second surface electrode is placed on the subject for noise reduction.

Neonav components are designed to attach easily to standard catheter and IV therapy components via standard luer lock connections. The only patient contacting component of the ECG Adapter. It has indirect contact with the patient via fluids and is composed of biocompatible polycarbonate and stainless steel.

The Neonav ECG Tip Location System is intended for navigation and positioning of central venous access devices (CVADs). The acceptance criteria and supporting study details are outlined below based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not explicitly state a specific sample size for a clinical test set used to prove the device meets acceptance criteria related to its primary function of tip location accuracy. The document primarily references non-clinical bench tests and compliance with various standards.

There is a mention of "most current literature and effectiveness of PICCs in infants and neonates" supporting expanded indications, but this is not described as a direct device performance study.

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

The document does not specify the number of experts or their qualifications for establishing ground truth for any performance study.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it quantify any improvement in human reader performance with or without AI assistance. The Neonav system "displays the intravascular ECG to the user makes their own decision regarding catheter navigation of the real-time intravascular ECG signal," suggesting it's an assistance tool rather than a fully automated AI interpretation.

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

The document does not explicitly describe a standalone performance study of the algorithm without human-in-the-loop. The description of Neonav states it "displays the intravascular ECG to the user makes their own decision regarding catheter navigation of the real-time intravascular ECG signal," implying a human-in-the-loop operation. "Neonav does not provide computation of ECG signal for navigation. Neonav displays the intravascular ECG to the user makes their own decision regarding catheter navigation of the real-time intravascular ECG signal."

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for performance evaluation. Given the device's function and the comparison to X-ray and fluoroscopy, it is highly probable that ground truth in any clinical validation would involve imaging modalities (e.g., chest X-ray or fluoroscopy confirmation) or direct physician assessment of catheter tip position, but this is not explicitly detailed in the provided text.

8. The Sample Size for the Training Set

The document does not provide any information regarding the sample size for a training set.

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

The document does not provide any information on how ground truth was established for a training set.

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The VPS Rhythm Device is indicated for the positioning of central venous catheters including PICCs. It provides catheter tip location information by using the patient's cardiac electrical activity. The VPS Rhythm Device is indicated for use as an alternative method to chest x-ray or fluoroscopy for confirmation of central venous catheter tip placement in adult patients. The TipTracker Technology is an optional accessory for use with the VPS Rhythm Device, indicated for visual navigation of a peripherally-inserted central catheter (PICC) as it is inserted through the vasculature. The TipTracker technology is used for catheter tip navigation purposes only; it is not used to determine final catheter tip placement.

Note: In general, devices that utilize ECG technique to observe P-wave are limited, but not contraindicated, for patients where cardiac rhythms may change presentation of the P-wave; including

• Atrial fibrillation
• Atrial flutter
• Severe tachycardia
• Pacemaker-driven rhythm
• Chronic obstructive pulmonary disease (COPD)
  Such patients are easily identified prior to central catheter insertion. In these specific cases, use of an additional confirmation method is necessary to confirm catheter tip location.

The VPS Rhythm Device with Optional TipTracker Technology is a medical device system consisting of nonsterile, reusable electronic components and accessories, as well as single-use, sterile components. All of which are utilized together to facilitate the final confirmation of central venous catheter tip placement by using the patient's cardiac electrical waveform. The system features an electronic monitor with graphical user interface display, as well as connection cables and accessories which allow for the display of the patient's external and intravascular cardiac ECG waveforms. Interpretation - by the clinician - of changes in the patient's intravascular cardiac ECG waveform morphology, which are displayed in real-time on the VPS Rhythm Device monitor as the central venous catheter is inserted, is utilized for confirmation of the final position of the catheter tip as an alternative to radiographic confirmation.

The optional TipTracker Technology includes software algorithms and accessory components (the TipTracker T-piece and Stylet) which facilitate the real-time visualization of the catheter's track and direction as it is inserted by the clinician through the vasculature. The TipTracker T-piece is a non-sterile, reusable component consisting of a magnetic emitter array that is connected to the VPS Rhythm Device monitor. In use, the TipTracker T-piece is placed externally on the patient's chest. When the sterile, singleuse TipTracker Stylet is assembled with the PICC which is to be inserted by the clinician, the VPS Rhythm Device with Optional TipTracker Technology facilitates the visualization of the catheter's insertion track and direction relative to the location of the TipTracker T-piece. The TipTracker Technology is not intended as an indicator of specific catheter location nor is it intended to be utilized for confirmation of final PICC tip location.

The provided document is a 510(k) premarket notification for the "VPS Rhythm™ Device with Optional TipTracker™ Technology." It indicates that no human clinical data was provided to support substantial equivalence (Section 8). Therefore, it is not possible to describe a study that proves the device meets acceptance criteria based on clinical performance.

However, the document does list non-clinical performance data that was submitted. This non-clinical data focuses on verifying the device's technical performance, electrical safety, electromagnetic compatibility, software, material properties, sterilization, biocompatibility, and usability.

Based on the provided information, I can address the available non-clinical performance data and the usability study.

Here's a breakdown of the requested information based on the non-clinical data and the usability study:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) and no clinical studies are reported, specific acceptance criteria for clinical performance (e.g., accuracy, sensitivity, specificity) for the device are not described in the document. The non-clinical testing, however, implies meeting industry standards and internal design requirements.

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

• Human Factors Study Test Set (Usability): The document mentions "independent clinician participants" but does not specify the sample size for this test set.
• Data Provenance for Human Factors Study: This was a prospective study conducted with clinicians. The country of origin is not explicitly stated, but given the context of a US FDA submission, it can be inferred to be a US-based study or following US regulatory guidelines.
• Other Non-Clinical Testing: Sample sizes for material integrity, electrical, EMC, and software testing are not specified. These are typically lab-based tests.

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

• For the Usability Study (Human Factors): The "ground truth" here would be the predefined usability criteria and the assessment of whether clinicians could successfully perform tasks. The "experts" would be the independent clinician participants, but their specific qualifications (e.g., years of experience) are not detailed. The study assessed the device's functions against predetermined usability criteria.
• For other non-clinical tests: Ground truth is established by engineering specifications, international standards (IEC, ISO, ASTM), and internal design requirements.

4. Adjudication Method for the Test Set

• For the Usability Study (Human Factors): An explicit adjudication method (e.g., 2+1) is not described. The document states that "The results of the human factors study were compiled and assessed," suggesting an analysis against predefined usability criteria rather than an expert consensus on a subjective outcome.
• For other non-clinical tests: Adjudication is typically against established engineering specifications and standards.

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

• No MRMC study was done. The document explicitly states "No human clinical data was provided to support substantial equivalence." An MRMC study would fall under clinical data.

6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)

• Yes, in the context of the device's ECG technology and TipTracker navigation:
  • The "VPS Rhythm Device" as a standalone component uses software algorithms to acquire, process, and display ECG waveforms for catheter tip location. Its performance in this function relies on the algorithm interpreting cardiac electrical activity.
  • The "TipTracker Technology" also involves "software algorithms" to facilitate real-time visualization of the catheter's track and direction using magnetic field-based technology. This is also a standalone algorithmic function.
• The non-clinical testing, particularly "Software Verification and Validation Testing" and "TipTracker Stylet Performance," would evaluate these standalone algorithmic and system performances against specified requirements.

7. Type of Ground Truth Used

• For the Human Factors Study (Usability): "Predetermined usability criteria" established prior to the study, likely by device designers and regulatory/human factors experts.
• For TipTracker Stylet Performance and Physical Integrity: Engineering specifications, material science standards (e.g., ISO 11070), and internal design requirements.
• For Electrical Safety, EMC, Sterilization Residuals, Biocompatibility: International and national standards (e.g., IEC 60601 series, ISO 10993 series, ASTM F2096).

8. Sample Size for the Training Set

• The document does not mention a training set for any AI/machine learning models. The description of the device's technology points to signal processing and magnetic tracking algorithms rather than learnable AI models in the modern sense. Therefore, "training set" is not applicable in the context described.

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

• As no training set is mentioned (see point 8), this information is not applicable/provided.

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