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The Celerity System is intended to provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the superior vena cava.

The Celerity System is indicated for use as a supplemental aid in positioning of Peripherally Inserted Central Catheters (PICC) in adult patients. It provides real-time catheter tip location information by using the patient's cardiac electrical activity. Confirmation of tip placement should be verified according to clinical judgment and established hospital protocol (e.g., chest x-ray, fluoroscopy).

Note: Limiting, 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 confirmation method is necessary to confirm catheter tip location.

The Celerity System includes the Celerity Monitor/Software, ECG Patient Cable, Remote Control Cable, Battery, Power Supply Cord and ECG Clip Cable (alligator clip). Procedural accessories including ECG Snap Leads, ECG Electrodes, Cable Cover and Prep Pads are provided as a convenience for the clinician.

The Medcomp Celerity System is a device intended to provide real-time tip location information of a central venous catheter by utilizing ECG to observe P-wave changes as the tip approaches the right atrium. The device's performance was evaluated through design verification and validation activities in accordance with 21 CFR 820.30 and testing per IEC 60601 standards.

Here's the breakdown of the acceptance criteria and the supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list specific numerical acceptance criteria for device performance (e.g., accuracy percentages, sensitivity/specificity thresholds for tip location). Instead, it states that "Design Verification and Validation activities were performed in accordance with Design Control requirements per 21 CFR 820.30 and demonstrate that the subject Celerity System meets predetermined performance specifications."

The performance evaluation focused on demonstrating safety and essential performance through compliance with recognized electrical safety and electromagnetic compatibility standards.

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

The document does not explicitly state the sample size used for any specific performance test set related to the accuracy of P-wave changes or tip location. It broadly mentions "Design Verification and Validation activities" and "safety and performance testing."

Furthermore, there is no information provided regarding the country of origin of the data or whether the data was retrospective or prospective.

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

This information is not provided in the document. The document refers to "clinical judgment and established hospital protocol (e.g., chest x-ray, fluoroscopy)" for confirming tip placement, but it does not detail how ground truth was established for the device's own performance evaluation.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing ground truth or evaluating the test set.

5. 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

No MRMC comparative effectiveness study is mentioned in the document. The Celerity System is described as a "supplemental aid" to assist clinicians in positioning PICCs using ECG, but there's no study comparing human performance with and without the device. The device itself is not an "AI" in the modern sense but rather a real-time monitoring system.

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

The document describes the Celerity System as providing "real time tip location information" by utilizing ECG to observe P-wave changes. While this implies a standalone algorithm for processing ECG data and identifying P-wave changes, there is no separate "algorithm only" performance study detailed with specific metrics for accuracy or reliability of its ECG analysis in isolation from a clinical user. Its function is inherently presented as an aid for the clinician.

7. The Type of Ground Truth Used

The document states that "Confirmation of tip placement should be verified according to clinical judgment and established hospital protocol (e.g., chest x-ray, fluoroscopy)." This suggests that the ultimate ground truth for actual tip location in clinical practice (and presumably in any validation studies) would be based on imaging methods (chest x-ray, fluoroscopy) and expert clinical judgment. However, the specifics of how this ground truth was applied to prove the device meets its acceptance criteria are not detailed.

8. The Sample Size for the Training Set

The document does not provide any information about a training set or its sample size. This type of information is typically associated with machine learning or AI algorithms, which are not explicitly mentioned for the Celerity System's core function.

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

As no training set is mentioned, information on how its ground truth was established is not applicable.

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