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The Celerity System is indicated for the positioning of Peripherally Inserted Catheters (PICC) in adult patients. It provides real-time catheter tip location by using the patient's cardiac electrical activity. The Celerity System is indicated for use as an alternative method to chest x-ray or fluoroscopy confirmation of PICC tip placement in adult patients.

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 PCC insertion. Use of an 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, Surface Electrodes, Cable Cover and Prep Pads are provided as a convenience for the clinician.

Here's an analysis of the provided text to extract information about the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The provided text does not explicitly present a table of acceptance criteria with specific performance metrics. Instead, it refers to the device meeting "predetermined performance specifications" and suitability for its intended purpose. The core claim is that the device is suitable as an alternative to chest X-ray or fluoroscopy for PICC tip confirmation.

2. Sample size used for the test set and the data provenance

The document mentions "Simulated Use / Human Factors Testing" but does not explicitly state the sample size (number of patients or simulated cases) used for this test set, nor does it specify the provenance (country of origin, retrospective or prospective) of the data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document.

4. Adjudication method for the test set

This information is not provided in the document.

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

The document describes the Celerity System as an "alternative method to chest X-ray or fluoroscopy confirmation." While this implies a comparison to traditional methods, it does not describe a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human readers improving with AI assistance. The Celerity system itself determines the tip location, replacing the need for human interpretation of X-rays for that purpose. Therefore, an effect size of human readers improving with AI assistance is not applicable in the context described.

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

The Celerity System provides "real-time catheter tip location by using the patient's cardiac electrical activity." This indicates a standalone performance where the device (algorithm) determines the tip location. The "Simulated Use / Human Factors Testing" would likely involve human interaction with the device using its standalone output, but the core function of tip determination is presented as automated.

7. The type of ground truth used

The document implies that the ground truth for evaluating tip positioning accuracy (even if not explicitly detailed) would be based on the established gold standard for PICC tip confirmation, which are chest X-ray or fluoroscopy. The device is presented as an alternative to these methods, suggesting they would serve as the comparator for accuracy.

8. The sample size for the training set

The document makes no mention of a training set or its sample size. The device appears to be based on physiological principles (P-wave changes) rather than a machine learning model that would require a distinct training set.

9. How the ground truth for the training set was established

As no training set is mentioned, this information is not applicable.

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