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The I2 probe is for use with the Deltex Medical CardioQ for the monitoring of cardiac output and fluid status. The I₂ is only approved for oral or nasal placement into the esophagus of a single patient 16 years of age or older. The probe may be placed orally or nasally in sedated or anesthetized patients. The probe must be placed nasally in awake patients.

Esophageal probe for measuring blood flow in the descending aorta. Sterile. For single use only. Overall length 89 cm (35"). Shaft construction Spring enclosed in silicone rubber. Shaft color Clear (non-pigmented) shaft. Shaft flexibility (N) 0.095. Main shaft diameter 14 FG (~4.8 mm). Distal tip diameter 19FG (~6.3 mm). Maximum Usage time (hours) 6, 24 or 72. Main shaft wall thickness 0.03" (~0.7mm). Marks in the shaft The probe shaft has three depth markers at 35, 40 and 45 cm. Color of transducer head "clear" (non-pigmented). Color of the molded connector "white" (pigmented). Color of the shaft "clear" (non-pigmented). Connection to the monitor non-reversible connector with ROM to identify probe type. Doppler transducer / Central frequency 4MHz. Doppler transducer / Global maximum output 195 mW/cm². Doppler transducer / Mechanical index 0.039. Spring wire 0.030" (0.76 mm) diameter to BS5216 HS3, Pre-galvanized. Spring length 550mm (+/- 25 mm). Spring internal diameter 1.80/2.00 mm. Spring external diameter 3.30/3.50 mm. Spring pitch The spring has fewer turns per unit of length (it has a larger pitch than DP 240). ROM memory This ROM memory is characteristic for the particular probe. Mode of operation Esophageal probe transmits and receives 4 MHz Continuous Wave Doppler (CWD) ultrasound from the probe tip at a fixed angle to the descending aorta, by excitation of a piezo-electric transducer. The ultrasound is reflected by the red blood cells and is received by a separate transducer in the probe tip. Signals are returned via the Patient Interface Cable (PIC) to CardioQ Monitor. This permits to measure blood flow velocities in the descending thoracic aorta. Compatible Monitor CardioQ monitor. Rx Status Rx. Physicians Caution included in labeling Yes.

The provided document is a 510(k) Summary for the Deltex Medical Ltd I2n Series Doppler Probe. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than presenting a standalone study with specific acceptance criteria and performance data for the subject device.

Therefore, many of the requested elements regarding acceptance criteria, study design, and performance metrics are not explicitly stated within this 510(k) summary. The document focuses on comparing the design and materials of the new I2n Series probe to existing predicate devices (DP240 Hour Doppler Probe, CardioQ Probe, and Hemosonic 100 Esophageal Probe). The "study" mentioned is implicitly a comparison of physical and operational specifications to demonstrate equivalence, rather than a clinical performance study with defined acceptance criteria.

Specific answers to your questions based on the provided text:

1. Table of acceptance criteria and the reported device performance:
   The document does not explicitly present acceptance criteria or reported device performance in the format of a clinical performance study with quantitative results against predefined thresholds. Instead, it provides a comparative table outlining the features of the subject device (I2n-series) against three predicate devices. The "performance" demonstrated is through feature-by-feature comparison, indicating that the new device is either identical or has minor, non-significant differences from the predicates, particularly highlighting the improved shaft flexibility.

   Implicit Comparison Table (derived from the document's comparative table):

The "acceptance criteria" here are essentially "substantially equivalent to" or "demonstrates an equivalent or improved characteristic compared to" the predicate devices for each feature. The study demonstrates this equivalence through a detailed comparison of specifications and materials.

2. Sample size used for the test set and the data provenance:
No specific "test set" with a defined sample size (e.g., number of patients or cases) is described in the context of a clinical performance study. The data provenance is from internal testing and comparison against the specifications of existing devices, manufactured by Deltex Medical Ltd, located in the United Kingdom. This is a comparison of device specifications and changes rather than a clinical trial.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable, as no clinical test set requiring expert ground truth establishment is described. The assessment is based on engineering specifications and comparison with predicate devices.

4. Adjudication method for the test set:
   Not applicable, as no clinical test set requiring adjudication is described.

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:
   Not applicable. This device is an extravascular blood flow probe, not an AI-assisted diagnostic imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:
   The "ground truth" implicitly used for demonstrating substantial equivalence is the established performance and safety profile of the predicate devices based on their 510(k) clearances and recognized standards for material, manufacturing, and performance characteristics. For instance, the stated flexibility (0.095 N) is a directly measured characteristic of the new device which is then compared against the measured flexibility of the predicate.

8. The sample size for the training set:
   Not applicable, as there is no machine learning or AI component requiring a training set.

9. How the ground truth for the training set was established:
   Not applicable.

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