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Entarik NI Feeding Tubes (FTs) are intended for the administration, fluids and medications by the nasoenteric or orogastric route for neonatal patients who have an intact gastrointestinal tract but are physically unable to manage nutritional intake through normal mastication and deglutition.

The Entarik NI Feeding Tube System (Entarik NI System) is designed to aid, in conjunction with institutional protocols, qualified operators in the placement of the Entarik NI Feeding Tube (FT) into the stomach of neonatal patients requiring enteral feeding. The Entarik FTs are equipped with sensors designed to provide information about the tube tip relative to the stomach, thus assisting in reducing the incidence of misplacement during first positioning. The Entarik NI FTs are provided sterile.

The Entarik NI System also monitors the feeding tube position continuously during the course of feeding and automatically and in real time alerts of tube migration.

The Entarik NI System provides continuous monitoring of gastric and esophageal temperature. The Entarik device can be used solely for the purpose of monitoring gastric and esophageal temperature in situations where invasive monitoring is indicated.

The Entarik NI system is intended to record, store, view and analyze impedance in the pharynx and stomach.

The Entarik NI Feeding Tube System (Entarik NI System) consists of the Entarik NI Feeding Tube (disposable) and the Entarik NI Monitor (reusable) with Power Supply. The Entarik NI System is designed for enteral feeding and to aid in the placement of the Entarik NI Enteral Feeding Tube into the stomach of neonatal patients requiring enteral feeding. The Entarik NI System also continuously monitors feeding tube position, gastric and esophageal temperature, and gastrointestinal impedance and reflux. The feeding tubes are single use devices intended for prolonged use (less than 30 days). The Entarik NI Feeding Tubes are provided sterile.

The provided text describes the acceptance criteria and study proving the device meets those criteria for the Entarik NI Feeding Tube System.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it describes various tests performed and states that the device was found to be "safe and effective". We can infer the "acceptance criteria" from the fact that no issues were raised during these tests, indicating successful outcomes for all mentioned evaluations.

2. Sample Sizes and Data Provenance

• Training Set Sample Size: 16 subjects.
• Test Set Sample Size: 11 subjects for the validation study.
• Data Provenance: The document does not explicitly state the country of origin. The studies appear to be prospective clinical studies, as they involved the placement and monitoring of the device in new participates for the purpose of the study.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number of experts used or their specific qualifications (e.g., "radiologist with 10 years of experience") for establishing ground truth. It mentions that the validation study's placement confirmation was "per institutional standard of care," which implies reliance on qualified medical professionals within the clinical setting.

4. Adjudication Method

The document does not describe a specific adjudication method (e.g., 2+1, 3+1, none) for the test set. It mentions "placement was confirmed per institutional standard of care," suggesting that the medical institution's standard procedures were followed for verifying tube placement.

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

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any effect size of how much human readers improve with AI vs. without AI assistance. The study focuses on the device's ability to aid operators and monitor position, not on comparing human reader performance with and without AI.

6. Standalone (Algorithm Only) Performance

The document describes two clinical studies. The first (observational study) collected data silently for algorithm training and optimization without providing placement guidance. This suggests an initial phase where the algorithm was developed and refined, but standalone performance against a ground truth is not explicitly reported in terms of metrics like sensitivity/specificity for tube placement. The second (validation study) involved the device aiding qualified operators, indicating a human-in-the-loop scenario rather than a purely standalone algorithm evaluation of performance directly supporting a diagnostic claim.

7. Type of Ground Truth Used

• For the validation study's tube placement: "placement was confirmed per institutional standard of care." This likely refers to methods such as X-ray confirmation, pH testing of aspirate, or visual confirmation, as standard practice in clinical settings for feeding tube placement. While not explicitly stated, this would be a clinical ground truth established by medical professionals following established protocols.
• For continuous monitoring of tip location: The device itself automatically and in real time alerts of tube migration. The validation study confirmed this functionality was "safe and effective," implying these alerts were indeed accurate relative to actual tube migration conditions (though the specific ground truth for judging "tube migration" during continuous monitoring is not detailed).

8. Sample Size for the Training Set

The training set for the algorithm involved 16 subjects.

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

In the observational study for algorithm training and optimization, the Entarik NI Monitor "did not provide any placement guidance or verification. It collected impedance and temperature data silently that was used to train and optimize the placement and monitoring algorithm." This implies that while the device collected its data, the true tube position (ground truth) during this training phase was independently established by standard clinical methods (e.g., X-ray) by the clinicians or institution, and this independent ground truth was then used to train the algorithm. The document doesn't explicitly state the method for ground truth establishment during the training phase, but it must have been an independent reference standard.

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The Mucosal Impedance Measurement System is indicated for use by medical personnel trained in the usage of enteral feeding tubes for the treatment of adult patients requiring gastric decompression or enteral feeding for the delivery nutrition, fluids, and medications to the patient from an enteral feeding svringe or feedings set designed with ENFit connectors. The measurements of the Mucosal Impedance Measurement System are collected in patients indicated for enteral feeding. This product is single use for no longer than 24 hours.

The Mucosal Impedance Measurement System is equipped with sensors designed to collect and display real time and continuous gastric reactance "XL" measurements. The device is not for use as a sole diagnostic screening tool and is restricted to prescription use in a hospital environment.

The Mucosal Impedance Measurement System senses passive electrical features of the gastric tissue that corelate to of epithelial integrity through a technique known as 'bioimpedance spectroscopy'. Bioimpedance spectroscopy measures the ability of tissue to conduct electricity (resistance) and the ability of tissue to store charged particles (reactance).

The Florence monitor model ISMO 1.0 is an electronic device that delivers electrical current to a small region of the gastric tissue through the Athena Catheter; the device measures the resultant voltage, and then calculates and displays impedance information in numeric and graphic representations. More specifically, to measure the bioimpedance of the gastric mucosa impedance, the device delivers electric current through the Athena Catheter. The resulting voltage developed between the two inner electrodes is sensed, filtered, amplified, and then digitized by the electronic circuits of the monitor. Once the measured voltage from the gastric tissue has been digitized, a proprietary algorithm processes the information and calculates the impedance spectrum and the Central Reactance parameter (XL). The device displays the information as either a function of frequency or as a function of time.

Here's a breakdown of the acceptance criteria and the studies performed for the Mucosal Impedance Measurement System, 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

• Non-clinical/Bench Studies: The specific sample sizes for each bench test (e.g., flow rate, tensile strength) are not explicitly stated as numerical values in the provided text, but are implied by the use of standards that typically define such sample sizes. The text mentions "a statistically significative number of measurements" for thermal and temporal stability, indicating appropriate methodology.
• Animal Study:
  • Control group (CG): N=5
  • Shock group (SG): N=16
  • Data Provenance: This was a GLP prospective, controlled animal trial. The country of origin of the data is not specified.

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

For the non-clinical/bench studies, animal studies, and human factors, the "ground truth" is established by adherence to recognized international and FDA standards/guidances (e.g., ISO, EN, ASTM, FDA guidance documents). There is no mention of specific human experts establishing ground truth for these quantitative technical performance tests in the same way an expert would for an AI diagnostic algorithm.

4. Adjudication Method for the Test Set

Not applicable in the context of these device performance studies, which involve objective measurements against predefined engineering and biological performance criteria, rather than expert-based interpretation.

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

No. The provided text does not describe an MRMC comparative effectiveness study involving human readers with and without AI assistance. The device is described as measuring and displaying "XL" values, which are direct measurements, not an AI-based interpretation or diagnostic aid for human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, in essence. The internal performance evaluations (e.g., thermal stability, temporal stability, electrical safety, software validation) and the animal study tested the device's ability to accurately collect and process data and function as intended without human interpretation as the primary endpoint. The device's output (XL measurements) is for human interpretation and clinical decision-making, but the studies described focus on the accuracy and stability of the measurement itself rather than a diagnostic output of an AI algorithm. The device is "not for use as a sole diagnostic screening tool."

7. Type of Ground Truth Used

• Bench Studies: Established by defined physical properties, engineering specifications, and compliance with international standards (e.g., ISO, EN, ASTM).
• Biocompatibility: Established by compliance with ISO 10993-1 and FDA guidance, indicating a lack of toxicity, irritation, and sensitization.
• Software: Established by compliance with FDA guidance for software functions, ensuring no hazardous situations.
• Electrical Safety & EMC: Established by compliance with IEC standards.
• Human Factors: Established by compliance with EN 60601-1-6 and FDA guidance, ensuring usability for safety and effectiveness.
• Animal Study: Established by measuring physiological parameters and comparing the device's XL measurements to established markers of global perfusion under induced hypovolemic shock conditions in a controlled, prospective GLP study.

8. Sample Size for the Training Set

The provided text does not mention a training set, as this device's performance evaluation focuses on the accuracy and stability of direct physiological measurements and its engineering compliance, rather than a machine learning model that requires training data. The "proprietary algorithm" processes measured voltage to calculate the impedance spectrum and Central Reactance parameter (XL), but there's no indication it's a machine learning algorithm requiring a separate training phase with labeled data in the context of this submission.

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

Not applicable, as no training set for a machine learning model is described.

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