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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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The MiVu Mucosal Integrity Testing System is indicated for use by gastroenterologists, surgeons, and medical personnel trained in endoscopic procedures during an endoscopy to obtain real-time measurement of esophageal epithelial integrity as an adjunct for the evaluation of esophageal disorders. The device is not for use as a sole diagnostic screening tool.

The Diversatek Healthcare MiVu Esophageal Endo Cap is the candidate accessory device for use with the approved predicate Diversatek Healthcare's MiVu Mucosal Integrity Testing system (MiVu System). The MiVu Esophageal Endo Cap is a new patient-contacting accessory that will be used in place of the MiVu Balloon Probe already approved as part of the MiVu System.

The MiVu Esophageal Endo Cap device consists of a patient contacting sensor tip that is installed over the working end of an endoscope. The tip is a flexible thermoplastic elastomeric tube with a single row of four (4) gold plated pads, providing three (3) impedance sensors evenly spaced along the length of the impedance sensors are mounted on a pivoting platform to promote even contact of all sensor pads with the tissue. A polyurethane conduit tube containing interconnecting wires connects the individual impedance sensor pads on the sensor tip to the circuit board inside the connector housing. The connector is then attached to the remainder of the predicate MiVu System through the MiVu Endo Cap Cable. The MiVu System digitizes the impedance signals and passes the data to the PC-based Zvu software for display and analysis.

The provided text describes a 510(k) premarket notification for the MiVu™ Esophageal Endo Cap, a device intended to replace the MiVu™ Balloon Probe as an accessory for the MiVu Mucosal Integrity Testing System. The submission aims to demonstrate substantial equivalence to the predicate device.

Here's an analysis of the acceptance criteria and study information:

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

The document does not explicitly state quantitative acceptance criteria in a table format for performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the clinical study aims to demonstrate "clinically equivalent or better results" compared to the predicate device based on "disease probabilities."

However, we can infer some criteria based on the testing performed:

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

• Sample Size:
  • Comparative Test Set: 17 random patients were tested using both the MiVu Esophageal Endo Cap and the predicate MiVu Balloon Probe.
  • Endo Cap Only Test Set: An additional 7 random patients were tested using only the MiVu Esophageal Endo Cap.
  • Total Patients in Clinical Study: 24 patients.
  • Patient Demographics: Adult age (20 to 70 years), 12 males, 8 females, 4 unknowns.
• Data Provenance: Clinical studies were performed at one United States located facility. The study was prospective as patients were enrolled and tested within the context of the study.

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

The document does not explicitly state how ground truth for the test set was established or the number/qualifications of experts involved in determining the actual disease state (GERD, non-GERD, EoE) for the patients in the clinical study.

The study compared the device's generated "disease probabilities" against those generated by the predicate device, implying the predicate device's output or a physician's interpretation of it might serve as a de facto reference point for "clinically equivalent or better results."

It does mention that the clinical studies were performed by three gastroenterologists who were familiar with both MiVu System configurations. While these gastroenterologists performed the studies and interpreted the results, it's not explicitly stated if they established a definitive "ground truth" for each patient's actual disease. The system itself "generates a probability of the tissue disease type (GERD, non-GERD, EoE) which is used by the physician as an input to the treatment plan."

4. Adjudication method for the test set

The document does not specify any formal adjudication method (e.g., 2+1, 3+1) for the clinical study. The conclusion states that results were "clinically equivalent or better results than the MiVu Balloon Probe based on the disease probabilities generated by the MiVu System," suggesting a direct comparison of the outputs of both systems, possibly evaluated by the performing gastroenterologists.

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

• MRMC Study: While the study involved three gastroenterologists and multiple cases, it was not a traditional MRMC comparative effectiveness study focused on "human reader improvement with/without AI assistance." The study's primary goal was to compare the performance of the new accessory (Endo Cap) to the predicate accessory (Balloon Probe) within the existing MiVu System, which already includes an algorithm for determining disease probabilities. The comparison was device-to-device, not human-with-AI vs. human-without-AI.
• Effect Size of Human Readers: No such effect size is reported as this was not the objective of the study. The device's output ("disease probabilities") is an input for the physician's treatment plan, but the study doesn't isolate the impact of this input on a human reader's diagnostic accuracy.

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

Yes, the MiVu System, which includes the algorithm, generates "disease probabilities for GERD (Gastro-Esophageal Reflux Disease), non-GERD and EoE (Eosinophilic Esophagitis)." This is an algorithm-only output. The clinical study compares these probabilities generated when using the new Endo Cap versus when using the predicate Balloon Probe. The system's output is then "used by the physician as an input to the treatment plan," indicating the algorithm provides a standalone assessment.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document primarily refers to comparing the "disease probabilities generated by the MiVu System" when using the new Endo Cap versus the predicate Balloon Probe. It does not explicitly state that a definitive, independent ground truth (e.g., biopsy/pathology results, long-term outcomes, or a gold-standard expert consensus) was established for each patient's condition to validate the accuracy of these probabilities themselves. The comparison is largely relative to the predicate device's performance within the same system.

The study selected patients "based on the known or highly suspected esophageal disease type (GERD, non-GERD, EoE)," which implies some pre-existing diagnostic information, but whether this served as the formal "ground truth" for the device's output validation is not explicitly detailed.

8. The sample size for the training set

The document for the MiVu™ Esophageal Endo Cap does not provide information on the sample size for the training set used to develop the algorithm within the MiVu System. It only describes the clinical study for the new accessory and its comparison to the predicate. The algorithm for determining disease probabilities (GERD, non-GERD, EoE) was developed for the original MiVu System. The submission refers to the De Novo submission for the MiVu System (DEN180067) for details on the operating principle and changes in mucosal conductivity, which likely includes information about the algorithm's development.

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

Similar to the training set size, the document for the MiVu™ Esophageal Endo Cap does not detail how the ground truth was established for the training set of the MiVu System's algorithm. This information would typically be found in the original De Novo submission (DEN180067) for the MiVu System, which introduced the core technology and its algorithm. The current submission focuses on the substantial equivalence of a new accessory, not the development of the underlying diagnostic algorithm itself.

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The Mucosal Integrity Conductivity Test System is indicated for use by gastroenterologists, surgeons, and medically trained personnel during an endoscopy to obtain a real time measurement of esophageal epithelial impedance. The device is not for use as a sole diagnostic screening tool.

The Mucosal Integrity Conductivity (MI) Test System provides real-time measurements of alterations in esophageal evithelial integrity. The device is intended to aid in the evaluation of esophageal epithelial integrity by means of a balloon probe with direct electrical contact with the mucosal epithelium of the esophagus along with associated signal conditioning, hardware, and software for measuring and displaying information.

The provided text describes the "Mucosal Integrity Conductivity (MI) Test System," an esophageal tissue characterization system. However, the document does not contain information about a study that assesses the device's performance against specific acceptance criteria using a test set of patient data or
human readers in a comparative effectiveness study. The "Performance Testing - Bench" section details benchtop tests of the device's physical properties and electrical measurement capabilities, but this is distinct from a clinical performance study using patient data.

The "Summary of Clinical Information" section briefly mentions two prospective clinical studies where the device was used in patients, noting its ability to measure esophageal mucosal impedance and the occurrence of few adverse events. However, these descriptions do not provide specific acceptance criteria, performance metrics (like sensitivity, specificity, accuracy), or details on how ground truth was established for diagnosis or classification of esophageal conditions based on the impedance measurements, which would typically be part of a study proving the device meets clinical acceptance criteria for its intended use as an aid in evaluation.

Therefore,Based on the provided text, I cannot answer all parts of your request as it does not detail a study that proves the clinical performance of the device against specific acceptance criteria for diagnostic accuracy or human-in-the-loop improvement for clinical decision making. The information focuses on bench testing, safety, and general functionality.

However, I can extract the acceptance criteria and performance for the benchtop performance tests.

Acceptance Criteria and Reported Device Performance (Benchtop Testing)

Here's a table summarizing the acceptance criteria and reported "Pass" results for the benchtop performance testing:

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