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The IscAlert™ sensor system measures the partial pressure of carbon dioxide in peripheral tissue, such as forearm muscle tissue, where the sensor is inserted. The system is intended for monitoring trends in this parameter as an adjunct in the evaluation of the perfusion status of tissue in patients at risk of developing ischemia. IscAlert values are relative within an individual and should not be used as the sole basis for decisions as to diagnosis or therapy. The IscAlert™ sensor system should not be used in peripheral brain tissue, intra cranial tissue, all organ tissues including cardiac and kidney, and other peripheral muscle tissues other than forearm muscle.

The IscAlert sensor system measures partial pressure of CO2 (pCO2) in peripheral tissue, such as forearm muscle tissue, where the sensor is inserted. The system is intended to monitor pCO2 trends as an adjunct in the evaluation of perfusion status of tissue in patients at risk of developing ischemia.

Ischemia is a medical term for a shortage of blood supply to tissue. If severe, it can lead to death of the affected tissue (infarction). The tissue pCO2 increases significantly during the early and reversible stages of ischemia. This methodology provides the ability to identify the onset of ischemia events through real-time data.

The IscAlert sensor system consists of three parts:

• 1. The sterile disposable Sensors
• 2. The Connection Unit (CU)
• 3. Software to be installed in an off-the-shelf PC unit

The sterile, disposable, catheter tip sensors are placed 2-5 cm into organ tissue with a split-off needle that is removed after insertion.

The sensor is connected via a cable to the Connection Unit (CU). The CU processes the signals from the sensor unit. It is connected via a cable to a PC with the IscAlert software application installed. The software enables visualisation of the monitoring results.

The provided text describes the IscAlert Sensor System (K071165), which measures partial pressure of CO2 (pCO2) in peripheral tissue, specifically forearm muscle. The system is intended to monitor pCO2 trends as an adjunct in evaluating the perfusion status of tissue in patients at risk of ischemia.

Unfortunately, the provided text does not contain detailed acceptance criteria or the specific results of a study that proves the device meets these criteria in a structured format. It mentions that "The IscAlert Sensor System has been tested for function according to the product requirements" and that "The results of these tests and a proof-of-concept clinical study using Neurotrend as comparative device show the IscAlert Sensor System to be safe and effective for its intended use." However, it does not elaborate on what those product requirements (acceptance criteria) were or the specific performance metrics achieved.

Therefore, I cannot provide a table of acceptance criteria and reported device performance.

Here's a breakdown of what can be extracted from the provided text regarding a study, even without specific performance metrics:

Study Information (Based on text)

• Study Type: A "proof-of-concept clinical study" was conducted.
• Comparative Device: The Neurotrend Cerebral Tissue Monitoring System (K980308) was used as a comparative device.
• Purpose: To demonstrate the safety and efficacy of the IscAlert Sensor System for its intended use.
• Outcome (General): The study results, along with other tests (EMC and safety), "show the IscAlert Sensor System to be safe and effective for its intended use."

The remaining requested information (sample size, data provenance, expert details, adjudication, MRMC, standalone performance, ground truth type, training set details) is not available in the provided document.

Here is a summary of the information that could be extracted and the information that is missing:

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The CODMAN Neurotrend Cerebral Tissue Monitoring System measures Intracranial oxygen, carbon dioxide, pH and temperature, and is intended as an indicallarial oxygon, and in these parameters, indicating the perfusion and metabolic acidosis/alkalosis status of cerebral tissue local to sensor placement. metabolic academand values are relative within an individual, the Neurotrend should not be used as the sole basis for decisions as to diagnosis or therapy. It is intended to provide data additional to that obtained by current clinical practice, in cases where hypoxia/ischaemia is a concem.

The Neurotrend Sensor (C7004S) is a modified version of the Fluorescent Paratrend 7 sensor which has been cleared for the US Market (K953893). The measurement parameters for Neurotrend are essentially the same as the Fluorescent Paratrend 7. The sensor does not require a heparin treatment, as a consequence of the application - to monitor cerebral tissue and fluid gas parameters.

The provided text describes the Neurotrend Multiparameter Sensor, a device intended to measure intracranial oxygen, carbon dioxide, pH, and temperature. The submission focuses on demonstrating substantial equivalence to a predicate device by showing that the modification (absence of heparin treatment) does not negatively impact performance.

Here's an analysis of the acceptance criteria and study information based on the provided text:

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in terms of specific thresholds for bias, precision, or drift. Instead, the "acceptance criteria" appear to be met by demonstrating comparable performance between the modified device (non-heparin treated) and the predicate device (heparin treated) in terms of accuracy characteristics.

Study Information

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set Sample Size:
     • Heparin-treated sensors (predicate): n = 8
     • Non-heparin treated sensors (device under review): n = 7
   • Data Provenance: The study was an in vitro test, not involving human data. The devices were manufactured in the UK (based on the submitter's address).

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

   • The ground truth for the in vitro test set was established using precision gas mixtures and the Henderson-Hasselbalch equation for pH in tonometers maintained at 37°C. This is a laboratory-based, objective method, so no human experts were used to establish the ground truth for this in vitro study.

3. Adjudication Method for the Test Set:

   • No adjudication method was mentioned as the ground truth was objectively determined by precision instruments and physical/chemical equations.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

   • No, a multi-reader, multi-case comparative effectiveness study was not done. This was an in vitro performance study comparing device characteristics.

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

   • This is not applicable in the context of this device. The Neurotrend Sensor directly measures physiological parameters. The "standalone" performance described here is the in vitro performance of the sensor itself, without human interpretation of the raw measurements.

6. The Type of Ground Truth Used:

   • For the in vitro study, the ground truth was established by precision gas mixtures for partial pressures of O2 and CO2, the Henderson-Hasselbalch equation for pH, and a reference thermometer for temperature within equilibrated tonometers. This is an objective, laboratory-based physical/chemical ground truth.

7. The Sample Size for the Training Set:

   • The document does not describe the development or training of an algorithm in the traditional sense. It's a sensor device providing direct measurements. Therefore, there's no "training set" for an AI algorithm as typically understood. The sensors themselves are calibrated according to the Instructions For Use (IFU), but this is part of device manufacturing and operational procedure, not an algorithm training process.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable as no algorithm training set is described. The "calibration" of the sensors is done against primary standards in a manufacturing/testing environment.

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