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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 modified SensiCath Sensor, when used as part of the Point-of-Care Blood gas Monitor System is intended to provide on-demand arterial blood gas monitoring in the operating room and at the bedside for critically ill patients requiring an arterial pressure monitoring line. The ABG information is available to the attending qualified medical professional on demand and within approximately 60 seconds of the time the sample cycle was initiated. The intended use of the modified SensiCath Sensor is the same as the predicate SensiCath Sensor.

It is the intention of Optical Sensors Incorporated (OSI) and Marquette Electronics Incorporated (MEI) to introduce into commercial distribution a modification to the SensiCath Arterial Blood Gas Sensor. The modified sensor has a longer useful life and allows a greater number of ABG measurements. The modified sensor is substantially equivalent to the SensiCath Sensor presented in the SensiCath™ Point-of-Care Blood Gas Monitor System which received Food and Drug Administration (FDA) clearance to market, 510(k) K95 1094. The modified SensiCath Sensor operates with the SensiCath Point-of-Care Blood Gas Monitor System, just as the predicate SensiCath Sensor. As with the predicate sensor, the modified SensiCath Sensor measures blood gas parameters of partial pressure of oxygen (PO2), partial pressure of carbon dioxide (PCO2) and the blood's hydrogen ion concentration, (pH). The modified SensiCath Sensor is manufactured and sterilized by Optical Sensors Incorporated, as is the predicate SensiCath Sensor.

The document describes a medical device, the SensiCath™ Arterial Blood Gas Sensor, and a modification to it. It details the device's intended use and compares the modified version to a predicate device. The performance data section focuses on demonstrating that the modified sensor meets predetermined specifications.

Here's an analysis of the provided text in relation to the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that the modified SensiCath Sensor "meets the same performance specifications as the predicate SensiCath Sensor over 144 hours of use and 200 ABG measurements." However, it does not provide a quantifiable table of acceptance criteria or specific performance values for precision and accuracy. It mentions that precision and accuracy tests were conducted, but the actual results or the specific numerical thresholds for acceptance are not detailed.

Without specific numerical acceptance criteria from the document, a precise table cannot be generated. However, based on the text, the implicit acceptance criteria are:

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

• Sample Size: The document does not explicitly state the numerical sample size (number of sensors, number of tests, or number of blood samples) used for the precision and accuracy tests. It only mentions that "Tonometered bovine blood was equilibrated with several gas mixtures" and "measurements were taken."
• Data Provenance: The tests were conducted using "Tonometered bovine blood." This indicates that the data is from a controlled laboratory setting, likely a bench study rather than human clinical data. The study appears to be prospective in the sense that the modified device was tested in a controlled environment to gather performance data. The country of origin of the data is not specified, but the submitting entity is in Minneapolis, MN, USA, suggesting the testing was likely conducted in the USA.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. The study described is a technical performance test of a sensor, not a diagnostic study requiring expert interpretation of results to establish ground truth about a patient's condition. The "ground truth" for the sensor's measurements (PO2, PCO2, pH) would be established by the reference measurements from the tonometered blood, not by human experts.

4. Adjudication Method for the Test Set:

Not applicable. This type of performance study does not typically involve an adjudication method as seen in clinical studies where multiple reviewers assess images or clinical outcomes. The "ground truth" for the sensor measurements is determined by the preparation of the tonometered blood, not through human consensus.

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

No, an MRMC comparative effectiveness study was not conducted. The reported study focuses on the standalone performance of the device against predefined specifications, not on how human readers' performance with or without the device's assistance.

6. If a Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, a standalone performance study was done. The document describes tests to evaluate the "performance of the modified SensiCath Sensor" itself. This involved measuring its precision and accuracy when applied to tonometered bovine blood. This is an evaluation of the device's technical specifications in a controlled setting, which is inherently a standalone performance assessment.

7. The Type of Ground Truth Used:

The ground truth for the sensor measurements (PO2, PCO2, pH) was established by the known concentrations/parameters of the tonometered bovine blood. Tonometering involves equilibrating biological fluids with gas mixtures of precisely known concentrations, effectively creating a "gold standard" for the gas parameters.

8. The Sample Size for the Training Set:

Not applicable. This document describes a performance validation study for a sensor, not a machine learning model. Therefore, there is no concept of a "training set" in the context of this submission.

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

Not applicable, as there is no training set for this type of device validation.

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