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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 TrendCare Calibrator is an accessory for use with the TrendCare Monitors. Sensors and Patient Data Modules calibrated with the TrendCare Calibrator may be used with the TrendCare Satellite Monitor (TCM6000) or TrendCare Senior Monitor (TCM7000).

The TrendCare Calibrator is a microprocessor-based device powered from the mains (line) supply. The device incorporates:

• A LCD display for user prompts.
• A series of LEDs for system status indication.
• Keys for selecting and initiating calibration.
• Calibration chamber.
• Connections to calibration gas cylinders.
• Location fixtures for the multiparameter sensors.

The calibration chamber is located on the front of the Calibrator unit, and is opened by pressing the latch to release the door.

The sensor is calibrated by connecting it to the PDM patient cable, placing the tonometer in the calibration chamber, closing the door and securing the introducer, and pressing the START CAL key.

A three point calibration of the sensor is performed by bubbling three precision mixtures of oxygen, carbon dioxide and nitrogen in sequence through the tonometer solution surrounding the sensor. These gases change the partial pressure of oxygen and carbon dioxide and the pH in the tonometer to defined values.

The calibration gases are contained in cylinders located at the base of the Calibrator. The cylinders are identical to the predicate device. Each cylinder contains a different precision mixture of gases. These gases are automatically passed in sequence through the tonometer when the calibration sequence is initiated.

Each of the cylinders contains sufficient gas for multiple calibrations. The cylinders are disposable, and should be discarded when empty (see the Instructions on the cylinder labels).

The provided text is a 510(k) summary for the TrendCare Calibrator. It outlines the device description, intended use, technological characteristics, and claims of substantial equivalence to predicate devices. However, it does not contain specific details about acceptance criteria for device performance, nor does it describe a study with quantitative results demonstrating that the device meets such criteria.

The document states: "The data presented above satisfies product accuracy claims and shows comparable results for both the TrendCare Calibrator and the TrendCare Senior Monitor." However, it does not provide this data or the methods used to obtain it. It also mentions "a three point calibration of the sensor is performed by bubbling three precision mixtures of oxygen, carbon dioxide and nitrogen in sequence through the tonometer solution surrounding the sensor." This describes the calibration process, but not the accuracy or performance of the calibration itself, nor the acceptance criteria for successful calibration.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study proving device performance using the provided text. The document focuses on regulatory submission and a high-level description of the device's function and substantial equivalence.

To answer your request, information typically found in a validation or verification report would be needed, which is not present in this 510(k) summary.

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The Neotrend Multiparameter Sensor is inserted via an intravascular access device into the vascular system, e.g. umbilical artery (neonates), femoral artery (paediatrics, adults). It is intended to be used in the management of critically ill patients of any age, but especially neonates, by providing continuous blood gas data while permitting the simultaneous monitoring of blood pressure via an external transducer.

The Neotrend sensor is designed for use in conjunction only with the custom umbilical artery catheter supplied when the umbilical artery is to be the access site.

The sensor is used in conjunction with the Paratrend 7 Multiparameter Senior and/or Satellite Monitor systems.

Within the United states market, the use of this device should be limited to 72 hours.

The Neotrend Sensor (N7004S) is a modified version of the currently legally marketed device, the Paratrend 7 sensor (MPS7004). The measurement of pO2 using an electrochemical sensor (Clark electrode) in the predicate Paratrend 7 sensor has been replaced in the Neotrend device by a sensor based on optical fibre/fluorescence quenching technology. All other measurement parameters are essentially unchanged. The application has been expanded to include umbilical artery access.

The provided text describes the Neotrend Multiparameter Sensor, a modified version of the Paratrend 7 sensor. It details the device's technical characteristics, intended use, and claims substantial equivalence to previously cleared devices. However, the document does not describe acceptance criteria or a study that proves the device meets specific acceptance criteria.

Instead, it presents a comparison of the Neotrend sensor's accuracy to its predicate device, the Paratrend 7. This comparison focuses on bias and precision for pO₂, pCO₂, and pH measurements. The study methodology is outlined, but specific acceptance criteria (e.g., maximum allowable bias or standard deviation) are not provided. Therefore, it's impossible to report whether the device "meets" acceptance criteria based on this document.

Here's a breakdown of the information that is available and the parts that are missing based on your request:

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

• Acceptance Criteria: NOT PROVIDED. The document states "The data presented above satisfies product accuracy claims and shows comparable results for both Senior and Satellite," but it does not specify what those "product accuracy claims" are in terms of concrete numerical acceptance criteria (e.g., ΔpO₂

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Not Found

Fluorescent Paratrend 7 Intravascular Monitoring System (MPM7000S)

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device. It does not contain any information about acceptance criteria, device performance, specific studies, sample sizes, ground truth establishment, or expert involvement for a device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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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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The Olympus System is intended to provide on-demand arterial blood gas monitoring in the operating room and at the bedside for critically ill patients with a pre-existing 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.

It is the intention of Optical Sensors Incorporated (OSI) to introduce into commercial distribution an Olympus Critical Care Monitoring System (Olympus System). The Olympus System supports modules and sensors used in monitoring critical parameters at the patient bedside. The module and sensor referenced in this submission are the cleared-to-market arterial blood gas module (ABG Module) and SensiCath optical sensor unit (SensiCath Sensor). When the Olympus System includes an ABG Module and SensiCath Sensor, monitoring of arterial blood gas at the point-of-care is accomplished.

The Olympus System has three main components:

• 1. an optical arterial blood gas sensor, hereafter referred to as the SensiCath Sensor.
• 2. a module, the Arterial Blood Gas (ABG) Module, hereafter referred to as the ABG Module and,
• 3. an operator interface (display, control knob) with electrical and mechanical support for the ABG Module, hereafter referred to as the Olympus Monitor.

The provided text describes the Olympus Critical Care Monitoring System, focusing on its arterial blood gas (ABG) monitoring capabilities. The submission refers to a previous 510(k) clearance (K951094) for the "Point-of-Care Blood Gas Monitor System" as its predicate. The document emphasizes that the Olympus System's performance meets the same specifications as the predicate.

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

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states that the Olympus System performance meets the same performance specifications as the predicate Point-of-Care Arterial Blood Gas Monitoring System (K951094). The specific numerical acceptance criteria for PO2, PCO2, pH, accuracy, and precision are not detailed in this submission but are implicitly referenced as those established for the predicate device.

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

The document does not explicitly state:

• The sample size used for the test set.
• The data provenance (e.g., country of origin, retrospective or prospective) for the performance testing.

It mentions "Precision and accuracy tests were conducted on the Olympus System over the range of ABG specifications" but does not detail the methodology or the data sources for these tests.

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

The document does not provide information on:

• The number of experts used to establish ground truth.
• The qualifications of those experts.

Given that it's an ABG monitor, ground truth would likely be established by a reference laboratory analyzer, not human interpretation.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for a test set. This is typically not applicable for objective measurements like blood gas analysis, where ground truth is typically derived from a reference standard.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or interpretation tasks where human readers are involved. For an automated blood gas monitor, the focus is on the device's ability to accurately measure physiological parameters.

6. Standalone Performance Study

Yes, a standalone performance study was done. The document states: "Precision and accuracy tests were conducted on the Olympus System over the range of ABG specifications. The Olympus System performance meets the same performance specifications as the predicate Point-of-Care Arterial Blood Gas Monitoring System." This indicates that the device itself was tested for its performance characteristics.

7. Type of Ground Truth Used

The type of ground truth used is implied to be reference standard measurements. For blood gas analysis, this would typically involve:

• Calibrated laboratory blood gas analyzers.
• Certified control solutions.
• Potentially spiked blood samples with known concentrations.

The document refers to "ABG specifications," which are objective and quantitative, suggesting comparison against a highly accurate and precise reference method.

8. Sample Size for the Training Set

The document does not provide information on the sample size for a "training set." This term is typically used in the context of machine learning or AI algorithm development. For a device measuring physiological parameters, "training" usually refers to calibration and validation against known standards, rather than a machine learning training set in the conventional sense.

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

Given that there is no mention of a "training set" in the context of an AI/ML algorithm, the document does not describe how ground truth for a training set was established. The "training" of such a device would involve factory calibration and internal quality control procedures, where the device samples are measured against known standards and adjusted if necessary.

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