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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 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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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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The Paratrend 7+ System is intended to be used in the management of the critically ill patient by providing continuous blood gas data while permitting the simultaneous monitoring of blood pressure via an external transducer. The Paratrend 7+ Multiparameter Sensor is inserted via an intravascular access device into the vascular system (e.g. radial, femoral arteries). Within the United States market, the use of this device should be limited to 72 hours.

The Paratrend 7 Plus Sensor (MPS7004P) 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 Paratrend 7 Plus device by a sensor based on optical fibre/fluorescence quenching technology. All other measurement parameters are essentially unchanged. The telescopic introduction mechanism in the predicate Paratrend 7 sensor has been replaced by a rotary advancing mechanism. The application has been expanded to include venous access.

This document describes the Paratrend 7 Plus Multiparameter Sensor, a modified version of the Paratrend 7 sensor, intended for continuous blood gas monitoring in critically ill patients.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of specific performance thresholds for bias, precision, or correlation coefficients. Instead, it presents the approach taken to demonstrate "product accuracy claims" and "comparable results" to a predicate device.

The study aimed to show substantial equivalence to the predicate device, Paratrend 7, and its own previously cleared versions, as well as to Optex and Baxter Swan-Ganz systems.

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

• Sample Size: The document does not specify the exact sample size (number of measurements) used in the tonometer study. It mentions data collected "over the relevant range of gases."
• Data Provenance: The study was conducted by Diametrics Medical Limited, a UK-based company. The data appears to be prospective as it involves setting up tonometers and taking measurements with the device under review.

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

The ground truth in this study was established using precision gas mixtures and the Henderson-Hasselbalch equation to determine "actual" partial pressures and pH values in tonometers. This approach does not involve human experts establishing ground truth; it relies on established chemical and physical principles.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by physical and chemical methods (tonometers with precision gas mixtures and calculation). There was no human interpretation or adjudication involved in determining the "actual" values.

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

Not applicable. This device is an intravascular blood gas monitoring system, not an imaging or diagnostic device that involves human reader interpretation or AI assistance in that context. The study focuses on device performance against a controlled "actual" value.

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

The primary study described is a standalone performance evaluation of the device. The device's measurements (algorithm/sensor output) were compared to a known ground truth (tonometer values). Human "in-the-loop" performance in terms of interpretation or decision-making was not evaluated in this accuracy study, though the device's output is intended for use by clinicians.

7. The Type of Ground Truth Used

The ground truth used was physico-chemical ground truth, established by:

• Pre-equilibrated precision gas mixtures for "actual" partial pressures.
• Calculation using the Henderson-Hasselbalch equation for "actual" pH values.

8. The Sample Size for the Training Set

Not applicable. This document describes the performance evaluation of a medical device (sensor and monitor systems), not a machine learning or AI algorithm that typically requires a large training set. The device's measurement technology (fibre optic, fluorescence quenching, photometric absorption, thermocouple) is based on established physical and chemical principles, not on learned patterns from a training dataset.

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

Not applicable, as there is no mention of a "training set" in the context of this device's development or evaluation.

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