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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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