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The SCT 3000 Heated Humidifier is indicated for use with breathing circuits when healthcare professionals require humidified and /or heated gas being delivered to patients.

Servo-Controlled Tracking SCT 3000 heated humidifier is designed to provide heated, humidified gas to a patient whose own humidification system - the nose and upper airway - is compromised. The unit is used primarily during anesthesia or prolonged respiratory therapy to prevent damage to the upper airway and lungs caused by dry gas while helping to maintain the patient's body temperature stable. The whole system, including disposable humidification chambers, heated wire breathing circuits and no-wire (vent) circuits, achieves precise control of delivered gas temperature and humidity by a servo controlled mechanism. The SCT 3000 employs a feedback loop where the temperature input from the thermistors controls the heating elements. The SCT 3000 has two thermistors that provide analog input. This information, in turn, is used to control the amount of time that the two heating elements are cycled on/off. The SCT's microprocessor - the Intel P80C32, regulates this servo mechanism. the advanced design allows simple operation, sophisticated diagnostic routines and superior safety features to be built into the instrument, resulting in better performance and safer operation.

The provided text describes a 510(k) premarket notification for the Marquest SCT 3000 Heated Humidifier. The information focuses on demonstrating substantial equivalence to predicate devices, rather than a study with specific acceptance criteria and detailed performance metrics of a device, especially not one using AI or machine learning. Therefore, I cannot fully complete the requested table and sections.

Here's an analysis based on the provided document, highlighting why certain questions cannot be answered:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria or provide specific quantitative performance metrics for the new SCT 3000 Heated Humidifier in the way a study for a diagnostic AI device would. Instead, it relies on comparison to predicate devices, indicating equivalency in function and safety features.

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Heated wire circuits to be used with the SCT 3000 are indicated as breathing circuits for patients under going anesthesia or mechanical ventilation.

Various configurations of anesthesia, volume ventilator circuits and heated limbs for use with SCT 3000 Heated Humidifier.

The provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria. Instead, the document describes "Heated wire breathing circuits and limbs" and compares them to predicate devices, focusing on attributes like intended use, design, and materials.

The document discusses "Performance Testing" by stating that the device "Meets ASTM breathing systems standard," but it doesn't provide details about:

1. Specific acceptance criteria: What are the numerical or qualitative thresholds that define "meeting the ASTM standard" for this device?
2. A study proving compliance: There's no description of a study (e.g., methodology, results, sample sizes) that demonstrates the device actually meets the ASTM standard.

Therefore, I cannot populate the requested table or answer the specific questions about sample sizes, ground truth, expert qualifications, or study types like MRMC or standalone. The document's purpose is to outline the device's characteristics and its similarity to existing devices for regulatory submission, not to detail the results of a performance study against specific acceptance criteria.

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