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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.

2. Sample size used for the test set and the data provenance:

• Not applicable. This document is a 510(k) submission for a heated humidifier, not an AI/ML device that uses test sets or data. The "test set" in this context refers to the device itself being tested for compliance with standards and functional equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. Ground truth, in the context of an AI/ML device, refers to verified labels or outcomes. For this medical device, safety and performance are assessed through engineering and regulatory testing against established standards and predicate device specifications.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. Adjudication methods are typically used in studies where multiple human readers assess data, and a consensus mechanism is needed to establish ground truth or resolve discrepancies, common in diagnostic imaging studies for AI.

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:

• No. This is not an AI-assisted device. Therefore, no MRMC study comparing human readers with and without AI assistance would have been conducted.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is a hardware medical device, not an algorithm. Performance is assessed through engineering testing and compliance with regulatory standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable in the AI/ML sense. The "ground truth" for this device's performance would be derived from:
  • Engineering specifications and measurements: e.g., actual temperature readings, alarm activation thresholds.
  • Compliance with recognized standards: UL 544, CSA C22.2 No. 125-M1984, ANSI Z79.9-1979.
  • Comparison to predicate device performance: Demonstrating the new device performs equivalently or better on critical safety and functional aspects.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:

• Not applicable. As above, no training set for an AI/ML model is involved.

Summary of the Study/Evidence:

The "study" presented here is a 510(k) premarket notification. The primary goal is to demonstrate "substantial equivalence" to legally marketed predicate devices (Marquest SCT 3000 - K903138 and Fisher & Paykel 730 Respiratory Humidifier - K913368).

The evidence provided focuses on:

• Device Description and Intended Use: Clearly outlining the function and purpose of the SCT 3000.
• Comparison Table (Attributes): A detailed comparison of the new SCT 3000 with its predicate devices across various attributes including:
  • Indications for use (anesthesia, respiratory therapy)
  • Targeted population (adult, pediatric, neonate)
  • Circuit types (heated wire, no-wire, specific manufacturer circuits)
  • Application types (single patient, reusable)
  • Chamber types (low flow, high flow)
  • Compatibility (ventilators, anesthesia systems)
  • Design features (microprocessor control)
  • Safety Features: High and low temperature alarms (with specific thresholds), maximum heater plate temperature, alarm mute duration, and safety alarm display.
  • Performance Testing: Stating compliance with specific national and international electrical and medical device safety standards (UL 544, CSA C22.2 No. 125-M1984, ANSI Z79.9-1979).

The document explicitly states that "Any differences that do exist would not have an effect on the safety or effectiveness of the device," which is key to a 510(k) submission for substantial equivalence. The "study" is more of a regulatory compliance review of engineering specifications and testing against established standards and predicate device performance, rather than a clinical trial or AI evaluation study.

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