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The device is intended for oral or nasal intubation and for airway management.

Yikang endotracheal tube is a device intended for oral or nasal intubation and for airway management. It is a sterile and single use device, it is made from medical grade PVC. The Yikang endotracheal tube has cuffed and uncuffed, and is available in size I.D. 2.0mm through I.D. 10.0mm, and has a Murphy eye. It basically consists of tube shaft, cuff, inflation line, pilot balloon, one-way valve, and a male 15mm conical connector. A radiopaque line is incorporated into the full length of the tracheal tube.

When used tracheal tube is inserted through the trachea to convey gases to and from the trachea. Cuffed tracheal tube is intended to seal and protect aspiration of secretions, and to provide an unobstructed airway in patients during ventilation. A radiopaque line helps to determine proper placement of the tracheal tube with the characterization of visibility of tracheal tube in X-rays.

The provided document is an FDA 510(k) summary for the Yikang Endotracheal Tube. It details the device's characteristics and its comparison to a predicate device to establish substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the sense of quantitative thresholds for specific performance metrics (like sensitivity/specificity for an AI device). Instead, the acceptance criteria for this endotracheal tube are compliance with recognized international standards for medical devices and meeting specified performance requirements. The reported device performance is that it meets these standards and requirements.

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

The document does not specify a "test set" in the context of an AI/algorithm study. For a physical medical device like an endotracheal tube, performance testing typically involves a sample of manufactured units. The document states "Performance testing have been conducted on YiKang Endotracheal Tube per ISO5361: 2016," but it does not mention the specific sample size (number of tubes) used for these tests.

Data Provenance: The testing was conducted by Jiangxi Yikang Medical Instrument Group Co., Ltd. in Nanchang, Jiangxi, China. This would imply the data provenance is China. The testing is implied to be prospective as it's performed on the proposed device to demonstrate compliance.

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

This question is not applicable to the type of device and study described. Endotracheal tubes are assessed based on engineering specifications, material properties, and functionality standards (ISO 5361, ISO 10993), not through expert consensus on diagnostic interpretations (like for an imaging AI). Therefore, no "experts" in the sense of radiologists establishing ground truth are involved.

4. Adjudication Method for the Test Set

Not applicable. As this is not an AI/algorithm study involving subjective interpretation or classification, there's no need for an adjudication method for ground truth. The "ground truth" is established by direct measurement and adherence to defined physical and performance standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC study is relevant for AI-assisted diagnostic tools where human readers' performance with and without AI assistance is compared. This document concerns a physical medical device (endotracheal tube) and therefore, an MRMC study was not conducted nor is it relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Not applicable. This is not an AI/algorithm device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by compliance with international standards (ISO 5361:2016 for performance, ISO 10993-1 for biocompatibility). This involves:

• Direct Physical Measurements and Engineering Tests: For aspects like tube length, diameters, cuff diameter, etc.
• Functional Performance Tests: For properties like cuff herniation, leakage, tube collapse, kink resistance, tracheal seal.
• Chemical and Biological Testing: For biocompatibility, including cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, subchronic toxicity, and implantation.
• Sterility Assessment: Meeting specific sterility assurance levels.

8. The Sample Size for the Training Set

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

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

Not applicable. As there is no training set for an AI algorithm, there is no ground truth established for one.

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