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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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The YiKang Latex Foley Catheter is intended to be placed in the bladder, through the urethra, to drain urine and other fluids from the urinary bladder.

The YiKang Latex Foley Catheter is a flexible tubular device that is passed through the urethra into the bladder to drain urine and other fluids from the urinary bladder. The catheter is manufactured from natural latex, consists of a shaft with eyelets near the tip, balloon, drainage funnel, inflation funnel, irrigation funnel (only for 3-way) and valve. The eyelets allow for drainage of urine from the tip of the catheter through the drainage lumen. The balloon once inflated with sterile water retains the catheter within the bladder. The valve allows for inflation and deflation of the balloon. The YiKang Latex Foley Catheter offers various balloon volumes and shaft sizes to accommodate pediatric and adult use, it is supplied in French size ranging from 6Fr to 30Fr and balloon size 3cc(ml), the 6Fr, 8Fr and 10Fr are for pediatric use, remaining size for adult use. The YiKang Latex Foley Catheter consists of two types (2-way & 3-way) of devices. Two-way catheters are used for urological bladder drainage only. Three-way Foley catheters offer the option of irrigating the bladder through a 3rd lumen. The catheter is coated with a silicone elastomer through a dipping process. The product is individually packaged with a sterile barrier pouch which is produced of plastic film plus paper through heat sealing. The product is ethylene oxide sterilized (per ISO11135), the catheter is for single use.

The provided text is a 510(k) summary for the YiKang Latex Foley Catheter and does not contain information about studies for an AI-powered device, nor does it provide details about acceptance criteria and performance for such a device.

The document describes the YiKang Latex Foley Catheter, which is a physical medical device (a urological catheter), and its substantial equivalence to a predicate latex Foley catheter. The performance data presented are for physical properties of the catheter itself, not for an AI algorithm.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance for an AI-powered device.
• Sample size and data provenance for a neural network test set.
• Details on experts establishing ground truth for a test set.
• Adjudication methods.
• MRMC comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used for an AI.
• Sample size and ground truth establishment for a training set.

The document focuses on the following performance aspects for the physical catheter:

• Flow Rate through Drainage Lumen
• Balloon Integrity (Resistance to Rupture)
• Inflated Balloon Response to Traction
• Balloon Volume Maintenance
• Balloon Size and Shaft Size
• Deflation Reliability (Failure to Deflate)
• Biocompatibility (cytotoxicity, sensitization, irritation per ISO10993-1)
• Sterility (SAL=10^-6)

It states that "all the testing results meet requirements of ASTM F623-99 (Reapproved 2013) and defined acceptance criteria," but it does not list the specific numerical acceptance criteria or the numerical performance metrics achieved for each of these tests. It only confirms compliance with the ASTM standard.

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