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The Sterile Disposable Endotracheal Tube device is intended for oral or nasal intubation and for airway management.

The Accu-Cuff device is intended to inflate cuffs and to monitor intra-cuff pressures of endotracheal, supraglottic airways, or tracheostomy tubes.

The tracheal tube is disposable and supplied as sterile. It is available in a number of sizes/variants. The tracheal tube is primarily made of polyvinyl chloride. The device is used for airway management by connecting to oxygen delivery equipment via a connector. Reinforced ETTs may be used to reduce the potential for kinking whenever an unusual positioning of the head or neck is required following intubation. All variants have a radio-opaque line embedded into the tube which enables identification the device when the patient is X-rayed. All variants have a hole at the tip called a Murphy's eye and a standard connector.

Cuffed variants are composed of an inflatable cuff, a lumen and pilot balloon with a one-way valve or pressure indicator. The cuff is specified with high volume and standard volume which is intended to be inflated in the trachea in order to seal the device to prevent loss of gas bypassing the tube and the inhalation of vomit.

The patient end, the cuff and the tubular body of these tracheal tubes have short-term contact (< 30 days) with mucous membrane of upper airway.

Separately, Accu-cuff™ is used for pre-use check and monitoring the cuff pressure in intubation, treatment and extubation process. The user can Judge the change of intra-cuff pressure by observing the change of black line's location. When the black line point to the zone between the Minimum level of green zone and white line, it means the intra-cuff is too low and need to inflate to cuff. When the black line point to the zone between the Maximum level of green zone and red line, it means the intra-cuff is over-pressurizing and need to deflate.

The provided text is a 510(k) summary for a Disposable Endotracheal Tube, Sterile, and Accu Cuff™. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and detailed device performance through a standalone study. Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, and training set details for an AI/algorithm-based device is not available in this document.

However, based on the information provided, I can extract details about the performance data and testing standards used to demonstrate equivalence.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative table with corresponding "reported device performance" in the context of an AI/algorithm. Instead, it compares the specifications of the proposed device to predicate devices to establish substantial equivalence.

For the Accu Cuff™, the key performance criterion mentioned is the working pressure range.

For the Disposable Endotracheal Tube, Sterile, the document lists various specifications and states that the proposed device's performance is either identical or similar and meets relevant ISO standards. No specific quantitative "acceptance criteria" for each parameter are explicitly listed in a comparative table against a particular performance study result for the proposed device itself, but rather through comparison to predicate devices and adherence to standards like ISO 5361.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not available in the document as it describes a 510(k) submission for a medical device that does not involve AI/algorithm performance testing on a test set of data in the typical sense. The performance data listed (biocompatibility, sterilization, shelf life, dimensional, leakage, kinking, radiopacity) refer to physical device testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not available. The submission pertains to a physical medical device, not an AI/algorithm requiring expert-established ground truth for a test set.

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

This information is not available. Adjudication methods are typically relevant for human review of AI output or complex clinical assessments, which is not the subject of this 510(k) submission.

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

There is no mention of an MRMC comparative effectiveness study. This document discusses a physical medical device (endotracheal tube and cuff pressure indicator), not an AI-assisted diagnostic or decision support tool that would typically involve a human-in-the-loop study.

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

A standalone algorithm performance study was not done as this is not an AI/algorithm-based device. The "performance data" section (Section VII) refers to physical and biological tests of the device itself.

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

This concept of "ground truth" as typically applied to AI/algorithmic devices is not applicable here. The performance data for the physical device focused on adherence to technical standards and predicate device specifications through various laboratory and bench tests (e.g., dimensional measurements, leakage tests, biocompatibility tests). These tests themselves serve as the "truth" for the mechanical and biological properties being evaluated.

8. The sample size for the training set

This information is not available. This device is not an AI/algorithm, so there is no training set in the context of machine learning.

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

This information is not available. Not an AI/algorithm-based device.

Summary of what is available from the document regarding performance:

• Study Title: Not explicitly a single study, but rather a collection of performance tests detailed under "VII. PERFORMANCE DATA."
• Device Tested: Disposable Endotracheal Tube, Sterile and Accu Cuff™
• Performance Tests Performed:
  • Biocompatibility testing (ISO 10993-1, -3, -5, -6, -10)
  • Device performance (e.g., dimensional, leakage, kinking, radiopacity testing per ISO 5361)
  • Sterilization validation
  • Shelf life validation
  • EO/ECH residue analysis
  • Seal strength (ASTM F88/F88M-09)
  • Radiopacity (ASTM F640-2012)
• Conclusion: Tianjin Medis Medical Device Co., Ltd. considers the devices to be as safe, effective, and substantially equivalent to the predicate devices based on these performance data.
• Data Provenance: Not explicitly stated for specific tests, but the manufacturer is Tianjin Medis Medical Device Co., Ltd. in CHINA, suggesting laboratory tests were likely conducted by or for the manufacturer. The nature of the tests (bench testing, biocompatibility) implies controlled, prospective testing in a laboratory setting.

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