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

The Reinforced Endotracheal tube is intended for airway management by oral or nasal intubation of the trachea during anesthesia. It is a device inserted into the trachea through the mouth or nose to facilitate breathing and it may be used where the patient's neck is likely to be moved of flexed or the prone position so that a non-reinforced tracheal tube might become kinked.

The Endotracheal tubes are used for oral or nasal intubation and for airway management, which are mainly for patients that require repeated anesthesia, artificial ventilation and assisted breathing. The Endotracheal tube is available in cuffed and uncuffed variants. The cuff is intended to provide a seal against the trachea, ensuring that inspiratory and expiratory gasses are routed through the tube and not allowed to escape to the patient's upper airway. The structure of Cuffed Endotracheal tube contains a main tube (patient end, machine end and murphy eye), cuff, and inflating system (including inflating tube, valve and pilot balloon). The uncuffed Endotracheal tube contains main tube (patient end, shaft and machine end). All variants have a Murphy eye. The products are primarily made from polyvinyl chloride (PVC) materials. The Endotracheal tubes are available in a number of sizes: the nominal inside diameter of uncuffed Endotracheal tubes are from 2.0mm to 10.0mm; the nominal inside diameter of cuffed Endotracheal tubes are from 2.5mm to 10.0mm. The Endotracheal tubes are disposable and are supplied sterile. The contact time should be no more than 30 days.

The reinforced Endotracheal tubes are a tracheal tube with additional metal wire spiral reinforcement to provide kink-resistance. The products are always used during operations where a high degree of flexibility is required from the tube. The reinforced Endotracheal tubes are also available in cuffed and uncuffed variants, and nominal inside diameter of both the uncuffed and cuffed reinforced Endotracheal tubes are from 3.0mm to 9.0mm. The only difference between reinforced Endotracheal tubes and Endotracheal tubes is the metal wire spiral inside the tube, which is made by 304 stainless steel and used for reinforcement that maintains the patency of the lumen.

The provided document describes the acceptance criteria and the study conducted for the Endotracheal Tube and Reinforced Endotracheal Tube manufactured by Zhanjiang Star Enterprise Co., Ltd. This is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving novel effectiveness.

Here's the breakdown of the information requested:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the devices are based on compliance with international standards, primarily ISO 5361: 2012 for performance and ISO 10993-1 (and #G95-1) for biocompatibility. The reported device performance is that the "endotracheal tubes meet the requirement of ISO 5361" and that "all of the results meet the acceptance criteria" for shelf-life testing. The devices also passed various biocompatibility tests.

Table of Acceptance Criteria and Reported Device Performance:

1. Size designation
2. Dimensions (ID, OD, connectors, machine and patient ends, opening)
3. Tracheal tube bevel (angle, free from sharp edges)
4. Tracheal tubes cuffs (tube collapse, free of sharp edges)
5. Inflating system for cuffs (OD, angle, pilot balloon)
6. Curvature of the tube (radius, maintain intended shape)
7. Kink resistance
8. Additional requirement for Murphy eye
9. Sterility assurance
10. Marking | "The results showed that the endotracheal tubes meet the requirement of ISO 5361."
    "The testing results demonstrate that the proposed devices meet the requirements of the standards listed above." (Referencing ISO 5361:2012 for the proposed device and ISO 5361:1999 for the predicate for reinforced ETT) |
    | Biocompatibility | #G95-1 and ISO 10993-1 - covering tests such as:
11. In Vitro Cytotoxicity
12. Skin Sensitization
13. Oral mucosa Irritation
14. Oral mucosa Prolonged Irritation
15. Genotoxicity Test
16. Implantation Test
17. Acute Systemic Toxicity Test
18. Subchronic Systemic Toxicity Test
19. Endotoxin Test
20. Pyrogen
21. EO and ECH Residual Test
22. DEHP Residual Test | "The proposed device is considered as external communicating device in contact with tissue less than 30 days, and evaluation was conducted in accordance with #G95-1 and ISO 10993-1,...There is no additional risk for the proposed products when compared with the predicate devices. The Biocompatibility testing show below: [list of all tests mentioned as passed]" |
    | Shelf Life | Package integrity and physical performance after accelerated aging | "all of the results meet the acceptance criteria. Therefore, the product has a shelf life of 5 years was proved." |
    | Sterilization | ISO 11135-1:2007 (Ethylene oxide sterilization) - covering:
    Sterilization validation, bioburden test, product sterility test, Biological Indicators (BI) sterility test | "The sterilization validation was conducted according to ISO 11135-1:2007... The sterilization validation, bioburden test, product sterility test, and Biological Indicators (BI) sterility test were conducted." (Implies successful completion and meeting of criteria) |

Breakdown of Study Information:

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

• The document primarily describes non-clinical performance testing, which involves testing device samples against specified technical standards and biocompatibility requirements. It does not refer to a "test set" in the context of a clinical study or expert review of data from patients.
• Data Provenance: The tests (physical performance, biocompatibility, shelf-life, sterilization) were performed on samples of the manufactured devices. The origin of the data is from these laboratory evaluations and not from patient data from a specific country or retrospective/prospective study.

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

• This information is not applicable to the type of studies described. The "ground truth" for these tests is defined by the requirements of the international standards (e.g., ISO 5361, ISO 10993). Experts are typically involved in setting these standards and conducting the laboratory tests, but there's no mention of a specific ground truth established by a panel of experts for a clinical test set in this document.

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

• This information is not applicable. Adjudication methods are typically used in clinical studies or image-based diagnostic evaluations to resolve discrepancies among multiple expert readers. This document describes laboratory and bench testing against pre-defined technical standards.

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, an MRMC comparative effectiveness study was not done. This document is for an endotracheal tube, a physical medical device, not an AI or diagnostic software.

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

• No, a standalone algorithm performance study was not done. This product is a physical medical device, not a software algorithm.

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

• For performance testing (ISO 5361), the ground truth is defined by the specifications and measurement tolerances provided within the ISO standard. This involves objective physical measurements and functional evaluations.
• For biocompatibility testing (ISO 10993), the ground truth is established by biological test methods and criteria outlined in the standard, which assess the device's interaction with biological systems through various assays (cytotoxicity, irritation, sensitization, etc.).
• For shelf-life and sterilization testing, the ground truth is based on pre-established quality parameters and microbial inactivation levels as defined by the relevant standards (e.g., ISO 11135-1).

8. The sample size for the training set:

• Not applicable. This submission is for a physical medical device, not a machine learning or AI algorithm, so there is no "training set."

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

• Not applicable. As there is no training set for an AI/ML algorithm.

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