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The Endotracheal Tube with Evacuation Lumen is intended for oral intubation and drainage of the subglottic space for airway management.

The Endotracheal Tube with Evacuation Lumen is sterile, single-use devices supplied with a standard 15mm connector. The Endotracheal Tube with Evacuation Lumen is a Magill curved construction with primary lumen for patient ventilation. Two (2) narrower lumens within the primary wall are used for cuff inflation and subglottic evacuation (vacuum). A low pressure, conformable cuff is inflated through the inflation tube with pilot balloon using a standard syringe (air only) through a non-return valve. For evacuation of subglottic secretions, a separate suction line, with a capped connector, connects to standard hospital vacuum receptacles. The tube incorporates a radiopaque line to assist in radiographic visualization. The Endotracheal Tube with Evacuation Lumen is PVC (polyvinylchloride) tube with a cylindrical-shaped cuff. The cuff is available with two materials PVC (polyvinylchloride) and PU(polyurethane). It is available in sizes 6.0, 6.5, 7.0, 7.5, 8.0, 8.5 and 9.0mm and consists of tube, cuff, inflation tube, non-return valve, pilot balloon, 15mm connector, suction line.

This document is a 510(k) Premarket Notification from the FDA for a medical device called the "Endotracheal Tube with Evacuation Lumen." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific clinical performance acceptance criteria in the way AI/ML devices might.

Therefore, the information typically requested in your prompt (e.g., acceptance criteria tables for AI performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, ground truth establishment methods) is not applicable to this document.

This FDA clearance is based on the device being substantially equivalent to a predicate device (K110269-Well Lead Endotracheal Tube with Evacuation Lumen), primarily by demonstrating that material modifications (changing PVC containing DEHP to DEHP-free PVC and PU) did not alter the intended use, fundamental scientific technology, or raise new safety and effectiveness issues.

Here's a breakdown of why your specific questions aren't addressed:

• Clinical Performance vs. Substantial Equivalence: This submission is about comparing a modified device to an existing one, not about establishing novel clinical performance metrics with an AI/ML algorithm.
• No AI/ML Component: The device is a physical medical device (an endotracheal tube), not an AI/ML software device. Therefore, there are no "algorithms," "training sets," "test sets," "expert readers," or "ground truth" to evaluate in the context of an AI's diagnostic or predictive performance.
• Focus on Bench Testing and Biocompatibility: The "study" mentioned for this device is non-clinical performance testing (bench testing) and biocompatibility testing to ensure the new materials and design maintain the same safety and performance characteristics as the predicate device.

However, I can extract information relevant to the device's validation and the comparison made for substantial equivalence:

Device Name: Endotracheal Tube with Evacuation Lumen

Predicate Device: K110269-Well Lead Endotracheal Tube with Evacuation Lumen

Reason for New Submission: The only modification made is to the materials of the cuff, main tube, inflation tube, suction line, and pilot balloon, changing from PVC containing DEHP to DEHP-free PVC and PU.

1. Acceptance Criteria and Reported Device Performance (Non-Clinical/Bench Testing):

The acceptance criteria here are implicitly that the modified device performs as well as the predicate device and meets established safety/performance standards for endotracheal tubes. The study involved a series of bench tests and biocompatibility tests.

• Suction Line O.D. & Length
• Tensile Force Test (Inflating tube and tracheal tube)
• Tensile Force Test (Suction tube and the connector of suction tube)
• Negative Pressure Resistance of Suction Line
  Conclusion: "Bench-top testing was conducted to assure conformance to... standards" and "The test results demonstrated that the device meets the performance requirements for its intended use." (Implies meeting or being equivalent to predicate device performance). |
  | Biocompatibility | Performed in accordance with ISO 10993-1.
  Specific tests:
• Cytotoxicity
• Sensitization
• Irritation/Intracutaneous reactivity
• Acute systemic toxicity
• Subchronic systemic toxicity
• Genotoxicity
• Material-mediate pyrogenicity
• Implantation
  Conclusion: "Biocompatibility testing provided in this submission demonstrate that the modified Endotracheal Tube with Evacuation Lumen is as safe and effective and performs as well as the predicate device." |
  | Sterilization | Validation of Ethylene Oxide sterilization.
  Conclusion: "Sterilization by ethylene oxide has been validated for Endotracheal Tube with Evacuation Lumen." |
  | Risk Analysis | Performed according to ISO 14971 - Medical Devices Application of risk management to medical devices, using "Failure Mode and Effect Analysis" technique.
  Conclusion: "No new issues of safety and effectiveness were identified during this process." |

The following information is not applicable to this 510(k) submission for a physical medical device. These questions are typically asked for AI/ML-driven diagnostic devices.

2. Sample size used for the test set and the data provenance: Not applicable. This refers to physical device testing, not data analysis for AI.
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): Not applicable. No "ground truth" in this AI/ML sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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The device is intended for airway management by oral intubation and aid in the removal of subglottic secretions.

The proposed device, Endotracheal Tube is indicated for airway management and aid in the removal of subglottic secretions. The proposed device is available in ETT-X32 and ETT-X22 two types, the difference between these two types is that the ETT-X32 is provided with pressure indicator which is used to monitor intra-cuff pressure. Both two types are available in a series sizes from 6.0mm in an increment of 0.5mm. The proposed device is intended for adult, provided in sterile and single use.

The provided text describes the regulatory clearance of an Endotracheal Tube (K190274) and details some of the non-clinical tests performed to demonstrate its substantial equivalence to predicate devices. However, it does not contain information about a study that uses 'acceptance criteria' in the context of device performance against specific metrics like accuracy, sensitivity, or specificity, which are typically found in clinical effectiveness studies or standalone algorithm performance evaluations for AI/ML devices.

The document focuses on demonstrating substantial equivalence through non-clinical testing (physical, mechanical, chemical, biocompatibility, sterilization, and packaging) and comparison to predicate devices, rather than a clinical effectiveness study with defined performance acceptance criteria.

Therefore, the following points will be addressed based on the available information, noting where the requested information is not present in the provided document:

1. A table of acceptance criteria and the reported device performance

The document provides a list of non-clinical tests conducted and states that the test results "met all design specifications" or "comply with related standards requirements" or "can meet the requirements of ISO 10993 series standards." However, it does not explicitly list quantitative acceptance criteria for each test and then report a specific numerical performance result against that criterion. Instead, it broadly states compliance.

Here's an example of the closest information available, framed as acceptance criteria and performance based on the general statements:

regarding clinical efficacy or AI/ML performance, is not discussed.

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

The document primarily describes non-clinical bench testing. For these tests, specific sample sizes are not explicitly provided (e.g., how many tubes were tested for kink resistance or biocompatibility). Data provenance in a geographic sense is not applicable as these are laboratory tests rather than human subject data. The tests are prospective in the sense that they were conducted for the purpose of this submission.

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 question is not applicable as the document describes non-clinical engineering and biological safety testing, not clinical studies requiring expert ground truth for interpretation (e.g., image annotation for an AI device).

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

This question is not applicable for the same reasons as point 3.

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

This question is not applicable. The device is an Endotracheal Tube, not an AI/ML-powered diagnostic or assistive tool. No MRMC study was conducted or mentioned.

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

This question is not applicable as the device is not an algorithm.

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

For the non-clinical tests performed, the "ground truth" refers to the established international and national standards (e.g., ISO 5361, ISO 10993, ASTM standards, USP). Compliance with these standards serves as the "ground truth" for confirming the physical, mechanical, chemical, and biological safety and performance of the device.

8. The sample size for the training set

This question is not applicable as the device is not an AI/ML system requiring a training set.

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

This question is not applicable for the same reason as point 8.

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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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JEM Series Endotracheal Tube Changers provide a simple, rapid technique for changing endotracheal and orotracheal tubes, with specific inside diameters. JEM Series Endotracheal Tube Changers are intended for single patient use. This device is intended for sale by or on the order of a physician.

The JEM Series Endotracheal Tube Changer consists of an extruded open lumen, imprinted with graduated markings. The graduated markings are used as a guide for the successful replacement of a tracheal tube.

The provided text is a 510(k) Summary for JEM Endotracheal Tube Changers. It describes the device, its intended use, and the purpose of the 510(k) submission, which is to add ethylene oxide as an alternate sterilization method and to expand the user instructions.

However, the provided document does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria.

The document is a Special 510(k) submission, which means it addresses minor changes to a previously cleared device. In such a submission, the focus is typically on demonstrating that the changes do not alter the substantial equivalence of the device, rather than conducting new performance studies against acceptance criteria for the core functionality. The original PMS submission (Premarket Approval of the JEM 400 in 1981) would have contained such data, but it is not included in this document.

Therefore, I cannot provide the requested information from the given text.

Specifically, the document does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts or their qualifications for ground truth establishment.
4. Adjudication method.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Information about a standalone algorithm performance study.
7. The type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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

Tracheal Tube uncuffed (chart 1) and with cuffed (chart uncuffed of Tracheal Tube only make up of body and connector. Tracheal Tube with cuffed make up of body and connector、cuff、inflating tube、Pilot balloon、Valve。Tracheat tube with a radius of curvature.。 a line for x-radial through the body.。 All tubes have an angle of 38±10° . Length marks in centimeters measured from the patient end. The murphy eye on the side of the tube opposite the bevel. The tube machine end have the connector .It can connect the anesthesia machine or respiratory equipment. The inflating pilot balloon includes a valve fitting with a 6% (Luer) taper.

Each tracheal tube was contained in an individual pack . Sterilized by EOT. Single use only

The provided text does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) summary for a medical device (Endotracheal Tube) and primarily focuses on establishing substantial equivalence to a predicate device.

Specifically, the document states:

• "There are no new safety concerns when compared to the already available predicate devices. For these reasons, we feel the Chilecom Tracheal tube fulfills all criteria to be found substantially equivalent to the predicate devices and should be cleared for marketing." This indicates that the primary method of demonstrating safety and effectiveness is through comparison to existing device, rather than through a detailed performance study with acceptance criteria.
• "Performance Characteristics (If/when applicable) J. 1. See the Exhibits." However, the exhibits themselves are not provided in the given text.

Therefore, I cannot provide the requested information.

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