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The Well lead Tracheostomy Tubes and Disposable Inner Cannula is a single patient disposable tracheostomy tube for airway management of tracheostomotized patients.

The Well lead Tracheostomy Tubes and Disposable Inner Cannula includes an outer cannula, disposable inner cannula, introducer, neck strap and obturator. The disposable inner cannula acts as a removable liner for the outer tube; it can be withdrawn and changed after the airway has been cleaned, such as phlegm suction. The disposable inner cannula facilitates the airway management to make it easy to clean and prolong the use of the device. The device is used to provide an artificial airway in order to provide access to the patient's airway for airway management. The device is introduced into a tracheotomy incision in the patient's neck that provides access to the trachea. The tracheostomy tube is secured by the means of the swivel neck plate/flange. When appropriately connected the device provides a secure artificial airway for spontaneous or mechanical ventilation.

The provided text describes a 510(k) summary for the Well Lead Tracheostomy Tubes and Disposable Inner Cannula. It focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria for a new, innovative device.

Instead, the submission demonstrates that the new device has the same intended use and similar technological characteristics as the predicate device (K042684). Therefore, the "acceptance criteria" here refer to demonstrating this equivalence through adherence to relevant standards and a comparative analysis of features.

Here's a breakdown based on the provided text, addressing your questions where possible:

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

For this specific submission, the "acceptance criteria" are not quantitative performance metrics but rather qualitative conformity to established standards and similarity to a predicate device.

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

This document describes a substantial equivalence submission, not a clinical performance study with a test set of patient data. The "testing" mentioned refers to engineering and quality assurance tests demonstrating conformity to ISO standards, not tests on a clinical population. Therefore, there is no sample size for a test set or data provenance in terms of patient data.

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. This is not a study requiring expert readers to establish a ground truth for a test set. The evaluation is based on technical specifications and comparison to a predicate device.

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

Not applicable. As there is no test set in the clinical sense, there is no adjudication method.

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. This is not a study involving AI or human readers for diagnostic interpretation.

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

Not applicable. This device is a medical instrument (tracheostomy tube), not an algorithm or AI-powered system.

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

Not applicable. The "ground truth" here is the established safety and effectiveness of the existing predicate device and the accepted international standards for such devices. The new device demonstrates conformance to these standards and equivalence to the predicate.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-driven device requiring a training set.

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

Not applicable. See point 8.

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The device is a single patient disposable tracheostomy tube for airway management of tracheostomotized patients.

The tracheostomy tubes are made from the raw material of PVC for medical use, with the The trachetoney wave. The tracheostomy tubes have such good performances as the tube with appropriate hardness, the cuff with big capacity and low pressure, smooth tube and excellent biocompatibility.

The provided document is a 510(k) summary for the Well Lead Tracheostomy Tubes, which was cleared in 2005. It describes the device, its intended use, and its equivalence to a predicate device.

However, the document does not contain the detailed study information typically associated with establishing acceptance criteria and proving device performance through a clinical or performance study involving human readers or algorithmic standalone performance. This type of submission (510(k)) focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive new clinical studies for safety and effectiveness.

Here’s a breakdown of the information requested, based on the provided text, and where gaps exist:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not applicable / Not provided. This submission does not describe a clinical performance study with a test set of data. The performance claims are based on conformance to international standards (ISO 5366-1 and ISO 5366-3) and comparison to a predicate device.

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

• Not applicable / Not provided. See above. Ground truth, in the context of clinical studies for AI/algorithms, is not relevant to this type of device submission which focuses on physical and material specifications.

4. Adjudication method for the test set

• Not applicable / Not provided. See above.

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 / Not provided. This device is a physical medical instrument (tracheostomy tube), not an AI/software-as-a-medical-device (SaMD) that would assist human readers or perform diagnostic interpretations.

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

• Not applicable / Not provided. This device is a physical medical instrument.

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

• Not applicable / Not provided. For this type of device, "ground truth" would relate to its physical and material properties meeting specified engineering and biocompatibility standards rather than diagnostic accuracy. The provided text indicates conformance to ISO standards and biocompatibility.

8. The sample size for the training set

• Not applicable / Not provided. This submission does not involve an AI algorithm with a training set.

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

• Not applicable / Not provided. This submission does not involve an AI algorithm.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is primarily an engineering and materials conformance study against established international standards and comparison to a predicate device, rather than a clinical trial or an AI performance study.

The document states:
"The dimension, design, material, sterility and packaging of Well Lead tracheostomy tubes are conformed with ISO 5366-1 and ISO 5366-3."
Additionally, claims are made about "good performances as the tube with appropriate hardness, the cuff with big capacity and low pressure, smooth tube and excellent biocompatibility."
Finally, "The device has the same dimensions and design as the predicate device (Section 9)."

This implies that the manufacturer conducted internal testing and verification to ensure their device met the physical, material, and performance specifications outlined in the ISO standards and matched the predicate device’s characteristics. The FDA's 510(k) clearance is a determination of "substantial equivalence" based on this documentation, verifying that the new device is as safe and effective as a legally marketed predicate device.

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