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The device is intended for Oral intubation and drainage of the subglottic space for airway management.

Well Lead Endotracheal Tube with Evacuation Lumen-Oral (6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0mm) The Well Lead Endotracheal Tube with Evacuation Lumen is sterile; single-use devices supplied with a standard 15mm connector. It is made of Polyvinylchloride. In addition to the main lumen, the tube has a separate lumen which has a dorsal opening above the cuff. Access to the lumen is accomplished via a clear connecting tube with a capped Luer connector. The tube incorporates a Magill curve, a tip with Murphy Eye and a radiopaque line to assist in radiographic visualization.

The provided text describes a 510(k) submission for a medical device, the "Well Lead Endotracheal Tube with Evacuation Lumen," and its substantial equivalence to predicate devices. However, this submission does not contain the kind of detailed study information (like a comparative effectiveness study with human readers, specific performance metrics, ground truth establishment, or sample sizes for training/test sets) that would be relevant for an AI/ML powered device.

The study described is a non-clinical performance evaluation against established standards for endotracheal tubes. Therefore, I cannot fully complete the requested table and information, as much of it pertains to AI/ML device evaluations which are not present in this document.

Here's what can be extracted and inferred from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable. This was a non-clinical performance test against engineering standards, not a study involving patient data or a "test set" in the AI/ML context. The submission doesn't specify the number of devices tested for each parameter.
• Data Provenance: Not applicable in the context of patient data. The non-clinical tests were conducted on the device itself.

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

• Not applicable. Ground truth, in the context of expert consensus, is not relevant for this type of non-clinical device testing, which focuses on adherence to engineering standards.

4. Adjudication method for the test set

• Not applicable. There was no need for adjudication as the testing involved objective measurements against established standard limits.

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, a MRMC comparative effectiveness study was not done. This device is an endotracheal tube, not an AI-powered diagnostic or assistive tool for human readers.

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

• Not applicable. This is not an algorithm-based device.

7. The type of ground truth used

• The "ground truth" for this submission was the established engineering and performance specifications defined by the EN1782:1998 and ISO 5361-1:1999 standards for endotracheal tubes. The device's physical and functional characteristics were measured and compared against these predefined limits.

8. The sample size for the training set

• Not applicable. There is no AI/ML component, so no training set was used.

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

• Not applicable. There is no AI/ML component, so no training set or its ground truth establishment is relevant.

Summary of the study that proves the device meets the acceptance criteria:

The study was a series of non-clinical performance tests conducted on the Well Lead Endotracheal Tube with Evacuation Lumen. These tests evaluated various physical and functional attributes of the device, such as surface finish, dimensions, connector integrity, cuff characteristics (herniation, resting diameter, inflation), tube curvature, bevel angle, and the security of the evacuation lumen construction.

The device was tested according to EN1782:1998 and ISO 5361-1:1999 standards. The results of all these tests reportedly fell within the required limits of the respective standards, thereby demonstrating the device's compliance and substantial equivalence to legally marketed predicate devices. This type of testing is standard for demonstrating the safety and performance of medical devices like endotracheal tubes, which are subject to specific material and functional requirements.

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

The tracheal tubes are made from medical grade PVC, with a connector and valve. The tracheal tubes may be cuffed or uncuffed and are for oral or nasal use.

The provided text is a 510(k) summary for an Endotracheal Tube, seeking clearance from the FDA. It does not describe specific acceptance criteria and a study proving the device meets those criteria in the way a medical device performance study typically would. Instead, it relies on substantial equivalence to predicate devices.

However, I can extract the information that is present and highlight what is missing based on your request.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a "test set" in the context of a formal performance study with a specific number of devices tested. The submission relies on conformance to an ISO standard and comparison to predicate devices, inferring that the design and manufacturing process meet these criteria. It doesn't detail a specific test sample size for an investigative study.
• Data Provenance: N/A for a specific test set. The submission itself is from China (Well Lead Medical Instruments Ltd, Guangzhou City, China). The basis for comparison is market-cleared predicate devices.

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

• N/A. This device clearance is based on substantial equivalence to predicate devices and conformance to an international standard (ISO 5361:1999(E)), not on a clinical or performance study requiring expert ground truth establishment for a test set. The FDA's review and clearance process involves their own experts, but not in the context of establishing ground truth for a specific device efficacy or diagnostic accuracy study.

4. Adjudication method for the test set

• N/A. No specific test set requiring adjudication in this context.

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

• N/A. This is a physical medical device (endotracheal tube), not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant here.

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

• N/A. This is a physical medical device, not an algorithm.

7. The type of ground truth used

• N/A. Not applicable for this type of device clearance. Instead of ground truth, the submission relies on:
  • Conformance to an International Standard: ISO 5361:1999(E)
  • Substantial Equivalence: Comparison to existing market-cleared predicate devices (Kendall - Pre-Amendment, RÜSCHELIT K961837, K993786, K961840, K931163, K93786).

8. The sample size for the training set

• N/A. Not applicable. There is no AI training set for this physical device.

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

• N/A. Not applicable. There is no AI training set for this physical device.

Summary based on the provided text:

The clearance for the Well Lead Endotracheal Tube (K042683) was based on demonstrating substantial equivalence to predicate devices and conformance to the ISO 5361:1999(E) standard for dimensions, design, material, sterility, and packaging. This is typical for Class II physical medical devices where a new clinical performance study is not required if the device is sufficiently similar to existing devices on the market. The text does not describe a clinical study with specific acceptance criteria, test sets, or ground truth establishment as would be expected for a novel diagnostic or therapeutic device requiring de novo authorization or a PMA.

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