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The sOLVe Tube™ is used to isolate the left or the right lung of a patient for surgery, one lung ventilation or one lung anesthesia.

The Simple One Lung Ventilation for Everyone (sOLVe) Tube is a single use dual lumen endobronchial tube (DLT) intended for lung isolation and for lung ventilation by healthcare professionals (HCP) in hospitals. The sOLVe Tube can function as both a left-sided and a rightsided DLT. The distal tip of the tube will fit in either the left or right mainstem bronchus. The sOLVe Tube is packaged and provided to the HCP as a kit. The kit includes the following components: 1. sOLVe Tube with pre-installed pliable aluminum 10Fr intubation stylet 2. Dual Bronchoscopy Swivel adapter with integrated safety clamp 3. Haider TubeGuard endotracheal tube holder/bite block with strap 4. Soft suction catheters 5. Two syringes (3 mL and 10 mL)

The provided text is a 510(k) summary for the sOLVe Tube™, a medical device intended for lung isolation and ventilation. The document describes the device, its intended use, comparison to a predicate device, and a summary of non-clinical testing. However, it does not contain specific acceptance criteria, reported device performance metrics against those criteria, details about sample sizes for test or training sets, data provenance, expert qualifications, adjudication methods, or results from MRMC or standalone studies.

Therefore, I cannot fully answer your request with the information provided. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench and animal testing, rather than reporting quantitative performance metrics against pre-defined acceptance criteria.

Based on the available information, here is what can be extracted and what is missing:

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

• Information Provided: The document lists several performance tests conducted (e.g., Determination of Cuff Diameter, Resistance to Cuff Tube Collapse, Cuff Compliance Leak Test, Bronchoscope Insertion Test, Ease of Insertion in animal model, Performance of tracheal/bronchial balloon, Success of lung isolation and one lung ventilation).
• Missing: Specific quantitative acceptance criteria for each of these tests are not provided. The document only states that "The results of these tests support the substantial equivalence of the sOLVe Tube to the predicate device," implying that the device met some internal or industry-standard criteria, but these criteria and the exact results are not detailed.

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

• Information Provided: The document mentions "Cadaver Trial to test the Universal Design" and "Performance Testing (Animal)."
• Missing: The specific sample sizes for these tests (e.g., number of cadavers, number of animals) are not provided. Data provenance (country of origin, retrospective/prospective) is also not provided.

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)

• Missing: This information is not provided as the studies appear to be primarily non-clinical (bench and animal testing). There is no mention of human experts establishing "ground truth" in the context of diagnostic performance.

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

• Missing: This information is not provided as it relates to expert review of data, which is not described for the non-clinical tests.

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

• Missing: This is inapplicable. The described device is an endobronchial tube, not an AI software/diagnostic tool that would involve human "readers" or an "AI assistance" component.

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

• Missing: This is inapplicable. The described device is an endobronchial tube, not an algorithm.

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

• Information Provided: For bench tests, the "ground truth" would be the direct measurement against the test standard (e.g., ISO specifications). For animal trials, it would be direct observation of "Ease of Insertion," "Performance of the Tracheal and Bronchial Balloon," and "Success of Lung Isolation and One Lung Ventilation."
• Missing: Specific details on how success was quantified or measured consistently are not provided.

8. The sample size for the training set

• Missing: Not applicable. The device is a physical medical device, not a machine learning model that requires a training set.

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

• Missing: Not applicable for the same reason as above.

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