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The CrossCountry™ Transbronchial Access Tool is to be utilized through a flexible endoscope with an extended working channel by physicians who are trained in endoscopic techniques to puncture the tracheobronchial wall and facilitate access of additional endobronchial tools for patients with endobronchial lesions, peripheral lung nodules, or lung masses.

The CrossCountry™ transbronchial access tool (CrossCountry Tool) is a flexible endobronchial tool made up of two components: a wire and a catheter. The wire is used inside of the catheter. The product is used through a flexible endoscope with an extended working channel. The CrossCountry tool is designed to puncture a hole in the tracheobronchial wall then, using the catheter to dilate the channel, allows for subsequent endoscopic tool placement. This allows for access to lesions without a bronchus sign (outside the airways). The product is packaged in a Tyvek™ pouch and sterilized with ethylene oxide.

The provided text describes a 510(k) premarket notification for the CrossCountry™ Transbronchial Access Tool. It includes information about the device's characteristics, comparison to predicate devices, and performance data from various tests, including an animal study. However, it does not explicitly state acceptance criteria in a quantitative or categorized manner, nor does it provide detailed numerical results for device performance against specific criteria.

Based on the available information, here's an attempt to answer your questions, with significant limitations due to the lack of specific numerical data for acceptance criteria and device performance:

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

The document mentions that an animal study was conducted and that "All of the acceptance criteria were met." However, it does not specify what those criteria were or provide quantitative results for how the device performed against them. Therefore, a table with specific criteria and performance cannot be created from the provided text.

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

• Sample Size for Test Set: The document mentions "A preclinical study was conducted using the CrossCountry access tool on one side of the lung and a control device on the opposite side of the lung." This implies a sample size of at least one animal, with the device tested on one side and a control on the other. The exact number of animals is not specified beyond "one" for the study description itself, though it could be interpreted as at least one animal was used with the device tested in one lung and a control in the other.
• Data Provenance: Not specified. It's an animal study, which is typically prospective in nature. The country of origin of the data is not mentioned.

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. The document discusses an animal study, not a study involving human experts establishing ground truth for imaging or clinical diagnosis. The "ground truth" in this context would likely be based on the physical outcome of the procedure in the animal model (e.g., successful puncture, dilation, and access).

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

Not applicable. This concept typically applies to human reader studies where there are disagreements in interpretation. For an animal study evaluating device function, adjudication methods like 2+1 or 3+1 are not relevant. The assessment of study outcomes would likely be performed by the researchers conducting the experiment.

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. This document does not mention an MRMC comparative effectiveness study, nor does it involve AI assistance. The device is a physical tool, not an AI diagnostic system.

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

Not applicable. This device is a physical medical instrument requiring human intervention, not an algorithm.

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

For the animal study, the "ground truth" would be outcomes data related to the device's mechanical function, such as:

• Successful puncture of the tracheobronchial wall.
• Successful dilation of the created channel.
• Ability to facilitate access for additional endobronchial tools.
• Absence of significant adverse events or damage in the animal model.

This is inferred from the statement "This study showed the CrossCountry access tool design meets its intended use."

8. The sample size for the training set

Not applicable. This is a medical device, not a machine learning model that requires a training set. The various verification and validation tests (Biocompatibility, Design, Animal Study) are for device performance and safety, not for training an algorithm.

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

Not applicable, as there is no training set for a machine learning model.

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