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The Yield Tissue Sampler is indicated for use in aspiration in carinal, paratracheal and hilar lesions of the bronchial tree where biopsy forceps cannot obtain a submucosal sample.

This premarket notification covers Broncus' Yield Tissue Sampler. The Yield Tissue Sampler is a transbronchial aspiration needle used for transbronchial retrieval of tissue samples. It is compatible with flexible 2-mm working channel bronchoscopes and is available in two sizes, 18 and 21 gauge.

The provided text describes a 510(k) premarket notification for the Broncus Technologies, Inc. Yield™ Tissue Sampler. The document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study proving the device meets specific acceptance criteria related to AI or algorithm performance. Therefore, many of the requested categories are not applicable.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only states that the device "passed pre-established acceptance criteria" for strength and aspiration, and that "all items tested were within specification tolerances" for dimensional testing. Specific numerical values for acceptance criteria or performance are not provided.

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

• Not applicable. This document describes performance testing for a medical device (transbronchial aspiration needle), not a study involving a test set of data for an AI algorithm. The performance tests mentioned (dimensional, strength, aspiration, biocompatibility) are laboratory-based and device-specific, not data-driven in the context of 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. As above, this is not an AI algorithm study requiring expert-established ground truth.

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. This device is a physical medical instrument, not an AI system designed to assist human readers or perform diagnostic tasks.

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. For the physical device testing, "ground truth" would equate to established engineering standards, material properties, and manufacturing specifications.

8. The sample size for the training set:

• Not applicable. There is no AI training set mentioned or implied for this physical device.

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

• Not applicable. There is no AI training set.

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