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The BroncTru Transbronchial Access Tool is indicated for use in conjunction with a flexible bronchoscope to puncture the lung, dilate, and establish a working channel, facilitating the guidance of other endoscopic tools to reach target lesions.

The BroncTru Transbronchial Access Tool is a single-use sterile disposable catheter made up of four (4) components:

• i) Needle - used for puncturing of the transbronchial wall.
• ii) Dilator - the long-tapered tip dilator is used to dilate the opening in the transbronchial wall created by the needle. It also provides protection around the sharp needle tip during vascular access.
• iii) Sheath - the sheath inserted into the dilated tracheobronchial wall, provides a port through which a variety of endoscopic tools can be inserted.
• iv) Handle - The handle is operated by the operator to advance and to pull the dilator out leaving only the sheath to guide other devices to the target.

The BroncTru Transbronchial Access Tool is designed to puncture the tracheobronchial wall, the long-tapered tip of the dilator acts to stretch the opening in the tracheobronchial wall to allow for the insertion of the larger sheath. The dilator is then removed, leaving only the sheath inserted into the tracheobronchial wall, providing a channel which allows for subsequent endoscopic tool placement. This allows for access to lesions without a bronchus sign (outside the airways).

The BroncTru Transbronchial Access Tool is a medical device, and the provided document is an FDA 510(k) premarket notification. This document focuses on demonstrating substantial equivalence to a predicate device rather than fulfilling specific performance acceptance criteria for an AI/CADe device.

Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI performance metrics (like sensitivity, specificity, or MRMC studies) is not applicable to this device and the provided document. The device is a physical tool, not an AI, CADe, or image-processing software.

The document primarily discusses the device's physical characteristics, intended use, and various non-clinical performance data to demonstrate that it is as safe and effective as a legally marketed predicate device.

However, I can extract information related to the device's physical performance testing:

Summary of Performance Data for the BroncTru Transbronchial Access Tool (Not AI-related)

The performance data provided supports the substantial equivalence determination by demonstrating the device's physical and functional properties, and its safety, compared to predicate devices.

1. Acceptance Criteria and Reported Device Performance (Non-AI)

The document lists various performance tests conducted, with results indicating "Pass," meaning the device met the established criteria for each test. Specific numerical acceptance criteria are not detailed in the summary, but the "Pass" result indicates compliance.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified in the provided summary for bench/biocompatibility tests. These are typically laboratory tests performed on a defined number of device units.
• Data Provenance: The tests are described as having been conducted "in accordance with" various international and FDA-recognized standards. This implies controlled laboratory settings rather than clinical data from specific countries or retrospective/prospective studies.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable: For a physical device and the types of tests described (biocompatibility, sterilization, bench testing), "experts to establish ground truth" in the context of image interpretation or clinical diagnosis are not relevant. These tests rely on standardized protocols and measurements.

4. Adjudication Method for the Test Set

• Not Applicable: Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in human expert interpretations, typically in clinical studies or expert consensus for ground truth. This is not relevant for the engineering and safety tests described here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not Applicable: An MRMC study is designed to evaluate how human reader performance changes with or without AI assistance, or to compare different AI systems. As this is a physical medical tool, such a study is not relevant. The document explicitly states: "No clinical study was performed to demonstrate substantial equivalence."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not Applicable: This device is a physical tool, not an algorithm or software. Therefore, there is no AI or algorithm-only performance to study.

7. Type of Ground Truth Used

• Not Applicable in the AI/Clinical Sense: For the types of tests performed, "ground truth" refers to the established scientific and engineering principles, material properties, and performance specifications defined by the relevant standards (e.g., ISO, ASTM, USP). The device is tested against these defined physical and chemical properties.

8. Sample Size for the Training Set

• Not Applicable: This is a physical device, not an AI model. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

• Not Applicable: As above, this is not an AI model, so there is no training set or its associated ground truth establishment.

In conclusion, the provided FDA 510(k) summary for the BroncTru Transbronchial Access Tool details the non-clinical and non-AI-related performance testing conducted to demonstrate its substantial equivalence to a predicate device. The information requested regarding AI/CADe acceptance criteria and studies is not relevant to this type of medical device submission.

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