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The EasyPath RF Introducer Sheath is a single-use device intended to be used with flexible bronchoscopes as a working channel through which endoscopic tools may be introduced to target tissue. It is indicated for electrosurgical procedures involving cutting and coagulation of soft tissue in the upper airways and tracheobronchial tree.

The EasyPath RF Introducer Sheath is a sterile, single-use, monopolar endoscopic device intended to be inserted through the working channel of a flexible bronchoscope, with an inner diameter (ID) of 2.8 mm or greater, which provides an extended working channel through which endoscopic tools, such as needles, biopsy forceps, or other endoscopic devices may be introduced to target sites. Similar to Empower RF Catheter, the EasyPath incorporates a distal electrode for delivering RF energy for cutting and coagulation of soft tissue in the upper airways and tracheobronchial tree. The monopolar electrode at the distal tip facilitates cutting the target tissue using controlled monopolar radiofrequency (RF) energy.

The EasyPath has a flexible shaft with a 2.65 mm OD with braid reinforced tubing and a stylet, to resist kinking during device advancement and articulation. The stylet is used to provide an atraumatic tip and to provide rigidity (i.e., pushability). Removal of the stylet allows for standard 2.0 mm working channel bronchoscopic accessories to be inserted through the lumen of the sheath. The electrode tip of the sheath is visible, as well as the marker bands to provide the user with an indication of movement relative to the bronchoscope. Radiopaque markers are at the distal end of the sheath to aid visualization of the sheath under fluoroscopy, if utilized.

The provided document is a 510(k) Pre-Market Notification for the Broncus Medical EasyPath RF Introducer Sheath. It describes the device, its intended use, comparison to predicate devices, and performance data to demonstrate substantial equivalence.

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" against "reported device performance" in a quantitative manner as typically seen for AI/software devices. Instead, it lists the types of testing performed to demonstrate that the device meets product specifications and is "safe and effective for its intended clinical use." The "reported device performance" is essentially that the device met the specifications for each test, thereby supporting substantial equivalence.

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

The document describes various engineering and biological tests, not a clinical study with a "test set" of patient data in the context of AI performance.

• Sample Sizes: Not specified for individual bench or in vivo tests. However, typical regulatory submissions for devices like this involve a sufficient number of samples to ensure statistical significance for each test.
• Data Provenance (Country of Origin, Retrospective/Prospective): Not applicable in the context of this device type. The tests are laboratory-based (bench, in vitro, in vivo animal model) and conducted by the manufacturer or contracted labs as part of the design verification process. The in vivo testing was conducted on porcine lungs.

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

This information is not applicable to this device type. There is no "ground truth" to be established by human experts in a diagnostic sense for this electrosurgical introducer sheath. The "ground truth" for its performance is determined by meeting engineering specifications and safety standards through the described testing.

4. Adjudication Method for the Test Set

Not applicable. There is no concept of a "test set" requiring adjudication by human readers for this device.

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

No. This is not an AI device or a diagnostic device that would typically undergo an MRMC study.

6. Standalone (Algorithm Only) Performance Study

No. This is a physical medical device (introducer sheath) with an electrosurgical function, not a standalone algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's safety and effectiveness is established through:

• Engineering Specifications: The device's physical dimensions, material properties, electrical characteristics, and functional performance must meet predefined design specifications.
• Regulatory Standards: Compliance with recognized international and national standards (e.g., ISO, IEC, ASTM) for biocompatibility, sterilization, electrical safety, and packaging.
• Bench Test Results: Direct measurement and observation of device performance under controlled laboratory conditions.
• In-vivo Animal Model Data: Functional and thermal effects demonstrated in living biological tissue (porcine lung).

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device. There is no concept of a "training set" for this type of medical device submission.

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

Not applicable, as there is no "training set."

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