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The Empower RF Catheter is a single-use, electrosurgical device designed to be used with flexible bronchoscopes. It is indicated for electrosurgical procedures involving soft tissue obstructions in the upper airways and tracheobronchial tree.

The Empower RF Catheter is a sterile, single-use monopolar endoscopic device intended to be inserted through a flexible bronchoscope or a working channel of a flexible bronchoscope with an inner diameter of 2.0 mm. It has a stainless-steel electrode at the distal end, a flexible catheter shaft comprised of a nitinol wire covered by insulation tubing to prevent kinking and facilitate pushability during bronchoscopic procedures and a standard male banana plug at the proximal end. The banana plug connects to a monopolar connecting cable of a compatible electrosurgical unit. Empower is activated by a footswitch accessory supplied with the electrosurgical unit. Empower is provided in a monopolar configuration and thus, must be used in conjunction with a commercially available compatible patient return electrode to complete the return path for the RF electrical current.

The provided text describes a 510(k) premarket notification for the "Empower RF Catheter," an electrosurgical device. The document primarily focuses on demonstrating substantial equivalence to a predicate device, the "EC 2.7 Endoscopic Cutter (K120909)," through comparative analysis and performance testing.

It is important to note that this document does not describe a study involving an AI-based device or a multi-reader, multi-case (MRMC) study. Therefore, several of the requested sections related to AI performance, sample sizes for AI training/testing, ground truth establishment for AI, expert qualifications, and human reader performance improvement with AI assistance cannot be extracted from this text.

The acceptance criteria and performance data provided are for a medical device (an RF catheter), demonstrating its safety and effectiveness through well-established engineering and biological testing standards, rather than clinical efficacy studies or AI performance metrics.

Here's an analysis of the provided text based on the request, focusing on the information that is present:

Device: Empower RF Catheter (Electrosurgical Device)

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present acceptance criteria in a quantitative table format suitable for a direct "acceptance criteria vs. reported performance" comparison. Instead, it describes various tests performed to ensure the device meets design requirements and standards. The "performance data" section lists the types of tests conducted, implying that the device "meets" the requirements of these tests.

Therefore, a direct table of acceptance criteria and reported device performance as typically seen for AI device metrics (e.g., sensitivity, specificity thresholds) cannot be constructed from this document. The performance is demonstrated by compliance with the referenced standards and successful completion of the listed tests.

Note: The document only states that these tests were "performed" and that the results "demonstrate that Empower meets the defined design requirements and supports its safety and effectiveness." Specific quantitative results for each test (e.g., exact tensile strength values, specific electrical leakage currents) are not provided in this summary.

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

This document describes engineering and biological performance testing for a physical medical device, not a data-driven AI model. Therefore, the concept of a "test set" in the context of AI models (e.g., a set of medical images) does not apply here.

• Sample Size for Testing: The document does not specify exact sample sizes for each type of bench or biological test (e.g., how many catheters were subjected to tensile testing, or how many biological samples were used for biocompatibility). This information is typically found in detailed test protocols, not summary documents.
• Data Provenance: Not applicable in the context of a medical device's physical and biological performance testing. The "data" are generated from laboratory and bench tests.

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

Not applicable. This device is not an AI model requiring experts to establish ground truth for image interpretation or diagnosis. The "ground truth" for a physical device's performance is established by scientific and engineering standards and validated test methods.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" in the context of human interpretation or AI output requiring adjudication. Performance is measured against engineering and biological standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This document pertains to regulatory clearance for a physical medical device, not a diagnostic AI system or a system requiring human interpretation.

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

Not applicable. This device is a physical electrosurgical catheter, not an algorithm.

7. The Type of Ground Truth Used

For the performance testing of the Empower RF Catheter, the "ground truth" is based on:

• Compliance with recognized international and national standards: e.g., ISO 10993 series for biocompatibility, AAMI TIR 33, ISO 11137 series for sterilization, IEC 60601 series for electrical safety.
• Established engineering principles and test methodologies: For bench tests like tensile testing, dimensional inspection, corrosion resistance, and ex-vivo ablation.
• Defined design requirements: The document states that testing demonstrated the device "meets the defined design requirements."

8. The Sample Size for the Training Set

Not applicable. This is not an AI device.

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

Not applicable. This is not an AI device.

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