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The Telescoping PenEvac ABC is intended to be used only during open surgical procedures as the active handpiece in a combination argon beam coagulator/electrosurgery generator system that uses monopolar electrodes and to facilitate the removal of smoke that is generated.

The Telescoping PenEvac ABC is a combination of an argon beam coagulator pencil and an electrosurgery switching handpiece with a smoke evacuation shroud. It is intended to be used with argon beam generators that include electrosurgery capabilities. The device has push button switches to allow the surgeon to select CUT, COAG, or ARGON functions on the generator. An ARGON ASSIST mode can be selected by sliding the tip of the ABC Telescoping Tip back to expose the monopolar electrode. The device consists of three major components: PenEvac Body, ABC Adapter, and ABC Telescoping Tip. The PenEvac Body contains the pushbutton switches and ESU cord and connector. The ABC Adapter fits into the rear of the PenEvac Body and contains flexible tubing, generator connector, electrical conductor, and a rigid metal tube that fits into the PenEvac Body. The ABC Telescoping Tip is used during open surgical procedures. The tip may be extended or shortened as desired. It also has a sliding tip that can expose, or conceal, the electrode during argon procedures.

This document is a 510(k) summary for a medical device called the "Telescoping PenEvac ABC". It aims to demonstrate that this new device is substantially equivalent to existing, legally marketed predicate devices.

Let's break down the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, there are no explicitly stated numerical "acceptance criteria" or detailed quantitative "reported device performance" metrics in the way one might expect for a clinical study with quantifiable endpoints (e.g., sensitivity, specificity, accuracy).

Instead, the summary focuses on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics and non-clinical testing. The "acceptance criteria" here are implicitly that the new device functions "the same" as or "comparably" to the predicate devices and does not introduce new safety or effectiveness concerns.

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

• Sample Size for Test Set: Not explicitly stated numerically. The text refers to "Samples of all proposed tip materials" for flammability testing and "a number of different electrosurgery generators and an argon beam coagulator" for bench testing. This suggests a small, representative sample of materials and equipment rather than a statistically powered clinical trial sample.
• Data Provenance: The testing was "bench tested" and "nonclinical." This means the data was generated in a laboratory or engineering environment, not from human subjects. The country of origin is not specified, but the submission is to the FDA (United States). The testing is prospective for this specific device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This type of information is not applicable to this 510(k) summary. The testing described is non-clinical bench testing, not clinical studies involving expert interpretation of medical images or patient outcomes. The "ground truth" for these engineering tests would be derived from physical measurements against established engineering standards or direct comparison to the functional performance of predicate devices. The "Chief Engineer" is mentioned as overseeing some tests, implying engineering expertise.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable to this type of non-clinical bench testing. Adjudication methods are typically used in clinical studies when multiple human observers evaluate data and their interpretations need to be reconciled.

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 an electrosurgical handpiece, not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies and "improvement with AI" are not relevant here.

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

Not applicable. This device is a physical surgical instrument, not an algorithm. Its function inherently involves a human operator (the surgeon).

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests described:

• Flammability: Ground truth is based on physical flammability characteristics and established safety standards.
• Functional Performance (smoke evacuation, electrocautery, argon beam coagulation): Ground truth is the observed functional output compared to the specifications and performance of the legally marketed predicate devices. This is a direct comparison to known, accepted performance.
• Electrical/Cable Compliance: Ground truth is established by adherence to the ANSI/AAMI HF-18: 1993 Electrosurgical Device standard.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not a machine learning model, so there is no concept of a "training set" in the context of its development and testing.

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

Not applicable, as there is no training set for this device.

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