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SafeAir Telescopic Smoke Pencil is designed for general electrosurgical applications, including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.

SafeAir Telescopic Smoke Pencil is designed for general electrosurgical applications and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.

SafeAir Telescopic Smoke Pencil has got telescopic function which allows to extend the length of pencil by up to 120 mm. Extension is possible after twisting the green lock-ring.

The provided document is a 510(k) premarket notification for a medical device (SafeAir Telescopic Smoke Pencil). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the typical sense of a clinical trial or algorithm validation.

Therefore, many of the requested pieces of information (acceptance criteria for a study, sample sizes for test/training sets, expert consensus for ground truth, MRMC studies, standalone performance of an algorithm) are not applicable to this type of regulatory submission, as it is primarily about demonstrating that a new device is as safe and effective as an already cleared device through non-clinical testing and comparison of characteristics.

The document emphasizes substantial equivalence to a predicate device (Stryker Neptune E-SEP Smoke Evacuation Pencil, K160693) through:

• Identical intended use.
• Similar technological characteristics.
• Non-clinical performance data (bench testing) to show it meets safety and performance standards.

Here's an attempt to address the points based on the provided document, noting where information is not available or not applicable:

Acceptance Criteria and Study for the SafeAir Telescopic Smoke Pencil

The provided document is a 510(k) Premarket Notification, which seeks to demonstrate "substantial equivalence" of a new device to a legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria through clinical or algorithmic studies. Therefore, many of the requested details related to clinical trials, multi-reader studies, AI algorithm performance, and ground truth establishment (as typically seen in diagnostic device submissions) are not present or applicable in this context. The "acceptance criteria" here are primarily about meeting established safety and performance standards for electrosurgical devices and demonstrating equivalence to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" are implied by the standards and characteristics that the SafeAir Telescopic Smoke Pencil must meet to be considered substantially equivalent and safe/effective. The "reported device performance" is the manufacturer's assertion and testing results confirming the device meets these standards and is comparable to the predicate.

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

• Sample Size: Not applicable in the context of typical test sets for algorithmic or diagnostic performance. The "testing" refers to bench testing of the device itself (e.g., electrical safety, sterility), not a dataset of patients or images. The document does not specify the number of units tested for each non-clinical performance test.
• Data Provenance: The testing was conducted internally by the manufacturer (LiNA Medical ApS) based on internal requirements and international standards. (Page 8) The manufacturing facility is in Poland. (Page 5)

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

• Not applicable. This is not a study requiring human expert interpretation of data (e.g., images for a diagnostic AI). The ground truth for device performance is established by a combination of engineering specifications, international standards (e.g., ISO, IEC, ASTM), and the expected performance of an electrosurgical device for its intended use.

4. Adjudication Method for the Test Set

• Not applicable. There is no "test set" in the sense of data requiring human adjudication.

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

• No. This is explicitly stated: "Based on the similarities in design, intended use and comparability in design verification results to the predicate device, human clinical testing was not required to establish substantial equivalence." (Page 8) This means no MRMC study was conducted.

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

• Not applicable. This device is a manual medical instrument (an electrosurgical pencil), not an algorithm or AI system.

7. The Type of Ground Truth Used

• The "ground truth" for the device's acceptable performance is defined by adherence to recognized national and international consensus standards (e.g., ISO, IEC, AAMI/ANSI, ASTM for biocompatibility, electrical safety, sterilization, packaging, etc.), as well as its functional equivalence to a legally marketed predicate device. This is a demonstration of engineering validation and comparison, not clinical outcomes or expert consensus on clinical data.

8. The Sample Size for the Training Set

• Not applicable. There is no training set as this is not an AI/ML device.

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

• Not applicable.

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