The Telescoping PenEvac is intended to be used as the active monopolar electrosurgery generator system and to facilitate the removal of smoke that is generated during the procedure.

The Telessoping PenEvac is a combination of an electrosurgery switching handpiece and a smoke evacuation shroud with a telescoping tip that allows the surgeon to adjust the tip length. It includes pushbutton switches to allow the surgeon to select "cut" or "coagulation" operating modes on typical electrosurgery generators.

The device will be marketed in two versions:
As a complete single use sterile product.
As a partially reusable product with the PenEvac body and electrosurgery cord being reusable and the remainder of the device as a sterile single use product.

Electrodes of various lengths and shapes will be available.

This 510(k) summary for the I.C. Medical Telescoping PenEvac does not contain the level of detail typically found in a study demonstrating device performance against specific acceptance criteria. This document is a summary primarily focused on establishing substantial equivalence to predicate devices, rather than a detailed report of performance testing with specified acceptance criteria and outcomes.

Therefore, for your request, I will have to extract what information is present regarding testing and make inferences about "acceptance criteria" where they are not explicitly stated as numerical targets.

Here's the breakdown of the information based on your request:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

This 510(k) submission details modifications to an existing device (Telescoping PenEvac) and claims substantial equivalence to predicate devices. The "studies" described are primarily non-clinical bench tests and material compatibility tests, not clinical studies with human participants. The acceptance criteria are largely inferred from the statement of equivalence to predicate devices and compliance with industry standards.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not explicitly stated with a specific number for each test. The document refers to "samples of all proposed tip materials" for flammability and "the prototype devices" for ANSI/AAMI compliance. For the bench testing of functionality, it mentions "a number of different electrosurgery generators," implying multiple tests but not a precise count of devices or test runs.
• Data Provenance: The tests appear to be retrospective in the sense that they were conducted internally by I.C. Medical, the Chief Engineer, and/or the manufacturer of components, to support the 510(k) submission. There is no mention of external labs or country of origin other than the submitter's address in Glendale, AZ, USA. These are non-clinical tests, so there's no patient data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Experts: The "Chief Engineer and/or the manufacturer of the cable/connector/switches" are mentioned as having tested the prototype devices for compliance with ANSI/AAMI HF-18.
• Qualifications: "Chief Engineer" implies relevant engineering expertise in electrosurgical devices. The manufacturer of components would also possess expertise related to their specific parts. No further specific qualifications (e.g., years of experience, certifications) are provided.

There is no mention of clinical experts (like radiologists) as these are non-clinical, bench and material tests.

4. Adjudication method for the test set

• Adjudication Method: Not applicable or explicitly stated as there is no mention of multiple raters or consensus-building processes for these types of non-clinical tests. The tests involve direct measurement, observation of functionality, and material testing, rather than subjective interpretations requiring adjudication.

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

• MRMC Study: No. This device is an electrosurgical pencil and smoke evacuation system, not an AI-based diagnostic tool. Therefore, an MRMC study and discussions of AI assistance are not relevant to this 510(k) submission.

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

• Standalone Performance: Not applicable. This is a physical medical device, not an algorithm or AI system. Its performance is inherent to its design and materials, and evaluated through bench testing simulating use conditions, not through an algorithm's standalone output.

7. The type of ground truth used

• Ground Truth: The "ground truth" for these tests is implicitly defined by:
  • Predicate Device Performance: The functional behavior and material properties of the legally marketed predicate devices (I.C. Medical ESU Shroud, Valleylab Disposable/Reusable Handswitching Pencils) serve as a comparative ground truth.
  • Industry Standards: Compliance with "applicable portions of ANSI/AAMI HF-18: 1993 Electrosurgical Device standard" represents a defined ground truth for electrical safety and performance.
  • Material Certifications: "USP Class VI certified" is a specific industry standard for biocompatibility, acting as a ground truth.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This submission concerns a physical medical device, not an AI/machine learning model that requires a training set.

9. How the ground truth for the training set was established

• Ground Truth for Training Set Establishment: Not applicable, as there is no training set for an AI/machine learning model.

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