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The Gyrus ACMI PK® Button Electrode is a bipolar instrument intended for use in urological surgical procedures involving the ablation or removal of soft tissue and where associated hemostasis is required. The specific urological indication for the PK® Button is transurethral electrovaporization of the prostate (TUVP/TVP) for benign prostatic hypertrophy only. The PK® Button is not to be used to resect tissue.

The proposed PK® Button is a bipolar, sterile/disposable, vaporizing/coagulating electrode) that uses the same Gyrus ACMI PlasmaKinetic™ (PK®) SuperPulse® Generator and footswitch, as the predicate bipolar Plasma V vaporizing/coagulating electrode. The PK® Button is a Frônt Loading Urological Instrument Device (FLUID) that will be front loaded into the reusable Elite USA 1 and 2 resectoscope (cleared under K021166).

The provided text describes a 510(k) submission for the Gyrus ACMI PK® Button Electrode, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full clinical trial to establish novel acceptance criteria and prove its meeting through a statistical study.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not directly applicable or explicitly stated in the provided document, as a 510(k) typically relies on bench and animal testing for performance comparison, not large-scale clinical trials with defined acceptance criteria for a new clinical endpoint.

However, based on the information available, here's an attempt to answer as much as possible:

1. Table of Acceptance Criteria and Reported Device Performance

Formal, quantifiable acceptance criteria in the sense of a clinical trial's primary endpoint are not explicitly provided. Instead, the document states that the device's performance was evaluated against the "known tissue vaporization and coagulation performance characteristics of the predicate Plasma V and TURis Button electrodes." The "reported device performance" is that it met these requirements and exhibited comparable performance characteristics.

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

• Test Set Sample Size: Not specified. The document mentions "Bench and animal testing," but does not provide details on the number of samples, animals, or specific experimental runs.
• Data Provenance: The testing was conducted in a lab setting (bench testing) and on animals (animal testing). The country of origin for this data is not specified, but the manufacturer is based in the UK and the submitter in the USA. The testing would be prospective within the context of these specific experimental designs.

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

Not applicable/Not specified. For bench and animal testing comparing device characteristics, "ground truth" as established by experts in a clinical context (e.g., radiologists for imaging) is not relevant. Performance characteristics would be measured objectively (e.g., lesion size, coagulation depth) by qualified laboratory or animal study personnel, whose specific number and qualifications are not detailed here.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or clinical endpoints. For bench and animal testing of device performance characteristics, the results are typically quantitative and directly measured.

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 electrode and does not involve AI or human "readers" interpreting data. Therefore, an MRMC study is not relevant.

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

This question is geared towards AI/software devices. The PK® Button Electrode is a physical electrosurgical tool. Its primary performance is measured in a standalone fashion in bench and animal tests, meaning the device's inherent functional characteristics are evaluated directly, without human "interpretation" of its output in a diagnostic sense.

7. The Type of Ground Truth Used

The "ground truth" for the performance comparison was the "known tissue vaporization and coagulation performance characteristics" of the predicate devices (Plasma V and TURis Button electrodes). This would have been established through prior testing and understanding of those predicate devices. For the bench and animal tests of the PK® Button, the ground truth would be the measured physical effects on the tissue, such as depth of vaporization or coagulation, as determined by laboratory analysis (e.g., histology of treated tissue).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device. There is no "training set" in the context of developing this medical instrument.

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

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

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