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The Gyrus ACMI General Surgery Workstation is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in surgery.
The generator is indicated for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in surgery.

The currently marketed Gyrus ACMI General Surgery Workstation is a bipolar RF generator that accepts a variety of disposable hand pieces that utilize a PlasmaKinetic (PK) or PlasmaCision (PC) waveform. The generator face includes two sockets that allow a range of hand pieces to be utilized in a dry field environment, although only one socket may be active at any given time.
The Gyrus ACMI General Surgery Workstation General Purpose Electrosurgical Generator employs a system of automatic instrument detection, through a resistor located in the hand piece connector plug. This ensures that only the allowable range of waveform output and power level can only be applied to the instrument irrespective of the output socket. Accessories presently provided with the Gyrus ACMI General Surgery Workstation include a power cable and a foot switch. It should be noted that this footswitch is also used with the Gyrus ACMI SuperPulse generator (cleared under K031085).
This Special 510(k) proposes the addition of a new optional accessory, the Dual Footswitch Connector Cable. The Dual Footswitch Connector Cable allows for easier use of the Gyrus ACMI General Surgery Workstation when multiple surgeons are present. This is achieved by allowing the connection and use of two footswitches on the same generator. The indications for use, principles of operation, energy waveform outputs, and accessories of the Gyrus ACMI General Surgery Workstation with the Dual Footswitch Connector Cable accessory remain the same as the currently marketed Gyrus ACMI General Surgery Workstation.

The provided text is a 510(k) summary for the Gyrus ACMI General Surgery Workstation. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device. However, it does not contain information about:

• Specific acceptance criteria in a quantitative or qualitative table format.
• A study designed to "prove" the device meets acceptance criteria, beyond the claim of substantial equivalence.
• Sample sizes for test sets or training sets.
• Data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or types of ground truth.

The document primarily focuses on regulatory approval based on equivalence, not on a detailed performance study with specific metrics. Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred and explicitly stated:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission is a Special 510(k) for an accessory, focusing on substantial equivalence rather than a new clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.

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
This information is not provided in the document. This device is an electrosurgical workstation, not an AI or imaging device, so an MRMC study would not be relevant in this context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document. This is not an algorithm-only device. The submission is for a physical medical device and an accessory.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not provided in the document. Given this is a 510(k) for an electrosurgical device accessory, the "truth" is typically established through engineering bench testing and comparison to the predicate device's established performance, rather than clinical ground truth as might be seen for diagnostic devices.

8. The sample size for the training set
This information is not provided in the document.

9. How the ground truth for the training set was established
This information is not provided in the document.

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