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The Bipolar Generator section of the G3 RF Workstation and accessories are indicated for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (Head and Neck) surgery including:
• Adenoidectomy
• Cysts
• Head, Neck, Oral, and Sinus Surgery
• Mastoidectomy
• Myringotomy with effective Hemorrhage Control
• Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates
• Nasopharyngeal / Laryngeal indications including Tracheal Procedures, Laryngeal Polypectomy, and Laryngeal Lesion Debulking
• Neck Dissection (Radical and Modified Neck Dissection)
• Neck Mass
• Papilloma Keloids
• Submucosal Palatal Shrinkage
• Tonsillectomy
• Traditional Uvulopalatoplasty (RAUP)
• Tumors
• Tissue in the Uvula/Soft Palate for the Treatment of Snoring
• Uvulopalatopharyngoplasty (UPPP)
• Parotidectomy

The Gyrus ACMI Dissector Plasma Knife is indicated for resection and coagulation of soft tissue and hemostasis of blood vessels in head and neck surgery including Neck Dissection, (Radical and Modified Neck Dissection), Tonsillectomy, Parotidectorny and UPPP when used with the bipolar generator section of the G3 Workstation.

The Gyrus ACMI® G3 Generator is an electrosurgical generator containing five key components: A dual output electrosurgical generator; Monopolar output side Bipolar output side Disposables; Monopolar electrodes (TCRF) Bipolar PlasmaCision Electrodes -Connector Cables Monopolar return pad; and Footswitch.

The Gyrus G3 System Generator has two principal modes of operation dependant on which type of electrode is attached - The monopolar mode has controls for maximum temperature and has readouts for total energy delivered, impedance, temperature and time of energy delivery. - The bipolar mode has controls for output for two thermocouples and power. The unit has readouts for set power and waveform type and power. Connectors on the front panel include a monopolar connector for active electrode and dispersive electrode and connectors for PlasmaCision electrodes and bipolar instruments. The device is operated by a foot pedal, connected on the back panel.

The Dissector Plasma Knife is a single use disposable bipolar instrument designed for use with the G3 generator within an ambient air environment. The instrument incorporates a suction channel which the SS generates which of fluids and gases during operative procedures when connected to an appropriate suction facility.

The provided text is a 510(k) summary for the Gyrus ACMI G3 Generator and Accessories - Dissector Plasma Knife. It describes the device, its intended uses, and claims substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria or specific studies proving the device meets acceptance criteria in the way typically expected for performance claims (e.g., sensitivity, specificity, accuracy, or functional metrics with numeric thresholds).

Instead, this document focuses on substantial equivalence to an existing predicate device (Gyrus ACMI G3 Generator and Accessories - Dissector Plasma Knife K041285). The core argument is that "The Gyrus ACMI® G3 Generator and Accessories - Dissector Plasma Knife are identical to the identical features of the predicate. There are no changes to the design of the generator or instrument pursuant to this submission. Therefore In summary, the Gyrus ACMI is substantially equivalent to the predicate device and presents no new questions of safety or efficacy."

Therefore, for your request, I must conclude that the provided text does not offer the detailed information you are seeking regarding acceptance criteria and performance studies.

Here's a breakdown of why this information is missing based on your template:

1. Table of acceptance criteria and reported device performance:

• Missing. The document claims identity to a predicate device, implying that its performance is implicitly accepted as equivalent to the predicate. No specific performance metrics or acceptance criteria are stated.

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

• Missing. No new testing or clinical data is presented for this 510(k) submission, as it relies on substantial equivalence to a previous device.

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

• Missing. Not applicable, as no new test set or ground truth establishment is described.

4. Adjudication method for the test set:

• Missing. Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• Missing. Not applicable. This device is an electrosurgical tool, not an AI-assisted diagnostic or interpretive device.

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

• Missing. Not applicable. This is not an algorithmic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Missing. Not applicable.

8. The sample size for the training set:

• Missing. Not applicable.

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

• Missing. Not applicable.

In summary: The provided 510(k) notification states the new device is substantially equivalent to a previously cleared predicate device because there are "no changes to the design of the generator or instrument." This type of submission relies on the prior clearance of the predicate device and does not typically require new performance studies or the establishment of new acceptance criteria for the current submission when the device is identical.

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