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The Gyrus ACMI Inc. PKS Omni Instrument is intended for electrosurgical coagulation, mechanical grasping, and dissection of tissue, and sealing of vessels up to 3mm, during the performance of laparoscopic and general (open) surgical procedures when used in conjunction with the Gyrus ACMI G400 workstation.

The PKS Omni Instrument is a single-use device with a classic laparoscopic so layout, with a 5mm shaft available in several lengths from 15 to 45cm, supporting symmetrically opening steel jaws. These are curved in a manner similar to Maryland forceps and other laparoscopic graspers, and contain bipolar electrosurgical elements that allow coagulation, cutting and vessel sealing. It is intended for use with the Gyrus ACMI G400 workstation

The provided text describes a 510(k) premarket notification for the Gyrus ACMI Inc. PKS Omni Instrument. This is for an electrosurgical device, and the information provided focuses on demonstrating substantial equivalence to predicate devices, rather than a clinical study with detailed performance metrics against acceptance criteria. Therefore, most of the requested information (acceptance criteria table, sample sizes, expert details, adjudication, MRMC study, standalone performance, ground truth types, training set details) is not available in the provided text.

Here's a summary of what can be extracted based on the nature of a 510(k) submission for this type of device:

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

This information is not provided in a traditional clinical study format. For electrosurgical devices, acceptance criteria are generally established through bench testing (e.g., burst pressure for vessel sealing, energy delivery consistency, mechanical strength, biocompatibility), and performance is demonstrated against these engineering specifications. The 510(k) summary focuses on "substantial equivalence" to predicate devices rather than direct clinical performance metrics.

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

Not applicable in the context of this 510(k) summary. This submission doesn't describe a clinical "test set" in the way one would for an AI/diagnostic device. Performance is typically established through bench validation, and for a 510(k), this involves comparing the new device's technical characteristics to those of predicate devices.

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

Not applicable. This device is not an AI/diagnostic tool requiring expert-established ground truth for a test set. Its safety and effectiveness are established through engineering and performance testing.

4. Adjudication method for the test set:

Not applicable.

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 is an electrosurgical instrument, not an AI-assisted diagnostic tool.

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

Not applicable.

7. The type of ground truth used:

For this type of device, "ground truth" would relate to validated engineering specifications and performance benchmarks (e.g., vessel sealing strength measured in ex vivo tissues, cutting efficiency, heat dissipation, biocompatibility testing results). The document does not detail these specific "ground truths."

8. The sample size for the training set:

Not applicable. This device is not an AI system that undergoes "training."

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

Not applicable.

Summary based on the provided document:

The 510(k) notification for the Gyrus ACMI Inc. PKS Omni Instrument focuses on demonstrating substantial equivalence to existing legally marketed predicate devices. This is a common pathway for medical devices that are similar in intended use, technological characteristics, and principles of operation to devices already on the market.

The key arguments for substantial equivalence are:

• Intended Use: The device is intended for electrosurgical coagulation, mechanical grasping and dissection of tissue, and sealing of vessels up to 3mm, in laparoscopic and general (open) surgical procedures, used with the Gyrus ACMI G400 workstation. This intended use is stated to be similar to the predicate devices.
• Technological Characteristics: The device is described as a single-use device with a classic laparoscopic layout, 5mm shaft, symmetrically opening steel jaws, and bipolar electrosurgical elements for coagulation, cutting, and vessel sealing. It utilizes Gyrus's PlasmaKinetic (PK) technology, relying on simultaneous contact of both active and return electrodes with tissue.
• Principles of Operation: The device induces cutting or coagulating/sealing tissue effects when the applicable generator mode is actuated, similar to its predicate devices.
• Materials: Constructed of similar materials as other Gyrus ACMI electrosurgical devices.

The document explicitly states: "The Gyrus ACMI Inc. PKS Omni Instrument, as described in this submission, is substantially equivalent to the predicates in intended use, principles of operation and fundamental scientific technology and raises no new issues of safety and effectiveness."

Predicate Devices cited:

• Gyrus Medical Inc. Zip Wing Cutting Dissector (K023493)
• Gyrus Medical Open Forceps (K024286)
• Gyrus Medical Plasma Seal (K061975)
• Gyrus Medical Plasmacision and Plasmablend Electrodes (K050460)
• Valleylab Ligasure Sealing System/ Ligasure V (K031011)
• Gyrus General Purpose Electrosurgical Generator (K050550)

The FDA's decision letter confirms that the device is "substantially equivalent" to the referenced predicate devices, allowing it to be marketed. This regulatory pathway does not typically involve the type of clinical performance studies with detailed acceptance criteria, sample sizes, and ground truth establishment that would be associated with novel diagnostic algorithms or AI devices. Performance is inferred through similarity to devices already proven safe and effective.

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