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The ETHICON™ Total Energy System is intended to supply energy to surgical devices.
The ETHICON™ Total Energy System is an electrosurgical generator that provides power to monopolar, bipolar, and ultrasonic surgical instruments. It is indicated for surgical procedures requiring cutting or coagulation of soft tissue.

The subject device, The ETHICON™ Total Energy System, is an electrosurgical generator that integrates Advanced Energy (Advanced Bipolar and Ultrasonic) and Core Monopolar and Bipolar energy modalities into one system, the Ethicon Total Energy System. The subject device consists of two modules: the Communications Module (ETHCM and ETHUSC) and the Energy Module (ETHEM). Atop the Energy Module is the Communications Module and the User Screen. The Communications Module contains the power button and speakers, connects to the User Screen, distributes power to the system, and provides external interfaces for other connectivity to external devices including Ethernet and USB. One or two Energy Modules can be connected to the Communications Module. When two Energy Modules are connected, each Energy Module can independently power any of the energy modalities. This feature allows for simultaneous use of two surgical instruments in one system to support complex surgical procedures where two surgeons are operating on a patient at the same time. The User Screen features a touch-operable graphical user interface (GUI) for system settings adjustment, user profile management, and alarm troubleshooting. The ETHICON™ Total Energy System accessories include a cart for system transport, footswitches (single, double, round), and an output verification key. The cart provides a mobile platform with adjustable shelves and accessory storage. Additionally, the cart has custom features to create stability for the system including cut-outs on the top shelf for holding the rubber feet of a second module layers. Casters provide 360° mobility with locking tabs that lock to prevent unwanted cart movement. Footswitches may be used to control power delivery to connected instruments, enabling surgeons to activate the energy output hands-free. The different footswitches can be used for various energy modalities and instruments. Up to four footswitches can be connected to the Communications Module of the Ethicon Total Energy System at the same time. The footswitches are assigned to the desired instrument port via the User Screen GUI. Output Verification is a service mode of the system used to periodically confirm that the power outputs of each energy modality are within the required specifications. The Energy Output Verification Key is used by biomed/hospital facility servicing personnel to complete this process for annual maintenance on the Energy Module, with on-screen guidance to assist in this process. The ETHICON™ Total Energy System is compatible with Ethicon HARMONIC™, Ethicon ENSEAL™, and Ethicon MEGADYNE™ monopolar and bipolar instruments.

The provided FDA 510(k) summary for "The ETHICON™ Total Energy System" does not contain the specific details regarding acceptance criteria and the comprehensive study results typically found in a full scientific report.

However, based on the information provided, I can infer the general nature of the acceptance criteria and the studies performed, and explain what is missing from a complete answer regarding detailed acceptance criteria and proof of meeting them:

General Conclusion from the Document:
The FDA 510(k) summary states, "The subject device showed either equivalent or improved performance compared to the predicate devices and met all functional requirements of its features. It successfully met the acceptance criteria for bench testing, animal studies, usability, and electrical testing, demonstrating no new safety or effectiveness issues compared to the predicate."

This indicates that acceptance criteria were established and met for various aspects, but the specific, quantifiable criteria and the detailed results proving they were met are not explicitly listed in the provided text.

Here's an attempt to answer your request based on the available information, highlighting what is present and what is absent:

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

Missing Information: The document states that the device "met the acceptance criteria for bench testing, animal studies, usability, and electrical testing" and "demonstrated equivalent output, stability, and thermal spread control" compared to predicates. However, specific quantitative acceptance criteria and their corresponding reported device performance values are not provided in this 510(k) summary. For example, it doesn't state "Acceptance Criterion: Vessel burst pressure > X mmHg, Reported Performance: Y mmHg."

To illustrate what would be in such a table, based on the mentioned tests:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Missing Information: The document does not specify the sample sizes (e.g., number of vessels, number of animal subjects, number of tissue samples, number of human factors participants) for any of the test sets. It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective, though animal studies are typically prospective.

Available Information (Implied/General):

• Test Set: Multiple types of test sets were used, including:
  • Bench testing materials (tissue models, test equipment for electrical and EMC)
  • Animal subjects (for in vivo studies on vessel and tissue transection)
  • Human participants (for human factors testing)
• Data Provenance: Not specified. Animal studies and human factors testing would typically be prospective, conducted in a controlled lab or simulated clinical environment.

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)

Missing Information: The document makes no mention of specific experts or their qualifications used to establish ground truth for any of the studies (bench, animal, human factors). For animal studies, surgical observers and pathologists would typically be involved, but their number and experience are not detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Missing Information: No adjudication method is mentioned for any of the studies. For objective measurements like electrical output or burst pressure, adjudication might not be relevant. For subjective assessments in animal studies (e.g., visual assessment of hemostasis, healing response) or human factors (e.g., observation of user errors), adjudication could be used, but it's not described.

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 (Based on Device Type): The ETHICON™ Total Energy System is an electrosurgical generator, not an AI-powered diagnostic imaging device or an AI-assisted interpretation tool for human readers. Therefore, an MRMC comparative effectiveness study involving "human readers" and "AI assistance" is not relevant to this device.

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

Not Applicable (Based on Device Type): The device is a physical electrosurgical generator with embedded software for controlling energy delivery. Its performance is inherently "standalone" in terms of its electrosurgical function. There isn't a separate "algorithm only" performance to evaluate in the way one would for a diagnostic AI algorithm. Its software validation focuses on the accurate and safe control of the hardware.

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

Available Information (Implied):

• Bench Testing: Ground truth is established by objective physical measurements against established engineering specifications and predicate device performance (e.g., output power levels measured by calibrated equipment, thermal readings from thermocouples, force measurements for burst pressure).
• Animal Studies: Ground truth for hemostasis, tissue effects, and healing response would typically be established through:
  • Direct surgical observation during acute phase.
  • Pathological examination of excised tissue samples in both acute and chronic phases.
  • Standard physiological measurements.
• Human Factors Testing: Ground truth for usability and safety is established by observing user interactions and identifying potential use errors, comparing them against safe use criteria.

8. The sample size for the training set

Not Applicable (Based on Device Type/Software Description): The software described for the ETHICON™ Total Energy System is primarily involved in "precise energy delivery, enhance device usability, and support overall safety." This indicates a deterministic control system and user interface software, not a machine learning or AI algorithm that would typically require a "training set" in the context of data-driven learning. The software was validated according to general software validation guidance, implying traditional software engineering verification and validation (V&V), not machine learning model training.

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

Not Applicable: As there's no indication of a machine learning component requiring a training set, the concept of establishing ground truth for a training set does not apply in the context described in the document. Software validation for this type of device typically uses requirements specifications as the "ground truth" against which the software's performance is tested.

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