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Aesculap's Nelson delix® Electrosurgical is intended to be used in surgery to generate electrical power for both Monopolar and Bipolar cutting and coagulating in microsurgery and macrosurgery.

Aesculab's Nelson dollar Electrosurgical Unit is an Electrosurgical unit (ESU) capable of generating high frequency electrical current, driven through a software based program, for use in monopolar and bipolar electrosurgery. The Nelson asunt Electrosurgical Unit is equipped with two monopolar and two biopolar outlets. All software and electrical components are housed within a combination metallic and thermoplastic enclosure and the product is provided with a universal power cord, which automatically adapts to voltages ranging from 100-240 volts. A monopolar or bipolar cord connects the instruments to the coagulator. The unit is activated by means of a foot control or hand piece.

This document, a 510(k) Summary for the Nelson deluxe Electrosurgical Unit, does not contain information about specific acceptance criteria or a study proving the device meets those criteria.

Instead, it's a premarket notification to the FDA, demonstrating substantial equivalence to previously cleared devices. It focuses on the device's intended use, description, and comparison to predicate devices, rather than detailed performance study results against specific acceptance criteria.

Here's what can be extracted based on the provided text, and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated in terms of measurable performance metrics (e.g., power output accuracy within a certain percentage, impedance range a device can handle). The document mentions conformance to "applicable IEC standards and the requirements of the Canadian Standards Association (CSA) for medical electrical equipment," but it doesn't list the specific criteria from these standards.
• Reported Device Performance: No specific performance data (e.g., measured power outputs, waveform characteristics, safety features efficacy) is reported in the text.

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

• Sample Size: Not applicable as no specific performance test set is described.
• Data Provenance: Not applicable.

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

• Not applicable as no specific performance test set with expert-established ground truth is described.

4. Adjudication Method for the Test Set

• Not applicable as no specific performance test set is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study is mentioned. This type of study is more common for diagnostic imaging AI, not electrosurgical units.

6. Standalone Performance Study

• No standalone (algorithm only) performance study is mentioned. The device is hardware-based with a software-driven component for generating electrical current, but it's not a standalone diagnostic algorithm.

7. Type of Ground Truth Used

• Not applicable as no specific performance test with ground truth is described.

8. Sample Size for the Training Set

• Not applicable as this document predates and doesn't involve AI/ML device training sets in the modern sense. The "software-based program" mentioned likely refers to control logic, not a machine learning model.

9. How Ground Truth for the Training Set Was Established

• Not applicable.

Summary of what the document does provide:

• Intended Use: Used in surgery to generate electrical power for both Monopolar and Bipolar cutting and coagulating in microsurgery and macrosurgery.
• Device Description:
  • Generates high-frequency electrical current.
  • Software-based program drives the current.
  • Equipped with two monopolar and two bipolar outlets.
  • Universal power cord (100-240 volts).
  • Activates via foot control or handpiece.
• Substantial Equivalence: Claimed based on similar features, functions, intended use, labeling, and basic operating principles to predicate devices:
  • Conmed / Aspen Laboratories' System 7500 ABC Electrosurgical Unit (#K981220)
  • Erbe's Erbotom ICC 300 & 350 (#K953738 & #K933002)
  • ValleyLab's Force FX (#K944602)
• Regulatory Compliance: Conforms to "applicable IEC standards and the requirements of the Canadian Standards Association (CSA), for medical electrical equipment." This implies that the device was tested against these standards, but the specific acceptance criteria and results are not detailed in this summary.

Conclusion:

This 510(k) summary is a regulatory filing focused on establishing substantial equivalence for market clearance. It explicitly states, "No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices." Therefore, it does not describe a performance study against specific, pre-defined acceptance criteria in the way a modern AI/ML device submission would. The "performance data" section only states compliance with international safety and electrical standards, without detailing the clinical or technical performance metrics and results a device like this might otherwise have.

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