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The Easylnstruments are indicated for cutting, grasping, dissecting and coagulation of tissue in laparoscopic surgical procedures.

The A.M.I. EasyInstruments device is a modular instrument system for use in laparoscopic highfrequency (HF) surgery and is designed for monopolar application. The Easylnstruments system comprises three-part detachable instruments, which include 1) different functional handles (EasyHandle), 2) instrument shafts of various diameters and lengths (EasyShaft), and 3) a wide range of different, application-specific attachments (EasyTips). It is intended during laparoscopic procedures to mobilize, manipulate, grasp, hold, fix, retract, dissect, cut, and coagulate tissue.

This FDA 510(k) summary describes a medical device, the EasyInstruments, which are electrosurgical cutting and coagulation devices and accessories. The document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and performance against those criteria in a clinical study for a new AI/software component. Therefore, much of the requested information (like number of experts, adjudication methods, MRMC studies, ground truth for test/training sets, effect size of AI improvement) is not applicable or cannot be extracted from this document because it pertains to the evaluation of AI/software in a clinical context, which is not the subject of this 510(k) for electrosurgical instruments.

However, I can extract information related to the performance testing that was conducted to demonstrate safety and efficacy compared to predicate devices for these hardware instruments.

Here's an attempt to answer the questions based on the provided text, noting where the requested information is not present or applicable:

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

The document does not explicitly state acceptance criteria in precise numerical terms or detailed performance metrics in a table. It lists numerous tests performed to demonstrate safety and performance relative to predicate devices. The "reported device performance" is summarized as "The results of these tests indicate that the EasyInstruments are substantially equivalent to the predicate devices" and "it can be concluded that the subject device does not raise new issues of safety or efficacy compared to the predicate devices."

Below is a summary of the types of tests performed and the general outcome:

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

• Sample size for test set: Not explicitly specified for each test. For "Thermal effects on tissue," it mentions "ex vivo animal tissues (liver, kidney, and muscle)," implying a sample of tissue, but the quantity is not detailed. For bench performance, it refers to "disposable tips," "reusable tips," "EasyHandle," and "EasyShaft," suggesting multiple units were tested, but precise numbers are not provided.
• Data provenance: Not specified. The manufacturer is based in Austria, but the location where the tests were specifically conducted or the origin of the animal tissues is not stated. The tests are non-clinical (bench, ex vivo).

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)

Not applicable. This document pertains to the 510(k) clearance of electrosurgical instruments (hardware), not an AI/software device that requires expert-established ground truth for image interpretation or diagnosis. The "ground truth" here related to performance testing (e.g., measurements of thermal damage, visual inspection criteria, electrical readings), not clinical diagnoses.

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

Not applicable, for the same reasons as #3. Adjudication methods are typically used in clinical studies involving interpretation of medical data, where there might be disagreement among experts.

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 not an AI/software device, so no MRMC study or AI assistance evaluation was performed.

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

Not applicable. This is not an AI/software device.

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

For the non-clinical performance and thermal effects testing, the "ground truth" would be established by:

• Engineering specifications and standards (e.g., for electrical safety, dimensions, opening angles, grasping strength, continuity checks).
• Histological assessment for thermal damage (directly observing tissue changes).
• Standardized methods for cleaning/sterilization efficacy.
• Biocompatibility test results against established safety limits.

8. The sample size for the training set

Not applicable. This is not an AI/software device that requires a training set.

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

Not applicable, for the same reasons as #8.

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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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