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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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