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These AEM Instruments incorporate the use of AEM technology and are intended for use in delivering monopolar electrosurgical energy during laparoscopic procedures only. AEM Instruments are intended for use with the AEM Monitoring System and electrosurgical generators having compatibility with the AEM Monitor. Scissors Inserts are intended for use on soft tissue only.

The AEM enTouch® 2X Scissors Inserts are designed for use with the ES8000 / ES8200 series AEM enTouch® Handles. All scissors will fit through standard 5.5mm trocars.

The provided document is an FDA 510(k) Premarket Notification for the Encision AEM enTouch® 2X Scissor. It details the device, its intended use, design changes from a predicate device, and the testing conducted to demonstrate substantial equivalence.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The core of the device's validation is presented in the "Risk Analysis: Risk Assessment Summary" table (pages 9-10). This table directly lists the changes from the predicate device, associated risks, verification methods, acceptance criteria, and results.

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

The sample sizes for the various tests are explicitly stated in the "Risk Assessment Summary" table:

• 22 samples for most mechanical, visual, and material integrity tests (e.g., indicator diameter, actuation force, indicator scraping, embrittlement, etc.).
• 15 samples for cutting performance tests.
• 20 samples for usability/indicator interpretation tests by Central Processing personnel.

Data Provenance: The document indicates that all testing was "bench testing" (page 8). This implies the data were collected in a controlled laboratory environment. There is no information regarding the country of origin of the data or whether it was retrospective or prospective in the context of clinical use, as these were all bench tests.

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

This section is not explicitly addressed in the provided document. The ground truth for this device's performance is established through adherence to recognized industry standards (e.g., ISO, ASTM) and internal design control procedures. For the "Usability" tests (Correct Use of device based on indicator color), it mentions "Central Processing personnel," implying trained individuals are the evaluators, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

The document does not describe any formal adjudication method (like 2+1 or 3+1 consensus). The tests are based on objective measurements (e.g., calipers, multimeter, visual inspection against criteria) or adherence to pass/fail benchmarks from recognized standards. For the usability tests regarding indicator color interpretation, it implies direct observation of correct identification rather than a consensus process.

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

No MRMC study was performed. The document explicitly states: "No animal or clinical testing is required" (page 8). This is a bench-tested device with minor modifications from a predicate, demonstrating substantial equivalence through engineering and laboratory tests, not comparative clinical performance or human reader studies.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

This question is not applicable to this device. The Encision AEM enTouch® 2X Scissor is a surgical instrument, not an AI/algorithm-based diagnostic or therapeutic system. Its performance is inherent to its physical design and material properties, not an algorithm.

7. Type of Ground Truth Used

The ground truth used for proving device performance is primarily objective engineering measurements, adherence to established international and domestic standards (ISO, ASTM, IEC), and internal design control procedures. These tests aim to ensure the device meets predefined physical, mechanical, electrical, and functional specifications, as well as sterility and biocompatibility requirements. For the "user interpretation" aspect of the indicator, the ground truth is simply the correct identification of the color (black for reprocess, orange for dispose).

8. Sample Size for the Training Set

This question is not applicable. Since this device is not an AI/machine learning system, there is no concept of a "training set" for an algorithm. The testing described focuses on validating the physical and functional aspects of the manufactured device.

9. How the Ground Truth for the Training Set Was Established

As there is no training set mentioned or implied for this device, this question is not applicable.

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The EndoShield Burn Protection System is an accessory for use with electrosurgical generators and is designed to safely deliver electrosurgical energy and to prevent injury caused by insulation failure and capacitive coupling. EndoShield performs acive electrode monitoring intended to control stray monopolar energy, caused by insulation failure and capacitive coupling in surgical instruments, along the instrument.

EndoShield is a self-contained battery-powered electronic module (about the size of a cell phone) with integral instrument and HF power cords:
• Module plugs directly into return-electrode receptacle of ESU

• Integral cords connect module to
  • AEM laparoscopic instrument
  • Foot-control power output receptacle of ESU

The EndoShield Burn Protection System is an accessory for use with electrosurgical generators, designed to safely deliver electrosurgical energy and prevent injury caused by insulation failure and capacitive coupling by performing active electrode monitoring.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (EM3 AEM Monitor) rather than detailing specific numerical acceptance criteria. However, we can infer the performance standard from the claim of equivalence and the description of the device's functions.

The study supporting these claims is described as Bench Testing.

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

• Sample Size for Test Set: "Essential performance tested in 10 units" of the EndoShield Burn Protection System.
• Data Provenance: The document does not specify the country of origin for the data, but it falls under the jurisdiction of the FDA (United States). The testing appears to be prospective as it involves new units of the EndoShield device undergoing performance evaluation.

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

This information is not provided in the document. The testing described is technical bench testing against design control requirements and predicate device performance, not clinical evaluation requiring expert interpretation of results for ground truth.

4. Adjudication Method for the Test Set:

This information is not provided. Given the nature of the bench testing, an adjudication method as typically understood in clinical studies (e.g., 2+1, 3+1 for discordant reads) is not applicable. The documentation suggests direct measurement and comparison against established performance metrics of the predicate device and relevant standards.

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:

No MRMC comparative effectiveness study was done or reported. This device is a hardware accessory designed to prevent injury by monitoring stray energy and shutting down the ESU if necessary, not an AI-assisted diagnostic or interpretive tool that would involve human readers.

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

The device itself is a standalone electronic module that actively monitors and controls electrosurgical energy based on its internal logic and DSP (Digital Signal Processor) measurements. The "Bench Testing" section implicitly covers its standalone performance against design control requirements and the predicate device's monopolar function. There is no specific mention of an "algorithm only" standalone study in the context of an AI/ML algorithm. The "logic" described is battery-powered digital and analog electronic circuitry with DSP for HF current measurement.

7. The Type of Ground Truth Used:

The ground truth for the bench testing was the performance parameters and established functional behavior of the predicate device (monopolar function of the EM3 AEM Monitor) and compliance with recognized international standards (IEC 60601 series). It also includes internal design control requirements per 21 CFR 820.30.

8. The Sample Size for the Training Set:

This information is not applicable/not provided. The device is a hardware accessory with electronic logic, not an AI/ML system that utilizes a "training set" in the conventional sense. The development likely involved traditional engineering design, simulation, and hardware testing.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable/not provided for the reasons stated above (not an AI/ML system). The device's operational principles and intended effects are based on known physics of electrosurgery and established safety standards, not learned from a data training set.

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