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The Argon Handset is an electrosurgical accessory intended to be used in open or laparoscopic and thoracoscopic surgical procedures (general, neurosurgical, gynecologic) where monopolar standard or argon-enhanced electrosurgery is desired. The electrosurgical energy is controlled by the electrosurgical generator during cutting and coagulation and the argon gas flow is controlled by the argon gas delivery system, via the Argon Handset, during argon-shrouded cutting and argon-enhanced coagulation. When the Argon Handset is activated in the argon-enhanced mode, argon gas plasma is created between the electrode and target tissue.

The Argon Handset is intended to be used in electrosurgical procedures where monopolar standard or argon enhanced electrosurgery is desired. The pre-installed blade electrode is used in open surgery, while the longer argon electrodes can replace the blade electrode to be used in minimally invasive procedure. The Argon Handset has to be in conjunction with an electrosurgical generator, argon gas delivery system and patient return electrode. During the operation, the argon handset performs like a standard electrosurgical pencil, while it receives both the argon gas and high frequency current, and delivers the electrosurgical energy onto a target tissue for either a standard or argon-enhanced procedure. The Argon Handset is sold in sterile packaging and is a single use device. These devices can be used in hospitals and are used by trained professionals only. The Argon Handset is designed for fitting into the Covidien Argon Gas Delivery Unit II or Force™ GSU Argon Gas Delivery Systems, and Covidien Force EZ™ or Force FX™ series electrosurgical generators. The blade electrode of the Argon Handset is replaceable by the New Deantronics Argon Electrode Series or Covidien E35XX series Argon Electrodes depending on the surgical procedures required.

This document is a 510(k) Premarket Notification for the Argon Handset device, a type of electrosurgical accessory. It seeks to demonstrate substantial equivalence to a predicate device, the Valleylab Force Argon II Argon Enhanced Electrosurgical System (K964636).

The document does not describe a study that proves the device meets acceptance criteria related to AI/ML algorithm performance, nor does it pertain to a diagnostic or assistive AI medical device that would involve human readers, ground truth establishment by experts, or MRMC studies.

Instead, this 510(k) submission focuses on the safety and performance of a physical medical device (an electrosurgical accessory) through bench testing, electrical safety, EMC testing, shelf-life testing, biocompatibility testing, and package testing.

Therefore, most of the requested information (sample size for test/training sets, data provenance, number/qualification of experts, adjudication methods, MRMC studies, standalone algorithm performance, ground truth types for AI) is not applicable to this type of device and submission.

However, I can extract the acceptance criteria and the methods used to prove the device meets these criteria for this physical medical device.

Acceptance Criteria and Study for the Argon Handset (Electrosurgical Accessory)

The document primarily demonstrates substantial equivalence through technical and performance characteristics compared to a predicate device, supported by extensive non-clinical testing rather than clinical or AI performance studies.

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that "All the test results demonstrate the performance of Argon Handset meets the requirements of its pre-defined acceptance criteria and intended uses." Specific quantitative acceptance criteria are not explicitly tabulated in this document; rather, it details the types of tests conducted and concludes that the device passed them, implying the predefined criteria were met. The performance is reported as meeting "requirements" or "passing" standards.

• Electrode slide
• Activation force
• Activation overtime
• Continuity
• Gas filter test
• Impact and back pressures
• HF breakdown with argon gas
• Thermal Effects on Tissue (within a system) |
  | Electrical Safety | The Argon Handset passed all electrical safety tests.
  Tested in accordance with:
• IEC 60601-1:2005+AM1:2012 (General requirements for basic safety and essential performance)
• IEC 60601-2-2:2017 (Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories). |
  | Electromagnetic Compatibility (EMC) | The Argon Handset passed all EMC tests.
  Tested in accordance with:
• IEC 60601-1-2:2014 (Electromagnetic disturbances - Requirements and tests). |
  | Shelf-Life | Established that the device and packaging remain functional and maintain sterility for 2 years through accelerated aging studies.
  Tested in accordance with FDA guidance and internal requirements. |
  | Biocompatibility | Demonstrates that the materials in the device will not cause a biocompatibility reaction when used as intended.
  Tested in accordance with:
• ISO 10993-1:2009/AC:2010 (Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process)
• FDA guidance documents. |
  | Package Integrity | The sterile package integrity remains uncompromised and the sterile barrier is not adversely affected after testing.
  Verified and validated in accordance with associated ASTM package standards. |

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not explicitly stated as a number of devices. Testing typically involves a representative sample of devices, but the exact quantity is not detailed in this summary.
• Data Provenance: The testing was conducted by New Deantronics Taiwan Ltd. ("New Deantronics") and its "extended team," implying internal testing conducted by the manufacturer. The document doesn't specify data origin by country other than the manufacturer's location (Taiwan). It's not relevant whether it's retrospective or prospective, as this applies to clinical data, not bench/lab testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• N/A. This device is a physical electrosurgical accessory. The "ground truth" (i.e., whether the device performs as intended and is safe) is established through engineering and laboratory testing against defined standards and specifications, not through expert human interpretation of data like in an AI medical device.

4. Adjudication method for the test set:

• N/A. Adjudication methods like 2+1 or 3+1 are used for human review of medical images or data in studies involving expert consensus on ground truth. This is not applicable to an electrosurgical accessory undergoing physical and electrical bench testing.

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. An MRMC study is not relevant to this device. This is a physical electrosurgical tool, not an AI or imaging-based diagnostic/assistive device that would involve human readers.

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

• No. This is not an algorithm. Therefore, "standalone performance" in the context of an algorithm is not applicable.

7. The type of ground truth used:

• For this device, the "ground truth" is defined by international consensus standards (e.g., IEC, ISO, ASTM) and the predetermined design specifications and acceptance criteria of the manufacturer, all validated through bench, electrical, and materials testing. It is not expert consensus, pathology, or outcomes data in the sense used for diagnostic/AI devices.

8. The sample size for the training set:

• N/A. There is no "training set" for this type of device, as it does not involve machine learning or AI.

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

• N/A. As there is no training set, this question is not applicable.

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