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The Trigger Switch and Cord are accessories that are intended for use in monopolar laparoscopic and thoracoscopic electrosurgical procedures where handswitching of laparoscopic instruments is desired.

The Trigger Switch and Cord are an electrical connecting cord assembly, intended to provide an electrical path between an RF electrosurgery generator and an RF surgical electrode. The insulated wire of the Cord is 10ft long. The Cord is intended to be plugged into an in-line Trigger Switch which is attached to the RF electrode handle with an adhesive backing. The Trigger Switch allows hand switching of the electrical current through the Cord during surgery. These devices can be used in hospitals and are used by trained professionals only.

The Trigger Switch and Cord are compatible with the monopolar instruments with a shrouded 4mm male electrical connector and with an electrosurgical generator.

Typically, these application devices are used in place of foot switches in the flow of electrosurgical current to the target site.

These devices are sold as sterile, single-use devices.

The provided document is a 510(k) premarket notification for a medical device: the New Deantronics Trigger Switch and Cord. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the device meets novel acceptance criteria for an AI/ML powered device.

Therefore, many of the specific questions you've asked (e.g., sample size for test set, number of experts for ground truth, MRMC study, sample size for training set, how ground truth for training set was established, effect size of human readers improving with AI) are not applicable to this document. This document deals with electrosurgical accessories, which are hardware devices, not software or AI-driven systems.

However, I can extract information related to the acceptance criteria and study that does apply to this electrosurgical accessory, focusing on performance and safety testing against established standards and the predicate device.

Here's the information extracted from the document, tailored to the context of a hardware medical device and addressing the relevant parts of your request:

Acceptance Criteria and Device Performance for New Deantronics Trigger Switch and Cord

This document (K200455) is a 510(k) premarket notification for a traditional medical device (electrosurgical accessory), not an AI-powered one. Therefore, the "acceptance criteria" and "study" are focused on demonstrating the device's safety and effectiveness and its substantial equivalence to a predicate device through engineering and performance testing, rather than clinical efficacy studies with human readers or AI algorithm performance.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by adherence to recognized international and domestic standards for electrosurgical devices, as well as meeting predefined performance thresholds in mechanical and electrical tests. Performance is reported as "Pass" or "Fail" for each test.

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

This document does not specify exact sample sizes for each bench test conducted. The testing described is primarily bench testing (engineering and electrical safety tests), not human subject clinical trials. The data provenance is internal testing performed by New Deantronics Taiwan, Ltd. and its contractors. The studies are prospective in the sense that they were conducted for this premarket submission.

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

Not applicable in the context of an AI/ML device. For this hardware device, "ground truth" is established by adherence to recognized engineering standards (e.g., IEC, ASTM) and predefined physical and electrical specifications. The expertise would lie in the engineers and technicians performing and verifying the tests in accordance with these standards.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like "2+1" or "3+1" are relevant for clinical endpoints adjudicated by multiple experts, typically in clinical trials. For bench testing, test results are typically objective measurements against a Pass/Fail criterion.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. MRMC studies are specific to evaluating diagnostic accuracy and reader performance, commonly used for imaging AI. This device is an electrosurgical accessory, not a diagnostic tool.

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

Not applicable. This device is a hardware accessory and does not contain an algorithm in the sense of an AI/ML model. Its performance is evaluated through physical and electrical tests.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is the engineering specifications and safety standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, ASTM D4169) to which the device must conform to be considered safe and effective. It's based on established physical and electrical properties, not clinical outcomes or expert consensus on a medical condition.

8. The Sample Size for the Training Set

Not applicable. This device is a hardware accessory, not an AI/ML model that requires a training set.

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

Not applicable. As the device is not an AI/ML model, there is no training set or ground truth associated with it in that context.

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The Trigger Switch and Cord accessories are intended for use in monopolar laparoscopic and thoracoscopic electrosurgical procedures where handswitching of laparoscopic or thoracoscopic instruments, such as scissors and graspers, is desired.

The Trigger laparoscopic switch system consists of a sterile, single use switch and a sterile single use cord that is used to deliver monopolar RF current from a standard electrosurgical generator to a laparoscopic or thoracoscopic instrument.

The switch contains a female electrical connector that mates with the electrosurgical connector post on a laparoscopic or thoracoscopic instrument and a male connector that mates with the power cord. The adhesive on the switch button allows it to be placed on the instrument in a user-selected location. When the switch assembly is connected via the power cord to an electrosurgical generator, depression of the switch button results in the activation of the coagulation output of the generator.

This document describes a medical device, the "Trigger Switch and Cord," which is an accessory for electrosurgical procedures. However, the provided text does not contain any information related to AI or machine learning performance, nor does it describe a study involving an AI device.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets those criteria in the context of AI. The provided text outlines the device's intended use, its components, how it functions, and the standards it has been tested against (IEC 601-1, IEC 601-2-2, ANSI/AAMI HF18). It also states that it's "substantially equivalent" to other legally marketed devices based on its function and intended use.

Here's why I cannot provide the requested information based on the input:

• No AI Device: The document describes a physical medical accessory (a switch and cord) for electrosurgical procedures. There is no mention of an AI component, software, algorithm, or any form of artificial intelligence.
• No Performance Metrics for AI: The document doesn't discuss metrics like sensitivity, specificity, AUC, F1 score, or other performance indicators typically associated with AI device evaluation.
• No Testing Methodologies for AI: There is no mention of test sets, training sets, ground truth establishment, expert review processes, MRMC studies, or standalone algorithm performance, which are standard for AI device validation.
• Compliance with Electrical Safety Standards: The testing mentioned (IEC 601-1, IEC 601-2-2, ANSI/AAMI HF18) are electrical and general medical device safety standards, not performance or validation studies for AI algorithms.

If you have a different document or information pertaining to an AI medical device, I would be happy to analyze it according to your requested criteria.

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