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The Smoke Evacuation Button Switch Pencil and Telescoping Smoke Evacuation Switch Pencil are intended for general electrosurgical applications, including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The Pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.

The application devices, the Smoke Evacuation Button Switch Pencil and the Telescopic Smoke Evacuation Button Switch Pencil (referred to hereafter as the Smoke Evaluation Pencils), are a collection of electrosurgical electrodes with an integrated smoke collection tube. The flat blade electrode provided in each pencil can be removed and replaced with a compatible electrode.

New Deantronics is requesting clearance two series Smoke Evacuation Pencils.

The simplified series includes two different housing styles (round and oval) of pencil body design. Each housing style has two different lengths of attached tubing at the proximal end of the pencil body, 10ft and 15ft; thus, there are 4 models in this and the premium series. These 4 simplified series models share the same design elements (functional design, technology design, packaging, sterilization method and process, etc.)

The premium series embodies one of two extender mechanisms. There are 2 smoke nozzle extender/fixation mechanism designs in this series; with and without lock mechanism. Each design includes two lengths of spiral tube and cable, while all the other design elements, such as cosmetic appearance, grip characteristics, construction materials, packaging, sterilization method, etc., are identical in this premium series to the simplified series.

The Smoke Evacuation Pencils are designed to be used with a compatible electrosurgical generator and smoke evacuation system.

These devices are single use and are sold sterile.

The provided text is a 510(k) summary for a medical device (Smoke Evacuation Button Switch Pencil) seeking FDA clearance. It focuses on demonstrating substantial equivalence to a predicate device. This type of document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria, particularly in the context of an AI/algorithm-driven device.

The document describes the device as an electrosurgical accessory for cutting, coagulation, and smoke evacuation, and its performance is evaluated against engineering standards (e.g., IEC 60601 series, ISO 10993-1) and physical tests (e.g., button activation force, weld integrity). It does not mention any AI or algorithmic components, nor does it describe a study involving human readers or expert consensus for ground truth.

Therefore, I cannot fulfill the request using the provided text. The questions posed in the prompt (regarding acceptance criteria for AI performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone performance) are relevant to the evaluation of AI/ML-based medical devices, which this document is not about.

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The Electrosurgical Generator is an electrosurgical generator containing monopolar and bipolar technology. It is intended for use with accessories during surgical procedures where the surgeon requires electrosurgical cutting and coagulating.

The application device, the Electrosurgical Generator, is a solid state generator designed to supply radiofrequency electrical energy for general electrosurgical purposes, with physical dimensions around 37cm (L) x 29cm (W) x 17cm (H) and 5kg unit weight. The Electrosurgical Generator supplies high frequency electrosurgical power from low power (100W, Coag>70W). The Electrosurgical Generator outputs high frequency energy in the following modes: 1. Monopolar CUT: Pure Blend 1 Blend 2 2. Monopolar COAG: Pin Point Spray 3. Bipolar: Standard The Electrosurgical Generator can be activated via a hand switch or a foot switch. The Electrosurgical Generator has a Return Electrode Contact Quality Monitor to alert the user when inadequate contact is being made with the Return (aka Neutral) Electrode. The Electrosurgical Generator is mains powered.

This document is a 510(k) premarket notification for an Electrosurgical Generator (Model: ES300) and describes its substantial equivalence to a predicate device, the Covidien Force FX™ Electrosurgical Generator (K143161). The focus of the provided text is on demonstrating the device's adherence to relevant standards and its similarity in function and design to the predicate, rather than providing details of a study with specific acceptance criteria and performance metrics in the format requested.

Therefore, the requested information (acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and MRMC study details) is not explicitly available in the provided text in the detailed format you requested for an AI/device performance study. The document primarily focuses on regulatory compliance through comparison to a predicate device and adherence to established electrical safety and performance standards.

Here's an attempt to extract and infer information based on the provided text, while also noting what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present acceptance criteria and reported device performance in a numerical table for clinical or diagnostic accuracy as would be found in a study for an AI-powered diagnostic device. Instead, "acceptance criteria" are implied by adherence to and compliance with recognized standards and guidelines. "Device performance" is largely described qualitatively and by comparison to the predicate device's established performance.

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

This information is not provided in the document. The testing described is primarily related to compliance with electrical, safety, and performance standards for the device itself, rather than a clinical study with a test set of patient data. The provenance of data from such compliance testing would typically be from laboratory settings or engineering evaluations, not patient data.

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

This information is not provided. The document describes regulatory compliance and engineering testing, not a study involving expert-established ground truth for a test set of cases.

4. Adjudication Method for the Test Set

This information is not provided. As there's no mention of a clinical test set with ground truth, an adjudication method is not applicable in this context.

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

This information is not provided. The device is an electrosurgical generator, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device and was not conducted.

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

This information is not applicable/not provided. The device is a physical electrosurgical generator, not an algorithm. Performance tests mentioned are for the physical device's electrical outputs and safety features, not standalone algorithmic performance.

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

For the type of device described (an electrosurgical generator), "ground truth" would typically refer to objective measurements and adherence to specified performance parameters defined by engineering standards (e.g., output power within tolerance, impedance monitoring accuracy, alarm functionality). The document indicates that the device was "tested and found to be in compliance" with various IEC standards and FDA guidance, which serve as the "ground truth" or benchmarks for electrical safety and performance.

8. The sample size for the training set

This information is not applicable/not provided. As this is not an AI/machine learning device, there is no "training set" in the computational sense.

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

This information is not applicable/not provided. There is no training set for this type of device.

In summary: The provided FDA 510(k) summary document focuses on demonstrating substantial equivalence of an electrosurgical generator to a predicate device through adherence to recognized technical standards and comparison of features. It does not contain information about a clinical or diagnostic study with acceptance criteria, sample sizes, expert ground truth, or AI-related performance metrics as requested for an AI/CAD-type device.

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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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A Monopolar Cord is intended to be used with a compatible electrosurgical generator and an RF electrode to cut tissue and control bleeding by use of high-frequency electrical current.

The Monopolar Cord, sold as sterile packaged, and ready for use devices, is intended to be used with compatible accessories to cut tissue and control bleeding by use of high-frequency electrical current. The Monopolar Cord is compatible with the monopolar instruments with shrouded 2.5 mm female electrical connections, electrosurgical generator, and patient return electrode. During the operation, the sterile cord should connect to the sterile accessory, and then generator connector end is inserted into the adapter and generator which it receives the high frequency current and delivers the current onto a target tissue for cutting and coagulation in a procedure. These devices can be used in hospitals and are used by trained professionally only.

This is a medical device for electrosurgical cutting and coagulation, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth type for test set, training set size, and training set ground truth) are not applicable.

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance: Not applicable. This device is subjected to bench and electrical safety testing, not a clinical test set with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a device like this is established through engineering and regulatory standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth is based on established engineering and safety standards (e.g., IEC 60601 series, ASTM D4169) and the functional requirements for an electrosurgical accessory.

8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set. The device development process involves design, prototyping, and testing against pre-defined specifications.

9. How the ground truth for the training set was established: Not applicable.

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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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The Flexible Argon Electrode is intended to be used in open or laparoscopic and thoracoscopic surgical procedures (general, neurosurgical, gynecologic) where argon-enhanced monopolar coagulation is desired.

The Retractable Argon Electrode is intended to be used in laparoscopic and thoracoscopic surgical procedures (general, neurosurgical, gynecologic) where standard monopolar electrosurgery (cutting and coagulation) or argon-enhanced monopolar coagulation is desired.

The New Deantronics Argon Electrodes have to be attached to the argon handset and are the electrosurgical electrodes applied in electrosurgical procedures.

The New Deantronics Argon Electrode is designed to connect to a third-party argon handset. The electrosurgical energy is conducted from the argon handset, through the electrode to the electrosurgical target site, as is the argon gas flow. When the device is activated, the argon gas will be transformed into a plasma state flowing out of the electrode. By directly or indirectly contacting the energized electrode with the target tissue, the New Deantronics Argon Electrode can facilitate argon-enhanced coagulation, as well as standard electrosurgical cut and coagulation, as indicated.

The provided text describes the New Deantronics Argon Electrodes, which are electrosurgical accessories, and asserts their substantial equivalence to a predicate device based on various comparisons and non-clinical testing. However, the document does not contain the detailed information required to answer all parts of your request, particularly regarding specific acceptance criteria metrics and a human-focused study design.

Here's a breakdown of what can be extracted and what is missing:

1. Table of acceptance criteria and the reported device performance

The document mentions "pre-defined acceptance criteria" but does not provide a specific table outlining those criteria or the reported performance against them for functionality, safety, or clinical effectiveness. The only specific performance data mentioned related to criteria is:

Beyond these electrical safety parameters, the document states: "Electrical safety testing and bench testing has demonstrated that the performance of New Deantronics Argon Electrodes meet the requirements of its pre-defined acceptance criteria and intended uses." This is a general statement rather than specific data.

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

The document mentions "electrical safety testing and bench testing" but does not specify the sample size for the test sets used in these non-clinical tests. It also does not mention the data provenance or whether the tests were retrospective or prospective. Given that it's bench testing, it's typically conducted in a controlled lab environment.

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)

This information is not applicable as the document describes non-clinical "electrical safety testing and bench testing," not a study involving human interpretation or expert ground truth establishment for a test set.

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

This information is not applicable for the same reason as point 3.

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

The document describes development and testing of an "Electrosurgical accessory" (Argon Electrodes) and explicitly states it conducted "electrical safety testing and bench testing." It does not mention a MRMC comparative effectiveness study involving human readers or AI. Therefore, there is no effect size related to human readers improving with or without AI assistance.

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

The document details "electrical safety testing and bench testing" of the device itself (Argon Electrodes), which can be considered a form of standalone performance evaluation for the device's physical and electrical characteristics. However, it's not an "algorithm only" standalone performance as the device itself is a physical medical instrument, not software.

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

For the electrical safety and functional bench testing, the "ground truth" would be established by engineering specifications, industry standards (e.g., IEC 60601 series), and controlled measurements using calibrated equipment, not expert consensus, pathology, or outcomes data which are typically associated with clinical or diagnostic studies.

8. The sample size for the training set

This information is not applicable. The device is an electrosurgical accessory, not an AI/ML algorithm that requires a "training set." The testing described is for physical product performance, not algorithm training.

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

This information is not applicable for the same reason as point 8.

In summary:

This document focuses on regulatory clearance for an electrosurgical accessory based on its physical properties and electrical safety, largely through comparison to a predicate device and non-clinical bench testing. It does not involve AI, human reader studies, or complex clinical ground truth assessments as would be relevant for diagnostic imaging or similar AI-driven medical devices.

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These electrodes are intended for use in minimally invasive surgical procedures where monopolar electrosurgical cutting and coagulation are desired. Irrigation and suction capabilities via the same handset are available as well.

The New Deantronics Laparoscopic Hollow Electrodes, sold as sterile packaged, and ready for use devices, are intended for use in minimally invasive surgical procedures where monopolar electrosurgical cutting and coagulation are desired. The laparoscopic electrodes are used in conjunction with a Valleylab™ E2750 Laparoscopic Handset and 5 mm (internal diameter) or larger trocar, electrosurgical generator, and patient return electrode. During the operation, the electrode tip and the insulated shaft are to be inserted through a trocar, then conductive shaft end is inserted into the nose of an electrosurgical pencil from which it receives the high frequency current and delivers the current onto a target tissue for cutting and coagulation in a laparoscopic procedure. These devices can be used in hospitals and are used by trained professionally only.

This document is a 510(k) Pre-market Notification for Laparoscopic Hollow Electrodes. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.

Here's a breakdown of the requested information based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All the test results demonstrate the performance of New Deantronics Laparoscopic Hollow Electrodes meet the requirements of its pre-defined acceptance criteria and intended uses." However, specific quantitative acceptance criteria or detailed reported performance values for each test are not explicitly provided in this document. The document broadly states that the device "passed all" relevant tests and "met the requirements."

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

The document does not specify the sample sizes used for any of the bench, electrical safety, EMC, shelf-life, or biocompatibility tests. It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. These were all bench tests conducted by New Deantronics, presumably in their facilities in Taiwan, R.O.C., as per the sponsor information.

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

This information is not applicable as the evaluation involved physical, electrical, and material testing of a medical device, not a diagnostic or prognostic system requiring expert interpretation of results for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as above. The tests performed are objective measurements against predefined standards or specifications.

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

An MRMC comparative effectiveness study was not performed, nor is it applicable to this type of device (electrosurgical electrodes). The device is a tool used by a surgeon, not a diagnostic aid that would improve human reader performance.

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

This is not applicable as the device is a physical electrosurgical electrode and does not involve any algorithms or AI for its function.

7. Type of Ground Truth Used

The "ground truth" for the tests performed was established through objective engineering and material science standards and specifications.

• Bench Testing: Internal requirements, FDA guidance (Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery).
• Electrical Safety & EMC: International standards (IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2).
• Shelf-Life Testing: FDA guidance and internal requirements.
• Biocompatibility Testing: ISO 10993-1 and FDA guidance.

8. Sample Size for the Training Set

This is not applicable as the device does not employ machine learning or AI, and therefore does not have a "training set."

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

This is not applicable as there is no training set for this device.

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The Irrigation Tubing Bipolar Cord Sets are intended to provide irrigation and energy simultaneously to bipolar forceps specifically designed for irrigation.

The Irrigation Tubing Bipolar Cord Se is designed to connect to both an electrical generator and bipolar forceps via an electrically conducting cord and to a saline source for irrigation via a catheter to provide simultaneous coagulation capabilities and irrigation capabilities. A co-extrusion manufacturing process is applied to integrate a bipolar cord with irrigation tubing into one unit. This integrated Irrigation Tubing Bipolar Cord set are helpful to keep the bipolar electrosurgery organized. The electrically conducting cord is formed with a pair of copper wires each coaxially surrounded by an outer insulation sheath. The insulated bipolar cord (24 AWG) provides safety protection to patients and surgical staff. The fluid catheter is formed of PVC and silicone tubing connected by connectors and is defined as fluid passage pathway.

This is a 510(k) premarket notification for a medical device called "Irrigation Tubing Bipolar Cord Sets." As per the provided document, the device's acceptance criteria are demonstrated through non-clinical testing, specifically electrical safety testing and bench testing.

Here's a breakdown of the requested information based on the provided text:

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

The document states: "Electrical safety testing and bench testing has demonstrated that the performance of New Deantronics Irrigation Tubing Bipolar Cord Sets meet the requirements of its pre-defined acceptance criteria and intended uses."

The specific acceptance criteria and detailed performance metrics are not explicitly laid out in a table format in the provided text. However, the document lists the standards the testing was performed in accordance with:

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

The document does not specify the sample size used for the electrical safety testing and bench testing, nor does it explicitly state the data provenance (e.g., country of origin or retrospective/prospective nature). The testing appears to be non-clinical.

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

This information is not provided in the document. Electrical safety and bench testing typically rely on established engineering standards and test protocols rather than expert consensus on a "ground truth" derived from human interpretation.

4. Adjudication method for the test set

This information is not applicable and is not provided in the document. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes, which is not the nature of the electrical safety and bench testing described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes non-clinical electrical safety and bench testing, not a clinical study involving human readers or cases.

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

This question is not applicable to the device described. The device is hardware (irrigation tubing bipolar cord sets) and does not involve an algorithm or AI. The testing described is for the physical and electrical performance of the hardware.

7. The type of ground truth used

For electrical safety and bench testing, the "ground truth" is typically defined by established engineering standards and specifications (e.g., IEC standards for electrical safety and performance parameters for fluid flow, cable length, etc.). The device's performance is measured against these objective, predefined criteria.

8. The sample size for the training set

This information is not applicable and is not provided in the document. The device is hardware, not an AI or machine learning model that requires a training set.

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

This information is not applicable, as there is no training set for this hardware device.

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The New Deantronics E Green™ Electrosurgical Monopolar Pencils are intended to remove tissue and control bleeding by use of high-frequency electrical current.

The E Green™ Reusable Monopolar Cord is an electrosurgical accessory used with E Green™ Disposable Electrosurgical Pencil. Electrosurgical Pencils are intended to remove tissue and control bleeding by use of high-frequency electrical current. This product is a monopolar, electrosurgical pencil which is used for most open surgeries. The pencil can be divided in two parts, one is a gamma sterilized disposable electrosurgical pencil and another is a reusable cord which needs to be autoclaved by the user before use in a standard operating room environment. The E Green™ Reusable Monopolar Cord is used ONLY in combination with E Green™ Disposable Electrosurgical Pencil. The number of uses of the Reusable Monopolar Cord following steam sterilization is 100 times.

The provided document is a 510(k) premarket notification for a medical device: New Deantronics E Green™ Electrosurgical Monopolar Pencils. This document describes the device, its intended use, and substantial equivalence to a predicate device based on non-clinical testing. It does not contain information about a study involving expert readers assessing AI performance, human improvement with AI assistance, or data provenance, as would be typical for an AI/ML medical device submission.

Therefore, many of the requested elements (especially those related to AI/ML device studies like MRMC studies, training/test set details, expert ground truth establishment, and adjudication methods) cannot be extracted from this document, as it pertains to a traditional electrosurgical device.

However, I can extract information related to acceptance criteria and performance based on the non-clinical testing described.

Here's the breakdown of what can be extracted and what cannot:

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

The document states: "All the test results demonstrate the performance of New Deantronics E Green™ Electrosurgical Monopolar Pencil meet the requirements of its pre-defined acceptance criteria and intended uses." However, it does not provide a specific table listing the acceptance criteria and the numerical reported performance for each criterion. It only lists the standards to which the device was tested.

Table of Acceptance Criteria (Inferred from standards tested) and Reported Device Performance

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: The document does not specify sample sizes (e.g., number of devices tested) for the non-clinical tests.
• Data Provenance: The tests are non-clinical, likely bench testing or lab testing to ensure compliance with standards. The company is based in Taiwan (New Deantronics Taiwan Ltd.). No mention of human patient data or its origin.

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)

• This information is not applicable and not present in the document. This is a traditional medical device, not an AI/ML device requiring expert-established ground truth from medical images or clinical data.

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

• This information is not applicable and not present in the document.

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 was not done. This device is not an AI/ML diagnostic tool.

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

• No, this is not an AI/ML algorithm. The performance evaluation is based on non-clinical testing against pre-defined standards for an electrosurgical pencil.

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

• For the non-clinical tests described, the "ground truth" would be compliance with the technical, safety, and performance specifications established by the listed international and national standards (e.g., IEC, ISO, AAMI, ASTM). There isn't a "ground truth" derived from patient data or expert consensus in the typical sense applied to AI/ML in diagnostics.

8. The sample size for the training set

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

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

• Not applicable.

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The disposable laparoscopic electrodes are intended for use in minimally invasive surgical procedures where monopolar electrosurgical cutting and coagulation are desired.

The disposable laparoscopic electrodes are classified by FDA as an "Electrosurgical, Cutting & Coagulation Device and Accessories", under the General & Plastic Surgery Panel, Product Code GEI, Regulation number 878.4400, Class II, panel 79. The devices are provided to healthcare professional only.

The New Deantronics disposable laparoscopic electrodes are used in conjunction with monopolar electrosurgical pencils that accept 2.36 mm connectors, trocars or cannulas with appropriate 5 mm adapters, electrosurgical generator, and patient return electrode. During the operation, the electrode and the insulated shaft are to be inserted through a trocar and the conductive shaft end is inserted into the nose of the electrosurgical pencil from which it receives the high frequency current while contacting target tissue for cutting and coagulation in laparoscopic procedure. The New Deantronics laparoscopic electrodes are single use.

The New Deantronics laparoscopic electrodes consists of four distinct sections, including a conduction insulated shaft, a conductive shaft end, and an electrode tip and a shaft end protector.

There are two groups of laparoscopic electrodes, including non-coated and coated laparoscopic electrodes. The coated laparoscopic electrodes have the same configuration but the electrode tips are coated with non-sticking coating material. The devices are available in five electrode tip configurations and two different shaft lengths.

There are sixteen models of New Deantronics laparoscopic electrodes available.

The provided text describes the New Deantronics Disposable Laparoscopic Electrodes, non-coated and coated, and refers to non-clinical testing to demonstrate its performance and substantial equivalence to predicate devices. However, the document does not contain information about acceptance criteria and reported device performance in the format of a table, nor does it detail a study that proves the device meets specific acceptance criteria as you've requested.

The document primarily focuses on establishing substantial equivalence through comparison of technological characteristics, intended use, and adherence to various recognized standards. It states that "All the test results demonstrate the performance of monopolar laparoscopic accessories meet the requirements of its pre-defined acceptance criteria and intended uses." and "A side by side study comparing the ND electrode to the predicate devices demonstrates substantial equivalence. A thermal Effect Study productions the New Deantronics electrode performs equivalent or better than the predicates. The device is safe and effective based on the non-clinical studies."

However, it does not explicitly list the "pre-defined acceptance criteria" or specific performance metrics in a structured table. Additionally, information regarding sample size, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, standalone performance data, or training set details is not present within this document.

The document mentions that the device "Passes test of 6.3 kV, according to IEC 60601-2-2, 201.8.8.3.104 Capacitive coupled HF current not exceed 50 mA" for electrical safety and "Wire electrode can survive 4 bends with no crack or failure" for mechanical safety. These could be considered acceptance criteria, but they are not presented in a comprehensive table with reported performance.

Therefore, I cannot fulfill your request for the comprehensive table and study details as the information is not provided in the input text.

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