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The Ultravision2™ System is indicated for use in surgery including laparoscopic surgery.

· The Ultravision2™ Generator is interface directly with the electrosurgical generator and serve as a passthrough for HF energy to HF electrosurgical instruments, to manage surgical smoke produced by energy-based instruments, and is indicated for use in surgery including laparoscopic surgery.

· The Ionwand™ Pack is intended to be used to manage surgical smoke and is indicated for use in surgery including laparoscopic surgery.

· The Ultravision™ 5mm Trocar is intended to be used to establish a path of entry for instruments and includes an Ionwand to manage surgical smoke, and is indicated for laparoscopic surgery.

· The Integrated Monopolar L-Hook (H/S)™ is intended to be used to facilitate the cutting and coagulation of soft tissue, to manage surgical smoke during laparoscopic surgical procedures, and is indicated for use in laparoscopic surgery.

· The IonPencil™ is intended to be used to facilitate the cutting and coagulation of soft tissue, to manage surgical smoke during general surgical procedures, and is indicated for use in surgery.

The Ultravision2™ System is a multifunctional system that synchronizes visual field clearing with the activation of smoke-producing electrosurgical devices. The system interfaces with commercially available electrosurgical instruments. The Ultravision2™ Generator connects directly to a commercially available electrosurgical generator (ESU) and passes the RF energy through to the desired electrosurgical instrument connected to the Utravision2™ Generator. The Ultravison2™ System is able to automate the activation of the Ionwand for visual field clearing to the electrosurgical device to synchronize visual field clearing with the generation of smoke.

The components of the overall system will be:

• Ultravision2TM system comprising: .
  • . Ultravision2TM generator
  • Link cables (x4)
  • . Power cable
  • Equipotential cable .
• . IonPencil™ accessory
• . Integrated Monopolar L-Hook(H/S)TM accessory
• Ionwand™ accessory
• . Ultravision™ 5mm Trocar accessory

The IonPencil™ is a bifunctional open surgery device that combines proprietary smoke management (via visual field clearing) and monopolar HF tissue cutting and coagulation in a single device. It's addition to the Ultravision 2 System adds the general open procedure capability to the Ultravision2™ indications of use along with the new single use accessory.

The IonPencil™ can only interface with the Ultravision2 generator which connects directly to a commercially available electrosurgical generator (ESU) for its HF monopolar energy source. The IonPencil™ provides two smoke clearing emitters that are automatically activated to clear the visual field when the device cutting function (HF) is activated. The mode of action of smoke management (visual field clearing) is electrostation as per the predicate Ultravision system. When the tissue cutting or coagulation is ceased, the visual field clearing signal is automatically switched off after a short delay period that is settable on the Ultravision2™ generator user interface.

Activation of the HF function of the IonPencil™ is via a yellow (Cut) or blue (Coag) button located on the handpiece, or via a footswitch if this connected to the parent electrosurgical generator which is connected to the Ultravision2™ system. The IonPencil™ itself is incompatible with the connectors of third-party electrosurgical generators. The IonPencil™ is provided with a 69mm long PTFE coated blade.

The following cleared accessories have not changed:

• The Integrated Monopolar L-Hook(H/S)™ is a bifunctional laparoscopic device that combines proprietary smoke management (via visual field clearing) and monopolar HF tissue cutting and coagulation in a single device.

· The Ionwand™ pack comprises a dedicated percutaneous 3mm trocar/catheter which accommodates the Ionwand™ cable that delivers low energy from the generator to the patient for smoke management.

• · The Ultravision™ 5mm Trocar includes a dedicated Ionwand™ cable.

The provided text describes the acceptance criteria and the results of non-clinical testing for the Ultravision2™ IonPencil. The study aims to demonstrate that the device is as safe, effective, and performs as well as or better than legally marketed predicate devices.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and the Reported Device Performance

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It typically does not contain the detailed methodology and results of a clinical study that would be used to prove novel device performance. The information outlines non-clinical testing and design validation under simulated use conditions.

Regarding the remaining questions, the provided text does not contain the requested information:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The text mentions "non-clinical testing" and "design validation under simulated use conditions" but does not specify sample sizes for these tests or the provenance of any data. These are likely bench tests and not human subject studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as the tests described are non-clinical, primarily focused on device specifications and performance rather than diagnostic accuracy involving human interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for non-clinical 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: Not applicable. This document describes a surgical smoke precipitator, not an AI-assisted diagnostic 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, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For non-clinical tests, "ground truth" is typically defined by engineering specifications, standard test methods, and comparison to predicate device performance. For biocompatibility, it's defined by the specific criteria of the ISO standards.
8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI/machine learning device.

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The devices are used to cut and coagulate soft tissue by means of high frequency electrical current during an electrosurgical procedure.

The Electrosurgical Pencil with coated and non-coated electrode is the monopolar active device which consists of a conductive electrode tip, an insulated shaft and a conductive post. The electrosurgical pencil consists of a plastic handle, electrical cable and a plug. The switching modes are for "CUT" and "COAG" function. A socket in front of the pencil casing is used to allow the insertion of an electrode. The electrode consists of a conductive electrode tip, an insulated shaft and a conductive post. The electrode tip may be blade, ball and needle. The electrode tip is either coated or non-coated. The diameter of the conductive post is 2,36mm. The pencil with electrode is to be connected to a general high frequency electrosurgical generator by means of the electrical cable and is used in conjunction with a patient grounding pad during an electrosurgical procedure. The switching method of electrosuraical pencil may be push button, rocker switch or foot switch, cable length of the electrosurgical pencil will be around 3m to 5m with 3-pins plug or 1-pin plug, the lengths of the blade, needle and ball electrode may be around 69mm to152mm, with coated or non-coated.

Here's a breakdown of the acceptance criteria and study information for the "Single Use Electrosurgical pencil with non-coated and non-stick electrode (Non-sterile and sterile)", based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly lay out acceptance criteria in a quantitative table format with corresponding reported performance for each criterion. Instead, it states that the device's performance "proved that the subject device and the predicate device are equivalent in the performance" through specific tests. The criteria are indirectly inferred from the performance tests conducted and the standards met.

Therefore, I will interpret the acceptance criteria as meeting the standards and demonstrating equivalence to the predicate device in the specified performance areas.

• IEC60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) (General requirements for basic safety and essential performance)
• IEC60601-2-2: 2009 (Fifth Ed) (Particular requirements for basic safety and essential performance of high frequency surgical equipment and accessories)
• IEC60601-1-2:2014 (Electromagnetic Disturbances - Requirements and Tests) |
  | Biocompatibility | Complies with ISO10993 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process). |
  | Shelf Life (3 years) | Accelerated aging tests were completed and support the proposed 3-year shelf life. |

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

• Sample Size: The document does not specify a numerical sample size for the "porcine tissue: kidney, liver, muscle" used in the performance testing. It only mentions that testing was performed on these tissue types. It also doesn't specify the number of devices tested for sterility, packaging, electrical safety, or biocompatibility, beyond implying multiple units to validate processes and claims.
• Data Provenance: The data is retrospective, as the tests were conducted to demonstrate equivalence for a 510(k) premarket notification. The country of origin of the data is not specified, but the applicant is based in Hong Kong, China. The testing itself doesn't inherently imply a specific country for data collection beyond the manufacturing location.

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

This information is not provided in the document. The performance testing involved bench testing on porcine tissue and comparison to a predicate device, as well as compliance with international standards. This type of testing typically relies on predefined test methods and measurements rather than expert consensus on a "ground truth" in the way it might for a diagnostic AI device.

4. Adjudication Method for the Test Set:

This information is not provided as it's not applicable to the type of bench testing and standards compliance reported for this electrosurgical pencil. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, often for diagnostic devices.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic performance with human readers, which is not the function of an electrosurgical pencil.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This question is not applicable to an electrosurgical pencil. This device is a physical tool used by a human surgeon; it does not involve any algorithms or AI component that would function in a standalone capacity.

7. The Type of Ground Truth Used:

For the performance tests on porcine tissue, the "ground truth" was established by direct measurement and observation of thermal effects and thermal zone sizes on the tissue, deemed equivalent to the predicate device. For other aspects, the "ground truth" was compliance with established international standards (e.g., ISO for sterilization and biocompatibility, IEC for electrical safety), which define acceptable performance parameters.

8. The Sample Size for the Training Set:

This question is not applicable. The device is an electrosurgical pencil, not an AI/ML-based device that requires a training set.

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

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

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MEGADYNE™ Telescoping Soft Tissue Dissectors are monopolar devices designed for general electrosurgical applications including cutting and coagulation (coag). The devices conduct an electrosurgical current from an electrosurgical unit (ESU) and deliver it to the target tissue to achieve the desired surgical effect. The electrosurgical active electrodes are intended to conduct radio frequency (RF) current for cutting and coagulation from the ESU to target soft tissue in a broad range of surgical procedures requiring the use of electrosurgery for cutting and cauterization. The electrosurgical active electrodes have a specific geometry that minimizes blanching and thermal damage in skin incisions when used in conjunction with the MEGADYNE™ ESU's Advanced Cutting Effect (ACE) mode or the MEGADYNE™ ESU's Geometric Electron Modulation (GEM) mode.

MEGADYNE™ Telescoping Smoke Evacuation Soft Tissue Dissectors and MEGADYNE Telescoping Smoke Evacuation Pencils are monopolar devices designed for general electrosurgical applications including cutting and coagulation (coag) and for removing smoke generated by electrosurgery when used in conjunction with a smoke evacuation system. The devices conduct an electrosurgical current from an electrosurgical unit (ESU) and deliver it to the target tissue to achieve the desired surgical effect. The [Megadyne PTFE coated] electrosurgical active electrodes are intended to conduct radio frequency (RF) current for cutting and coagulation from the ESU to target soft tissue in a broad range of surgical procedures requiring the use of electrosurgery for cutting and cauterization.

The [MEGADYNE™ Telescoping Smoke Evacuation Soft Tissue Dissector] electrosurgical active electrodes have a specific geometry that minimizes blanching and thermal damage in skin incisions when used in conjunction with the MEGADYNE™ ESU's Advanced Cutting Effect (ACE) mode or the MEGADYNE™ ESU's Geometric Electron Modulation (GEM) mode.

The Megadyne™ Telescoping Soft Tissue Dissectors, Megadyne Telescoping Smoke Evacuation Pencils, and Megadyne™ Telescoping Smoke Evacuation Soft Tissue Dissectors are sterile, single-use, hand-held electrosurgical pencils. These monopolar devices are designed for general electrosurgical applications including cutting and coagulation of tissue. The Megadyne™ Telescoping Smoke Evacuation Pencil and Megadyne Telescoping Smoke Evacuation Soft Tissue Dissector offer an additional design feature to remove smoke generated by electrosurgery, when used in conjunction with a smoke evacuation system.

The printed circuit board in the device and electrical cable provide the means for powering the devices. The device dome switch, with over-molded buttons, operate the cut and coagulate functions of the device. The yellow button controls the cut function of the device, the blue button controls the coagulate function of the device.

Within the pencil nozzle, there is a collet that holds the electrode in place. The Megadyne™ Telescoping Smoke Evacuation Pencil, and Megadyne Telescoping Smoke Evacuation Soft Tissue Dissector have a clear tube connected to the nozzle, which provides a route to remove captured electrosurgical smoke. The tubing terminates at a connector on the smoke evacuation system.

The devices are available in 10 ft. cord/tubing and 15 ft. cord/tubing. The packaged device includes:

• The pencil or handle with the attached power cord,
• A holster which may be used to hold the device when it is not in use during a surgical . procedure, and
• An electrode, which may be exchanged by the user as needed. Additional electrodes are ● distributed separately.

The provided document is a 510(k) summary for the Megadyne™ Telescoping Smoke Evacuation Pencils, Megadyne™ Telescoping Smoke Evacuation Soft Tissue Dissectors, and Megadyne™ Telescoping Soft Tissue Dissectors. It does not describe an AI/ML powered device or a study assessing algorithm performance against ground truth or human readers.

Therefore, the requested information regarding acceptance criteria, device performance measures like sensitivity, specificity, or AUC, sample sizes for test and training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or type of ground truth is not present in this document.

The document focuses on substantiating equivalence to a predicate device through:

• Bench performance testing: Including button cycling, device continuity, leakage current, fluid ingress, electrode extraction and retention, tube extension force, tube bend, biocompatibility, electrical safety, high frequency dielectric withstand, mains frequency dielectric withstand, button force, holster puncture force, thermal transfer of heat, summative usability validation, thermal spread of the electrode, electromagnetic compatibility, and package evaluations.
• Biocompatibility assessments: Including pyrogenicity, cytotoxicity, sensitization, irritation/intracutaneous reactivity, and acute systemic toxicity.
• Compliance with consensus standards: K200253 states that "All components... are in accordance with the following standards: ANSVA/AAMI/ISO 11137-2:2016, IEC 60601-1-2 ed 4 2014, ANSI AAMI 60601-1:2005, IEC 60601-2-2: 2017-03."

No specific quantitative acceptance criteria or reported values are provided for these tests within the excerpt. The document states that "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence."

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The ZIP PEN Smoke Evacuation Electrosurgical Pencil is a monopolar device designed 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. This device conducts an electrosurgical current from an electrosurgical generator and delivers it to the target tissue to achieve the desired surgical effect.

The ZIP Pen Smoke Evacuation Electrosurgical Pencil is a sterile, single use hand held electrosurgical pencil and smoke evacuation handpiece. It is a monopolar device designed 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 device consists of a printed circuit board, flexible electrical cable, dome switches, button switch mechanisms and sealing materials. The circuit board and electrical cable provide the means for powering the device. The dome switches operate the Cut and Coag functions. These components are enclosed within an upper housing and lower molded carriage and nozzle. which snap together. The buttons sit on top of the dome switches and extend through the upper housing and facilitate activation of the device. The button proximal to the electrode is yellow and controls the cut function of the device. The button distal to the electrode is blue and controls the coagulate function of the device. Within the nozzle, there is a metal collett that holds the electrode in place. The housing and other components are designed and assembled to prevent liquid from entering the electrical connections (preventing an electrical short). This is accomplished by over molding the circuit board with nonconductive materials. Clear tubing connects to the nozzle and provides a path for capturing electrosuraical smoke. The electro-surgical cable leaves the tubing through an open port and terminates at a 3-prong electro-surgical plug. The remaining portion of the tubing (without cable inside) terminates at a connector that attaches to the smoke evacuation filter. The connector is attached to the tubing and is included as part of the smoke evacuation pencil for connection to the filter. The ZIP Pen Smoke Evacuation Electrosurgical Pencil is available with 10 ft. and 15 ft. cord/tubing (catalog numbers 2525-10 and 2525-15, respectively) and is supplied with two additional items: A holster, which is used to hold the device when it is not in use during the procedure. The holster is a component of the device and will not be sold separately. A 2.5 inch Megadyne E-Z Clean electrode. The electrode is a separate, currently marketed device that received clearance in 2008 via K081791. The associated accessories include: Nozzle Extension can be used in electrosurgery procedures where a longer electrode is required to extend the smoke capture nozzle to the surgical site. Filter -- the ULPA and charcoal filters can be used with smoke evacuation units. They filter surgical smoke and odors removed from the surgical site. Adapter can be used to facilitate the tubing connection to a variety of smoke evacuation filter/units on the market.

The provided text describes the 510(k) summary for the ZIP Pen Smoke Evacuation Electrosurgical Pencil and does not pertain to an AI/ML medical device. Therefore, a table of acceptance criteria and reported device performance as typically expected for such a device, and information regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance, are not available in this document.

Instead, the document details the safety and performance testing conducted to demonstrate substantial equivalence to a predicate device. Here's a summary of the performance data presented:

1. Table of Acceptance Criteria and Reported Device Performance (Non-AI device context):

Specifics not applicable to AI/ML context:

• Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this type of medical device's performance testing. The description refers to physical tests on the device itself.
• 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 device does not have a "ground truth" derived from expert interpretation.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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/ML device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• The sample size for the training set: Not applicable. This is not an AI/ML device.
• How the ground truth for the training set was established: Not applicable.

Further details from the provided text (beyond typical AI/ML criteria):

• Software Verification and Validation Testing: "Not applicable. The ZIP Pen Smoke Evacuation Electrosurgical Pencil does not contain software."
• Animal Study: "Not applicable. Animal studies were not performed on the device."
• Clinical Studies: "Clinical studies were not performed as the indications for use are equivalent to the predicate device, and clinical testing is not required by applicable regulations."

The study described here focuses on demonstrating the physical, electrical, and biological safety and performance of the device through bench testing and compliance with relevant international standards, rather than evaluating an algorithm's diagnostic or predictive performance.

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