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The LigaSure™ 5mm Vessel Sealer-Divider is a bipolar electrosurgical instrument intended for use with the LigaSure Generator in general and gynecologic laparoscopic surgical procedures where ligation and division of vessels is desired. The instrument creates a seal by application of RF electrosurgical energy to vascular structures (vessels) interposed between the jaws of the instrument. A blade within the instrument is surgeonactuated to divide tissue.

Indications for use include general laparoscopic procedures including urologic, vascular, thoracic and thoracoscopic, and gynecologic laparoscopic procedures where ligation and division of vessels is performed. These procedures include: laparoscopically assisted vaginal hysterectorny, Nissen fundoplication, colectomy, adhesiolysis, oophorectomy, etc. The LigaSure Vessel Sealing System has not been shown to be effective for tubal sterilization or tubal coaqulation for sterilization procedures, and should not be used for these procedures.

The LigaSure 5mm Vessel Sealer-Divider can be used on vessels up to and including 7mm diameter, and tissue bundles as large as will fit in the jaws of the instrument.

The LigaSure 5mm Laparoscopic Sealer-Divider is a multi-functional electrosurgical instrument for use with the LigaSure Vessel Sealing Generator (K981916) when performing laparoscopic surgery. The instrument is capable of sealing vessels, dividing vessels and tissue clamped between its jaws, grasping tissue, and blunt dissection. The outer diameter of the instrument shaft is 5mm, with a working length of 37 cm. Controls are located on the instrument handle. All controls can be operated with either the right or left hand.

The instrument attaches to the generator with a "smart" connector that identifies the instrument type to the LigaSure generator, and a ten (10) foot cable. The instrument is supplied sterile for single-use.

The provided text is a 510(k) premarket notification for a medical device, the Valleylab LigaSure™ 5mm Laparoscopic Sealer-Divider. It asserts substantial equivalence to predicate devices and describes the device's intended use and technological characteristics. However, it does not contain detailed information about specific acceptance criteria, study designs, sample sizes, expert qualifications, or adjudication methods for performance data demonstrating the device meets acceptance criteria.

The document states: "Performance testing and pre-clinical studies were performed to ensure that the LigaSure™ 5mm Laparoscopic Sealer-Divider functions as intended, and meets design specifications. Sufficient data were obtained to show that the device is substantially equivalent to the predicate devices, and meets safety and effectiveness criteria."

This statement confirms that studies were done, but the specifics of how "design specifications" and "safety and effectiveness criteria" were defined, measured, and met are not included in the provided text.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported performance, sample sizes used, data provenance, number and qualifications of experts, adjudication methods, details of MRMC or standalone studies, or how ground truth was established, as this information is not present in the provided K031011 document.

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The E7512 Neonatal REM PolyHesive™ II Neonatal Patient Return Electrode is a single use, non-sterile dispersive electrode with a preattached cord. The electrode adheres to the patient over its entire surface. Its purpose is to complete the electrosurgical circuit between the generator, the active electrode, and the patient.

Indications for use are general monopolar electrosurgery on newborn or prematurely born patients of between approximately 1 and 6 lbs.

The E7512 Neonatal REM PolyHesive™ II Neonatal Patient Return Electrode is a single use, non-sterile dispersive electrode with a preattached cord, the purpose of which is to complete the electrosurgical circuit between the generator, the active electrode, and the patient. It is specifically designed for use on newborn and prematurely born patients whose small size creates a limited area for pad placement and makes placement of other, larger-size pads difficult.

The provided document is a 510(k) summary for a medical device (E7512 Neonatal REM PolyHesive™ II Neonatal Patient Return Electrode). It describes the device, its intended use, and its technological characteristics compared to predicate devices. It states that performance testing has been done to verify function and meet design specifications and standards. However, this document is a regulatory submission intended to demonstrate substantial equivalence, not a detailed study report that proves a device meets specific acceptance criteria with reported numerical performance values.

Therefore, I cannot extract the level of detail regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, or clinical study specifics (like MRMC studies or human-in-the-loop performance) that your request entails from this document.

The document primarily focuses on:

• Device Identification: Proprietary and common names, classification, and submitter information.
• Predicate Devices: Listing previously cleared devices for comparison.
• Device Description: Physical characteristics and function.
• Intended Use: The patient population and surgical context for the device.
• Technological Characteristics: How the device compares to predicates, noting differences in size, REM system inclusion, and adhesive border.
• Performance Data (General Statement): A general statement that "Performance testing has been performed to verify that the device functions as intended and that design specifications and applicable consensus standards have been met." It does not provide the specific acceptance criteria or the actual performance results.

In summary, the detailed information requested regarding the acceptance criteria and study particulars is not present in this 510(k) summary. This document confirms that performance testing was done, but not what the acceptance criteria were, how the device performed against them, or the specific methodology of those tests in detail.

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The BiSure™ Laparoscopic Bipolar Forceps is intended for use during laparoscopic bipolar coagulation.

The BiSure™ Laparoscopic Bipolar Forceps is a coagulating forceps device that is intended for laparoscopic use. Coagulation is achieved under laparoscopic visualization by applying electrosurgical energy to the forceps. The device is intended for use with bipolar outputs of compatible electrosurgical generators.

The device is comprised of a handle, inner and outer shafts, interchangeable forceps (electrodes), and connecting cable.

This K983743 document is a 510(k) submission for the BiSure™ Laparoscopic Bipolar Forceps and does not contain information regarding studies for acceptance criteria, device performance metrics, or clinical trial data.

The document explicitly states:
"Performance testing has been performed to verify that the device functions as intended and that design specifications have been satisfied."

However, it does not provide any specific details about the acceptance criteria, the results of the performance testing, sample sizes, ground truth establishment, or any comparative effectiveness studies.

The purpose of this 510(k) submission is to demonstrate substantial equivalence to a predicate device (Olympus Bipolar Forceps K955623), primarily based on technological characteristics and intended use, rather than presenting detailed clinical performance data against specific acceptance criteria. The changes mentioned are to non-patient contacting portions of the device, implying that the core functional performance related to coagulation is considered equivalent to the predicate.

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The LigaSure™ Vessel Sealing System is intended for use in general, laparoscopic, and gynecologic procedures where ligation of vessels is desired and as an alternative to mechanical claming (clips or staples) or suturing. The generator can also be used with standard bipolar devices where bipolar cutting or coagulation is desired.

Indications for use for this type of ligation include general, laparoscopic and gynecological procedures such as urological, thoracic, plastic and reconstructive, bowel resections, hysterectomies (LAVH and abdominal) cholesystectomics, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies, etc. The devices can be used on vessels up to 7 mm. and bundles as large as will fit in the jaws of the instruments.

The LigaSure™ Vessel Sealing Generator is an isolated, microprocessor based, bipolar only electrosurgical generator which incorporates three bipolar modes; standard, macro and vessel sealing. The generator will accept standard bipolar devices. In addition, the generator will also accept dedicated LigaSure™ Open and Laparoscopic Instruments for use in vessel sealing.

The LigaSure™ Open instruments are reusable forceps type devices with "snap-in" single use, disposable electrodes which are placed in the jaws of the devices. The LigaSure™ laparoscopic instrument is a sterile, single use device for use in grasping and vessel sealing in laparoscopic procedures. The device outer diameter is 5 mm and the working length is approximately 32 cms.

The system creates vessel ligation by the application of bipolar electrosurgical RF energy (coagulation/desiccation) to vessel tissue or vascular bundles interposed between the electrodes of the device.

The provided text does not contain detailed acceptance criteria with numerical targets. Instead, it describes general claims of effectiveness and safety, and outlines specific performance data evaluated.

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

Acceptance Criteria and Reported Device Performance

The document states that "Sufficient data was obtained to show the LigaSure™ Vessel Sealing system was equivalent to or better than the predicate devices and meet safety and effectiveness criteria." This implies the acceptance criteria were based on demonstrating equivalence or superiority to predicate devices in terms of safety and effectiveness, but specific quantitative metrics for these criteria are not provided.

Details of the Study

The document generally refers to "Preclinical laboratory (acute and chronic studies) and performance testing." It does not provide detailed specific study information such as sample sizes, data provenance, ground truth establishment, or specific types of studies often associated with AI/software device evaluation.

1. Sample size used for the test set and the data provenance: Not specified in the provided text. The text mentions "preclinical laboratory (acute and chronic studies) and performance testing," but does not detail the size of the test sets (e.g., number of vessels, animals, or human subjects) or the origin of the data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. This information is typically relevant for studies involving subjective medical image interpretation or clinical expert consensus, which is not the primary focus of this device (an electrosurgical system).
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable and not specified in the context of this device type and the provided information.
4. 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 device is an electrosurgical system for vessel sealing, not an AI-powered diagnostic or interpretive tool that assists human readers.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. As mentioned, this is a hardware electrosurgical system, not a standalone algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for device performance (e.g., sufficient sealing, lack of adverse events) would likely be established through direct observation, physical measurements (e.g., burst pressure), and histological analysis in preclinical studies, rather than expert consensus on interpretive data. However, the specific methods for establishing ground truth are not detailed.
7. The sample size for the training set: Not applicable as this is a hardware device, not a machine learning algorithm that requires a training set.
8. How the ground truth for the training set was established: Not applicable.

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The CUSA EXcel Ultrasonic Surgical Aspirator System is intended for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue is desirable, including: Neurosurgery Gastrointestinal and Affiliated Organ Surgery Urological Surgery Plastic and Reconstructive Surgery General Surgery Orthopedic Surgery Gynecological Surgery Thoracic Surgery Laparoscopic Surgery Thoracoscopic Surgery The system may also be combined with electrosurgery using the optional CUSA Electrosurgical Module (CEM).

The CUSA EXcel Ultrasonic Surgical Aspirator System is an ultrasonically vibrating surgical device which, in combination with irrigation and aspiration, fragments, emulsifies and removes unwanted tissue. It allows the selective dissection of target tissues while preserving vessels, ducts and other delicate structures. The CUSA EXcel System consists of a console which provides control and power functions, a surgical handpiece which provides ultrasonic mechanical energy to the surgical site, a titanium handpiece tip and flexible irrigation flue, and a suction/irrigation system (manifold tubing and cooling water canister). The CUSA EXcel System accommodates most commercially available suction canisters, and specimen traps (optional). A two-pedal footswitch is provided with the console. The CUSA EXcel System may be used with an external CUSA Electrosurgical Module (CEM), which will provide optional electrosurgical capability. The CEM module is a Force FX-8 Generator (FDA clearance was received for the Force FX Generator under K#944602). This provides the surgeon with the option of delivering cutting or coagulating current through the CUSA handpiece tip to the surgical site. The CEM function is controlled either with the Force FX-8 footswitch or by hand, using the CEM nosecone control button(s).

The provided text is a summary of safety and effectiveness information for the CUSA EXcel Ultrasonic Surgical Aspirator System, a medical device. It does not describe a study involving patient data, expert readers, or AI.

Therefore, many of the requested sections about acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance cannot be extracted from this document, as they pertain to clinical or AI-based performance studies which are not detailed here.

The document focuses on:

• Product Description: Explaining what the device is and its features.
• Intended Use: Listing the surgical procedures for which the device is intended.
• Safety and Performance Data: Stating compliance with various electrical and biocompatibility standards. It mentions "Validation and verification... will be accomplished through a combination of analysis and testing," including a "Risk Analysis and an electro/mechanical performance test on prototype units." It also states, "Testing has verified the safe performance and proper function of the product."
• Substantial Equivalence: Comparing the device to previously marketed predicate devices.
• FDA Clearance Letter: Confirming the device's substantial equivalence and clearance for marketing.

Here is what can be extracted based on the provided text:

Acceptance Criteria and Reported Device Performance

The document describes compliance with recognized standards rather than specific quantitative performance metrics against clinical acceptance criteria.

Study Details (Based on available information)

1. Sample size used for the test set and the data provenance: Not applicable. The document discusses device testing against standards and substantial equivalence, not a clinical study involving a "test set" of patient data. Testing was performed on "prototype units" and the "CUSA EXcel Handpiece and accessories."
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical "test set" with ground truth established by experts is described.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. 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 device is an ultrasonic surgical aspirator, not an AI or imaging diagnostic device, and no MRMC study is mentioned.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm or AI component is described. The "standalone" performance here refers to the device's functional and safety performance, which was verified through engineering tests.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical ground truth. The "ground truth" for the device's safety and performance was compliance with established engineering and biocompatibility standards, and functional testing on prototype units.
7. The sample size for the training set: Not applicable. There is no mention of a "training set" as this is not an AI or machine learning device.
8. How the ground truth for the training set was established: Not applicable.

In summary, the provided document details the regulatory clearance of a medical device based on compliance with established safety standards and substantial equivalence to predicate devices, rather than a clinical study evaluating diagnostic or prognostic performance with a patient cohort.

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The Indications for Use of the Valleylab OptiMumm™ Smoke Evacuator system are for the removal of smoke and incidental fluids produced during electrosurgery and/or laser surgery. The removal of smoke from the surgical site improves visibility and reduces potential health hazards associated with surgical smoke.

The Valleylab OptiMumm™ Smoke Evacuator system includes the OptiMumm™ smoke evacuator unit, footswitch, fluid canister ring, fluid canister kit, tubing sets, filters, adapters, remote activation unit (RapidVac™ Electrosurgery Sensor), and smoke evacuator wand. A centrifugal fan provides suction, drawing the smoke into and through the system and filters. The smoke evacuator unit is designed to provide an airflow (suction) of 2.70 cfm minimum to 20.0 cfm maximum with the 7/8" tubing set. The dimensions of the evacuator are 17"D x 13-3/8"W x 9"H (without feet) and it weighs approximately 34 lbs. (without filters).

The smoke evacuator is to be used with a variety of accessories including a wand, tubing, adapters, filters, and fluid canister. These accessories will be offered both sterile and non-sterile and will be sold under separate catalog numbers.

All of the controls for the smoke evacuator unit are located on the front panel. These are:

• Mode Selector A dial control for the unit operation with four mode settings: .
  Standby - powers up the unit without activating the motor or vacuum flow.
  Footswitch - used to turn the smoke evacuator on or off with the optional footswitch.
  Remote Flow Control (RapidVac) - used to control the vacuum flow simultaneously with activation of a Valleylab electrosurgical pencil. The mode is controlled with the optional generator Interlink or electrosurgery sensor.
  Continuous - used to operate the evacuator using continuous air flow.
• . Variable Speed Selector - This dial controls five variable speed settings. The user set speed setting is indicated by LED's.
• Pressure Sensor Test and Status Light Indicator A button is pressure drop across . an ULPA filter. The filter status is indicated by two LED's: green (good filter), red (replace filter), and , flashing red (filter not installed).
• RapidVac Connect Accepts the cord for the remote flow control via the current monitor. ●
• Footswitch Connect Accepts one pneumatic footswitch. .

The rear panel of the smoke evacuator incorporates the AC line receptacle, which fits a detachable line cord and contains a locking mechanism, the Rapid Vac connect which accepts the cord for remote flow control by way of the ECG blanking output of certain Valleylab generators, and, a circuit breaker. A handle is also included on the rear of the unit for carrying purposes

The OptiMumm™ Smoke Evacuator system requires the use of two filters; an ULPA filter and a disposable prefilter. The ULPA filter is a two stage filter the first stage of which is a charcoal media and the second stage, the ULPA filter. The ULPA is 99.999% efficient at 0.12 microns and will have an estimated useful life of approximately 25 hours. It is designed to trap microscopic particles and absorb odors generated by electrosurgical procedures. The disposable prefilter is a single use 0.3 micron filter and is designed to trap gross particulate matter. Its useful life is approximately 30 minutes of continuous use with heavy smoke.

Surgical smoke is collected at the surgical site by tubing or a wand which is attached by tubing to the smoke evacuator unit. It can also be collected by the Valleylab Accuvac smoke attachment which clips to the Valleylab electrosurgical pencil. Activation of the smoke evacuator unit can be controlled through a footswitch, or the unit can be placed in a continuous flow mode, or it can be activated via the remote sensor, the Valleylab Rapid Vac.

The remote flow control unit, RapidVac, allows flow control of the smoke evacuator unit on activation of the electrosurgical pencil (active). The unit is basically a current sensor through which the cord of the electrosurgical pencil is inserted. When the pencil is keyed (activated), the sensor detects current flow through the pencil cord and activates the smoke evacuator so that the operating speed increases to the speed pre-selected by the user. When the pencil is deactivated, the smoke evacuator reduces flow to a low flow purging setting.

The Valleylab OptiMumm™ Smoke Evacuator system, as described in the provided text, does not detail acceptance criteria and a study proving device performance in the manner typically expected for diagnostic AI/ML models (e.g., sensitivity, specificity, AUC, human-AI comparative studies). Instead, the document focuses on safety and performance data related to engineering specifications, regulatory compliance, and biological safety for a physical medical device (a smoke evacuator).

Here's an analysis based on the information provided, framed to address your requested points where applicable, and noting where information is absent for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable in the context of this device's evaluation. The evaluation described is for a physical medical device, not a diagnostic AI/ML model requiring a test set of data samples (e.g., images, patient records). The testing refers to bench testing and validation/verification of the device's physical and electrical properties, and material biocompatibility.
• Data Provenance: Not applicable. The "data" here are engineering measurements, material test results, and compliance checks, not 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, in the AI/ML context, refers to expert-annotated labels for data. For this smoke evacuator, the "ground truth" is based on established engineering principles, regulatory standards (UL, EN, ISO, USP), and documented material properties. The experts involved would be engineers, materials scientists, and regulatory compliance officers, but their roles are not defined as "establishing ground truth for a test set" in the AI/ML sense.

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

• Not applicable. Adjudication methods are used to resolve discrepancies in expert labeling of data for AI/ML models. This is a physical device evaluation.

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 relevant for evaluating the impact of AI assistance on human performance (e.g., diagnostic accuracy). This document describes a physical device, not an AI diagnostic tool, so such a study was not performed.

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

• Not applicable. This is not an algorithm. The device performance (e.g., airflow, filter efficiency) is a standalone measurement of the device's physical capabilities.

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

• The "ground truth" for this device's performance relies on established engineering specifications, adherence to recognized industry standards (UL, EN, ISO, USP), and validated bench testing results. For example, filter efficiency is a quantifiable physical property, not subject to expert consensus in the diagnostic sense. Biocompatibility relies on material testing protocols vs. established biological safety criteria.

8. The sample size for the training set

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

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

• Not applicable. No training set for an AI/ML model is involved.

Summary of the Study Proving the Device Meets Acceptance Criteria:

The document states that the safety and performance of the Valleylab OptiMumm™ Smoke Evacuator and its accessories have been "evaluated and verified through validation/verification and bench testing."

Specifically, the study proving the device meets its "acceptance criteria" (which are primarily engineering specifications and regulatory compliance) consists of:

• Bench Testing: This involved directly measuring the device's physical properties, such as airflow (reported as 2.70 cfm minimum to 20.0 cfm maximum for the 7/8" tubing set) and verifying the functionality of controls and indicators.
• Conformance to Standards: Testing was conducted to ensure compliance with specific electrical and electromagnetic standards (UL2601, EN55011). The document explicitly states, "Product testing showed conformance to design specifications and also to the above standards."
• Biocompatibility Testing: Materials used for components like tubing sets, adapters, and wands were tested according to USP Class III minimum and ISO Standard 10993-1, Part 1. This ensures that the device's components are safe for biological interaction.
• Filter Efficiency and Lifespan Evaluation: The characteristics of the ULPA filter (99.999% efficient at 0.12 microns, ~25 hours lifespan) and prefilter (~30 minutes lifespan) were determined, presumably through laboratory testing under specified conditions.

The overall "study" demonstrating the device meets its criteria is a comprehensive set of engineering tests, material evaluations, and regulatory compliance checks, as opposed to a clinical study with patient data or an AI/ML model evaluation.

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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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The Force Argon™ II Argon Enhanced Electrosurgical System is intended for use in both open, laparoscopic, and thoracoscopic surgical procedures (general. neurosurgical, gynecologic) where monopolar electrosurgery (cutting and coagulation) is normally used. The Force Argon™ II Argon Enhanced Electrosurgical System provides a controlled flow of argon to electrosurgical handsets during cutting and coagulation. When the handset is activated in the gas enhanced modes, an argon gas plasma is created between the electrode and the tissue.

The Force Argon™ II Argon Enhanced Electrosurgical System is designed to provide a controlled flow of argon (an inert, non-reactive gas) to custom designed electrosurgical handsets powered by Valleylab electrosurgical generators. The handsets allows the surgeon to perform argon enhanced electrosurgery in open and laparoscopic procedures. Depending on the handpiece, the system can function in the following argon enhanced modes: - Argon Shrouded Cut Argon gas is delivered through the handset . while the attached electrosurgical generator is activated in the cut mode. - Argon Enhanced Coag Argon gas is delivered through the handset while . the generator is activated in the coag mode. The Force Argon™ II Argon Enhanced Electrosurgical System has two gas flow modes; one for laparoscopic procedures (Low Flow Mode, 0.5 - 4.0 SLPM) and one for open procedures (Standard Flow Mode, 0.5-12 SLPM). In addition, the system monitors the peritoneal pressure during laparoscopic procedures. The physician can set the desired pressure on the Force Argon™ II Argon Enhanced Electrosurgical System. When the peritoneal pressure approaches a predefined percentage of the set pressure, an alarm is activated to alert the user. A second alarm sounds when the actual peritoneal pressure reaches the set point. The physician can then vent the peritoneal cavity to relieve the pressure. The Force Argon™ Argon Enhanced Electrosurgical System is designed to allow the physician to continue to use argon enhanced electrosurgery when the peritoneal pressure set limit is reached. The Force Argon™ II unit is designed to fit on a table top or a cart. Tank holders will be offered for use with the Valleylab Gas Delivery System carts which will accommodate argon tank sizes ranging from 14 to 42 cubic feet.

The provided text does not contain detailed acceptance criteria or a study proving the device meets those criteria in the format requested. The document is a "Summary of Safety and Effectiveness" which focuses on product description, intended use, and general validation methods, primarily for regulatory submission (K96636), rather than a specific clinical study with detailed performance metrics.

Here's an analysis of what is available and what is missing:

The document mentions validation, but not in the context of statistical acceptance criteria and reported device performance as would be found in a clinical study.

What can be extracted:

• Device Name: Force Argon™ II Argon Enhanced Electrosurgical System
• Intended Use: For use in both open, laparoscopic, and thoracoscopic surgical procedures where monopolar electrosurgery (cutting and coagulation) is normally used, providing a controlled flow of argon to electrosurgical handsets during cutting and coagulation.
• Validation Methods mentioned:
  • Preclinical testing
  • Hardware validation and testing (against standards like IEC 601-1, IEC 601-2-2, EN 60601-1-2, IEC 801-3, ANSI/AAMI HF18)
  • Software validation (in accordance with accepted industry standards)
  • Biocompatibility testing (USP Class V for peritoneal pressure tubing materials)
  • Preclinical and Laboratory Bench Testing (using a swine model and simulated laparoscopic model)

Specifically addressing your requested points based on the provided text:

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

   • Not Available. The document states "Preclinical and laboratory bench testing... showed the Force Argon™ II Argon Enhanced Electrosurgical System functioned according to specification and monitored peritoneal pressure as designed." However, the specific specifications or detailed performance metrics (with values) are not provided.

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

   • Not Available. The document mentions a "swine model" and a "simulated laparoscopic model" for preclinical and bench testing. No sample sizes are given for these models, nor is information about a "test set" in the context of human data.

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

   • Not Applicable. The testing described is preclinical and bench testing, not clinical studies involving expert interpretation of data.

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

   • Not Applicable. No human adjudication of results is mentioned in the context of the described preclinical/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:

   • Not Applicable. This device is an electrosurgical system, not an AI-powered diagnostic imaging tool. MRMC studies are not relevant to its validation.

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

   • Not Applicable. Again, this is a medical device for surgical procedures, not an algorithm. However, the hardware and software components were validated "standalone" in their respective validation sections.

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

   • For the preclinical/bench testing, the "ground truth" was likely the expected functional performance of the device according to its design specifications (e.g., argon flow rates, pressure monitoring accuracy). For biocompatibility, it was adherence to USP Class V.

8. The sample size for the training set:

   • Not Applicable. This is not an AI/machine learning product where a "training set" would be used in that context. Software validation followed "accepted industry standards," suggesting traditional software engineering testing.

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

   • Not Applicable. See point 8.

In summary: The provided text outlines the regulatory submission for a medical device and describes various validation activities for its hardware and software components. It does not contain the detailed clinical study information (acceptance criteria, specific performance metrics, human reader studies, or AI training data details) that your questions are geared towards. The document focuses on demonstrating that the device functions as intended and meets relevant safety standards, primarily through engineering tests and preclinical models, and establishing substantial equivalence to previously cleared devices.

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