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

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

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

The LigaSure 5mm Blunt Tip Laparoscopic Sealer-Divider is a multifunctional electrosurgical instrument for use with the ForceTriad™ generator when performing laparoscopic surgery. The instrument is capable of sealing vessels and lymphatics, dividing tissue (including vessels) clamped between the jaws, grasping tissue, and blunt dissection. The outer diameter of the instrument shaft is 5mm, with a working length of 37 cm. The following controls are located on the instrument handle: A lever for opening and closing the instrument jaws. The mechanism incorporates a latch to hold the jaws in the closed position during vessel sealing and cutting. An activation button for generator power to initiate vessel sealing. A trigger for actuating the cutter. The cutter can only be actuated when the jaws are closed and latched. A knob to rotate the instrument jaws. The jaws can rotate 179 degrees to facilitate surgeon access and visibility. All controls can be operated with either the right or left hand. Vessel scaling can be initiated using the activation button, or utilizing a footswitch connected to the generator. The instrument attaches to the ForceTriad generator via a ten foot cord with a "Smart" connector that identifies the instrument type to the generator. The instrument is supplied sterile for single use.

The provided text is a 510(k) summary for the LigaSure 5mm Blunt Tip Laparoscopic Sealer-Divider. It describes the device, its intended use, and states that non-clinical testing was performed, but no specific acceptance criteria or detailed study results are provided in the document. The summary only generally states that "The data obtained showed that the device is substantially equivalent to the predicate and meets the safety and effectiveness criteria," without listing criteria or performance metrics. Furthermore, it explicitly states, "No clinical testing was conducted."

Therefore, I cannot fulfill all parts of your request with the given information.

Here's what can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• The document does not provide a table of acceptance criteria or specific reported device performance metrics that can be accurately tabulated. It only states that the device "meets design specifications" and "meets the safety and effectiveness criteria."

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

• Sample Size: Not specified. The document mentions "ex-vivo tissue studies" and "in-vivo tissue studies (porcine and canine model)" but does not detail the number of samples or animals used.
• Data Provenance: The studies were non-clinical, involving ex-vivo and in-vivo (porcine and canine model) tissue studies. The country of origin for these studies is not specified, but the applicant's address is Boulder, CO, USA. The studies were retrospective, as they were conducted to support a Special 510(k) for a modified device.

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

• Not applicable. As this was non-clinical testing (ex-vivo and in-vivo animal models), the concept of "experts establishing ground truth" in the context of clinical interpretation of data (e.g., radiologist consensus) is not relevant. The ground truth would likely be established through physical measurements, histological analysis, and observed physiological outcomes in the animal models, rather than expert interpretation of images or clinical assessments.

4. Adjudication method for the test set

• Not applicable. Given that the testing was non-clinical and did not involve human interpretation of results requiring adjudication (like image analysis in a clinical study), an adjudication method is not described or relevant.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, 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 a surgical instrument, not an AI-assisted diagnostic or interpretive tool that would involve human readers or AI assistance in that context.

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

• Not applicable. This device is a manual surgical instrument. The concept of an "algorithm only" or "human-in-the-loop performance" does not apply to its function.

7. The type of ground truth used

• Non-clinical (Ex-vivo/In-vivo observations): Ground truth would have been established through direct measurements, histological examination of sealed tissues, observation of immediate and delayed physiological effects in live animal models (e.g., vessel patency, bursting strength, thermal spread), and technical performance assessment against design specifications.

8. The sample size for the training set

• Not applicable. This device is a physical surgical instrument, not an AI or machine learning model that requires a "training set."

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

• Not applicable. As above, there is no training set for this type of device.

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The Cool-tip™ Switching Controller is to be used with the Cool-tip™ RF System and is intended for use in percutaneous, laparoscopic, intraoperative coagulation and ablation of tissue, such as the partial or complete ablation of non-resectable liver tumors, and osteoid osteoma tumors within bone.

The Cool-tip™ Switching Controller (CTSW Control) is an adjunct device for the Cooltip™ RF Ablation Generator. Power from the generator is routed to the controller and allows the physician to ablate lesions with one single Cool-tip electrode or one cluster electrode, or simultaneously with two or three single pre-placed electrodes. The controller sequentially switches power between the electrodes. Power is applied to the first electrode until the tissue impedance rises to the target value (30 percent above the baseline value), or until 30 seconds have elapsed. Then power is switched to the next electrode. Power is switched repeatedly until the selected procedure time is reached. The controller does not alter the basic functions available on the generator. The controller has the same timing, temperature measurement, and impedance measurement functions available on the generator. The controller does not change the power available at the electrodes compared to the generator without the controller. The indications for use and the control mechanisms for the Switching Controller remain the same as for the generator. The Switching Controller is an accessory that allows for the simultaneous activation of multiple electrodes. Activation of multiple electrodes during a single treatment session is a convenience for the physician and allows for the ablation of multiple lesions simultaneously, or for the ablation of one large tumor when the electrodes are placed 2 cm apart. Placing three single electrodes in close proximity produces a cluster electrode where the physician is controlling the cluster spacing. The controller automates the manual function of cauterization of the electrode track by controlling the temperature during electrode removal. The front panel of the Switching Controller contains an on/off power switch, activation switches for ablation and cauterization, ablation timer displays and buttons, three (3) electrode ports for the connection of selected electrodes, three (3) buttons for activating selected electrode channels, three (3) temperature probe displays with adjacent green bars to indicate the activated electrode channel, and three (3) current/watts displays for each electrode channel. The Cool-tip™ Switching Controller is comprised of the following components: Switching controller, Cable, which delivers power from the generator to the controller. The Switching Controller is connected to the Cool-tip RF generator by a dedicated cable that delivers power from the generator to the switching controller. The Switching Controller cannot direct power to the electrodes without the generator.

The Cool-tip™ Switching Controller is an adjunct device for the Cool-tip™ RF Ablation Generator, designed to facilitate the simultaneous activation of multiple electrodes. It routes power from the generator, allowing the physician to ablate lesions with one single electrode, one cluster electrode, or simultaneously with two or three pre-placed electrodes. The controller sequentially switches power between electrodes until the selected procedure time is reached. It also automates the manual function of cauterization during electrode removal.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state numerical acceptance criteria for a specific performance metric (like accuracy, sensitivity, or specificity). Instead, the acceptance is based on the device demonstrating safety and efficacy comparable to a predicate device. The key performance aspect is the ability of the switching controller to produce similar therapeutic effects (lesions) as the predicate device when using various electrode configurations.

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

The study involved preclinical testing on bovine liver, both ex vivo (outside the body) and in vivo (in a living organism). The document does not specify a precise numerical sample size (e.g., number of livers, number of ablation procedures, or number of electrodes tested).

However, the data provenance is clearly stated as bovine liver, indicating an animal model. The study is described as "preclinical testing," implying it's a prospective study designed to compare the new device to the predicate.

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

The document does not provide information on the number or qualifications of experts used to establish ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method for the test set. The comparison of lesion characteristics likely involved direct measurement and observation rather than expert consensus on a diagnostic outcome.

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

No, an MRMC comparative effectiveness study was not conducted. This device is an accessory to an existing RF ablation system and its performance demonstration focuses on the equivalence of the generated lesions, not on diagnostic accuracy involving human readers.

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

This question is not applicable in the context of this device. The Cool-tip™ Switching Controller is a hardware accessory that automates power delivery for RF ablation electrodes. It does not involve algorithms for interpretation or generate diagnostic outputs that would have a "standalone performance" in the typical sense of AI/software. Its performance is intrinsically tied to its interaction with the RF generator and electrodes.

7. The Type of Ground Truth Used

The ground truth for this study was based on the characteristics of the lesions produced by the RF ablation. The statement "lesions produced... are comparable" implies a physical assessment of ablation zones (e.g., size, shape, completeness) as the reference for comparison. This would likely involve macroscopic and/or microscopic examination of the ablated tissue.

8. The Sample Size for the Training Set

The document does not mention a training set. This is not a machine learning device, so the concept of a training set as used in AI development is not applicable here.

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

As there is no training set for this hardware device, this question is not applicable.

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The ForceTriad™ is a full-featured electrosurgical generator intended for open and laparoscopic surgical procedures where the surgeon requires electrosurgical cutting, coagulation, or vessel sealing (tissue fusion). The generator is intended for use in general, laparoscopic and gynecologic surgical procedures where ligation of vessels, pulmonary vasculature, or lymph vessels, is desired. The system creates a vessel ligation (seal) by the application of bipolar electrosurgical RF energy (coagulation) to vessels interposed between the jaws of the device. The generator can also be used with standard bipolar devices where bipolar cutting or coagulation is desired.

The indications for use include general (including urologic, thoracic, plastic and reconstructive), laparoscopic, and gynecological procedures where electrosurgical cutting and coagulation of tissue, and sealing (fusion) of vessels, including pulmonary vessels, and tissue bundles is performed. including such procedures as bowel resections, hysterectomies (both vaginal and abdominal), laparoscopic cholesystectomies, laparoscopically assisted vaginal hysterectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomy, etc. The devices can be used on vessels (arteries, veins, pulmonary arteries, pulmonary veins, lymph) up to 7mm and bundles as large as will fit in the jaws of the instruments.

The LigaSure tissue fusion function has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this function for these procedures.

The ForceTriad™ generator is a full-featured electrosurgical generator with monopolar, bipolar, and Valleylab LigaSure™ vessel sealing outputs. This 510(k) only applies to the LigaSure™ Vessel sealing portion of the generator. The generator is electrically isolated, microcontroller-based device, incorporating closed-loop control for all output modes implemented in the microcontroller firmware. The generator incorporates Instant Response™ technology to constantly measure the electrical impedance of the tissue and instantaneously adjust the generator output to maintain the desired power.

The generator is used with a selection of instruments designed for use with the ForceTriad and the LigaSure Vessel Sealing generator. All of the instruments are capable of sealing vessels up to, and including, 7mm, and tissue bundles as large as can fit in the jaws of each instrument. When a LigaSure™ instrument is applied to a vessel or tissue bundle and RF energy is applied, the collagen and elastin in the tissues are reformed by heat and pressure to fuse vessel walls, thereby forming a permanent seal. The microprocessor in the generator monitors the tissue properties, stops the application of energy, and allows a brief period of cooling before indicating that cycle is complete.

No changes are being made to the design or operation of any of the devices within the current system. The change as proposed in this 510(k) notification is to the intended use as described above and the resulting labeling changes.

This document describes the ForceTriad™ Electrosurgical Generator, specifically its LigaSure™ Vessel Sealing System component. The submission is a 510(k) for a change in intended use and labeling, as the technological characteristics of the device have not been modified.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

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

   The document does not explicitly state quantitative acceptance criteria in a table format. However, it implicitly defines successful performance for the LigaSure™ vessel sealing function:

   Acceptance Criteria (Implied)	Reported Device Performance
   Effective sealing of pulmonary vasculature	Pre-clinical studies (acute and chronic) and bench testing have shown that the ForceTriad Electrosurgical Generator effectively seals pulmonary vasculature.
   Seals with burst pressures substantially greater than physiologic pressures in the vessels	Pre-clinical studies (acute and chronic) and bench testing have shown that the ForceTriad Electrosurgical Generator produces seals with burst pressures substantially greater than the physiologic pressures in the vessels.
   Capability to seal vessels up to and including 7mm	All of the instruments are capable of sealing vessels up to, and including, 7mm. The devices can be used on vessels (arteries, veins, pulmonary arteries, pulmonary veins, lymph) up to 7mm.
   Capability to seal tissue bundles as large as can fit in the jaws of each instrument	All of the instruments are capable of sealing tissue bundles as large as can fit in the jaws of each instrument. The devices can be used on... bundles as large as will fit in the jaws of the instruments.
   Formation of a permanent seal to fuse vessel walls	When a LigaSure™ instrument is applied to a vessel or tissue bundle and RF energy is applied, the collagen and elastin in the tissues are reformed by heat and pressure to fuse vessel walls, thereby forming a permanent seal. The microprocessor in the generator monitors the tissue properties, stops the application of energy, and allows a brief period of cooling before indicating that cycle is complete.

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

   The document states: "Pre-clinical studies (acute and chronic) and bench testing have shown that the ForceTriad Electrosurgical Generator effectively seals pulmonary vasculature..."

   • Sample size: Not specified.
   • Data provenance: Not specified, but "pre-clinical studies" generally implies laboratory or animal studies, and "bench testing" is laboratory-based. No information on country of origin is provided. Both would be considered prospective studies in their design.

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)

   Not applicable. The performance is assessed through objective biophysical measurements (e.g., burst pressure) and physical observation of sealing, not through expert human interpretation of images or clinical outcomes that require expert consensus for ground truth.

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

   Not applicable. Adjudication methods like 2+1 are typically used for establishing ground truth from multiple human readers, often in image-based diagnostic studies. This study relies on objective physical measurements and observations.

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 a medical device performance study, not a diagnostic AI study involving human readers.

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

   Yes, the performance data presented is for the device operating in a standalone manner. The device itself (the ForceTriad™ Electrosurgical Generator with its LigaSure™ functionality) is assessed based on its ability to achieve effective vessel sealing and high burst pressures, without human intervention in the sealing process once initiated. The human's role is in operating the device, not in interpreting its output for the technical performance measurements.

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

   The ground truth is established through objective biophysical measurements (e.g., burst pressure testing) and direct observation of physical outcomes (e.g., effective sealing/fusion of vessels). This type of ground truth is based on engineering and physiological principles rather than expert interpretation of medical data.

8. The sample size for the training set

   Not applicable. This device is not an AI/machine learning model in the sense that it requires a "training set" of data to develop its algorithm. The device's operation is based on established electrosurgical principles and a microcontroller-based closed-loop control system. Its parameters are likely determined through engineering design and validation, not a data-driven training process.

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

   Not applicable, as there is no "training set" in the context of this electrosurgical generator's design and validation described here.

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The Valleylab LigaSure Advance™ is a 5mm laparoscopic, electrosurgical instrument that incorporates both monopolar and LigaSure™ tissue fusion (bipolar) functionality. It is intended for use with the Valleylab ForceTriad™ energy platform (electrosurgical generator) in general and gynecological, laparoscopic, surgical procedures where ligation of vessels, including lymph vessels, is desired. The monopolar feature of the instrument will be used where electrical dissection through tissue planes and creation of enterotomies or gastrotomies is desired.

Indications for use include general and gynecological, laparoscopic surgical procedures (including urologic, vascular, thoracic and thoracoscopic) where electrosurgical ligation and division of vessels, including lymph vessels, is performed. These procedures include: laparoscopic gastric bypass, laparoscopically assisted vaginal hysterectomy, Nissen fundoplication, laparoscopic colectomy, adhesiolysis, oophorectomy, ctc.

The Valleylab LigaSure Advance™ 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 Valleylab LigaSure Advance™ has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

The LigaSure Advance™ is a 5mm laparoscopic vessel sealer and divider with integrated monopolar capability for energy-based dissection. The Valleylab LigaSure Advance™ is for use only with the Valleylab ForceTriad™ energy platform (electrosurgical generator), reference 510(k) notification K051644. The device will be offered in two lengths, 34 cm and 44 cm.

The LigaSure Advance™ device will be used to seal vessels, including lymph vessels, up to and including 7mm in diameter and tissue bundles. The sealed vessels and other tissue structures may be divided by the deployment of a mechanical knife that will reside within the shaft of the instrument and extends forward in a slot within the jaws when actuated by a mechanism residing within the handle of the device.

The monopolar capabilities of the device will be used to electrically dissect through tissue planes and to create openings in bowel (enterotomies) and stomach (gastrotomies). This is accomplished through a small electrode that protrudes from the distal end of one of the jaws of the device.

The controls for the device are all located on the handle. The instrument attaches to the generator with "smart" connectors, that identify the instrument type to the LigaSure generator, and a ten (10) foot cable. The instrument is supplied sterile for single-use.

The Valleylab LigaSure Advance™ is a laparoscopic electrosurgical instrument with both monopolar and bipolar (LigaSure™ tissue fusion) functionality. It is intended for use in general and gynecological laparoscopic surgical procedures for vessel ligation and division, and for electrical dissection, enterotomies, and gastrotomies using its monopolar feature. The device can be used on vessels up to 7mm in diameter and tissue bundles that fit within its jaws.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly list quantitative acceptance criteria in a table format. However, it states that "Performance testing and pre-clinical studies were performed to ensure that the LigaSure Advance™ functions as intended, and meets design specifications." The overall acceptance criterion is that the device is "substantially equivalent to the predicate devices, and meets safety and effectiveness criteria."

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

The document mentions "Performance testing and pre-clinical studies" but does not specify the sample size used for these tests.
The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective. Given the nature of pre-clinical studies for a medical device prior to market release, it is highly likely that these were prospective studies, typically conducted in animal models or ex vivo tissue models.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth.

4. Adjudication Method for the Test Set:

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.

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 mentioned in the provided document. The focus is on demonstrating substantial equivalence to predicate devices, not on comparing human reader performance with and without AI assistance.

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

This device is an electrosurgical instrument for use by surgeons; it is not an AI algorithm. Therefore, the concept of a "standalone" study for an algorithm is not applicable to this device. The performance testing would inherently involve the device being used by operators (likely skilled surgeons or technicians) in pre-clinical settings.

7. The Type of Ground Truth Used:

The document does not explicitly state the specific type of ground truth used for performance testing. However, for a surgical device like this, ground truth would typically involve:

• Direct observation and measurement of seal integrity, burst pressure of sealed vessels, tissue damage, cutting effectiveness, and performance of monopolar dissection in pre-clinical models (e.g., animal studies, ex vivo tissue).
• Histopathological assessment of sealed tissues to confirm effective vessel occlusion and absence of thermal damage affecting surrounding structures.
• Functional assessment of mechanical knife deployment and cutting.

8. The Sample Size for the Training Set:

This device is a hardware electrosurgical instrument, not an AI algorithm that requires a training set. Therefore, the concept of a "training set" sample size is not applicable.

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

As explained above, this device is not an AI algorithm, so there is no training set and therefore no ground truth established for a training set.

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The VivaWave™ Microwave Ablation System is intended for coagulation (ablation) of soft tissue.

The VivaWave™ Microwave Ablation System is not intended for use in cardiac procedures.

Valleylab recommends against the use of microwave ablation in the following situations:

• . Pregnant patients - potential risks to the patient and/or fetus have not been established.
• Patients with implantable pacemakers and other electronic . implants. Implanted electronic devices may be adversely affected by microwave power output.

The VivaWave™ Microwave Ablation System consists of one or two microwave output modules and a pump for circulating cooling fluid, installed in an integrated cart. Each microwave module has three output channels, allowing one, two, or three microwave antennas (a.k.a. probes, applicators, accessories, or instruments) to be used simultaneously. Multiple antennas may be positioned to ablate separate areas, or placed closer together to produce larger single ablations. Each output channel is limited to 65 watts maximum; a microwave module can power all three channels simultaneously at full power if desired. Systems with two microwave modules have six output channels available for simultaneous use.

Microwave module controls provided to the operator include ablation power and ablation time. All output channels that have an antenna connected operate simultaneously. Each channel receives the same power, corresponding to the power setting on the microwave module front panel. Power delivery is initiated by pushing the Ablate button on the microwave module front panel. Power delivery continues until the duration time setting is reached, or until the Ablate button is pushed again.

The VivaWave™ Microwave Ablation System is designed for use with proprietary microwave antennas such as those cleared for Vivant Medical in submissions K011676 and K032702. (Note: Vivant Medical is owned by Valleylab, a Division of Tyco Healthcare Group LP.) The antennas are connected to the VivaWave System with a proprietary connector incorporating an identification device that allows the microwave module to verify that a correct antenna is attached.

Antennas designed for percutaneous use are cooled internally with sterile saline. They are connected to the VivaWave system cooling fluid pump via sterile tubing. The pump has capacity to supply coolant to six antennas simultaneously if desired. The microwave module monitors coolant temperature within each antenna using an internal thermocouple. Delivery of microwave energy is stopped if an unsafe temperature is reached. Coolant is confined within the antenna and tubing, and does not contact the patient. The pump is controlled by an ON/OFF/Speed Control switch located adjacent to the pump.

Each microwave module can also accommodate up to three proprietary auxiliary temperature probes. (Existing device, refer to K031556.) When auxiliary temperature probes are in use, the temperature at the probe tip is displayed on the microwave module front panel. Auxiliary temperature probes are not required for operation of the VivaWave™ system.

Here's an analysis of the provided text regarding the VivaWave™ Microwave Ablation System, structured to address your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific, quantifiable acceptance criteria or report performance metrics in a way that suggests a formal acceptance criteria table. Instead, it describes general performance testing to ensure the device "functions as intended, and meets design specifications." The primary "performance data" presented is that the device was found to be "substantially equivalent" to its predicate device. This substantial equivalence determination inherently suggests that the device performs comparably to the predicate, which is itself a legally marketed device.

Therefore, since explicit criteria and direct performance values are absent, I cannot create such a table from the given information. The "performance" assessment is based on regulatory substantial equivalence rather than a detailed list of engineering or clinical performance metrics.

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

The document does not specify a sample size for a "test set" in the context of clinical or performance data. The performance data section vaguely states, "Performance testing was performed to ensure that the VivaWave™ Microwave Ablation System functions as intended, and meets design specifications. Sufficient data were obtained to show that the device is substantially equivalent to the predicate device, and meets safety and effectiveness criteria."

There is no mention of data provenance (e.g., country of origin, retrospective or prospective) for any performance data. The focus is on technical equivalence to a predicate device.

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

This information is not provided in the document. The submission is a 510(k) for substantial equivalence, which often relies more on engineering and design specifications compared to a predicate device than on extensive clinical trials with expert-adjudicated ground truth.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or described in the provided text. The document focuses on the device's technical specifications and its substantial equivalence to a predicate device, not on assessing human reader performance with or without AI assistance. The VivaWave™ system is an ablation device, not an AI diagnostic tool.

6. Standalone (i.e. algorithm only without human-in-the-loop performance) Study

This concept is not applicable to the VivaWave™ Microwave Ablation System as described. It is a medical device for tissue ablation, not an AI algorithm. Its "performance" would be related to its ability to ablate tissue effectively and safely, as demonstrated through engineering tests and comparison to a predicate, rather than an "algorithm only" performance.

7. Type of Ground Truth Used

The document does not detail specific "ground truth" establishment in a clinical sense. The "ground truth" for this 510(k) submission appears to be regulatory substantial equivalence to the predicate device (Vivant Medical VivaWave™ Microwave System K011676). This implies that if the new device functions similarly and meets the same safety and effectiveness criteria as the predicate, it is considered safe and effective. The "Performance Data" section states, "Sufficient data were obtained to show that the device is substantially equivalent to the predicate device, and meets safety and effectiveness criteria."

8. Sample Size for the Training Set

The document does not mention a "training set" as would be relevant for an AI or machine learning model. The VivaWave™ system is a hardware device with software controls, not a learning algorithm that undergoes traditional "training."

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

As no "training set" is described for this device, the question of how its ground truth was established is not applicable.

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The Cool-tip™ RF Ablation System (Generator and accessories) is intended for use in percutaneous, laparoscopic and intraoperative coagulation and ablation of tissue, such as partial or complete ablation of non-resectable liver tumors.

The Cool-tip ™ RF System consists of a microprocessor based RF generator, a peristaltic pump, electrodes, inflow and outflow tubing for electrode cooling, and return pads. The generator pump and electrodes are designed to produce local tissue heating at the tip of the electrodes causing the coagulation (ablation) of the tissue. The Cool-tip ™ RF System generator is capable of delivering up to 200 watts (into a 50 Ohm resistive load) while monitoring tissue impedance and electrode tip temperature during the delivery of the RF energy The generator includes manual and impedance control and displays/monitors impedance. current, power and temperature. The Cool-tip™ RF System electrodes are available in either a single electrode or a cluster electrode configuration. The electrodes are monopolar devices. The cluster electrode is three electrode shafts combined into one handle in a triangular patter with approximately 0.5 cm separation. The electrodes are provided sterile, for single use only. The shaft of the electrode is stainless steel that is insulated to various lengths from the tip of the electrode. Embedded within the tip of each electrode is a thermocouple for temperature measurement. Cooling of the electrode is provided by chilled sterile water which is pumped (using the peristaltic pump) through the inflow tubing, the electrode and out through the outflow tubing. This is an enclosed system within the electrode and the sterile water does not contact the patient. Because of the monopolar nature of the electrodes, electrical current flows through the tip of the electrode, through the target tissue and to the return pad.

The Cool-tip™ RF System is intended for percutaneous, laparoscopic, and intraoperative coagulation and ablation of tissue, specifically for partial or complete ablation of non-resectable liver tumors.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document states: "Comparative in vivo and ex vivo product testing" and "Independent clinical studies." However, it does not specify the sample size for these tests or the clinical studies.

Regarding data provenance:

• "in vivo and ex vivo product testing" likely refers to studies performed on biological tissue, potentially animal models (in vivo) and excised tissue (ex vivo), without explicit mention of human subjects for the comparative testing directly.
• "Independent clinical studies" implies human subject data, but the country of origin and whether they were retrospective or prospective studies are not specified.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth in either the comparative testing or the independent clinical studies.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1) for establishing ground truth in the test sets.

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

The document does not mention or describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. There is no information provided regarding human readers improving with or without AI assistance, as AI is not a component of this device.

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

This device is a hardware system for RF ablation, not an AI algorithm. Therefore, the concept of a "standalone (algorithm only without human-in-the-loop performance)" study is not applicable to the Cool-tip™ RF System.

7. Type of Ground Truth Used

The document implies the ground truth for "coagulation/ablation of lesions" would be based on direct assessment of the ablated tissue, likely through histological examination (pathology) or macroscopic evaluation. For "clinical safety and effectiveness," the ground truth would be based on patient outcomes, imaging follow-up (e.g., to confirm tumor ablation), and adverse event monitoring. However, the specific methods for establishing ground truth are not explicitly detailed.

8. Sample Size for the Training Set

The document does not mention a training set in the context of an algorithm or machine learning. The "comparative in vivo and ex vivo product testing" and "independent clinical studies" serve as performance validation, not as training for an AI model.

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

As there is no mention of a training set in the provided information, this question is not applicable.

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The Valleylab Cool-tip RF System (generator and accessories) is intended for the use in percutaneous, laparoscopic, intraoperative coagulation and ablation of tissue, such as partial or complete ablation of non-resectable liver lesions and osteoid osteoma tumors within bone.

The Cool-tip™ RF Ablation System consists of a microprocessor based RF generator, a peristaltic pump, electrodes, inflow and outflow tubing for electrode cooling, and return pads. The generator, pump and electrodes are designed to produce local tissue heating at the tip of the clectrodes causing the coagulation (ablation) of the tissue. The Cool-tip™ RF Ablation System generator is capable of delivering up to 200 watts (into a 50 Ohm resistive load) while monitoring tissue impedance and electrode tip temperature during the delivery of the RF energy. The generator includes manual and impedance control and displays/monitors impedance, current, power and temperature. The Cool-tip™ electrodes are available in either a single electrode or a cluster electrode configuration. The electrodes are monopolar devices. The cluster electrode is three electrode shafts combined into one handle in a triangular patter with approximately 0.5 cm. separation. The electrodes are provided sterile, for single use only. The shaft of the electrode is stainless steel that is insulated to various lengths from the tip of the electrode. Embedded within the tip of each electrode is a thermocouple for temperature measurement. Cooling of the electrode is provided by chilled sterile water which is pumped (using the peristaltic pump) through the inflow tubing, the electrode and out through the outflow tubing. This is an enclosed system within the electrode and the sterile water does not contact the patient. Because of the monopolar nature of the electrodes, electrical current flows through the tip of the electrode, through the target tissue and to the return pad.

Here's an analysis of the provided text regarding the Cool-tip™ RF Ablation System, extracting the requested information about acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document, a 510(k) summary, does not explicitly state numerical acceptance criteria in the typical sense (e.g., "sensitivity must be > X%"). Instead, the primary "acceptance criterion" for a 510(k) submission is demonstrating substantial equivalence to a predicate device. The performance aspect focuses on safety and effectiveness.

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

The document states: "Independent Clinical data has shown the Cool-tip™ RF Ablation System to be safe and effective with regard to ablation of osteoid osteoma lesions."

• Sample Size: The exact sample size for the clinical data is not specified in this 510(k) summary.
• Data Provenance: The country of origin of the data is not specified. The document only mentions "Independent Clinical data." It also does not specify whether the data was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the 510(k) summary. The document does not detail how the ground truth for the clinical data, specifically regarding the "ablation of osteoid osteoma lesions," was established or by whom.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for the clinical data.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or described in the provided text. The submission focuses on the performance of the device itself, not on human readers' interpretive abilities with or without AI assistance.

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

This device is an RF ablation system, a surgical instrument, not an AI or diagnostic algorithm. Therefore, a "standalone algorithm only" study, as typically understood in the context of AI performance, is not applicable and was not performed or described. The clinical data evaluates the device's physical effect on tissue.

7. Type of Ground Truth Used

Based on the nature of the device (RF ablation system for osteoid osteoma lesions), the ground truth for effectiveness ("ablation of osteoid osteoma lesions") would most likely be established through:

• Histopathology/Pathology: Examination of tissue samples post-ablation to confirm coagulation/necrosis.
• Imaging Follow-up: Post-procedural imaging (e.g., MRI, CT) to assess the extent of ablation and lesion necrosis.
• Clinical Outcomes Data: Resolution of symptoms associated with the osteoid osteoma.

However, the specific method used to establish ground truth is not explicitly stated in the document.

8. Sample Size for the Training Set

The concept of a "training set" is typically associated with machine learning algorithms. Since the Cool-tip™ RF Ablation System is a physical medical device and not an AI algorithm, a "training set" in this context is not applicable and therefore, no sample size for such a set is provided.

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

As answered in point 8, the concept of a "training set" is not applicable to this physical medical device. Therefore, the method for establishing ground truth for a training set is not relevant or described.

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The indications for use include general (including urologic, thoracic, plastic and reconstructive, and arthroscopic), laparoscopic, and gynecologic procedures where electrosurgical cutting and coagulation of tissue, and sealing (fusion) of vessels and tissue bundles is performed, including such procedures as bowel resections, hysterectomies (both vaginal and abdominal), laparoscopically assisted vaginal hysterectomies, laparoscopic cholecystectomy procedures, Nissen fundoplication, adhesiolysis, oophorectomy, etc. Vessels (arteries, veins, lymph) 7 mm and smaller in diameter, and tissue bundles as large as will fit in the LigaSure™ vessel sealing device jaws, may be sealed with the LigaSure™ vessel sealing (tissue fusion) output.

The ForceTriad™ generator is a full-featured electrosurgical generator with monopolar, bipolar, and Valleylab LigaSure™ vessel sealing outputs. The generator is an electrically isolated, microcontroller-based device, incorporating closed-loop control for all output modes implemented in the microcontroller firmware. The generator incorporates Instant Response™ technology to constantly measure the electrical impedance of the tissue and instantaneously adjust the generator output to maintain the desired power.

Available output modes include:

Monopolar

• Cut : clean, precise cut in tissue, with little or no hemostasis .
• Blend: blended waveform for slower cutting and additional hemostasis
• Hemostasis with division (HWD): optimized division of tissue with controlled . hemostasis and minimal thermal damage to adjacent tissue
• Fulgurate: tissue coagulation by sparking .
• Spray: fulguration with shallower penetration over larger tissue areas t Bipolar
• Low: precise, controlled desiccation of tissue .
• Standard: general bipolar desiccation with consistent tissue effect .
• Macro: rapid coagulation and bipolar cutting in a wide range of tissues . LigaSure™ vessel sealing
• Seals vessels (arteries, veins, lymph) 7mm and less, and tissue bundles. .

The monopolar Cut, Blend, Fulgurate, and Spray output modes are designed for use with conventional handswitching or footswitching electrosurgical devices. The three bipolar output modes are designed for use with conventional handswitching or footswitching electrosurgical bipolar forceps. When using conventional electrosurgical devices, the user selects the mode and desired power using a touch screen display on the generator.

All monopolar output modes, including HWD, are also designed for use with Valleylab electrosurgical devices with surgeon power control. The surgeon power control devices utilize Valleylab Smart™ connector technology that allgows the generator to identify the type of device in use. After recognizing the device type, the generator establishes five power zones for each output mode. The generator defaults to power zone 3, but the surgeon may select an alternate power zone using the touch screen. From the sterile field, the surgeon then uses the slider switch on the device to select the desired power setting within the selected power zome. The surgeon activates the desired output mode (CUT, HWD, COAG) using the buttons on the device. The surgeon also has the option of using the touch screen controls to select power levels outside the pre-established power zones to accommodate unusual surgical situations.

Monopolar electrosurgery requires the use of a patient return electrode ("return pad" or "grounding pad") with Valleylab REM™ return electrode monitoring. The REM™ system continuously verifies contact between the patient and pad togs one headsite burns. (Valleylab REM™ electrodes were initially cleared for marketion on K822572, and have been used on all Valleylab electrosurgical generators since that time.) Bipolar devices and LigaSure™ vessel sealing devices do not require patient return electrodes.

The ForceTriad™ vessel sealing mode is designed for use with LigaSure™ vessel sealing devices. The LigaSure™ devices utilize Smart™ connector technology to allow the generator to recognize the device in use and set the generator output accordingly. (Refer to K981916, LigaSure™ Vessel Sealing System.)

The provided document is a 510(k) summary for the Valleylab ForceTriad™ Electrosurgical Generator. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies with detailed performance criteria as might be seen in a PMA (Pre-Market Approval) application. Therefore, much of the requested information regarding detailed acceptance criteria, specific study designs, or expert consensus will not be explicitly present in this document.

However, I can extract the information that is available and explain what is missing and why, based on the nature of a 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance:

The 510(k) summary states:

"Performance testing was performed to ensure that the ForceTriad™ Electrosurgical Generator functions as intended, and meets design specifications. Sufficient data were obtained to show that the device is substantially equivalent to legally marketed predicate devices, and meets safety and effectiveness criteria."

This statement confirms that internal performance criteria related to "design specifications" and "safety and effectiveness criteria" were met, and that the device was deemed "substantially equivalent" to its predicates. However, the document does not provide specific, quantifiable acceptance criteria or the reported performance metrics in a detailed table format. This level of detail is typically summarized internally by the manufacturer for the FDA's review of the 510(k) rather than being published in the public 510(k) summary.

The "performance" described refers to the device's ability to replicate the functions and outputs of the predicate devices (Valleylab Force FX™ Electrosurgical Generator and Valleylab LigaSure™ Vessel Sealing System). The document highlights that the ForceTriad™ generator has "the same basic technological characteristics as the predicate devices," and its output power and voltage for LigaSure™ vessel sealing are "equivalent" to the predicate.

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

The document does not specify a sample size for a "test set" in the context of a clinical study or specific data provenance (country of origin, retrospective/prospective).

For a 510(k) submission, "performance data" typically refers to:

• Bench testing: Verifying electrical outputs (power, voltage, waveform), impedance matching, safety features (e.g., REM™ system for patient return electrode monitoring), and mechanical integrity. This would involve testing of device units.
• Animal studies (if applicable): To demonstrate typical tissue effects without human subjects.
• Comparison to predicate device specifications: Ensuring the new device performs within the established parameters of the equivalent marketed device.

The study type is not explicitly described as a "clinical study" in the sense of a trial involving human patients for effectiveness data, but rather as "performance testing" to ensure it "functions as intended." Given the nature of a 510(k) for an electrosurgical generator, the primary evidence relies heavily on engineering verification and validation (V&V) and comparison to predicate devices, rather than large-scale clinical trials.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

The document does not mention the involvement of external experts to establish ground truth for a test set. This type of expert review is more common for diagnostic devices (e.g., imaging devices) where human interpretation is a critical part of the ground truth establishment. For an electrosurgical generator, the "ground truth" for performance would be based on objective physical measurements (e.g., electrical outputs) and tissue effects verified in controlled environments, often by engineers and medical professionals within the development team.

4. Adjudication Method for the Test Set:

As no specific "test set" in the clinical sense is described with expert review, there is no mention of an adjudication method like 2+1 or 3+1.

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

An MRMC study is typically conducted for diagnostic devices (especially those involving image interpretation) to assess how human readers' performance (e.g., accuracy, detection rate) changes with or without AI assistance. The ForceTriad™ Electrosurgical Generator is a therapeutic device, not a diagnostic one that requires human readers to interpret outputs for diagnosis. Therefore, an MRMC study was not performed or is not applicable in this context. There is no mention of "human readers" or "AI assistance" in the document.

6. Standalone Performance Study:

The document states, "Performance testing was performed to ensure that the ForceTrial ™ Electrosurgical Generator functions as intended, and meets design specifications." This indicates that the device's performance was evaluated independently to ensure it met its engineering and safety requirements. However, the evaluation framework is primarily one of substantial equivalence to existing devices rather than demonstrating novel "standalone" efficacy that is significantly different from established predicate devices. The performance data demonstrates substantial equivalence, meaning it can perform the same functions as the predicate devices safely and effectively.

7. Type of Ground Truth Used:

The "ground truth" for the performance testing would primarily be based on:

• Engineering specifications and standards: Confirming that electrical outputs (power, voltage, current, waveform) meet predefined ranges for each mode (Cut, Blend, HWD, Fulgurate, Spray, Bipolar Low, Standard, Macro, LigaSure™).
• Biophysical effects: Observing and quantifying tissue effects (e.g., cutting precision, coagulation depth, vessel sealing strength) in controlled laboratory or animal settings, often compared to the known effects of the predicate devices.
• Safety parameters: Verification of safety features like the REM™ system for patient return electrode monitoring.

There is no mention of "pathology" or "outcomes data" in the sense of long-term human clinical outcomes being used as ground truth for this 510(k) submission.

8. Sample Size for the Training Set:

The concept of a "training set" is typically associated with machine learning or artificial intelligence algorithms. The ForceTriad™ is an electrosurgical generator controlled by microcontroller firmware using closed-loop control and Instant Response™ technology. While this involves algorithms, it's not described as an AI system that undergoes "training" with a dataset in the modern sense. Therefore, there is no mention of a training set or its size. The "algorithms" are likely deterministic control systems based on established electrosurgical principles.

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

Since there is no "training set" as described in question 8, this question is not applicable. The "ground truth" for the device's control algorithms would be rooted in fundamental electrophysics, physiological tissue responses to electrical energy, and engineering specifications for desired output characteristics and safety.

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The Valleylab G3000 Electrosurgical Device is a single-use device intended for use in open surgical procedures (such as general, urologic, thoracic, plastic and reconstructive, gynecologic, arthroscopic) where the surgeon desires monopolar radio-frequency electrosurgical energy to cut and/or coagulate tissue. The G3000 Electrosurgical Device is intended for use with the Valleylab ForceTriad™ Electrosurgical Generator and conventional monopolar electrosurgical electrodes, such as blade, needle, ball, LLETZ loop, and arthroscopic electrodes.

The G3000 Electrosurgical Device is a handheld, single-use device designed to deliver monopolar RF electrosurgical energy to a surgical site to cut and/or coagulate tissue. The G3000 Electrosurgical Device is designed for use only with the Valleylab ForceTriad™ Electrosurgical Generator (510(k) application submitted), and has a connector that will only fit into the ForceTriad™ generator. The G3000 connector is a "smart connector" that allows the ForceTriad™ generator to verify the device type. The device body incorporates "soft touch" material to improve the surgeon's grip. The surgeon activates the desired electrosurgical mode from the sterile field by using one of three push buttons on the device. Three electrosurgical modes are available: Cut, Hemostasis with Division, and Coaq. The surqeon can also control the power settings of the electrosurgical generator from the sterile field using a slider control on the device. The G3000 Electrosurqical Device uses conventional electrosurgical electrodes. such as coated and uncoated blade, needle, ball, LLETZ loops, and arthroscopy electrodes, with a 2.4mm (3/32 inch) shaft diameter.

The provided text describes a 510(k) premarket notification for the Valleylab G3000 Electrosurgical Device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than establishing efficacy through clinical trials with specific acceptance criteria and ground truth. Therefore, much of the requested information, particularly regarding specific performance metrics, sample sizes, expert involvement, and ground truth methodologies, is not detailed in this document.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of quantitative acceptance criteria with corresponding performance metrics. Instead, it states:

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

• Sample Size: Not specified. The document globally refers to "Performance testing" and "Sufficient data," but does not quantify the number of devices tested or the amount of data collected.
• Data Provenance: Not specified, but generally, 510(k) performance testing is conducted internally by the manufacturer using laboratory or bench testing. There is no mention of country of origin for data or whether it was retrospective or prospective in a clinical setting. Given it's a device for surgical use, in vivo testing (animal or human) might have been part of "performance testing," but no details are provided.

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

This information is not applicable to a 510(k) submission for this type of device. The "ground truth" for a device like an electrosurgical device typically revolves around its mechanical, electrical, and functional performance, verified against engineering specifications and industry standards, not against expert consensus on clinical outcomes in the same way an AI diagnostic tool would be.

4. Adjudication Method for the Test Set

Not applicable. As no expert-based ground truth or comparative clinical study is described, there's no mention of an adjudication method.

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

No. An MRMC study is not mentioned or described. This type of study is relevant for diagnostic devices (especially imaging) where human reader performance is a key metric. The G3000 is an electrosurgical tool, not a diagnostic device.

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

Not applicable. The G3000 is a physical electrosurgical device, not an algorithm. Its performance is inherent to its physical and electrical characteristics and its interaction with the electrosurgical generator.

7. Type of Ground Truth Used

The ground truth for this device would primarily be:

• Engineering Specifications: Testing to ensure the device performs according to its design requirements (e.g., button actuation force, electrical insulation, material integrity, connector compatibility).
• Industry Standards: Compliance with relevant electrical safety and performance standards for electrosurgical devices.
• Bench Testing / In Vitro Models: Verification of tissue cutting and coagulation characteristics in controlled experimental settings.
• In Vivo (Animal or Pre-clinical) Testing: Potentially, testing in animal models to confirm functional performance in a biological environment, if required.

The document states "Performance testing was performed to ensure that the G3000 Electrosurgical Device functions as intended, and meets design specifications," indicating the ground truth was tied to these internal design specifications and anticipated function.

8. Sample Size for the Training Set

Not applicable. This device is not an AI model or a system that requires a "training set."

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

Not applicable, as there is no training set for this device.

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The LigaSure™ Vessel Sealing System includes a bipolar electrosurgical generator and dedicated bipolar electrosurgical instruments intended for use in general, laparoscopic and gynecologic surgical procedures where ligation of vessels, including lymph vessels, is desired. The system creates a vessel ligation (seal) by the application of bipolar electrosurgical RF energy (coagulation) to vessels interposed between the jaws of the device. The generator can also be used with standard bipolar devices where bipolar cutting or coagulation is desired.

The indications for use include general (including urologic, thoracic, plastic and reconstructive), laparoscopic, and gynecological procedures where ligation of vessels is performed, including such procedures as bowel resections, hysterectomies (both vaginal and abdominal), laparoscopic cholesystectomies, laparoscopically assisted vaginal hysterectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomy. etc. The devices can be used on vessels up to 7mm and bundles as large as will fit in the jaws of the instruments.

The LigaSure™ Vessel Sealing System has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

The LigaSure™ Vessel Sealing System consists of a microprocessor-based radiofrequency (RF) generator and a selection of instruments designed to be used exclusively with the LigaSure™ generator. All of the instruments are capable of sealing vessels up to, and including, 7mm, and tissue bundles as large as can fit in the jaws of each instrument. When a LigaSure™ instrument is applied to a vessel or tissue bundle and RF energy is applied, the collagen and elastin in the tissues are reformed by heat and pressure to fuse vessel walls, thereby forming a permanent seal. The microprocessor in the generator monitors the tissue properties, stops the application of energy, and allows a brief period of cooling before indicating that the seal cycle is complete.

No changes are being made to the design or operation of any of the devices within the current system. The change as proposed in this 510(k) notification is to the intended use as described above and the resulting labeling changes.

This document is a 510(k) premarket notification for the LigaSure™ Vessel Sealing System. The primary purpose of this notification is to advise the FDA of a change in the intended use and resulting labeling for the device, not to introduce a new device or demonstrate a new level of performance. As such, the information you're requesting regarding acceptance criteria and performance studies for a new device or algorithm development is largely not present in this submission.

The document confirms the safety and effectiveness of the device for its expanded indications based on pre-clinical studies and its substantial equivalence to a legally marketed predicate device.

Here's an attempt to answer your questions based on the provided text, highlighting what is explicitly stated and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

No specific numerical acceptance criteria (e.g., target accuracy, sensitivity, specificity) are defined or reported in this document. The document states that pre-clinical studies were conducted.

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

The document mentions "pre-clinical studies" but does not specify the sample size, the type of test set (e.g., animal models, cadaveric tissue), or the data provenance (e.g., country of origin, retrospective/prospective).

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

This information is not provided. The pre-clinical studies likely involved laboratory measurements and potentially histological analysis by trained personnel, but no details on expert consensus for ground truth are given.

4. Adjudication Method for the Test Set

This information is not provided.

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

No MRMC study is mentioned. This is a medical device for surgical procedures, not an AI diagnostic tool, so such a study would not be typically performed in this context.

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

This is not applicable as the LigaSure™ Vessel Sealing System is a physical medical device operated by a surgeon, not an AI algorithm.

7. Type of Ground Truth Used

Based on the "pre-clinical studies," the ground truth likely involved:

• Measurement of burst pressures: This is a direct physical measurement.
• Visual and/or histological examination of sealed vessels: To confirm complete and effective sealing.
• Functional tests: To ensure the seals withstand physiological pressures.

8. Sample Size for the Training Set

This information is not provided, nor is it directly relevant in the context of this type of device where "training set" for an algorithm is not applicable. The device's "training" refers to its design and engineering iterations.

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

This information is not provided, and the concept of a "training set ground truth" in the AI sense does not apply to this device. The design and validation of this medical device would have relied on engineering principles, material science, and pre-clinical testing to establish its performance and safety characteristics.

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