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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 (resecting, dividing, or separating), coagulation (hemostasis, coagulating, or desiccating), or vessel sealing or fusing.). 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 or with compatible resectoscopes for endoscopically controlled removal (resection) or coagulation of tissue using 0.9% NaCl solution (saline) as the irrigation medium.

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, oophorectorny, 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™ Electrosurgical Generator is a full-featured electrosurgical generator with monopolar, bipolar, and LigaSure™ vessel sealing output modes. TThe 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.

The generator is used with a selection of electrosurgical instruments designed for use with the ForceTriad and the LigaSure Vessel Sealing generator. All of the LigaSure 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, operation, or intended use of any of the current system except the software modifications to create the Bipolar Resection modes and to allow the ForceTriad to output system data to a computer. The subject of this 510(k) notification is in regards to the addition of specific definitions for "cut" and "coagulating" and the addition to the indications statement of a bipolar resection function for use with resectoscopes "for endoscopically controlled removal of tissue using 0.9% NaCl solution (saline) as the irrigation medium" and the hardware and software associated with the activation of this feature.

Here's an analysis of the provided text regarding the ForceTriad™ Electrosurgical Generator, focusing on acceptance criteria and supporting studies:

It's important to note that the provided document is a 510(k) premarket notification, which concerns substantial equivalence to predicate devices, rather than a detailed report of a new device's efficacy studies in the same way one might find for novel drug or medical device. Therefore, the information regarding specific acceptance criteria and detailed study outcomes for meeting those criteria is presented at a high level.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes (i.e., number of pork models or live porcine models) used for the bench and live animal testing. It also doesn't specify the country of origin for the data or whether the studies were retrospective or prospective, though animal model testing is inherently prospective.

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

This information is not provided in the document. The document refers to "bench testing" and "live porcine model" studies, but it doesn't detail how the "ground truth" or "acceptable results" were determined, nor does it mention the involvement or qualifications of experts in assessing the outcomes of these tests. For electrosurgical devices, ground truth might relate to tissue effects, seal integrity, or lack of collateral damage, which would traditionally be assessed by veterinary pathologists or surgeons.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of bench and animal testing for an electrosurgical device, it's less likely to involve the same type of "adjudication" seen in image-based diagnostic studies. Performance would likely be assessed against predefined engineering specifications (e.g., power output, tissue cut/coagulation characteristics).

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

• No MRMC study was done. The document explicitly states: "This premarket notification report does not rely on the assessment of clinical performance data to demonstrate substantial equivalence." This means there was no human reader study comparing effectiveness with and without AI assistance (as AI is not the primary focus here, rather software updates for device functionality).

6. Standalone (Algorithm Only) Performance Study

• No standalone algorithm performance study in the typical sense was performed or reported. This submission focuses on software updates to an existing electrosurgical generator to enable a bipolar resection feature. The "algorithm" here refers to the closed-loop control and Instant Response™ technology within the electrosurgical generator, which is designed to adjust output based on tissue impedance. The testing confirmed the device's functionality with these software updates, not an independent algorithm's diagnostic or predictive performance.

7. Type of Ground Truth Used

Based on the description of "bench testing using a pork model (to simulate prostate) and live porcine model using kidney (for hemostasis)," the ground truth for these tests would likely involve direct observation and measurement of tissue effects. This could include:

• Pathology/Histology: Microscopic examination of treated tissue to assess cut quality, depth of coagulation, cell viability, and collateral damage.
• Physiological Measurements: For hemostasis, this might involve quantitative measures of blood loss or time to achieve cessation of bleeding.
• Engineering Specifications: Measurement of power output, impedance feedback, and response times against predefined technical specifications.

The document states "Results were acceptable," implying that these assessments met predetermined performance standards.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI algorithm development. The software updates relate to activating a specific electrosurgical mode and recognizing accessories, not to a learning algorithm requiring a distinct training phase. The "software validation" and "testing" refer to verification and validation of the software's functionality and safety, not training an AI model.

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

As there is no mention of a "training set" for an AI algorithm, this question is not applicable to the provided document. The ground truth for the testing that was performed (bench and live animal) would have been established as described in point 7.

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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 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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