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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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