(112 days)
The Force Argon™ II Argon Enhanced Electrosurgical System is intended for use in both open, laparoscopic, and thoracoscopic surgical procedures (general. neurosurgical, gynecologic) where monopolar electrosurgery (cutting and coagulation) is normally used. The Force Argon™ II Argon Enhanced Electrosurgical System provides a controlled flow of argon to electrosurgical handsets during cutting and coagulation. When the handset is activated in the gas enhanced modes, an argon gas plasma is created between the electrode and the tissue.
The Force Argon™ II Argon Enhanced Electrosurgical System is designed to provide a controlled flow of argon (an inert, non-reactive gas) to custom designed electrosurgical handsets powered by Valleylab electrosurgical generators. The handsets allows the surgeon to perform argon enhanced electrosurgery in open and laparoscopic procedures. Depending on the handpiece, the system can function in the following argon enhanced modes: - Argon Shrouded Cut Argon gas is delivered through the handset . while the attached electrosurgical generator is activated in the cut mode. - Argon Enhanced Coag Argon gas is delivered through the handset while . the generator is activated in the coag mode. The Force Argon™ II Argon Enhanced Electrosurgical System has two gas flow modes; one for laparoscopic procedures (Low Flow Mode, 0.5 - 4.0 SLPM) and one for open procedures (Standard Flow Mode, 0.5-12 SLPM). In addition, the system monitors the peritoneal pressure during laparoscopic procedures. The physician can set the desired pressure on the Force Argon™ II Argon Enhanced Electrosurgical System. When the peritoneal pressure approaches a predefined percentage of the set pressure, an alarm is activated to alert the user. A second alarm sounds when the actual peritoneal pressure reaches the set point. The physician can then vent the peritoneal cavity to relieve the pressure. The Force Argon™ Argon Enhanced Electrosurgical System is designed to allow the physician to continue to use argon enhanced electrosurgery when the peritoneal pressure set limit is reached. The Force Argon™ II unit is designed to fit on a table top or a cart. Tank holders will be offered for use with the Valleylab Gas Delivery System carts which will accommodate argon tank sizes ranging from 14 to 42 cubic feet.
The provided text does not contain detailed acceptance criteria or a study proving the device meets those criteria in the format requested. The document is a "Summary of Safety and Effectiveness" which focuses on product description, intended use, and general validation methods, primarily for regulatory submission (K96636), rather than a specific clinical study with detailed performance metrics.
Here's an analysis of what is available and what is missing:
The document mentions validation, but not in the context of statistical acceptance criteria and reported device performance as would be found in a clinical study.
What can be extracted:
- Device Name: Force Argon™ II Argon Enhanced Electrosurgical System
- Intended Use: For use in both open, laparoscopic, and thoracoscopic surgical procedures where monopolar electrosurgery (cutting and coagulation) is normally used, providing a controlled flow of argon to electrosurgical handsets during cutting and coagulation.
- Validation Methods mentioned:
- Preclinical testing
- Hardware validation and testing (against standards like IEC 601-1, IEC 601-2-2, EN 60601-1-2, IEC 801-3, ANSI/AAMI HF18)
- Software validation (in accordance with accepted industry standards)
- Biocompatibility testing (USP Class V for peritoneal pressure tubing materials)
- Preclinical and Laboratory Bench Testing (using a swine model and simulated laparoscopic model)
Specifically addressing your requested points based on the provided text:
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A table of acceptance criteria and the reported device performance:
- Not Available. The document states "Preclinical and laboratory bench testing... showed the Force Argon™ II Argon Enhanced Electrosurgical System functioned according to specification and monitored peritoneal pressure as designed." However, the specific specifications or detailed performance metrics (with values) are not provided.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Available. The document mentions a "swine model" and a "simulated laparoscopic model" for preclinical and bench testing. No sample sizes are given for these models, nor is information about a "test set" in the context of human data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. The testing described is preclinical and bench testing, not clinical studies involving expert interpretation of data.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No human adjudication of results is mentioned in the context of the described preclinical/bench testing.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This device is an electrosurgical system, not an AI-powered diagnostic imaging tool. MRMC studies are not relevant to its validation.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. Again, this is a medical device for surgical procedures, not an algorithm. However, the hardware and software components were validated "standalone" in their respective validation sections.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the preclinical/bench testing, the "ground truth" was likely the expected functional performance of the device according to its design specifications (e.g., argon flow rates, pressure monitoring accuracy). For biocompatibility, it was adherence to USP Class V.
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The sample size for the training set:
- Not Applicable. This is not an AI/machine learning product where a "training set" would be used in that context. Software validation followed "accepted industry standards," suggesting traditional software engineering testing.
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How the ground truth for the training set was established:
- Not Applicable. See point 8.
In summary: The provided text outlines the regulatory submission for a medical device and describes various validation activities for its hardware and software components. It does not contain the detailed clinical study information (acceptance criteria, specific performance metrics, human reader studies, or AI training data details) that your questions are geared towards. The document focuses on demonstrating that the device functions as intended and meets relevant safety standards, primarily through engineering tests and preclinical models, and establishing substantial equivalence to previously cleared devices.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.