(107 days)
The Canady Plasma® SMART XL-1000™ Electrosurgical Generator with Accessories is intended to provide gas-enhanced coagulation during general surgery procedures. The Canady Plasma® SMART XL-1000™ Electrosurgical Generator with Accessories is designed for gas enhanced coagulation when used only with the Canady Plasma Electrosurgery Unit and compatible monopolar and/or bipolar handpieces.
The Canady Electrosurgery Unit Generators are intended to cut and/or coagulate tissue when used with compatible monopolar and/or bipolar RF handpieces. The Canady Electrosurgery Unit Generators are capable of monopolar argon gas enhanced coagulation when used with Canady Plasma Coagulator and probes.
The Canady Plasma® SMART XL-1000™ Electrosurgical Generator (CPSXEG) with Accessories is a High Frequency (HF) Electrosurgery Unit (ESU) used in combination with electrosurgical probes. The CPSXEG combines (HF) voltage to electrically enhanced plasma gas (i.e. Argon) to produce a plasma gas stream. Current density upon arrival at the tissue surface from Canady Plasma Probes causes coagulation of the tissue. The CPSXEG is also a monopolar and bipolar RF surgical device for cutting and coagulation. It is used for tissue removal and coagulation in accordance with the operative procedure performed by the physician. The unit provides various cutting, coagulation, hybrid plasma, and argon plasma modes to meet the physician's flexibility performing the specific procedure with the device.
The modified Canady Plasma Smart XL-1000™ ESU has the same intended use as the predicate SS-601/Argon 4 Canady Plasma® Electrosurgical Unit as well as the same performance specifications. The modified device has the same protective circuits as the predicate ESU which displays the equipment output error on the monitor screen with a graphic symbol so that the user can determine the cause of the error. The packaging, labeling (i.e. user manual) are the same.
The Canady Plasma® SMART XL-1000™ Electrosurgical Generator has a touch screen color monitor that provides the user with quick start, on screen tutorial and user manual as well as operational and settings. Various cutting, coagulation, bipolar, and plasma modes are the predicate unit, but the modified device has improved programmable software. When turned on, an APPS screen is displayed on the monitor screen. The user can decide which medical application is started by touching the particular application (i.e Pediatrics, orthopedics, endoscopy, gynecology). Upon activation of the device audio and visual error system malfunctions or user errors can be observed by the user. Once the device is activated, power in watts, gas flow rate, gas volume, PPM, and energy mode are displayed on the monitor screen.
The provided text describes a 510(k) premarket notification for the Canady Plasma® SMART XL-1000™ Electrosurgical Generator with Accessories. This is a submission to demonstrate substantial equivalence to a predicate device, rather than a study proving the device meets specific acceptance criteria in a clinical context.
Therefore, many of the requested details, such as sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set information, are not applicable or available in this type of regulatory document.
The document focuses on non-clinical performance data and a comparison to a predicate device to establish substantial equivalence.
Here's the information that can be extracted relevant to acceptance criteria and performance:
1. A table of acceptance criteria and the reported device performance
The document does not present "acceptance criteria" in the typical sense of a clinical performance study with specific endpoints and thresholds. Instead, it demonstrates performance through the comparison of technological characteristics with a predicate device and extensive non-clinical testing.
The acceptance criteria for this submission are implicitly that the modified device should perform as specified, in accordance with the predicate device's specifications, and not raise new questions of safety or effectiveness. The reported "performance" is that it meets these expectations.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Intended Use | Same as predicate device (Cut and/or coagulate tissue). |
| Principles of Operation | Same as predicate device (High Frequency Electrosurgery Unit generating HF voltage and electrically enhanced plasma gas). |
| Technological Characteristics | Same or similar to predicate device (Frequency, Peak to Peak Voltage, CPU Type, Monopolar/Bipolar, Modes, Input Voltage, Safety standards IEC 60601-1, -1-2, -2-2). Minor difference in Display Type (LED with backlight for predicate vs. LCD with backlight for subject device). |
| Physical Performance | Confirmed to meet product specifications and be equivalent to the unmodified predicate device through internal verification and validation testing. |
| Electrical Safety & EMC | Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, demonstrated through extensive testing (Conducted Emissions, Radiated Emissions, Harmonic Current Emission, Voltage Fluctuations/Flicker, various Immunity tests). |
| Functional Performance | Successful testing of: Crest Factor Comparison, Frequency, Peak to Peak Voltage, Monopolar Cut Mode, Maximum Watts, Maximum Voltage, Bipolar Cut Mode, Operation Modes Selection, Power Adjustment, Flow Rate Adjustment, Standby Mode Activation, Gas Tank Pressure Indication, Audio/Visual Warning, User Profile Selection/Editing, Font/Icon Visibility/Color, Power Button Speed, Patient Pad Connectivity, Touchscreen EMF Immunity, LCD Brightness, Audio Volume, Multitouch Prevention, Glove Test, Liquid Spill, Touchscreen LED, Touchscreen Impact, Chemical Resistance. |
| Software Performance | Improved programmable software compared to the predicate, with features like quick start, on-screen tutorial, user manual, and application selection. Design and development quality system procedures established for software. |
| Safety & Effectiveness | Does not raise new questions of safety or effectiveness compared to the predicate device. Performance testing demonstrated it is as safe and effective. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The testing described is non-clinical laboratory testing performed by the manufacturer, not a clinical trial or study with human subjects.
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)
This information is not applicable/provided. The testing performed is non-clinical performance and safety testing of an electrosurgical generator, not a diagnostic device requiring expert interpretation for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication methods are typically used in clinical studies involving interpretation of data/images, which is not the nature of this submission.
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
This information is not applicable/provided. The device is an electrosurgical generator, not an AI-assisted diagnostic or image interpretation tool. Therefore, MRMC studies and AI-related effect sizes are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. The device is a medical instrument (electrosurgical generator), not an algorithm that operates in a standalone capacity without human interaction in a clinical setting.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/provided in the context of clinical ground truth. For the non-clinical performance testing, the "ground truth" would be the established engineering specifications and compliance standards (e.g., maximum power output, frequency deviation, electrical insulation integrity) which were measured and validated.
8. The sample size for the training set
This information is not applicable/provided. This is a hardware device with "improved programmable software," but the document does not describe it as an AI/ML device that undergoes a "training" process in the sense of predictive modeling.
9. How the ground truth for the training set was established
This information is not applicable/provided for the reasons stated in point 8.
§ 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.