(110 days)
The Apyx One Console is indicated for delivery of radiofrequency energy and/or helium plasma to cut, coagulate and ablate soft tissue during open and laparoscopic surgical procedures. The helium plasma portion of the generator can be used only with dedicated Renuvion/J-Plasma handpieces.
The Apyx One Console is an electrosurgical generator that delivers radiofrequency (RF) energy to cut and coagulate soft tissue. It can also deliver Helium plasma energy for cutting, coagulation, and ablation of soft tissue. Like the predicate, the Apyx One Console provides standard electrosurgical energy and Helium Plasma energy, with no changes to the intended use, electrosurgical modes, output power waveforms, or maximum power settings. The Apyx One Console is a modified version of the primary predicate device that was cleared under K192867 (Apyx Helium Plasma Generator), with a no change to the intended use.
The Apyx One Console has a Graphical User Interface (GUI). Remote Services will be available using an attached cellular module to assist in troubleshooting the generator in the field, a helium Gas Pressure Transmitter, and two monopolar ports.
The Remote Service module will also provide non-HIPPA data to a cloud data system which will log the various settings of the generator throughout its use.
The Apyx One Console is an electrosurgical generator intended for the delivery of radiofrequency energy and/or helium plasma to cut, coagulate, and ablate soft tissue during open and laparoscopic surgical procedures. The helium plasma portion of the generator can only be used with dedicated Renuvion/J-Plasma handpieces.
Here's a breakdown of the acceptance criteria and the study proving the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standards Met) | Reported Device Performance (Results) |
|---|---|
| Electrical Safety Standards: | |
| ANSI/AAMI/IEC ES60601-1:2005/(R2012)+A1:2012 (General requirements for basic safety and essential performance) | The electrical functionality of the generator was verified to meet performance specification requirements. |
| AAMI/ANSI/IEC 60601-1-2:2014 (4th Edition) (Electromagnetic disturbances - Requirements and tests) | Complies with the standard. |
| AAMI/ANSI/IEC-60601-2-2:2017 (6th Edition) (Particular requirements for the basic safety and essential performance of high-frequency surgical equipment and accessories) | Complies with the standard. |
| Usability Standard: | |
| IEC 62366-1:2015+AMD1:2020 (Application of usability engineering to medical devices) | |
| Software/Firmware Performance: | |
| Field Programmable Gate Array (FPGA) Procedure and Logic Design Validation | The results demonstrated that the system and FPGA perform as intended and according to the product specifications. |
| Mechanical Performance: | |
| Mechanical Product and Performance Specification Requirements | The results verified that the mechanical design meets the product and performance requirements. |
2. Sample sized used for the test set and the data provenance
The document does not specify a separate "test set" in the context of clinical data for performance evaluation. Instead, the performance testing described focuses on engineering verification and validation. Therefore, information regarding sample size and data provenance for a test set (e.g., patient data) is not applicable here as it is not a clinical study in that sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This evaluation focuses on engineering performance rather than clinical endpoints requiring expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This was not a study requiring adjudication of interpretations.
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. The device is an electrosurgical generator, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical medical instrument, not an algorithm, so the concept of "standalone algorithm performance" is not relevant. The performance evaluation focuses on the engineering safety and effectiveness of the hardware and software in its intended operational context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's acceptance criteria primarily involved:
- Compliance with established international electrical safety, electromagnetic compatibility, and usability standards.
- Verification against product and performance specifications for electrical functionality, software/firmware operation, and mechanical design.
8. The sample size for the training set
Not applicable. This device, being an electrosurgical generator, does not utilize a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of medical device evaluation.
§ 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.