(147 days)
The Soniquence RF Generator is intended to provide high frequency energy for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels during surgical procedures and is used to deliver RF energy via an assortment of surgical devices to cut and coagulate different kinds of tissue.
The Soniquence Electrodes are intended for use by a physician familiar with resection, dissection, incision, and hemostasis in soft tissue surgical procedures.
The Soniquence RF Generators® are radiofrequency (RF) electrosurgical generators. It is a compact source of high-frequency RF energy employed for cutting and coagulation of soft tissue in a variety of surgical procedures. This action is achieved by front panel selection of waveforms and power levels. The subject device is designed to enable the performance of monopolar and bipolar functions for cutting, coagulation, and hemostasis in conjunction with separately-marketed electrosurgical accessories and ancillary equipment which have been developed for mutuallyexclusive use with the Soniquence® line of generators.
All selections are effected through push buttons and lamps, which give the operator feedback of status. The power level for each mode is indicated by front panel digital displays which also show the status of self-test and monitoring. The display is interlocked with controls to prevent operation when FAIL is displayed. The final output power control is made through foot and /or hand switches.
Soniquence Electrodes are used with the Soniquence RF Generator. The electrical power operating at radio frequency (RF) is transferred to tissue at the surgical site. The time-varying voltage produced by RF electrical power source yields a predetermined electrosurgical effect, such as tissue cutting or coagulation. The Soniquence family of electrodes is available in various shapes and sizes depending on the need of the surgeon. The devices are available in classic alloys (Tungsten, brass, stainless steel).
These devices are designed to comply with international safety standards including applicable IEC series electrical safety standards.
This document, an FDA 510(k) submission summary for the Soniquence RF Generator and Soniquence Electrodes, does not contain information about a study proving the device meets acceptance criteria related to AI/algorithm performance on a test set, expert ground truth establishment, or clinical effectiveness studies with human readers.
The document states:
- "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence." (Page 11)
- The non-clinical testing listed primarily focuses on electrical safety, EMC, Usability Engineering, sterilization, biocompatibility, and software verification and validation. It also includes "Energy output verification of each of the five modes and comparison to predicate" and "Thermal effect comparison for representative modes of the subject device and predicate on ex-vivo bovine tissue." (Page 11)
Therefore, I cannot provide the requested information regarding acceptance criteria and study details for AI/algorithm performance characteristics. The device appears to be a traditional electrosurgical unit, not an AI/algorithm-driven diagnostic or therapeutic device.
If you are looking for information about the performance of the Soniquence RF Generator and Soniquence Electrodes, the document primarily relies on substantial equivalence to predicate devices (Surgi-Max® Ultra (K170107), Bovie® IDS-310 Electrosurgical Generator (K134054), Elliquence Electrodes (K142410), and Cobbra RF™ Tissue Dissector (K160041)) based on technological characteristics and intended use.
Here's a summary of the performance testing mentioned, which is non-clinical and geared towards safety and functional equivalence, not AI performance characteristics.
Table of Acceptance Criteria and Reported Device Performance (Non-AI/Algorithm Related):
| Acceptance Criteria Category | Specific Tests/Performance Metrics Mentioned (Non-AI) | Reported Device Performance |
|---|---|---|
| Electrical Safety | AAMI ANSI ES60601-1 | Successfully performed |
| IEC 60601-1-2 (EMC) | Successfully performed | |
| IEC 60601-2-2 | Successfully performed | |
| Usability | IEC 62366 (Usability Engineering) | Successfully performed |
| Sterilization | ISO 11135 (EO sterilization) | Successfully performed |
| ISO 11737-1 (Microbiological methods: population) | Successfully performed | |
| ISO 11737-2 (Microbiological methods: sterility tests) | Successfully performed | |
| ISO 11138-1 (Biological indicators) | Successfully performed | |
| Biocompatibility | ISO 10993-1 (Risk management) | Successfully performed |
| ISO 10993-5 (Cytotoxicity) | Successfully performed | |
| ISO 10993-7 (EO residuals) | Successfully performed | |
| ISO 10993-10 (Irritation/sensitization) | Successfully performed | |
| ISO 10993-11 (Systemic toxicity) | Successfully performed | |
| Shelf Life | ASTM F1980-07 (Accelerated Aging of Barrier Systems) | Successfully performed |
| Software | IEC 62304 / FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" | Software verification and validation successfully performed |
| Functional Performance | Energy output verification of each of the five modes | Comparison to Predicate |
| Thermal effect comparison (ex-vivo bovine tissue) | Comparison to Predicate |
Since the requested information pertains to an AI/algorithm-driven device, and this document describes a traditional electrosurgical unit without AI components, the following points cannot be answered from the provided text:
- Sample size used for the test set and data provenance: No test set (in the AI sense) is mentioned.
- Number of experts used to establish ground truth & qualifications: Not applicable.
- Adjudication method: Not applicable.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How ground truth for the training set was established: Not applicable.
§ 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.