(58 days)
Electrosurgical generator intended for tissue cutting and coagulation with electrosurgical accessories and ancillary equipment.
The Olympus ESG-200 Electrosurgical Generators: (CELON Elite WA90001A, WA90002A and CELON Precision WA90008A, WA90009A), including its two variants the Celon Elite and Celon Precision are reusable, non-sterile electrosurgical generators that feature different mono- and bipolar cutting and coagulation modes. The maximum output power is 120 W. Both variants of the ESG-200 are intended for cutting and coagulation of tissue in open, laparoscopic and endoscopic surgery in conjunction with electrosurgical accessories and ancillary equipment. The front panels of the proposed ESG-200 features a touch screen GUI (graphical user interface) that displays the connection status of accessories and peripherals connected to the electrosurgical generator. Two contact quality indicators (one for split and one for non-split electrodes) are green illuminated if neutral electrodes are correctly connected and red if not. Three additional push buttons allow recalling a previously saved setting (Select Procedure), to assign a footswitch to a specific output socket (Footswitch), and to control several other functions (Menu), e.g. select language, touch tone control, output volume, or brightness. The touch screen is also used to show and modify the output settings (e.g. mode, output power, effect) as well as to control other functions (e.g. save settings). In addition, the proposed ESG-200 has a bipolar socket (with automatic instrument recognition of selected Olympus instruments), a monopolar socket (E- or B-Type depending on the model), and a neutral electrode socket.
This document is a 510(k) summary for the Olympus ESG-200 Electrosurgical Generator, asserting its substantial equivalence to predicate devices. It describes the device, its intended use, technological characteristics, and performance data. However, it does not explicitly define acceptance criteria or detail a specific study proving the device meets them in the format requested.
Here's an analysis based on the provided text, addressing the points where information is available or can be inferred:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of acceptance criteria with corresponding performance metrics. Instead, it discusses the assessment of "substantial equivalence" based on comparing the ESG-200's performance with predicate devices.
The general performance criteria for electrosurgical generators would typically revolve around:
- Tissue Effects: The ability to achieve comparable cutting and coagulation effects as the predicate device.
- Electrical Waveforms: Generation of electrical waveforms that are comparable to those produced by the predicate device for various modes.
- Safety Standards Compliance: Adherence to recognized international safety standards.
Based on the text:
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Comparable Tissue Effects | "The results demonstrate that comparable tissue effects and electrical waveforms are achieved with subject and predicate devices for all modes of operation." "Porcine muscle, kidney and liver tissue were used to demonstrated tissue effect equivalence between subject and predicate devices." "Testing confirmed that comparable tissue effects and electrical waveforms could be achieved for all modes of operation." |
| Comparable Electrical Waveforms | "The electrical waveforms of the ESG-200 were in all cases comparable to the electrical waveforms of the predicate. This was confirmed for all output modes (waveforms) at rated load." "The purpose of the bench validation testing was to show equivalence of the electrical waveform between the subject and predicate devices." "Performance and validation tests incorporated the same range of waveform outputs and power levels." "During the validation testing the waveforms and test results were compared directly between the subject and predicate devices." "Waveform Validation reports for ESG-200 at all outputs and at rated load are provided in Appendix 12c." |
| Compliance with Recognized Safety and Performance Standards | The document lists several FDA-recognized international standards to which the device complies, including: AAMI/ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-2-2, IEC 62304, IEC 60601-1-6, and ISO 14971. "The performance data support the safety of the device and demonstrate that the subject devices comply with the recognized standards as specified." |
| Software Validation (Moderate Level of Concern) | "The software validation activities were performed in accordance with the FDA Guidance, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' (May 11, 2005)." "The device software is considered a 'Moderate Level of Concern'." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document mentions the use of "Porcine muscle, kidney and liver tissue" for tissue effect equivalence testing, but it does not specify the sample size (e.g., number of tissue samples or repetitions).
- Data Provenance: Not explicitly stated, but bench testing on animal tissue (porcine) is indicated. The manufacturer, Olympus Winter & Ibe GmbH, is located in Hamburg, Germany, suggesting the testing likely occurred there or in a related facility. This would be prospective bench testing.
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 section is not applicable as the study described is a bench performance test comparing physical characteristics (waveforms, tissue effects) between devices, not a study requiring human expert assessment for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable for the reasons stated above. The comparison was objective measurement of electrical waveforms and qualitative assessment of tissue effects.
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 section is not applicable. The device is an electrosurgical generator, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable as the device is not an algorithm or AI. The performance testing was of the electrosurgical generator itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench testing described:
- Electrical Waveforms: The "ground truth" for electrical waveforms would be their direct measurement using an oscilloscope and high voltage probe and comparison against the established characteristics of the predicate device (which is itself a legally marketed, validated device).
- Tissue Effects: The "ground truth" for tissue effects would be the observed impact on porcine tissue. The assessment was a direct comparison to the effects produced by the predicate device, implying the predicate's tissue effects serve as the reference standard.
8. The sample size for the training set
This section is not applicable as the device is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
This section is not applicable as the device is not an AI/machine learning device that requires a training set.
§ 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.