(70 days)
The electrosurgical generator, in conjunction with electrosurgical accessories and ancillary equipment, is intended for cutting and coagulating tissue in endoscopic surgery.
The ESG-150 is a reusable, non-sterile electrosurgical generator that features different monopolar and bipolar cutting and coagulation modes. The maximum output power is 120 W. It is intended for cutting and coagulation of tissue in endoscopic surgery in conjunction with electrosurgical accessories and ancillary equipment. The front panel features a touch screen GUI and all settings are done via the touchscreen. The ESG 150 has three contact quality indicators (CQM); green, red and grey which indicate the connection status of the neutral electrode. The generator can store selectable settings and allows the user to adjust the volume of touch screen buttons and activation. In addition to the GUI, the ESG-150 has a bipolar socket, a monopolar socket (B Type), and a neutral electrode socket. The power switch turns the generator on and off. The rear panel includes the volume control, a ventilation hole, the equipotential bonding point, the AC power socket, and a footswitch socket.
The provided text describes the regulatory clearance of the Olympus Winter & Ibe GmbH Electrosurgical Generator ESG-150. Based on the document, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a discrete table of performance acceptance criteria with numerical targets. Instead, the acceptance criteria are implicitly tied to compliance with recognized standards and demonstrating substantial equivalence to the predicate device (Olympus ESG-400), particularly regarding safety and tissue effects. The device is deemed to meet these criteria if it performs comparably to the predicate device in relevant aspects and adheres to established safety standards.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Premarket Notification (510(k)) Guidance Compliance | "The data was prepared in accordance with the FDA guidance. Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery Guidance for Industry and Food and Drug Administration Staff, issued on August 15, 2016. The guidance was followed for all relevant sections." |
| Biocompatibility | "Biocompatibility testing according to ISO 10993 is not required." (because components do not come directly or indirectly into patient contact) |
| Electrical Safety and EMC | "The design of the ESG-150 complies with recognized standards as listed in section 2.8.8 of this summary." (e.g., AAMI/ANSI ES 60601-1, IEC 60601-1-2, ANSI AAMI IEC 60601-2-2). "The FDA guidance 'Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices', CDRH July 11, 2016 has been followed." |
| Thermal Safety | "The design of the ESG-150 complies with recognized standards as listed in section 2.8.8 of this summary." |
| Software Validation | "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), and in accordance with the FDA Guidance: 'Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery' (Aug. 15, 2016). This device type software presents a 'Major Level of Concern'." Compliance with IEC 62304. |
| Functional Performance (Bench Testing) | "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 device." "Basic safety and performance testing was performed in accordance with IEC standards." "Preclinical: Evidence obtained from preclinical simulated use studies demonstrate that the device performs substantially equivalent to the predicate device in relevant aspects associated with usability, tissue effects, and thermal effects." "For simulated use testing, three clinically relevant tissue types were evaluated in all applicable modes: porcine muscle, liver, and kidney." "The thermal damage of the tissue due to the HF current was measured in terms of size (length, width and depth) of the thermal coagulation zone." "Furthermore, each test included the minimum, default and maximum intensity settings. All modes were compared to the predicate." "Testing confirmed that comparable tissue effects could be achieved for applicable modes of operation with three tissue types." |
| Usability | "Usability and user interface was also assessed according to the risk management plan. The assessment was based on Olympus predecessor product. Use-related hazardous situations were assessed and risk mitigation measures in terms of usability design for safety were defined. The residual risk was evaluated as acceptable." Compliance with IEC 60601-1-6 and IEC 62366-1. |
| Risk Analysis | "Risk analysis was carried out in accordance with established internal acceptance criteria based on ISO 14971:2007." |
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set Sample Size: The document specifies that for simulated use testing, "three clinically relevant tissue types were evaluated in all applicable modes: porcine muscle, liver, and kidney." It doesn't provide a specific numerical count for samples within each tissue type for "length, width and depth" measurements.
- Data Provenance: The studies were preclinical simulated use studies using "porcine muscle, liver, and kidney" tissue. This indicates an in vitro or ex vivo setting, not human data. The country of origin of the data is not explicitly stated, but the manufacturer is based in Germany.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for the test set in the traditional sense of clinical assessment. The "ground truth" for the performance testing was based on direct measurements of tissue effects (thermal coagulation zone size) and comparison to the predicate device's performance according to established scientific and engineering principles.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
No adjudication method involving multiple human reviewers is mentioned or applicable, as the performance evaluation was based on objective measurements in preclinical bench and simulated use studies.
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
No MRMC study was conducted. This device is an electrosurgical generator, not an AI-powered diagnostic tool that assists human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
This question is not applicable. The ESG-150 is a medical device, not an algorithm. Its performance is evaluated through its functional output and interaction with tissue, which is inherently standalone in its operation (though intended for human use with instruments).
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)
For the preclinical simulated use studies, the "ground truth" was based on direct quantitative and qualitative assessment of tissue effects, specifically "thermal damage... measured in terms of size (length, width and depth) of the thermal coagulation zone" on animal tissue (porcine muscle, liver, and kidney). This is an objective, measurable physical effect, not subjective expert consensus or pathology on human samples. For other tests (electrical safety, EMC), the ground truth was conformance to recognized international standards.
8. The Sample Size for the Training Set
No training set is mentioned in the context of this device. This device is an electrosurgical generator, which does not typically involve machine learning or AI models that require training data. Its design and performance are based on engineering principles and electrical output characteristics.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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.