(92 days)
ESG-300: The electrosurgical generator ESG-300, in conjunction with electrosurgical accessories and ancillary equipment, is intended for cutting and coagulation of tissue in open surgery, laparoscopic surgery and endoscopic surgery. For monopolar argon plasma coagulation (MAPC) of tissue, the electrosurgical generator is intended to be used with a compatible Olympus argon plasma coagulation unit to deliver ionized argon gas.
Accessories:
APU-300: The argon plasma coagulation unit and its accessories, in conjunction with a compatible Olympus electrosurgical generator and monopolar argon plasma coagulation (MAPC) probes, are intended argon gas for monopolar argon plasma coagulation of tissue.
Pressure Reducer (accessory of APU-300): The pressure reducers are accessories and must only be used in conjunction with the compatible argon plasma coagulation unit APU-300. Observe the instructions for use of the compatible argon plasma coagulation unit APU-300 regarding: intended use/ contraindications/ environment of use/ compatible equipment
MAPC probes: The single use and flexible monopolar argon plasma coagulation with a compatible Olympus argon plasma coagulation unit and a compatible Olympus electrosurgical generator, are intended to deliver ionized argon gas for monopolar argon plasma coagulation of tissue.
The subject device ESG-300 is a reusable, non-sterile electrosurgical generator that features different monopolar and bipolar cutting and coagulation modes. In combination with the compatible argon plasma coagulation unit APU-300, it features monopolar argon plasma coagulation modes. The maximum output power is 120 W.
The front panel of the proposed ESG-300 features a touch screen GUI (graphical user interface) that displays the current settings of the chosen output mode, the connection status of accessories and peripherals connected to the electrosurgical generator. Soft keys are integrated into the GUI to switch between the output sockets, to enter the Menu in order to edit settings/ procedures (e.g. create/ edit userdefined settings/ procedures), to edit preferences (e.g. select language, touch tone control, output volume, or brightness) and to show service options (e.g. software version identifier, for service and maintenance purposes) or to assess user-defined settings and procedures.
The electrosurgical generator can be used in conjunction with the compatible Olympus argon plasma coagulation unit and its accessories as well as the monopolar argon plasma coagulation (MAPC) probes. The single use MAPC probes only will be provided in sterile condition.
The front panel of the argon plasma coagulation unit APU-300 features the Argon socket (to connect a compatible MAPC probe), a purge button (to purge the system with argon gas) and the power switch.
The single use MAPC probes are offered in three different beam types, length and outer diameter each. The plug is proprietary to the APU-300.
The provided text describes the submission for a 510(k) premarket notification for electrosurgical devices (ESG-300 with accessories: APU-300, Pressure Reducer, MAPC Probes).
The document is a Summary of a 510(k) submission, not a detailed study report. Therefore, it primarily focuses on demonstrating substantial equivalence to predicate devices through various tests and compliance with recognized standards, rather than proving the device meets specific acceptance criteria for a novel AI/ML medical device.
Based on the provided text, the device is an electrosurgical generator, not an AI/ML device. The "acceptance criteria" discussed in the document are primarily related to safety, performance (including tissue effects and electrical waveforms), and compliance with FDA recognized standards, rather than AI-specific metrics like AUC, sensitivity, or specificity.
Therefore, many of the requested points regarding AI/ML device validation (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance) are not applicable or not explicitly stated in the context of an electrical medical device submission like this one.
However, I can extract information relevant to the device's validation and "acceptance criteria" as described in this submission:
Acceptance Criteria and Device Performance (as inferred from the document):
The submission's core "acceptance criteria" revolve around demonstrating substantial equivalence to predicate devices in terms of:
- Safety: Compliance with electrical safety, EMC, thermal safety, and biocompatibility standards.
- Performance: Comparable tissue effects and electrical waveforms to the predicate devices across various modes and tissue types.
- Functionality: The device performs its intended cutting and coagulation functions.
- Usability: Acceptable residual risk and user interface design.
Since this is a submission to demonstrate substantial equivalence of a non-AI electrosurgical device, the acceptance criteria are largely qualitative and based on comparative bench testing and compliance with recognized standards, rather than quantitative metrics typically seen for AI/ML performance.
Table of Acceptance Criteria and Reported Device Performance (Inferred from the document):
| Acceptance Criteria Category (Inferred) | Specific Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Electrical Safety & EMC | Compliance with recognized standards (IEC 60601-1, IEC 60601-1-2, AAMI ANSI IEC 60601-2-2) and FDA guidance for EMC. | "The design of the ESG-300 with accessories complies with recognized standards as listed in section 2.10." and "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 | Compliance with recognized standards. | "The design of the ESG-300 with accessories complies with recognized standards as listed in section 2.10." |
| Biocompatibility | Compliance with ISO 10993-1 for patient-contacting components (MAPC probes). | "Biocompatibility testing of the MAPC probes accessories has been successfully conducted according to ISO 10993-1... Testing included the following tests: Cytotoxicity, Irritation, Sensitization." (ESG-300, APU-300, and Pressure Reducer do not require biocompatibility testing as they don't have direct/indirect patient contact). |
| Functional Performance (Tissue Effects) | Comparable tissue effects (size of thermal coagulation zone - length, width, depth) to predicate devices across different modes and tissue types. Quantitative & qualitative assessment. | "Testing confirmed that comparable tissue effects could be achieved for applicable modes of operation with the three tissue types." "For all modes the tests demonstrated comparable tissue effects and electrically comparable waveforms." "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." |
| Functional Performance (Electrical Waveforms) | Electrically comparable waveforms to predicate devices. | "For all modes the tests demonstrated comparable tissue effects and electrically comparable waveforms." "the waveforms of the generators were compared. For all modes the tests demonstrated comparable tissue effects and electrically comparable waveforms." "The range of output waveforms is identical but the power levels are decreased in comparison to the FDA cleared ESG-400..." (for primary predicate) / "The range of output waveforms is identical in comparison to the FDA cleared ERBE ESU Model VIO 300 D..." (for secondary predicate). |
| Software Validation | Compliance with FDA Guidance: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". | "The software validation activities were performed in accordance with the FDA Guidance..." "The device software is considered a 'Major Level of Concern'." |
| Usability | Acceptable residual risk based on risk management plan and ISO 14971. | "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." |
| Sterilization & Shelf Life (MAPC probes) | Sterile assurance level (SAL) of 10-6, EtO residuals within limits, and stability for stated shelf-life. | "A sterility assurance level (SAL) of 10-6 was reached during validation and will be used for routine sterilization..." "The EtO residuals are within the limits after tunnel degassing time." "Shelf Life testing was conducted... to support a shelf life of 1 year for the MAPC probes." |
Study Information (Based on the document):
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Sample Size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a number of "cases" or "patients" as would be seen for clinical or AI studies. The "test set" consisted of:
- Tissue types: "three clinically relevant tissue types: porcine muscle for endoscopic procedures, porcine liver for open procedures and porcine kidney for laparoscopic procedures." The number of individual tissue samples or repetitions per setting is not specified.
- Modes/Settings: Minimum, default, and maximum intensity settings for all applicable modes were tested.
- Instruments: A "representative selection of HF instruments" was used.
- Data Provenance: The preclinical (simulated use) evaluation was performed using porcine tissue. The location where these studies were conducted (e.g., country) is not specified. It is a preclinical bench study, not a clinical one, so it is neither retrospective nor prospective in the human patient sense.
- Test Set Sample Size: Not explicitly stated as a number of "cases" or "patients" as would be seen for clinical or AI studies. The "test set" consisted of:
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not stated. For this type of electrosurgical device, "ground truth" typically refers to objective measurements of tissue effects (e.g., coagulation zone size) and electrical waveforms, not expert consensus on image interpretation or diagnosis. The measurements were quantitative and qualitative assessments of physical effects. Thus, human "experts" establishing a diagnostic ground truth are not relevant for this type of submission.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. As above, this is not a diagnostic study involving human interpretation that would require an adjudication process. Measurements of tissue effects and electrical waveforms are objective bench tests.
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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. This is not an AI-assisted diagnostic device, and no MRMC study was performed. Clinical studies were explicitly stated as "not conducted for this submission."
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm. The device itself performs the function. The bench testing performed could be considered "standalone" in the sense that the device's physical output and effect were measured objectively, independent of a human operator's diagnostic interpretation.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For functional performance (tissue effects and electrical waveforms): The "ground truth" was established by objective measurements of characteristics such as:
- Size (length, width, depth) of the thermal coagulation zone in porcine tissue.
- Electrical waveforms (compared directly to predicate devices).
- For safety: Compliance with a multitude of recognized international standards and specific FDA guidances.
- For functional performance (tissue effects and electrical waveforms): The "ground truth" was established by objective measurements of characteristics such as:
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The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no "training set."
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How the ground truth for the training set was established:
- Not applicable. No training set was used.
§ 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.