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510(k) Data Aggregation
(157 days)
The EM3 AEM Monitor is an accessory for use with electrosurgical generators and electrodes that is designed to safely deliver electrosurgical energy and to prevent injury caused by insulation failure and capacitive coupling.
The EM3 AEM Monitor performs two distinct functions:
- Active electrode monitoring is intended to control stray monopolar energy caused by insulation failure and capacitive coupling in surgical instruments on the shaft of the instrument.
- End point monitoring is intended to aid the surgeon in determining the end point of bipolar electrosurgical desiccation.
The EM3 AEM Monitor is the "nerve center" and interface to the electrosurgical generator and instruments for AEM monitoring, a safety system for minimally-invasive electrosurgery.
- For monopolar electrosurgery. AEM technology prevents unanticipated or undetected burns from stray energy along the instrument outside the surgeon's field of view
- In bipolar electrosurgery, the EM3 displays the measurement of high-frequency current flowing through the instrument and tissue as an aid in determining the endpoint of bipolar desiccation
The EM3 AEM Monitor system comprises two components
- The Monitor or electronic unit.
- A specific or standard ESU Adapter.
An ESU Adapter is an accessory to the Monitor containing cords and connectors, which connect the Monitor to the electrosurgical generator (ESU). Multiple models of ESU Adapters are required due to the wide variety of electrosurgical generators in the marketplace and in use in the hospitals.
Here's a summary of the acceptance criteria and study information for the EM3 AEM Monitor, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria (Predicate EM2 AEM Monitor) | Reported Performance (EM3 AEM Monitor) |
|---|---|---|
| Intended Use | Monopolar active-electrode stray-energy shunting and monitoring and bipolar desiccation end-point monitoring | Identical to EM2 |
| Operating Principle | Monopolar high-frequency current shunting, measuring, threshold detection, and alarming; Bipolar high-frequency ammeter measuring and indicating current; Interruption of electrosurgical current under fault condition by tripping ESU contact quality monitor alarm | Monopolar high-frequency current shunting, measuring, threshold detection, and alarming; Bipolar high-frequency ammeter measuring and indicating current; Direct interruption of electrosurgical current to active electrode under fault condition |
| Materials | Typical electronic wires, connectors, analog and logic components, circuit boards, and enclosures | Same as EM2 |
| Energy Source | Mains power | Identical to EM2 |
| Technology | Discrete logic components, PAL logic device, analog electronics, logic-level relay | FPGA logic device, analog electronics, HF power relays |
| Sterilization | None | None |
| Performance: Shield circuit to ESU return potential impedance | < 55 pF | < 55 pF |
| Performance: Alarm threshold current | 350 mA | 400 mA |
| Performance: Visual/audible indication from monitor (Alarm response time) | < 150 ms | < 150 ms |
| Performance: Power delivery cessation (Alarm response time) | > 300 ms (dependent on ESU circuit) | < 150 ms |
| Performance: Fault indication | Simultaneous active and return faults alarmed: active on EM2, return on ESU | Singular active fault indication from monitor |
| Performance: Current graph granularity | ~30 mA | ~120 mA |
| EMC and Electrical Safety | Internal design control assurances, IEC 60601-1 (2nd ed) compliant, IEC 60601-1-2 compliance, IEC 60601-2-2 compliance | Internal design control assurances, IEC 60601-1 (3rd ed) compliant, IEC 60601-1-2 compliance, IEC 60601-2-2 compliance |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Complete verification and validation tests were performed in accordance with Design Control requirements per 21 CFR 820.30 for all essential specifications demonstrating substantial equivalence of the EM3 AEM Monitor to the predicate system." However, specific sample sizes for a test set (e.g., number of cases, number of devices) are not provided. The provenance of the data is not explicitly stated as retrospective or prospective, nor is the country of origin mentioned beyond the manufacturer being located in Boulder, CO, US.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The study appears to be a bench test focused on the technical performance compared to a predicate device, rather than a clinical study requiring expert ground truth for interpretation (e.g., image analysis).
4. Adjudication Method for the Test Set
This information is not applicable/not provided as the study described is a technical bench test and verification, not a study involving human interpretation requiring adjudication.
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 comparative effectiveness study was done or mentioned. This device is a safety monitoring system for electrosurgery, not an AI-powered diagnostic tool that human readers would use in conjunction with.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
The study described is essentially a standalone performance evaluation of the device's technical specifications. The "algorithm" here refers to the device's built-in logic (FPGA firmware) for monitoring and alarm functions. The performance metrics listed (e.g., impedance, alarm threshold, response time) are intrinsic to the device's function and were tested independently of a human operator, though the device's output (alarms, current display) interacts with the human surgeon.
7. The Type of Ground Truth Used
The ground truth for the bench tests appears to be established technical specifications and engineering requirements, along with the performance characteristics of the predicate device (EM2 AEM Monitor). For example, the "alarm threshold current" has a defined value (400 mA).
8. The Sample Size for the Training Set
Not applicable. This device is hardware with embedded firmware, and the testing described is verification and validation against specifications, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a machine learning algorithm. The "ground truth" for the device's design and testing is based on engineering principles, safety standards (e.g., IEC 60601-1), and the performance of the predicate device.
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