(145 days)
The Electrosurgical Generator is an electrosurgical generator containing monopolar and bipolar technology. It is intended for use with accessories during surgical procedures where the surgeon requires electrosurgical cutting and coagulating.
The application device, the Electrosurgical Generator, is a solid state generator designed to supply radiofrequency electrical energy for general electrosurgical purposes, with physical dimensions around 37cm (L) x 29cm (W) x 17cm (H) and 5kg unit weight. The Electrosurgical Generator supplies high frequency electrosurgical power from low power (100W, Coag>70W). The Electrosurgical Generator outputs high frequency energy in the following modes: 1. Monopolar CUT: Pure Blend 1 Blend 2 2. Monopolar COAG: Pin Point Spray 3. Bipolar: Standard The Electrosurgical Generator can be activated via a hand switch or a foot switch. The Electrosurgical Generator has a Return Electrode Contact Quality Monitor to alert the user when inadequate contact is being made with the Return (aka Neutral) Electrode. The Electrosurgical Generator is mains powered.
This document is a 510(k) premarket notification for an Electrosurgical Generator (Model: ES300) and describes its substantial equivalence to a predicate device, the Covidien Force FX™ Electrosurgical Generator (K143161). The focus of the provided text is on demonstrating the device's adherence to relevant standards and its similarity in function and design to the predicate, rather than providing details of a study with specific acceptance criteria and performance metrics in the format requested.
Therefore, the requested information (acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and MRMC study details) is not explicitly available in the provided text in the detailed format you requested for an AI/device performance study. The document primarily focuses on regulatory compliance through comparison to a predicate device and adherence to established electrical safety and performance standards.
Here's an attempt to extract and infer information based on the provided text, while also noting what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present acceptance criteria and reported device performance in a numerical table for clinical or diagnostic accuracy as would be found in a study for an AI-powered diagnostic device. Instead, "acceptance criteria" are implied by adherence to and compliance with recognized standards and guidelines. "Device performance" is largely described qualitatively and by comparison to the predicate device's established performance.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Indications for Use equivalence | The indications for use are "identical, except specific examples of clinical techniques were dropped as unnecessary." The device is intended for use with accessories during surgical procedures where the surgeon requires electrosurgical cutting and coagulating. |
| Operating Principle equivalence | "Identical" - both devices are radio-frequency (RF) electrosurgical generators delivering energy to compatible surgical instruments to produce heat for cutting and coagulation. |
| Output Configuration equivalence | "Identical" - Isolated. |
| Type (electrical protection) equivalence | "Identical" - CF. |
| Working Theories Monopolar/Bipolar equivalence | "Identical" - monopolar involves a cyclic circuit with an electrosurgical electrode and a neutral pad; bipolar involves a cyclic circuit between two tips of bipolar forceps. |
| Performance Specification (Output Mode, Waveforms) equivalence | Nonclinical differences exist but "have no influence on safety and performance." Both have monopolar CUT, monopolar COAG, and BIPOLAR modes with similar output power and crest factors. Waveforms have "similar shapes" and frequencies above 200 kHz, with "slight differences" due to component parameters, which "have no influence in the actual application process." |
| Safety and Essential Performance (IEC 60601-1) | "Tested and found to be in compliance" with IEC 60601-1: 2005+A1:2012. |
| Electromagnetic Compatibility (IEC 60601-1-2) | "Tested and found to be in compliance" with IEC 60601-1-2: 2014. |
| Particular Requirements for HF Surgical Equipment (IEC 60601-2-2) | "Tested and found to be in compliance" with IEC 60601-2-2: 2017. |
| Medical Device Software Life Cycle Processes (IEC 62304) | "Tested and found to be in compliance" with IEC 62304: 2006+AMD 1:2015. |
| Shipping/Transit Testing (ISTA 3A) | "Tested and found to be in compliance" with ISTA 3A: 2008. |
| Compliance with FDA Guidance | "Fully tested and in compliance with the FDA guideline Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery: Guidance for Industry and Food and Drug Administration Staff (9 March 2020)." |
| Similar Safety Features (Pad Control System, Activation Tones, Alarm Tone) | Pad Control System (CQM) is "identical" to predicate's REM. Activation Tones and Alarm Tone frequencies/number of tones are different but "do not affect device safety and performance." |
2. Sample Size Used for the Test Set and the Data Provenance
This information is not provided in the document. The testing described is primarily related to compliance with electrical, safety, and performance standards for the device itself, rather than a clinical study with a test set of patient data. The provenance of data from such compliance testing would typically be from laboratory settings or engineering evaluations, not patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided. The document describes regulatory compliance and engineering testing, not a study involving expert-established ground truth for a test set of cases.
4. Adjudication Method for the Test Set
This information is not provided. As there's no mention of a clinical test set with ground truth, an adjudication method is not applicable in this context.
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 information is not provided. The device is an electrosurgical generator, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device and was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. The device is a physical electrosurgical generator, not an algorithm. Performance tests mentioned are for the physical device's electrical outputs and safety features, not standalone algorithmic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the type of device described (an electrosurgical generator), "ground truth" would typically refer to objective measurements and adherence to specified performance parameters defined by engineering standards (e.g., output power within tolerance, impedance monitoring accuracy, alarm functionality). The document indicates that the device was "tested and found to be in compliance" with various IEC standards and FDA guidance, which serve as the "ground truth" or benchmarks for electrical safety and performance.
8. The sample size for the training set
This information is not applicable/not provided. As this is not an AI/machine learning device, there is no "training set" in the computational sense.
9. How the ground truth for the training set was established
This information is not applicable/not provided. There is no training set for this type of device.
In summary: The provided FDA 510(k) summary document focuses on demonstrating substantial equivalence of an electrosurgical generator to a predicate device through adherence to recognized technical standards and comparison of features. It does not contain information about a clinical or diagnostic study with acceptance criteria, sample sizes, expert ground truth, or AI-related performance metrics as requested for an AI/CAD-type 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.