(46 days)
The Force FX™ 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 (resecting, dividing, or separating) and coagulating (hemostasis).
The Force FX™ Electrosurgical Generators are microcontroller-based isolated output generators that provide power for cutting, desiccating, and fulgurating tissue during bipolar and monopolar surgery. Features included are:
- . Instant Response™ Technology - Automatically senses resistance and adjusts the output voltage to maintain a consistent effect across different tissue density.
- Three bipolar modes: precise, standard, and macro Low voltage, continuous current provides faster . desiccation without sparking.
- Three monopolar Cut modes: low, pure, blend Allows a wide range of power settings necessary to ● perform diverse surgical procedures.
- . Three monopolar Coag modes: desiccate, fulgurate, and spray - Helps control the size of the area and the depth of penetration during tissue coagulation.
- Support for Simultaneous Activation ●
- Covidien Energy-based Devices REM™ Contact Quality Monitoring System Monitors the quality . of electrical contact between the return electrode and the patient to eliminate risk of pad site burns.
- Handswitch or footswitch activation
- . Recall of most recently used mode and power settings
- Adjustable activation tone volume
- An RF activation port, RS-232 serial port, and expansion port .
The precise and standard bipolar modes of the Force FX™-8CA(S) models are equipped with an Autobipolar function. The autobipolar feature senses tissue impedance between the two bipolar electrodes and then uses the impedance information to automatically start or stop bipolar RF activation. Optionally, the user may choose between footswitch start and auto start, or program a delay between auto start and RF activation.
Here's an analysis of the provided text regarding the acceptance criteria and study proving device compliance, structured according to your request:
Device Name: Force FX Generators (Electrosurgical cutting and coagulation device and accessories)
510(k) Number: K143161
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Performance Requirements) | Reported Device Performance |
|---|---|
| Conformance to IEC 60601-1:2005 (Basic safety and essential performance) | Design verification testing confirmed conformance. |
| Conformance to IEC 60601-2-2:2009 (Safety and performance for electrosurgical units) | Design verification testing confirmed conformance. |
| Conformance to IEC 60601-1-2:2007 (Electromagnetic compatibility) | Design verification testing confirmed conformance. |
| Performance under varying environmental conditions (multiple AC mains voltages and temperatures) | Design verification testing, including application of multiple AC mains voltages and temperatures, ensured the proposed modifications perform within design parameters under varying environmental conditions. |
| Software Regression/Validation | Software regression/validation was performed. |
| No alteration of intended use | The intended use of the Force FX generator was not altered (electrosurgical cutting and coagulating during surgical procedures). The device continues to provide monopolar and bipolar technology. |
| No adverse effect on safety or performance due to modifications. | "The modifications made to the Force FX generator were found to not affect safety or performance through design verification testing, which continued conformance to applicable technical design specifications and performance requirements..." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes "design verification testing" and "software regression/validation" but does not specify the sample size used for these tests. It also does not mention the data provenance in terms of country of origin or whether the data was retrospective or prospective.
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)
The document does not mention the use of experts to establish ground truth for the test set. The evaluation relies on technical design specifications, performance requirements, and industry standards, rather than expert-derived ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method for a test set, as the evaluation type is primarily engineering verification against predefined standards and specifications.
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. The device (electrosurgical generator) is not an AI-assisted diagnostic or interpretative tool, and no human reader performance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The evaluation was a standalone technical performance assessment of the device (Force FX Generators) against technical specifications and industry standards. There is no "algorithm only" performance in the context of AI, as this is a hardware-based medical device with integrated software. The "standalone" aspect refers to the device's inherent functional capabilities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance evaluation is based on conformance to established technical design specifications, performance requirements, and industry safety and performance standards (e.g., IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2). This is not a clinical ground truth like pathology or outcomes data, but rather an engineering and regulatory compliance ground truth.
8. The sample size for the training set
The device is an electrosurgical generator, not a machine learning or AI-driven system in the context of image analysis or diagnostics that typically requires a "training set." Therefore, no training set sample size is applicable or mentioned.
9. How the ground truth for the training set was established
As there is no training set for this type of device, this question is not applicable.
§ 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.