Search Results

The product is used for generating high frequency electrical current for cutting and coagulating tissue electrosurgically.

The HF SURGERY GENERATOR 400KHZ is used for electrosurgical cutting and coagulation of living human tissue. For this purpose, electrical energy from the power supply network is transformed into high frequency current which allows this surgical property. The device offers a multitude of different profiled current forms which are optimized for the different surgical requirements. It is equipped for monopolar and bipolar cutting and coagulation in micro- and macrosurgical operations.

Here's a breakdown of the acceptance criteria and the study information for the HF SURGERY GENERATOR 400KHZ, based on the provided FDA 510(k) summary.

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. As such, it primarily reports on comparative testing and compliance with standards rather than detailed acceptance criteria and specific performance metrics of a novel algorithm or AI.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of specific acceptance criteria in numerical terms (e.g., minimum accuracy, sensitivity, or specificity) nor does it provide a numerical "performance" for such criteria. Instead, the acceptance criteria are largely implied by compliance with safety and performance standards, and comparison to the predicate device.

The "reported device performance" is primarily that the device meets relevant standards and is substantially equivalent to the predicate.

2. Sample Size Used for the Test Set and Data Provenance

This document does not describe a clinical study with a "test set" in the context of AI or diagnostic device performance based on patient data. The performance testing conducted for the HF SURGERY GENERATOR 400KHZ is primarily bench testing and animal testing.

• Sample Size for Test Set: Not applicable in the context of patient data for AI. For bench and animal testing, specific sample sizes are not detailed in this summary.
• Data Provenance: Not applicable for patient data. The testing involves engineering verification and validation.
  • One test mentioned is "Validation of the performance on tissue (Section 19 Performing Testing Animal)". This suggests animal models were used, but details on the number of animals or specific data are not provided in this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This device is an electrosurgical generator, which is a therapeutic device, not a diagnostic device that requires expert interpretation for a "ground truth" to evaluate an algorithm's performance.

4. Adjudication Method for the Test Set

Not applicable for the reasons stated above.

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

Not applicable. This device is an electrosurgical generator, not an AI-assisted diagnostic tool for human readers.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

The device contains software classified as a "Major Level of Concern." While "Software Verification and Validation" was performed, the document does not describe a standalone algorithm-only performance study in the way this question typically refers to AI performance (e.g., classifying images without human input). The software's role is in controlling the electrosurgical generator's functions, not performing diagnostic interpretations.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

For the "Validation of the performance on tissue (Section 19 Performing Testing Animal)" and "Validation of the performance based on waveform comparison," the "ground truth" would be established through:

• Bench Test Results: Measured electrical outputs (power, voltage, frequency, crest factor) compared against engineering specifications and predicate device characteristics.
• Animal Tissue Response: Observation and potentially histological analysis of tissue effects (cutting, coagulation) in animal models, likely assessed against expected outcomes for electrosurgery.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML-driven diagnostic or image analysis device that requires a training set of data. The software is likely rule-based or control-loop based, validated against specifications.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set is described for this type of device.

In summary, the provided FDA 510(k) substantial equivalence summary for the HF SURGERY GENERATOR 400KHZ focuses on demonstrating that the device is safe and effective by:

1. Compliance with recognized electrical safety and EMC standards.
2. Comparison of technological characteristics to a legally marketed predicate device.
3. Performance testing: This includes bench testing of electrical outputs, waveform comparison, animal tissue testing, software verification/validation, and transportation validation.

It is crucial to understand that the questions posed are typically relevant to AI/ML-enabled diagnostic medical devices, which this electrosurgical generator is not.

Ask a specific question about this device