(69 days)
The electrodes are used for dissection, for coagulation or removing and destroying tissue by use of unipolar high-frequency current under endoscopic view.
The electrodes are used for examination, diagnostics, and/or therapy by personnel who are qualified and suitably trained in connection with endoscopically used accessories in different medical disciplines, particularly suitable for outpatient and pediatric laproscopy.
The electrodes are part of the MICRO and MINI instrument set for laparoscopic microsurgery. They are particularly suitable for diagnostics, smaller interventions, and out-patient and pediatric microsurgery. The electrodes have the same design and material as earlier R. Wolf devices. The closed on the submitted devices and its predecessors is the small diameter for minimally invasive laparoscopy.
The provided text is related to a 510(k) submission for Monopolar Electrodes 3.5. This type of submission is for demonstrating substantial equivalence to pre-existing devices, rather than establishing efficacy through new clinical trials with acceptance criteria.
Based on the provided text, here's an analysis regarding your questions:
1. A table of acceptance criteria and the reported device performance
No acceptance criteria or reported device performance metrics are mentioned in the provided text. The submission explicitly states:
- "No know FDA performance standards exist." (Section 5.0 Performance Data)
- "No clinical tests performed." (Section 6.0 Clinical Tests)
The focus of this 510(k) is to demonstrate substantial equivalence based on design, materials, and intended use to predicate devices, rather than meeting specific performance metrics from a new study.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No test set was used because no clinical tests or performance studies measuring specific outcomes were performed.
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)
Not applicable. No ground truth establishment was described as no clinical tests were performed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set was used.
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 is not an AI-powered device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical instrument (monopolar electrodes), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth was established, as no clinical tests were performed.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device, so there is no concept of a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
Summary of what was done for this submission:
The submission focuses on establishing substantial equivalence to legally marketed predicate devices based on:
- Design and Materials: "The electrodes have the same design and material as earlier R. Wolf devices. The closed on the submitted devices and its predecessors is the small diameter for minimally invasive laparoscopy." (Section 3.0 Technological Characteristics)
- Intended Use: The intended use of the new device is consistent with the predicate devices.
- Predicate Devices: Several pre-enactment and 510(k) cleared devices from Richard Wolf, Karl Storz, and Jarit are cited as substantially equivalent.
The conclusion drawn is that the devices are "designed and tested to guarantee the safety and effectiveness when used according to the instruction manual," but this is a general statement based on engineering design and prior device history, not on new clinical performance data for this specific submission.
§ 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.