(86 days)
The Genesis is indicated for use in surgical procedures (general neurosurgical, laparoscopic, orthopedic, gynecologic, etc.) where monopolar electrosurgical cutting and coagulation are normally used. The Genesis instruments are an alternative to conventional monopolar electrosurgical electrodes used for these indications.
The Genesis is an instrument intended for use as a monopolar electrosurgical accessory. The device reduces the smoke emitted into the surgical area, uses lower power with less tissue damage and the outer layer provides a surface that reduces tissue accumulations and facilitates removing tissue residues, such as eschar, that may accumulate during use. Genesis devices are intended for use with monopolar electrosurgical accessories and will be packaged separately. Genesis instruments will also fit in currently marketed electrosurgical pencils offered by other manufacturers.
This document is a 510(k) summary for a medical device called "Genesis" from MEDISISS. It details the device's classification, indications for use, and a comparison to predicate devices, but lacks the specific performance data needed to populate all sections of your request.
Here's what can be extracted from the provided text, and where information is not available:
1. A table of acceptance criteria and the reported device performance
According to the provided text, the Genesis device is an electrosurgical accessory. The acceptance criteria and reported device performance would typically include quantifiable metrics related to its stated features: "reduces the smoke emitted into the surgical area, uses lower power with less tissue damage and the outer layer provides a surface that reduces tissue accumulations and facilitates removing tissue residues, such as eschar, that may accumulate during use."
However, this document does not contain a table of acceptance criteria or reported device performance with specific numerical values for these claims. The 510(k) summary itself focuses on establishing substantial equivalence to predicate devices, not on providing detailed performance metrics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not available in the provided text. The document describes the device and its indications but does not mention any specific studies, test sets, sample sizes, or data provenance.
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 available in the provided text. There is no mention of an expert panel or ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not available in the provided text. No adjudication method is described as no test set data is provided.
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. The Genesis is an electrosurgical device, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The Genesis is an electrosurgical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not available/Applicable in the provided text. As this is an electrosurgical accessory, the "ground truth" would likely relate to the physical effects of its operation (e.g., smoke reduction, tissue damage, eschar accumulation), which would be assessed directly during testing, not established through expert consensus or pathology in the same way a diagnostic device would. However, the specific methods are not described.
8. The sample size for the training set
Not applicable. The Genesis is a physical electrosurgical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 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.