Search Results
Found 1 results
510(k) Data Aggregation
(88 days)
The Autocon II 200 Electrosurgical Generator is intended for use by qualified surgeons to provide a high frequency (HF) electrical current for cutting and coagulating tissue during open and endoscopic surgeries, including general, plastic, urological, ENT, gynecologic, and arthroscopic procedures.
The Autocon II 200 consists of a generator, a dual pedal foot switch, and a power cord. The footswitch activates the power for cutting and coagulation. The Autocon II 200 is able to provide either monopolar or bipolar modes for cutting and coagulation. It can be linked to Karl Storz SCB.
This document pertains to a 510(k) submission for an electrosurgical generator, not an AI or imaging device. Therefore, much of the requested information regarding acceptance criteria, study design, ground truth, and human reader performance is not applicable. The provided text describes the device, its intended use, and its substantial equivalence to predicate devices, but does not include details of performance studies against specific acceptance criteria in the manner applicable to AI-driven diagnostic tools.
However, I can extract the relevant information that is present in the document.
1. A table of acceptance criteria and the reported device performance:
The provided document (K023924 510(k) Summary) for the Autocon II 200 Electrosurgical Generator does not explicitly state quantitative acceptance criteria or a formal performance study with reported device performance in a table format as might be seen for an AI diagnostic device.
For electrosurgical generators, "acceptance criteria" are generally met through substantial equivalence to predicate devices and adherence to relevant electrical and safety standards (e.g., IEC standards for electromedical equipment). The document highlights:
| Acceptance Criteria (Implied by 510(k) process for this device type) | Reported Device Performance |
|---|---|
| Safety and Effectiveness: No new issues of safety and effectiveness compared to predicate devices. | "The minor differences between the KSEA Autocon II 200 Electrosurgical Generator and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices." |
| Intended Use: Device performs its intended functions for cutting and coagulating tissue. | "The Autocon II 200 Electrosurgical Generator is intended for use by qualified surgeons to provide a high frequency (HF) electrical current for cutting and coagulating tissue during open and endoscopic surgeries..." (Implies the device can perform these functions). |
| Basic Design, Dimensions, and Features: Similar to predicate devices. | "The KSEA Autocon II 200 Electrosurgical Generator is substantially equivalent to the predicate devices since the basic design, dimensions, safety features, and intended uses are similar." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. The submission does not describe a "test set" of data or patient cases for evaluating performance in the context of an AI or diagnostic imaging device. The 510(k) relies on substantial equivalence and adherence to manufacturing and safety standards.
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 by experts for a test set is mentioned, as this is not an AI diagnostic device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No adjudication method for a test set is mentioned.
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-driven device, so an MRMC study comparing human readers with and without AI assistance was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is an electrosurgical generator, not an algorithm, so a standalone performance evaluation of an algorithm without human-in-the-loop performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. No ground truth for performance evaluation of a diagnostic nature is mentioned or relevant to this device type in this submission.
8. The sample size for the training set:
Not applicable. There is no "training set" as this is not an AI device.
9. How the ground truth for the training set was established:
Not applicable. There is no "training set" and therefore no ground truth establishment for such a set.
Ask a specific question about this device
Page 1 of 1