(181 days)
The Autocon II 400 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, neurological, and gynecologic procedures.
The Autocon II 400 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 400 is able to provide either monopolar or bipolar modes for cutting and coagulation. It can be linked to Karl Storz SCB.
This document is a 510(k) summary for the KSEA Autocon II 400 Electrosurgical Generator, indicating its substantial equivalence to predicate devices. It does not contain information on acceptance criteria or a study that proves the device meets those criteria in the context of device performance metrics, such as accuracy, sensitivity, or specificity, which would typically be found in an evaluation of AI/ML or diagnostic devices.
The document pertains to the regulatory submission for an electrosurgical generator, which is a medical device used for cutting and coagulating tissue. The assessment is focused on showing its substantial equivalence to existing devices rather than a performance study as described in your request. Therefore, most of the information requested in your prompt is not applicable to this document.
Here's a breakdown of why the requested information is absent based on the provided text:
- No AI/ML or Diagnostic Device: The KSEA Autocon II 400 Electrosurgical Generator is an electrosurgical generator. This type of device does not typically involve AI/ML algorithms or require performance metrics like sensitivity, specificity, or accuracy compared to a ground truth, as would be the case for a diagnostic or image analysis device. Its "performance" is generally assessed by electrical safety, power output consistency, and functional equivalence to predicate devices.
Specific answers to your questions, based on the provided text:
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A table of acceptance criteria and the reported device performance:
- Not applicable. The document focuses on demonstrating "substantial equivalence" to predicate devices. It states: "The KSEA Autocon II 400 Electrosurgical Generator is substantially equivalent to the predicate devices since the basic design, dimensions, safety features, and intended uses are similar. The minor differences between the KSEA Autocon II 400 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." This is the core "acceptance" criteria for this type of 510(k) submission, rather than specific performance metrics.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. This information is not relevant for the type of device and submission presented. There is no "test set" of data in the context of evaluating an algorithm's performance against ground truth.
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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. There is no "ground truth" establishment in the sense of expert review of images or diagnostic outcomes. The "ground truth" for an electrosurgical generator is its adherence to safety standards and functional specifications compared to established predicate devices.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set or adjudication method as described is present.
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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-assisted diagnostic device, so an MRMC study is not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithmic or AI-based device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the context of diagnostic performance. For this device, "ground truth" more closely relates to engineering specifications, electrical safety standards, and functional equivalence to predicate devices, which are assessed through engineering tests and regulatory comparisons, not medical ground truth methods.
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The sample size for the training set:
- Not applicable. There is no AI model or training set involved.
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How the ground truth for the training set was established:
- Not applicable. There is no AI model or training set involved.
In summary, the provided document is a regulatory submission demonstrating substantial equivalence for an electrosurgical generator, focusing on its design, safety features, and intended use as compared to existing devices. It does not involve the types of performance studies or acceptance criteria that would be relevant for AI/ML or diagnostic image analysis devices.
§ 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.