(34 days)
The Somnus™ Model 225 Electrosurgical Generator and Accessories are intended for use with the Somnus Soft Tissue Coagulating Electrodes for the coagulation of soft tissue. The system is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
The Somnus M Model 225 Electrosurgical Generator is an electrosurgical generator has controls for power delivered and time of energy delivery. The unit has readouts for total energy delivered, impedance, number of active channels and temperature for up to 6 thermocouples. Connectors on the front panel include connectors for electrodes and a footpedal.
Accessories included with the generator include a line power cable, single pedal footpedal, cables to connect the electrodes to the generator and a dispersive electrode.
The provided text is a 510(k) summary for an electrosurgical generator (Somnus™ Model 225) from 1996. This document is a regulatory submission for medical device clearance and focuses on demonstrating substantial equivalence to predicate devices. It does not contain the level of detail requested for acceptance criteria, performance studies, or ground truth establishment that would typically be found for a modern AI/ML-based medical device.
Therefore, I cannot extract the specific information you've requested based on the given text.
Here's why and what kind of information is missing:
- Acceptance Criteria and Reported Device Performance: While the document mentions "performance validation testing has been done to validate the performance of the device," it does not provide a table of specific acceptance criteria (e.g., accuracy, sensitivity, specificity, or specific electrical parameters with thresholds) or the results of that testing. For an electrosurgical generator, acceptance criteria would likely involve safety parameters (e.g., leakage current, output power accuracy with specific loads) and functional performance (e.g., ability to coagulate tissue effectively without excessive charring or collateral damage).
- Sample Size, Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth Type (for a "test set" in the context of an AI device): None of this information is present. The concept of a "test set" as understood in AI/ML performance evaluation (with defined ground truth, expert review, adjudication, etc.) is not applicable to this type of device and submission from 1996. The performance validation mentioned would have been engineering and bench testing, possibly animal or cadaver studies, but not a clinical study involving human readers or AI algorithms as you've described.
- Training Set Sample Size and Ground Truth Establishment (for an AI device): Similarly, this device is an electrosurgical generator, not an AI/ML algorithm. There is no concept of a "training set" or "ground truth establishment" in the AI sense for this product.
In summary, the provided 510(k) summary is for a hardware medical device and predates the common application of AI/ML in medical devices, thus it does not contain the information required to answer your specific questions about acceptance criteria and study details for an AI-powered device.
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963772
510(k) Summary of Safety and Effectiveness Somnus Medical Technologies, Inc.™ Model 225 Electrosurgical Generator and Accessories
OCT 23 1996
Intended Use:
The Somnus™ Model 225 Electrosurgical Generator and Accessories are intended for use with the Somnus Soft Tissue Coagulating Electrodes for the coagulation of soft tissue. The system is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
Submitted by:
Somnus Medical Technologies, Inc. 995 Benecia Avenue Sunnyvale, CA 94086 Tel: 408.773.9121 Fax: 408.773.9137
Contact Person:
Eve A. Conner, Ph.D. Vice President Clinical and Regulatory Affairs Telephone: (408) 524-6263 Digital Pager: 1-800-586-1439
Date Summary Prepared::
September 16, 1996
Name of the Device:
Somnus™ Model 225 Electrosurgical Proprietary Name: Generator and Accessories Electrosurgical Generator and Common/Usual Name: Accessories Electrosurgical Device (per 21 CFR Classification Name: 878.4400)
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Predicate Devices:
Erbe ICC 200 Erbe ICC 50 ZoMed VidaMed
Description:
The Somnus M Model 225 Electrosurgical Generator is an electrosurgical generator has controls for power delivered and time of energy delivery. The unit has readouts for total energy delivered, impedance, number of active channels and temperature for up to 6 thermocouples. Connectors on the front panel include connectors for electrodes and a footpedal.
Accessories included with the generator include a line power cable, single pedal footpedal, cables to connect the electrodes to the generator and a dispersive electrode.
Statement of Intended Use:
The Somnus Model 225 Electrosurgical Generator and Soft Tissue Coagulating Electrodes are intended for use in the coagulation of soft tissue.
This device is intended for use by qualified medical personnel trained in the use of electrosurgery.
Comparison to Predicate Devices:
The Somnus Model 225 Electrosurgical Generator and Accessories has been carefully compared to legally marketed devices with respect to intended use and technological characteristics. In addition, performance validation testing has been done to validate the performance of the device. The comparison and validation results presented in this 510(k) notification to the FDA show that the device is substantially equivalent to predicate devices and is safe and effective in its intended use.
§ 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.