(47 days)
The Somnus™ Model 215 Electrosurgical Generator and Accessories are intended for use with the Somnus Tissue Coagulating Electrodes for the coagulation of tissue. The system is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
The Somnus Model 215 Electrosurgical Generator, in combination with various Somnus electrodes, is indicated for the coagulation of tissue.
This device is intended for use by qualified medical personnel trained in the use of electrosurgery.
The SomnusTM Model 215 Electrosurgical Generator is an electrosurgical generator with controls for power delivered, time of energy delivery and in the automatic mode, maximum temperature. 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 an adapter for a dispersive electrode.
The provided text is a 510(k) summary for the Somnus Model 215 Electrosurgical Generator and Accessories.
Based on the provided document, here's an analysis regarding acceptance criteria and a study proving the device meets them:
1. A table of acceptance criteria and the reported device performance:
The document does not provide specific, quantifiable acceptance criteria or reported device performance in the format of a table. It states:
"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."
This indicates that internal testing was performed, and the results were deemed satisfactory for substantial equivalence, but the details of those tests, including specific performance metrics and acceptance thresholds, are not included in this publicly available summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify the sample size used for any test set or the data provenance. It only mentions "performance validation testing."
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):
This information is not provided in the document. The device is an electrosurgical generator, which typically involves objective performance measurements (e.g., power output, impedance, temperature control) rather than subjective interpretation by experts for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided. Given the nature of the device (electrosurgical generator), an adjudication method in the context of expert consensus is unlikely to be relevant in the same way it would be for AI-driven diagnostic imaging devices.
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:
This is not applicable to this device. The Somnus Model 215 Electrosurgical Generator is a medical device for tissue coagulation, not an AI-assisted diagnostic tool that aids human readers. Therefore, an MRMC comparative effectiveness study would not be performed for this type of product.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This is not applicable to this device. This is a hardware electrosurgical generator, not an algorithm. The phrase "standalone performance" typically refers to the performance of an AI algorithm independent of human interaction.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The document does not explicitly state the type of ground truth used. For an electrosurgical generator, "ground truth" would likely relate to objective measurements of electrical output, thermal profiles, and perhaps tissue effects in an experimental setting, rather than pathology or outcomes data in the context of a diagnostic test.
8. The sample size for the training set:
This information is not provided in the document. As an electrosurgical generator, it is a hardware device and does not involve a "training set" in the context of machine learning. Its design and performance are based on engineering principles and validated through physical and electrical testing.
9. How the ground truth for the training set was established:
This information is not provided, and the concept of a "training set" is not applicable to this type of device.
In summary:
The provided 510(k) summary focuses on establishing substantial equivalence to predicate devices based on intended use and technological characteristics, along with "performance validation testing." However, it does not detail the specific acceptance criteria, test methodologies, sample sizes, or expert involvement that would be typically found in a study demonstrating how a device meets specific, quantifiable acceptance criteria, especially for AI or diagnostic devices. The document is typical for a hardware medical device submission where the focus is on safety, effectiveness, and comparison to existing technology.
§ 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.