(81 days)
The Somnus™ Model 3000 Disposable Tri-Needle Coagulating Electrode is intended for use in the coagulation of tissue. The system is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
The Somnus Model 3000 Disposable Tri-Needle Coagulating Electrode is an electrosurgical device.
This document describes a 510(k) summary for a medical device submitted in 1996. The information provided is very limited and pertains to a disposable electrosurgical electrode (Somnus Model 3000 Disposable Tri-Needle Coagulating Electrode). Medical device regulations and the expectations for clinical studies, AI/ML, and detailed performance metrics have evolved significantly since 1996.
Based on the provided text, it is not possible to extract the detailed information requested in your prompt regarding acceptance criteria, study design, ground truth, and AI-related aspects. The document is a regulatory submission summary from an era before the widespread use of advanced AI in medical devices and does not contain the level of detail on performance metrics and study design you are looking for.
Here's an attempt to address your points based on the absence of the requested information in the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not specified in the provided text. For a device of this type and submission year, acceptance criteria would likely have focused on electrical safety, biocompatibility, sterilization efficacy, and functional performance (e.g., coagulation effectiveness, mechanical integrity) meeting industry standards or internal specifications, rather than detailed performance metrics like sensitivity/specificity for a diagnostic AI.
- Reported Device Performance: Not detailed in the provided text. The submission states, "performance validation testing has been done to validate the performance of the device," but no specific metrics or results are reported.
Summary Table (Based on absence of data):
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Not specified | Not specified | Not detailed |
| (e.g., Coagulation Effectiveness) | (e.g., Achieves consistent coagulation within X seconds) | (e.g., "Performance validation testing has been done to validate the performance of the device.") |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. This submission predates the common practice of detailing clinical study sample sizes in the summary for a device like an electrosurgical electrode, especially if the "validation" primarily involved bench testing or limited clinical use data for substantial equivalence.
- Data Provenance: Not specified. It's highly likely that any clinical data, if gathered, would have been from the U.S. given the FDA submission, but this is an inference, not stated.
- Retrospective or Prospective: Not specified.
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. This device is an electrosurgical electrode for tissue coagulation, not an AI-driven diagnostic device requiring expert interpretation for ground truth establishment. Any "ground truth" would likely relate to objective physical or physiological effects (e.g., tissue necrosis depth, current delivery) measured in laboratory or animal models, or clinical outcomes observed by trained surgeons. The document does not describe such a process.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. See point 3.
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
- No. This device is an electrosurgical tool, not an AI-powered diagnostic or assistive tool for human readers. MRMC studies are specific to evaluating human performance with and without AI assistance in interpretation tasks. This type of study would not be relevant for this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This device is a physical electrosurgical electrode and does not involve an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not specified. For this type of device in 1996, "ground truth" for performance would likely be based on:
- Bench testing data (e.g., electrical impedance, thermal distribution, mechanical strength)
- Animal model data (e.g., lesion creation, tissue effect)
- Limited human clinical data observed by the operating physician, focusing on safety and achieving the intended coagulation effect, often compared against predicate devices.
The document does not detail this.
8. The sample size for the training set
- Not Applicable. This device does not use a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
Conclusion: The provided 510(k) summary is for a medical device from 1996, an electrosurgical electrode. The regulatory context and technology at that time were vastly different from those involving AI/ML in medical devices today. Therefore, the document does not contain the information requested about AI-related acceptance criteria, study designs, or ground truth methodologies. The "study" mentioned ("performance validation testing") would have been primarily engineering bench tests and possibly animal or limited human clinical observations to demonstrate safety and effectiveness for substantial equivalence to predicate devices, not an AI performance study.
§ 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.