(123 days)
The Somnus™ Tissue Coagulating Electrodes are intended for coagulation of soft tissue.
The Somnus Model RC-1 and RC-2 Reusable Cables are intended to provide an electrical connection between the Somnus Medical Technologies Model 1100, 1110 and 2110 Tissue Coagulating Electrodes and the Somnus Medical Technologies Electrosurgical (RF) Generators
The Somnus™ Tissue Coagulating Electrodes and Reusable Cables provide a reliable means of coagulating soft tissue.
This 510(k) submission (K973701) for the Somnus™ Tissue Coagulating Electrodes and Somnus Reusable Cable generally states that "performance validation testing has been done to validate the performance of the device." However, it does not provide any specific acceptance criteria or detailed study results proving the device meets said criteria. Therefore, most of the requested information cannot be extracted from the provided text.
Here is a breakdown of what can be inferred or determined from the given text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided text | Not specified in the provided text |
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 for the test set: Not specified.
- Data provenance: Not specified (country of origin, retrospective or prospective).
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 specified. The document indicates "performance validation testing," which suggests lab-based or engineering tests rather than human expert evaluation for ground truth in a clinical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified. Given the nature of the device (electrosurgical accessories), adjudication methods typically associated with image-based diagnoses or clinical outcomes are unlikely to be relevant here.
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
- MRMC study: No. The device is a physical electrosurgical cable and electrodes, not an AI-powered diagnostic tool requiring human reader studies.
- Effect size of human reader improvement with/without AI: Not applicable, as there is no AI component.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone performance: The concept of "standalone performance" typically applies to AI algorithms. For this physical medical device, performance testing would involve demonstrating that the cable and electrodes transmit electrical energy effectively and safely to coagulate tissue as intended, which would be an "algorithm only" equivalent in the sense that it's the device's inherent function without human interpretive input. However, no details on such testing are provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not specified. For a device like this, ground truth would likely be based on engineering specifications, electrical performance metrics (e.g., impedance, power delivery), and possibly histological assessment of tissue coagulation in preclinical models or animal studies.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that would require a "training set." Performance validation for a physical device focuses on its functional characteristics.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for this type of device.
Summary of what is present:
The document primarily focuses on establishing substantial equivalence to predicate devices based on intended use and technological characteristics. It generally states that "performance validation testing has been done to validate the performance of the device," but it does not elaborate on the specific tests, acceptance criteria, methodologies, or results of this testing. The submission is a regulatory filing for a physical electrosurgical device and accessories, not a software or AI-based diagnostic tool, thus many of the requested categories (e.g., MRMC, AI assistance, training/test sets, expert adjudication) are not relevant to this specific device or the information provided.
§ 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.