(308 days)
The Somnus™ Model 6000 Disposable Tissue Coagulating Electrode is intended for use in the coagulation of tissue.
The Somnus™ Model 6000 Disposable Tissue Coagulating Electrode is a modification of the Model 3000 Disposable Tri-Needle Coagulating Electrode cleared for commercial distribution under 510(k) #K963884. The Model 6000 device has a maximum of six needles configured in two rows of three needles each. The Model 3000 has a maximum of 3 needles in a single row. Both devices provide a reliable method of performing coagulation on target areas of tissue using a handle grip for ease of placement. The configuration of the handle grip of the Model 6000 and Model 3000 are identical.
The provided text, a 510(k) summary for the Somnus Model 6000 Disposable Tissue Coagulating Electrode, lacks detailed information regarding specific acceptance criteria, study designs, sample sizes for training/test sets, expert qualifications, or adjudication methods typically found in comprehensive performance studies for medical devices.
The primary focus of this document is to establish substantial equivalence to a predicate device (Somnus Model 3000 Disposable Tri-Needle Coagulating Electrode) rather than presenting a standalone clinical performance study with defined acceptance criteria and detailed results.
However, based on the available information, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not explicitly state specific quantitative acceptance criteria or detailed performance metrics like accuracy, sensitivity, or specificity. The "performance validation testing" mentioned is generalized, and its results are summarized as supporting "substantial equivalence."
| Acceptance Criteria (Not explicitly stated, inferred from context) | Reported Device Performance |
|---|---|
| Functional Equivalence: Device performs its intended function (tissue coagulation) reliably. | The device is a modification of a previously cleared device (Model 3000). The description implies functional equivalence for tissue coagulation, with the primary change being the number of needles. |
| Safety: Device operates safely without posing undue risks. | The 510(k) submission, including "performance validation testing," concludes that the device is "safe and effective in its intended use," leading to an FDA finding of substantial equivalence. |
| Effectiveness: Device achieves its intended therapeutic effect (tissue coagulation). | The 510(k) submission, including "performance validation testing," concludes that the device is "safe and effective in its intended use," leading to an FDA finding of substantial equivalence. |
| Technological Characteristics: Similarities to predicate device. | "The Somnus has been carefully compared to legally marketed devices with respect to intended use and technological characteristics." The Model 6000 has a maximum of six needles (two rows of three), compared to the Model 3000's maximum of three needles in a single row. The handle grip configuration is identical. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified. The document mentions "performance validation testing" but does not provide details on the number of subjects, cases, or specific tests conducted for this validation.
- Data Provenance: Not specified. There is no mention of the country of origin of any data, nor whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No. The document does not describe an MRMC study comparing human readers with and without AI assistance. The device is an electrosurgical tool, not an AI diagnostic or interpretive device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: Not applicable as this is not an AI algorithm. The device is a physical electrosurgical electrode and its performance is inherently human-in-the-loop (qualified medical personnel).
7. The Type of Ground Truth Used
- Type of Ground Truth: Not specified. For a device like this, ground truth would typically relate to observed physical effects (e.g., successful tissue coagulation, absence of unintended damage) during testing. The document refers generally to "performance validation testing," which would have established this through experimental observation, but specifics are missing.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable/Not specified. As this is a physical medical device (an electrosurgical electrode) and not an AI/machine learning system, the concept of a "training set" in the context of data-driven model development does not apply.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable. See point 8.
§ 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.