(94 days)
The nContact Coagulation System is intended for the coagulation of soft tissue using Radiofrequency (RF) energy.
The nContact Coagulation System consists of a sterile, single-use, disposable coagulation electrode device (2cm & 5cm sizes provided) intended to be used to coagulate soft tissue. The flexible, cooled electrode device, with a suction stabilizer feature, transmits radiofrequency (RF) energy from an Electrosurgical Generator (non-sterile, re-useable) connected through an Instrument Cable (sterile).
The provided text describes a 510(k) summary for the nContact Coagulation System, an electrosurgical device intended for the coagulation of soft tissue using radiofrequency (RF) energy. However, the document does not contain specific acceptance criteria or a detailed study description with performance metrics.
The summary states that "Performance testing was completed to validate its intended use" and that "The nContact Coagulation System may be considered substantially equivalent to the predicate devices based on performance and comparative data, and does not raise new questions of safety and efficacy." This implies that the device likely met acceptance criteria, but the criteria themselves and the detailed results are not provided in this document.
Therefore, I cannot populate the requested table or answer most of the questions as the necessary information is not present in the provided text.
Based on the provided information, I can only state the following:
1. A table of acceptance criteria and the reported device performance
- Information Not Available: The document only generally states that "Performance testing was completed to validate its intended use" and that the device is "substantially equivalent to the predicate devices based on performance and comparative data." It does not provide specific acceptance criteria (e.g., minimum coagulation depth, maximum thermal spread) or quantitative performance metrics (e.g., specific coagulation results, efficacy rates).
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Information Not Available: The document mentions "Performance testing" but does not specify sample sizes, whether the data was from animal or human subjects, its country of origin, or if it was 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)
- Information Not Available: The document does not describe any study involving experts for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Information Not Available: The document does not describe any study that would require an adjudication method.
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
- Information Not Applicable/Not Available: This involves a medical imaging device with AI assistance, which is not what the nContact Coagulation System is. No such study is mentioned or relevant to this device's description.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Information Not Applicable/Not Available: This involves an algorithm, which is not part of the nContact Coagulation System's description.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Information Not Available: The document does not describe the specific type of ground truth used for performance testing beyond "to validate its intended use."
8. The sample size for the training set
- Information Not Applicable/Not Available: There is no mention of a training set, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Information Not Applicable/Not Available: As there's no training set, this question is not applicable.
§ 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.