(171 days)
Medline's Smoke Evacuation Pencil is designed for general electrosurgical applications including cutting and coagulating, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.
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The provided document is a 510(k) premarket notification letter from the FDA for a medical device (Medline Smoke Evacuation Pencil). It does not contain any information about acceptance criteria, device performance studies, or the methodologies used to establish ground truth or train AI models.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and reported device performance.
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth establishment.
- Adjudication method for a test set.
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
- Results of a standalone algorithm performance study.
- Type of ground truth used.
- Sample size for the training set.
- Method for establishing ground truth for the training set.
The document focuses on the regulatory clearance process for a relatively low-tech electrosurgical device, not on the validation of an AI/ML-based medical device.
§ 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.