(110 days)
The ConMed Linvatec Lightwave® Ablators are intended to be used for electrosurgical cutting and coagulation in arthroscopic procedures, using a conductive fluid environment. Additionally, the suction/aspiration versions of these devices have the capability for suctioning irrigation fluids. Electrosurgical cutting and coagulation may be performed in various joints such as the shoulder, ankle, wrist, elbow, knee, and hip.
The ConMed Linvatec LightWave® Ablators are comprised of a range of nonsuction and suction devices, operable by hand or foot control. The devices consist of an electrical, insulation-coated electrode and ceramic insulator attached to an integrated handle and cord set, allowing attachment to commonly available electrosurgical generators.
The provided text is a 510(k) summary for the ConMed Linvatec EL LightWave® Suction Ablator, which is a medical device application for market clearance. This type of document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than proving the device meets new acceptance criteria through a clinical study.
Therefore, the document does not contain the kind of detailed information about acceptance criteria, specific device performance against those criteria, or a study design (including sample sizes, ground truth establishment, expert qualifications, or MRMC studies) that you would typically find for an AI/CADe device.
The study mentioned is "Performance testing has demonstrated the devices conform to applicable sections of ANSI/AAMI HF18:2001 and IEC 60601-2-2:2006". These are electrical safety and electromagnetic compatibility standards, not performance standards related to diagnostic accuracy or clinical effectiveness for AI/CADe devices.
In summary, the provided document does not contain the information required to populate your table and answer your questions about a study proving the device meets acceptance criteria for an AI/CADe system. The device is an electrosurgical ablator, not an AI-powered diagnostic tool.
§ 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.