(163 days)
The TwitchView System is used for the quantitative monitoring of neuromuscular transmission by means of electromyography.
Not Found
I am sorry, but the provided text from the FDA document (K192958) for the TwitchView System does not contain the detailed information required to answer your request about acceptance criteria, device performance, study design, and ground truth establishment for an AI/ML device.
The document is a 510(k) clearance letter for an Electrical Peripheral Nerve Stimulator (Product Code: KOI), which is a device for quantitative monitoring of neuromuscular transmission via electromyography. It is not an AI/ML powered device, and therefore, the kind of study details you are asking for (e.g., sample size for test set, data provenance, expert adjudication, MRMC studies, standalone performance, training set details) are not relevant or present in this specific clearance.
The document primarily focuses on:
- Confirming substantial equivalence to a predicate device.
- Indications for Use.
- General controls and regulatory requirements for a Class II device.
The information you are requesting is typically found in:
- Premarket Approval (PMA) applications for novel high-risk devices, which often involve extensive clinical trial data.
- De Novo requests for novel low-to-moderate risk devices.
- Specific sections within 510(k) summaries or detailed review memoranda for AI/ML devices that explicitly describe performance studies, often in response to special controls or FDA guidance for AI/ML.
Since the provided text does not contain the requested information, I cannot fill out the table or describe the study details.
§ 868.2775 Electrical peripheral nerve stimulator.
(a)
Identification. An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases.(b)
Classification. Class II (performance standards).