(217 days)
The STIMPOD ST2-3010 is a nerve stimulation device designed to be used for the purpose of nerve locating using invasive electrodes or needles (not supplied)
The STIMPOD ST2-3010 device is a battery powered peripheral nerve stimulator that can be used for the purpose of nerve locating using invasive electrodes or needles (not supplied). The STIMPOD ST2-3010 is a precision nerve locating tool used for localizing specific neural pathways. Localization of nerves by electrical stimulation involves connecting the nerve stimulator to a conducting needle. The stimulus is generated by a constant current source. The waveform is a monophasic square wave with 3 options for pulse width. These are: 0.1, 0.2 and 0.3 milliseconds. The unit dimensions are 145mm x 90mm x 30mm with a weight of 130 g
I'm sorry, but the provided text does not contain the information needed to answer your request about acceptance criteria and study details for a medical device. The document is a 510(k) premarket notification for a nerve stimulator, focusing on demonstrating substantial equivalence to a predicate device. It details the device's technical characteristics, intended use, and comparison to a predicate, but it does not describe specific acceptance criteria and the results of a study (like a clinical trial or performance study) to prove the device meets those criteria.
In particular, the document lacks information on:
- A table of acceptance criteria and reported device performance.
- Sample size used for a test set or data provenance.
- Number of experts or their qualifications for establishing ground truth.
- Adjudication method for a test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
- Whether a standalone (algorithm only) performance study was done.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document discusses "safety testing" and references IEC standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10), indicating that the device passed these electrical and electromagnetic compatibility tests. However, these are general device safety standards, not specific performance criteria for a diagnostic or AI-based device's clinical accuracy that would require the kind of study details you've requested.
Therefore, I cannot fill in the table or provide the requested study details based on the provided text.
§ 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).