(65 days)
To measure bilateral differences in surface EMG along the spine
To measure surface EMG along the spine during functional tasks
To chart patient progress during the course of treatment
The Insight Genesis is a non-invasive, single-modality physiologic monitoring device. The Insight Genesis contains two surface EMG sensors used to measure muscle activity.
Hardware: The Insight Genesis hardware consists of an instrument console and two surface EMG sensors. The Insight Genesis will plug directly into the UL-2601 listed wall mounted power supply. The Instrument Console is powered by a computer (IBM compatible) via an isolated serial port connection.
Software: The Insight Genesis software displays real-time surface EMG, allowing the user to ensure that readings are stable prior to data collection. The Insight Genesis software allows the user to: (1) collect and store surface EMG, (2) view and analyze surface EMG, and (3) print out reports.
The provided document is a 510(k) summary for the Insight Genesis device. It's a premarket notification for a medical device and describes its equivalence to a predicate device, technical specifications, and intended use. However, it does not include performance criteria, a study proving acceptance criteria, or details regarding ground truth establishment, sample sizes for training/test sets, or expert involvement as requested in the prompt. This information is typically found in detailed device validation studies, which are usually separate from the 510(k) summary provided here.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for the test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method.
- MRMC comparative effectiveness study details or effect size.
- Standalone performance details.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document focuses on demonstrating substantial equivalence to a predicate device (Insight Millennium) based on design, indications for use, and technological characteristics, rather than presenting a performance study with acceptance criteria.
The information that can be extracted from the document is related to the device description and its comparison to the predicate device, which is not what was requested.
§ 882.5050 Biofeedback device.
(a)
Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.