(86 days)
- To measure bilateral differences in surface EMG along the spine .
- To measure surface EMG along the spine during functional tasks .
- To measure bilateral differences in skin temperature along the spine .
- . To measure Range of Motion of the three spinal regions
- . To chart patient progress during the course of treatment
Not Found
I am unable to provide a description of the acceptance criteria and study that proves the device meets the acceptance criteria based on the provided text. The document is an FDA letter granting substantial equivalence for the "Insight Millennium" device (K990778).
Here's why the requested information cannot be extracted:
- No Acceptance Criteria or Study Details: The letter approves the device for marketing and mentions its intended uses, but it does not contain any performance data, acceptance criteria, study design, or results. It's a regulatory approval document, not a scientific study report.
- Focus on Substantial Equivalence: The core of this document is the FDA's determination that the Insight Millennium is "substantially equivalent" to predicate devices marketed before May 28, 1976. This process primarily involves comparing the device's technological characteristics and proposed indications for use to an already legally marketed device, not necessarily requiring a new, comprehensive clinical study with specific performance metrics to be detailed in the approval letter itself.
- Missing Information: All aspects of your request (sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth types, training set size, ground truth establishment for training set) are completely absent from the provided text. These details would typically be found in the 510(k) submission itself or in published studies about the device, which are not part of this document.
§ 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.