(113 days)
The sonoSens® is a non-invasive device indicated for use in real-time measurement of range of motion.
Continuous real-time measurement of range of motion.
The sonoSens® is a non-invasive device indicated for use in real-time measurement of range of motion. The measuring device consists of a monitor central processing unit (CPU), the power supply, and an infrared interface for data transfer. The device is connected to eight sensors via cables. Each sensor is directly attached to the skin with an adhesive pad.
The provided text is a 510(k) premarket notification for the sonoSens® device. It describes the device and its intended use, and states that FDA has determined it to be substantially equivalent to predicate devices. However, this document does not contain information about acceptance criteria, clinical studies, or performance data for the sonoSens® device.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details for any study.
This document is a regulatory approval notice, not a clinical study report. To obtain the information you've requested, you would typically need to refer to a separate clinical validation or performance study report, which is not included in the provided text.
§ 888.1500 Goniometer.
(a)
Identification. A goniometer is an AC-powered or battery powered device intended to evaluate joint function by measuring and recording ranges of motion, acceleration, or forces exerted by a joint.(b)
Classification. (1) Class I (general controls) for a goniometer that does not use electrode lead wires and patient cables. This device is exempt from the premarket notification procedures of subpart E of part 807 of this chapter subject to § 888.9.(2) Class II (special controls) for a goniometer that uses electrode lead wires and patient cables. The special controls consist of:
(i) The performance standard under part 898 of this chapter, and
(ii) The guidance entitled “Guidance on the Performance Standard for Electrode Lead Wires and Patient Cables.” This device is exempt from the premarket notification procedures of subpart E of part 807 of this chapter subject to § 888.9.