(220 days)
The Personal Kinetigraph (PKG) System is intended to quantify kinematics of movement disorder symptoms in conditions such as Parkinson's disease, including tremor, bradykinesia. It includes a medication reminder, an event marker and is intended to monitor associated with movement during sleep. The device is indicated for use in individuals 46 to 83 years of age.
The Personal Kinetigraph (PKG) System is a small, wrist-worn activity monitor that continuously records and quantifies the kinematics of movement disorder symptoms over a 6 to 10 day period in movement disorder conditions such as Parkinson's disease. A report is produced using the recorded data that objectively distinguishes the movement patterns consistent with tremor, bradykinesia, and immobility. This information can be used by the clinician to assess the extent and severity of movement disorder symptoms, and how they very throughout the day, and from day to day. The PKG Data Logger has a medication reminder to indicate to the patient that it is time to take their medication, and an event marker for the patient to record when they have taken their prescribed medication.
The provided text describes a 510(k) premarket notification for the "Personal Kinetigraph (PKG) System." While it outlines the device's indications for use, its comparison to predicate devices, and general information required for FDA submission, it does not contain information about specific acceptance criteria or a detailed study proving the device meets said criteria.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I elaborate on sample sizes, ground truth establishment, expert qualifications, or MRMC studies for this specific submission based on the provided text.
The document primarily focuses on establishing substantial equivalence to previously cleared predicate devices by comparing technological characteristics and indications for use. It asserts that "The technological characteristics of bradykinesia are the not the same as the predicates but do not raise new types of safety or effectiveness questions and the method used correlates with accepted scientific methods, such as the UPDRS III." This statement suggests that an internal validation or correlation study might have been performed for bradykinesia, but the details of such a study are not included in this document.
In summary, the provided document does not contain the specific information requested regarding acceptance criteria and the detailed study that proves the device meets those criteria.
§ 882.1950 Tremor transducer.
(a)
Identification. A tremor transducer is a device used to measure the degree of tremor caused by certain diseases.(b)
Classification. Class II (performance standards).