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Kinesia is intended to monitor physical motion and muscle activity to quantify kinematics of movement disorder symptoms such as tremor and assess activity in any instance where quantifiable analysis of motion and muscle activity is desired.

Kinesia™ is designed to monitor and record motion and electrical activity of muscle to quantify kinematics of movement disorders such as tremor for research and diagnostic purposes. The patient unit consists of a wrist module and ring sensor. Motion sensors including accelerometers and gyroscopes are integrated into a finger worn unit to capture three dimensional motions. The finger worn sensor unit is worn on a finger band and is connected to a wrist worn module by a thin flexible wire. The wrist module provides an input for two channels of electromyography, battery power, on board memory, and an embedded radio for real-time wireless transmission of the collected signals. The wrist module is worn on a comfortable, adjustable wristband.

The signals are communicated between the patient module and the computer unit using wireless technology based on 2.4-2.484 GHZ frequencies. Kinesia will consist of four major components:

1. Patient Module(consists of ring and wrist module)

2. Computer Unit

3. Electromyography Leads

4. Interface Software

5. The Patient Module includes a user worn ring and wrist module connected by a thin cable. The patient module monitors eight channels of data including three channels of accelerometers (linear acceleration sensors), three channels of gyroscopes (angular velocity sensors), and two channels of electrical muscle activity (EMG). The data can be transmitted in real-time over a wireless telemetry link to a computer or be stored in onboard memory. The wireless link can either transmit only (one-way) or transmit and receive (two-way). The basic functional feature of the component is to acquire signals from the subject, perform analog-to-digital conversion (when appropriate), encode, format, and transmit the signals to the Computer Unit or store data in on board memory. The Patient Module will operate on DC power from either rechargeable or replaceable batteries. The Patient Module includes a push button patient diary so the patient can indicate when they have taken their medication and when their symptoms are severe.

6. The Computer Unit will have the ability to only receive (one-way) or receive and transmit (two-way) data from the Patient Module. The basic functional feature of this component is to receive data packets from the patient unit, perform error detection and correction, and then send the data to the PC Operator interface where the data can be monitored in real time or stored and analyzed at a later time.

3: The Electromyography Leads provide an input for two channels of EMG recordings. The leads provide five standard snap connector inputs including two differential channels of EMG and a patient ground. The leads are connected to a lemo connector. The lemo connector attaches to the lemo input on the Patient Unit wrist module.

4. The Interface Software program consists of several software modules that allow the user to acquire, store, and review data as acquired by the hardware.

The provided text describes the Kinesia™ device, its intended use, and its performance testing against various voluntary standards. However, it does not contain specific acceptance criteria, a detailed study proving device performance against such criteria, or information on sample size, data provenance, ground truth establishment, or expert involvement as requested.

The "Performance Testing" section states that Kinesia™ will be tested to certain voluntary standards (e.g., FCC Part 15.109, IEC60601-1 series). This indicates that the device intended to comply with these standards, but the document does not provide the results of these tests or specific acceptance criteria met.

Therefore, based solely on the provided text, a table of acceptance criteria and reported device performance, and details of a study meeting these criteria, cannot be fully generated.

Here's a breakdown of what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

Missing Information (Not found in the provided text):

• Specific quantitative acceptance criteria: The document lists standards but does not specify the pass/fail thresholds or performance metrics (e.g., accuracy, precision, sensitivity, specificity) for quantifying movement disorder symptoms or activity.
• Actual test results: The document states the device will be tested to these standards but does not provide any reported device performance data against these or any other criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test set sample size: Not provided.
• Data provenance: Not provided. The document outlines regulatory compliance testing (e.g., electrical safety, EMC), but not a clinical or performance study with a "test set" in the context of, for example, classifying tremor.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not provided. The listed "Performance Testing" refers to compliance with voluntary engineering and safety standards, not a study involving expert-adjudicated ground truth for clinical performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable/Not provided. The Kinesia™ device is described as a monitor and recorder of motion and electrical activity, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable/Not provided in the context of clinical performance algorithms. The device itself is a standalone measurement instrument.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable/Not provided in the clinical sense. The "ground truth" for the listed performance testing would be the specifications and requirements of the voluntary standards themselves (e.g., measured leakage current must be below X mA).

8. The sample size for the training set

• Not applicable/Not provided. This document does not describe the development of a machine learning algorithm; it describes a medical device with sensors and a software interface.

9. How the ground truth for the training set was established

• Not applicable/Not provided.

Conclusion based on provided text:

The document focuses on the technical description, intended use, and intent to comply with general safety and electromagnetic compatibility (EMC) standards. It does not provide details of a clinical performance study with specific acceptance criteria related to its quantitative analysis capabilities, nor does it include information about data sets (training or test), ground truth establishment, or expert involvement in such a study. The information provided is consistent with a 510(k) summary for a monitoring device primarily demonstrating substantial equivalence through technological characteristics and compliance with recognized safety standards.

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