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The Personal Kinetigraph (PKG) is intended to quantify kinematics of movement disorder symptoms in conditions such as Parkinson's disease, including tremor, bradykinesia, and dyskinesia. It includes a medication reminder, an event marker and is intended to monitor activity associated with movement during sleep. The device is indicated for use in individuals 46 to 83 years of age.

The Personal Kinetigraph (PKG) Gen 2 Plus utilizes a PKG Watch (movement data logger) worn by the patient on their wrist over 6-to-10 day recording cycles. The PKG Watch continuously records and quantifies the kinematics of movement disorder symptoms such as bradykinesia (BK), dyskinesia (DK), tremor, immobility, and dyskinesia fluctuations, in movement disorder conditions such as Parkinson's disease. Proprietary PKG Analysis Algorithms are used to analyze the movement data and generate a PKG-2A Report, which provides the clinical provider with a summary of these movement disorder symptoms, plotted over the full recording period. The PKG-2A Report includes an additional feature that allows the plots to be annotated by a qualified PKG Reporter. The PKG Watch includes a medication reminder to notify the patient when it is time to take their medication, and an event marker for the patient to record when they have taken their prescribed medication. The Personal Kinetigraph (PKG) Gen 2 Plus System includes the GKCM Cloud Platform (PKG Clinic Server), a cloud-based service for receiving and processing the movement data files and generating PKG-2A Reports. The Personal Kinetigraph (PKG) Gen 2 Plus is a modified version of the predicate Personal Kinetigraph (PKG) System Model GKC-2000 (Gen 2) cleared under K161717, incorporating several new or enhanced features, including a Docking Station for charging the PKG Watch and uploading movement data files to the GKCM Cloud Platform, and a Clinic Portal (housed in the GKCM Cloud Platform), providing customer facing functions such as creating and editing patient details, scheduling medication reminders, raising PKG orders and viewing the PKG-2A Report. The Personal Kinetigraph (PKG) Gen 2 Plus also includes a PKG Tablet and PKG Dock Cable, cleared previously under K161717. The PKG Tablet is an off-the-shelf Android based tablet that runs a custom software application to configure the PKG Watch before a recording session, extract recorded data after a recording session, and upload this data to the GKCM Cloud Platform. The PKG Dock Cable connects the PKG Watch to the PKG Tablet for configuration before a recording session, and allows for uploading of the movement data to the PKG Clinic Server after the recording session. The PKG Tablet and PKG Dock Cable are not required when using the Docking Station and Clinic Portal. The Personal Kinetigraph (PKG) Gen 2 Plus system consists of the following key components: PKG Watch (movement data logger) including wrist bands; PKG Docking Station; PKG Clinic Portal; GKCM Cloud Platform (PKG Clinic Server); PKG Analysis Algorithms; PKG-2A Report; PKG Tablet; PKG Dock Cable; and 5-Bay charger.

This document describes the regulatory clearance of the Personal Kinetigraph (PKG) System Gen 2 Plus. Based on the provided text, the device is a modified version of a previously cleared device (K161717) and primarily focuses on hardware and software enhancements rather than changes to core diagnostic algorithms or indications for use. Therefore, the performance data provided focuses heavily on engineering validations (electrical safety, mechanical safety, software V&V, cybersecurity, biocompatibility, human factors) and explicitly states that clinical data was not required for this submission.

Consequently, a multi-reader multi-case (MRMC) comparative effectiveness study, standalone algorithm performance, or a detailed description of ground truth establishment for a diagnostic test set, which are typical for AI/ML-based diagnostic devices, are not applicable in this context. The device's primary function remains to "quantify kinematics of movement disorder symptoms" using "Proprietary PKG Analysis Algorithms" which appear to have been validated in the prior submission or are considered substantially equivalent in their underlying function.

Given this, the requested information will be presented as per available details, with explicit notes about what is not applicable based on the provided FDA document.

Device: Personal Kinetigraph (PKG) System Gen 2 Plus (K211887)

Purpose: To quantify kinematics of movement disorder symptoms in conditions such as Parkinson's disease, including tremor, bradykinesia, and dyskinesia.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes engineering verification and validation testing for the modified device components rather than specific diagnostic accuracy metrics. The "acceptance criteria" are implied by compliance with the listed standards and successful completion of the tests.

Note: The document explicitly states: "Clinical data was not required for this submission as the changes to the Personal Kinetigraph (PKG) - Gen 2 Plus did not introduce any significant new risks, or changes to known risks, that would require clinical evaluation." This means there was no new clinical study specifically for this 510(k) submission to demonstrate the performance of the core "PKG Analysis Algorithms" in quantifying movement disorder symptoms. The substantial equivalence argument relies on the predicate device's prior clearance and the fact that the modifications are not considered to significantly alter the device's fundamental diagnostic function or safety profile.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not applicable in the context of a clinical performance study. The "test sets" referenced for performance data (e.g., electrical, mechanical, software, biocompatibility) are material or system test articles, not patient data for diagnostic accuracy.
• Data Provenance: Not applicable for a clinical performance study for this specific submission as no new clinical data was collected.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable as no new clinical data was collected or analyzed for this submission where expert ground truth would be established. The device's "Proprietary PKG Analysis Algorithms" rely on quantitative kinematics, and their prior validation/equivalence is assumed.

4. Adjudication Method for the Test Set

• Not applicable as no new clinical data was collected requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done. The submission states that "Clinical data was not required for this submission." Therefore, no assessment of human readers improving with or without AI assistance was performed. The device quantifies kinematics using algorithms, it's not described as an AI-assistance tool for human readers interpreting images.

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

• Not explicitly described as a new standalone performance study. While the device contains "Proprietary PKG Analysis Algorithms" which would inherently operate in a standalone manner to quantify kinematics, the document does not report new standalone performance metrics or studies in this submission. Its functional equivalence is tied to the predicate device whose algorithms would have been assessed previously.

7. The Type of Ground Truth Used

• For the engineering validation studies (e.g., electrical, mechanical, software, biocompatibility, cybersecurity, human factors), the "ground truth" is defined by the technical specifications, standards (e.g., IEC 60601, ISO 10993, IEC 62304), and regulatory guidance documents listed. For instance, for electrical safety, the ground truth is compliance with the limits set by IEC 60601-1.
• For the device's intended clinical function (quantifying movement disorders), the "ground truth" for the original validation of the PKG Analysis Algorithms (presumably done for the predicate device K161717) would typically involve comparison to clinical assessments by movement disorder specialists, standardized motor evaluations, or other objective measures (though this is not detailed in the current submission).

8. The Sample Size for the Training Set

• Not applicable for this 510(k) submission, as it focuses on modifications and substantial equivalence to a predicate device, rather than the initial development and training of new AI/ML algorithms requiring a "training set." The proprietary algorithms were developed previously.

9. How the Ground Truth for the Training Set was Established

• Not applicable for this 510(k) submission. Information on how the ground truth was established for the original development of the "Proprietary PKG Analysis Algorithms" is not provided in this document.

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The Personal Kinetigraph (PKG) is intended to quantify kinematics of movement disorder symptoms in conditions such as Parkinson's disease, including tremor, bradykinesia and dyskinesia. It includes a medication reminder, an event marker and is intended to monitor activity associated with movement during sleep. The device is indicated for use in individuals 46 to 83 years of age.

The new Personal Kinetigraph (PKG) System, Model GKC-2000 (Gen 2), utilizes a small, wrist-worn data logging activity monitor (the PKG Watch) 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. At the end of the recording period, the movement recording data is uploaded via a Tablet application at the supervising clinic, to a cloud-based server. A report is produced using the recorded data that objectively distinguishes the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility. This information can be used by the clinician to assess the extent and severity of movement disorder symptoms, and how they vary throughout the day, and from day to day. The PKG Watch has a medication reminder 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 the 510(k) premarket notification for the Personal Kinetigraph (PKG) System, Model GKC-2000 (Gen 2). The submission aims to demonstrate substantial equivalence to a predicate device (K140086 - Global Kinetics Corporation's Personal Kinetigraph (PKG) System).

Here's an analysis of the acceptance criteria and the study that indicates the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format for the device's diagnostic performance (e.g., sensitivity, specificity for detecting tremor or bradykinesia). Instead, the performance evaluation primarily focuses on demonstrating functional equivalence of the new Gen 2 system to its predicate device.

The main "acceptance criterion" for the system validation relevant to its intended use appears to be: "functional performance of the PKG Gen 2 System is identical to the predicate system (within the specified acceptance criteria of system variability) for all measures."

2. Sample size used for the test set and the data provenance

The document states: "The test was conducted over several days, with each of the test subjects wearing two recording loggers simultaneously on the same arm (PKG Watch and/or the predicate Data logger), performing predetermined actions and maintaining a diary."

The exact sample size (number of test subjects) is not specified in the provided text.

Data Provenance: The study was conducted as a "side-by-side validation of the new system with the predicate, when worn by test subjects." It appears to be a prospective study for this particular validation, conducted by the manufacturer. The country of origin of the data is not explicitly stated, but the manufacturer is based in Melbourne, Victoria, Australia.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not mention the involvement of experts for establishing ground truth in this specific comparative performance study. The comparison was primarily between the data generated by the Gen 2 device and the predicate device. The output reports are designed for use by a clinician, but the validation itself doesn't involve expert scoring of the device's output against a clinical ground truth.

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

There is no mention of an adjudication method in the context of expert review for this comparative performance study, as there were no experts establishing ground truth for the device's output. The comparison was statistical and functional between the two devices.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed or described. The study focused on the equivalence of the device's output (PKG PDF reports) between the new Gen 2 system and the predicate, not on how human readers (clinicians) improve with or without AI assistance from the device. The device quantifies movement disorder symptoms; it's not described as an AI diagnostic aid for human readers in the traditional sense of an MRMC study.

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

Yes, the functional performance comparison described is essentially a standalone (algorithm only) comparison. The "side-by-side comparative testing" focused on comparing the "PKG PDF Reports that resulted from each device" (Gen 2 vs. predicate) against each other, without involving a human clinician's interpretation as part of the primary equivalence assessment. The algorithm processes raw movement data to produce these reports.

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

For the "System Validation testing" comparing the Gen 2 and predicate systems, the "ground truth" was the performance of the legally marketed predicate device (K140086). The goal was to prove "performance equivalence" between the two systems. The PKG PDF reports generated by both devices were compared. The overall system's ability to quantify kinematics of movement disorder symptoms was previously established and cleared with the predicate device.

8. The sample size for the training set

The document does not mention a training set or any machine learning model training. The device quantifies movement based on kinematics, and the validation described focuses on comparing the output of the new hardware/software iteration with its predecessor. Therefore, the concept of a "training set" as it pertains to machine learning is not applicable here based on the provided text.

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

As no training set is mentioned, this information is not applicable based on the provided document.

Ask a specific question about this device

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.

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