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.

Device Description

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.

AI/ML Overview

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."

Acceptance Criteria (Inferred from Study)	Reported Device Performance (PKG Gen 2 System)
Functional Equivalence: The Gen 2 system's functional performance (movement recording, medication reminders, medication acknowledgment, PKG Analysis, PKG PDF report) should be identical to the predicate system's performance within specified system variability.	Met: "the 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, with the exception of accidental 'medication taken' acknowledgements, where the PKG Gen 2 System is improved over that of the predicate."
Biocompatibility: Device components in contact with skin must pose a low risk for cytotoxicity, irritation, and sensitization.	Met: All results demonstrated no adverse or unexplained events, no indications for cytotoxicity, irritation, and sensitization. Materials pose a low risk for surface application on intact skin for less than 30 days.
Electrical Safety and EMC: Compliance with relevant medical electrical equipment standards (IEC 60601 series, IEC 62133).	Met: The system complies with IEC 60601-1:2005, IEC 60601-1-11:2010, IEC 60601-1-2:2007, IEC 60601-1-2:2014 (selected tests), and IEC 62133:2012.
Mechanical Safety: Compliance with mechanical safety requirements of IEC 60601-1:2005.	Met: The PKG Watch complied with all tested mechanical safety parameters (push, drop, mold stress relief, altitude, thermal cycle, shock, broad-band random vibration, ingress protection).
Software Verification and Validation: Software should function as intended without introducing minor injury in case of failure.	Met: Verification and validation testing were conducted, and documentation provided. The software was deemed "moderate" level of concern.

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.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 20, 2016

Gkc Manufacturing Pty Ltd. % Marie Schroeder Advisory Services Quintiles 1801 Rockville Pike Suite 300 Rockville, Maryland 20852

Re: K161717

Trade/Device Name: Personal Kinetigraph (PKG) System Model GKC-2000 Regulation Number: 21 CFR 882.1950 Regulation Name: Tremor Transducer Regulatory Class: Class II Product Code: GYD, NXQ, ISD Dated: June 6, 2016 Received: June 22, 2016

Dear Marie Schroeder:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

William J. Heetderks -A

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K161717

Device Name

Personal Kinetigraph (PKG) System - Model: GKC-2000

Indications for Use (Describe)

The Personal Kinetigraph (PKG) 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 activity associated with movement during sleep. The device is individuals 46 to 83 years of age.

Type of Use (Select one or both, as applicable)
✖ Prescription Use (Part 21 CFR 801 Subpart D)	❏ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

5.1 SUBMITTER

GKC Manufacturing Pty Ltd Level 15, 440 Collins Street Melbourne, Victoria, 3000, Australia

Contact Person: Brendan Fafiani Phone: +61 459 999 582 Email: brendan.fafiani@globalkineticscorp.com

Date Prepared: May 24, 2016

5.2 DEVICE

Trade Name: Personal Kinetigraph (PKG) System - Model GKC-2000 (Gen 2)

Common or Usual Name: Movement Disorder Monitoring System.

Classification Name: Transducer, Tremor (21 CFR 882.1950)

Regulatory Class: II

Primary Product Code: GYD, ISD, NXQ

5.3 PREDICATE DEVICE

K140086 - Global Kinetics Corporation's Personal Kinetigraph (PKG) System, the previous version of the same system that is the subject of this 510(k).

The predicate has not been subject to a design-related recall.

No reference devices were used in this submission.

5.4 DEVICE DESCRIPTION

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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 thev have taken their prescribed medication. (See Figure 1 for system overview diagram.)

The Personal Kinetigraph (PKG) System, Model GKC-2000 (Gen 2), is an updated version of the predicate device, the Personal Kinetigraph System (PKG), which was cleared under K140086. While this new PKG System. Gen 2, has some design updates, the Indications for Use are identical to those of the predicate system (K140086).

The Personal Kinetigraph (PKG) System, Gen 2, consists of:

The PKG Watch (movement data logger)
The PKG Tablet
The PKG Clinic Server
The PKG PDF report, and
The PKG Accessories. .

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Image /page/5/Figure/2 description: The image shows a diagram of the PKG watch system. The diagram shows the steps involved in using the PKG watch, from configuring the watch to emailing the PKG to the patient's clinician. The steps are numbered from 1 to 6. The PKG watch is configured using the tablet, then the PKG watch is worn by the patient for at least six days. The data collected is uploaded from the PKG watch to the tablet, then the data is sent via the internet to GKC. The PKG is generated by GKC, then the PKG is emailed to the patient's clinician and sent back to the tablet.

Figure 1 - PKG Gen 2 System components and operation overview

The PKG Watch is a battery powered, microprocessor device containing hardware and software that records the movements of a patient with movement disorders such as Parkinson's disease. It is a compact wrist worn monitor that records the patient's movements throughout the day over multiple days. These movement records are then sent via the Internet to the Global Kinetics Corporation (GKC) cloud-based server where they are analyzed to distinguish the movement patterns of the patient throughout the day and to indicate compliance with their medications.

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 PKG Clinic Server.

The PKG Clinic Server is a cloud-based service, which receives the movement data files from the PKG Tablet, and then processes the files using the PKG Analysis Software. This results in a number of graphs that summarize the content of the recorded data, for use by the clinician. These graphs and some ancillary data are presented in the PKG PDF Report. The PKG Clinic Server sends the PKG PDF Report automatically back to the clinic by email, as well as a copy back to the originating PKG Tablet in the clinic.

The PKG PDF report includes graphs showing the Bradykinesia Score (BKS), representative of bradykinesia, and Dyskinesia Score (DKS), representative of

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dyskinesia, throughout the day on a time-of-day basis. Summary statistics are included to indicate the percentage of time spent at various levels of severity of BKS and DKS. The levels of severity are based on levels that exceed the specified percentile of recordings from normal control subjects. The clinician can use data in the PKG PDF report, together with other information, to adjust the patient's medications so that they spend more time in a normal movement state.

The PKG Accessories include:

. The 5-Bay charger - for charging the PKG Watch units, up to 5 at a time. Includes a mains USB adaptor and USB cable.
. The PKG Dock Cable - for connecting the PKG Watch to the PKG Tablet for configuration before a recording session, and for uploading the movement data to the PKG Clinic Server after the recording session.

5.5 INDICATIONS FOR USE

Note: The Indications for Use statement for the PKG Model GKC-2000 (Gen 2) is identical to the predicate, which is the previous version of the same system.

5.6 COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The key operating principle of the system (as with the predicate) continues to be movement recording of the patient over a 6-10 day period and processing of the resulting recording in order to provide the PKG PDF report to the clinician.

The substantive changes to the PKG System that are being reported in this application relate to the design update of the PKG Logger in the predicate into the PKG Watch, and the related software changes in the Tablet Software in order to support the new PKG Watch data format. There are other changes relating to the size and type of charger supplied, but these are functionally equivalent to the predicate system - all other system performance parameters remain unchanged. All changes are limited to those necessary to implement the updated PKG Watch. The Indications for Use are identical to those cleared for the predicate PKG System.

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At a high level, the new system and the predicate are based on the following same technological elements:

PKG Tablet and Tablet Software workflow. ●
PKG Clinic Server.
PKG PDF reports. ●
PKG Watch:
- o Data recording functions are unchanged.
- Colored LED indicators (Orange / Green) are the same and retain o the same meaning.
- Vibrating medication alert remains unchanged uses the same O meanings and alert patterns.
- Charged using a new charger, but the underlying technology is the o same.
- Configured using a different connecting cable to the PKG Tablet, o but the underlying technology is the same.

The following technological differences exist between the new and predicate systems:

. PKG Tablet software - one minor change to support revised data transfer format for the new PKG Watch. (Unchanged otherwise)
PKG Watch:
- Now has a touch screen display, with clock display o
- Adds a Battery recharge indicator O
- Revised Strap and Enclosure design now waterproof O
- Supplementary indicator symbol on display for medication O reminder ('Pill'icon.)
- Supplementary indicator symbol on display for medication o acknowledgement ("Tick" icon.)

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5.7 PERFORMANCE DATA

The following performance data have been provided in support of the substantial equivalence determination.

5.7.1 Biocompatibility Testing

The biocompatibility evaluation for the PKG Gen 2 System was conducted in accordance with the following FDA Guidance documents:

FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, " May 1, 1995.
FDA Draft Guidance: Use of International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing" Within a Risk Management Process," April 23, 2013.

The battery of testing included the following tests:

ISO10993-5 Cytotoxicity .
ISO10993-10 Dermal Irritation ●
ISO10993-10 Sensitization ●

The testing was performed by CPTC, an FDA recognized GLP testing facility - with all protocols and reports conforming to GLP.

The key component tested was the PKG Watch, which is a wrist worn, surface device that contacts intact skin and has a contact duration of >24 hours and ≤ 30 days.

The samples supplied to CPTC labs for biocompatibility testing were all in their final finished form: production-molded parts, using the final manufacturing process parameters, and that had been colored according to their design specifications.

All results demonstrated that there were no adverse or unexplained events and that there were no indications for cytotoxicity, irritation and sensitization. As such these materials pose a low risk for the purpose of surface application on intact skin for the specified contact duration of less than 30 days. In this context, the materials can be considered to have met the biocompatibility requirements for safety for use in the PKG2 System.

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5.7.2 Electrical Safety and electromagnetic compatibility (EMC)

An electrical safety and EMC evaluation was performed for the PKG Gen 2 System, which included Electrical and EMC testing on the system components including the PKG Watch, the 5-Bay Charger and the PKG Dock Cable. The system complies with the following standards:

IEC 60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. (Edition 3)

IEC 60601-1-11:2010 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment. (Edition 1)

IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests. (Edition 3)

IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests. (Edition 4 - selected tests were performed from this standard.)

IEC 62133:2012 - Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications.

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5.7.3 Mechanical Safety Testing

The PKG Watch underwent mechanical safety testing in accordance with the mechanical safety requirements of IEC 60601-1:2005.

Tests were performed for:

Push Testing ●
Drop Testing ●
Mold Stress Relief ●
Altitude Testing ●
Thermal Cycle Testing ●
Shock Testing
Broad-band Random Vibration Testing ●
Ingress Protection Testing.

The PKG Watch complied with all tests.

Software Verification and Validation Testing 5.7.4

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", May 11, 2005.

The software for the PKG Gen 2 System was considered as a "moderate" level of concern, since a failure or latent flaw in the software could result in a Minor injury to the patient in some situations.

5.7.5 System Validation testing

The specifications and performance of these key sections of the system have not changed significantly for the PKG Gen 2 System update:

Movement recording ●
Medication reminders
Medication acknowledgement ●
. PKG Analysis and PKG PDF report

These sections of the system are the key areas that may require use of new clinical data to re-validate them in the case that they were modified significantly.

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As none of these have changed significantly, re-validation of the PKG Gen 2 System relied upon both bench verification of the new system, as well as side-by-side validation of the new system with the predicate, when worn by test subjects. Further clinical validation was not considered necessary.

A review of all system verification testing that had been performed was undertaken. This included system verification testing; external safety testing; testing of the system with key use cases on users; and the evaluation of system ergonomics; as well as common fault testing and Clinic Software Validation.

As the final level of validation, system performance testing was undertaken for the PKG Gen 2 System against the predicate system. This exercise included the side-by-side analysis of the PKG Watch for Gen 2 and the PKG Logger for the predicate and subsequent analysis and comparison of the PKG PDF Reports generated. The primary aim of this exercise was to prove performance equivalence between the two systems.

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 PKG PDF Reports that resulted from each device were compared to determine any changes in system performance.

In summary the data and results from this side-by-side comparative testing show that the 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, with the exception of accidental 'medication taken' acknowledgements, where the PKG Gen 2 System is improved over that of the predicate.

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5.8 CONCLUSIONS

Although the predicate device was cleared based in part on clinical studies, based on our risk analysis, there have not been changes to the new PKG System (Gen 2) that require clinical revalidation. Therefore clinical testing was not required to support substantial equivalence.

The non-clinical data support the safety of the device and the hardware and software verification and validation demonstrate that the PKG System (Gen 2) should perform as intended in the specified use conditions.

The safety and bench test data demonstrate that the PKG System (Gen 2) performs comparably to the predicate that is currently marketed for the same intended use. Therefore the PKG System (Gen 2) is substantially equivalent.

Regulation Number and Section

§ 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).