NeuroRPM is intended to quantify movement disorder symptoms during wake periods in adult patients 46 to 85 years of age with Parkinson's disease. These symptoms include tremor, bradykinesia, and dyskinesia. NeuroRPM is intended for clinic and home environments.

Device Description

NeuroRPM is a software application for the Apple Watch that is prescribed by a health professional to quantify motor symptoms of Parkinson's disease including bradykinesia, dyskinesia, and tremor. NeuroRPM collects accelerometer and gyroscope data from the Apple Watch. The motion data are transmitted to cloud servers and analyzed using machine learning models developed to generate binary symptom classifications. Binary symptom classification output is generated every 15-minutes.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the NeuroRPM device, based on the provided text:

1. Table of Acceptance Criteria & Reported Device Performance

The acceptance criteria for NeuroRPM were based on achieving specific sensitivity and specificity thresholds for detecting tremor, bradykinesia, and dyskinesia. While explicit "acceptance criteria" values (e.g., "must meet X sensitivity") aren't directly stated as minimum required values, the study design aimed to demonstrate adequate performance to support its intended use and substantial equivalence to the predicate device. The reported performance is presented with 95% confidence intervals.

NeuroRPM Output	Acceptance Criteria (Implied)	Reported Sensitivity [95% CI]	Reported Specificity [95% CI]
Tremor	(Adequate performance for intended use)	0.7176 [0.6081, 0.8172]	0.9508 [0.9119, 0.9802]
Bradykinesia	(Adequate performance for intended use)	0.7143 [0.5894, 0.8332]	0.7740 [0.6787, 0.8597]
Dyskinesia	(Adequate performance for intended use)	0.7123 [0.5323, 0.8652]	0.9466 [0.9069, 0.9741]

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

Sample Size for Test Set: The study was conducted with 36 subjects. However, the analysis was based on "events" rather than subjects.
- Total number of events (from ground truth) for sensitivity evaluation:
  - Tremor: 170
  - Bradykinesia: 203
  - Dyskinesia: 73
- Total number of events (from ground truth) for specificity evaluation:
  - Tremor: 325
  - Bradykinesia: 292
  - Dyskinesia: 422
Data Provenance: The study was an "observational, non-intervention study." The subject demographics indicate the study took place at a single site and had 95.5% Caucasian subjects. This suggests the data is retrospective in terms of being collected from past observations, but the study itself was designed prospectively to collect this data for validation. The country of origin is not explicitly stated beyond being a "single site," but given the FDA submission, it implicitly aligns with U.S. regulatory standards.

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

Number of Experts: 3
Qualifications of Experts: Board-certified movement disorder specialists.

4. Adjudication Method for the Test Set

Adjudication Method: The ground truth for each sample was derived based on the majority score of the expert rater panel. This implies a 2-out-of-3 or 3-out-of-3 consensus approach.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance

No, an MRMC comparative effectiveness study was not done. The study evaluated the standalone performance of the NeuroRPM device in quantifying symptoms against expert-derived ground truth. It did not assess human reader performance with or without AI assistance.

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

Yes, a standalone performance study was done. The described clinical performance testing evaluates "NeuroRPM's ability to quantify Parkinson's symptom presence or absence" directly, without human intervention in the device's output interpretation or decision-making.

7. The Type of Ground Truth Used

Type of Ground Truth: Expert Consensus based on clinical scales. The experts provided scores using the Unified Parkinson Disease Rating Scale (UPDRS) and the Abnormal Involuntary Movement Scale (AIMS). The device's binary classifications (e.g., "Tremor detected" vs. "No tremor detected") were then mapped to specific score ranges on these validated clinical scales, and the majority score from the expert panel served as the ground truth.

8. The Sample Size for the Training Set

The document does not explicitly state the sample size for the training set. It mentions a "machine learning model developed to generate binary symptom classifications" but does not detail the dataset used for training. The clinical performance data provided (n=36 subjects) is specifically for the validation or test set.

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

The document does not explicitly state how the ground truth for the training set was established. While it mentions machine learning models were used, it does not provide details on the data used for training these models or how their ground truth was determined.

Summary

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March 17, 2023

New Touch Digital Inc. Chan Lee Chief Operating Officer 3124 Dumbarton Street NW Washington, District of Columbia 20007

Re: K221772

Trade/Device Name: NeuroRPM Regulation Number: 21 CFR 882.1950 Regulation Name: Tremor Transducer Regulatory Class: Class II Product Code: GYD, ISD Dated: February 15, 2023 Received: February 15, 2023

Dear Chan Lee:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Patrick Antkowiak -S

for

Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221772

Device Name NeuroRPM

Indications for Use (Describe)

NeuroRPM is intended to quantify movement disorder symptoms during wake periods in adult patients 46 to 85 years of age with Parkinson's disease. These symptoms include tremor, bradykinesia. NeuroRPM is intended for clinic and home environments.

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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K221772 Traditional 510(k) SUMMARY New Touch Digital Inc.'s NeuroRPM

Submitter:

New Touch Digital Inc. 3124 Dumbarton Street NW Washington, DC 20007

Contact Person: Chan Lee Phone: (703)201-9548 Email: chan.lee@newtouchdigital.com

March 17, 2023 Date Prepared: Name of Device: NeuroRPM K221772 Common or Usual Name: NeuroRPM Classification Name: Tremor Transducer 21 CFR 882.1950 Regulatory Class: Class II Primary Product Code: GYD Secondary Product Code: ISD

Predicate Device:

Manufacturer:	GKC Manufacturing Pty Ltd.
Trade/Device Name:	Personal Kinetigraph (PKG) System Model GKC-2000
510(K) Number:	K161717
Decision Date:	September 20, 2016

Device Description:

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K221772

Symptom	Output Classification	Output Description	Validated Scale
Tremor	NTD-TR A - No Tremor	No tremor detected.	UPDRS-III TR Score of 0
	NTD-TR B - Tremor	Tremor detected.	UPDRS-III TR Score of 1 andgreater
Bradykinesia	NTD-BK A - Normal to Low	No, minor or mild bradykinesiadetected.	Combined UPDRS-IIIBK Score of 0, 1, 2, 3
	NTD-BK B - Medium to High	Moderate or greater thanmoderate bradykinesia detected.	Combined UPDRS-IIIBK Score of 4 and greater
Dyskinesia	NTD-DK A - No Dyskinesia	No dyskinesia detected.	Total AIMS Score of 0, 1
	NTD-DK B - Dyskinesia	Dyskinesia detected.	Total AIMS Score of 2 andgreater

Table 1 - Description of NeuroRPM Outputs

Intended Use:

Summary of Technological Characteristics:

The proposed device and the predicate device have similar technological characteristics. Both devices obtain a patient's movement data from a wrist-worn device. Sensor data from both the proposed and predicate wrist-worn devices are transferred to a cloud server and analyzed using algorithms to quantify the movement disorder symptoms. The predicate algorithm uses equations and thresholds, while the proposed algorithm was developed using machine learning. Although the algorithms are different, both devices provide similar quantification of the presence or absence of motor symptoms. In addition, the outputs of both devices indicate the presence of movement disorder symptoms (i.e., bradykinesia, tremor, and dyskinesia) in adult patients diagnosed with Parkinson's disease. The predicate device provides symptom scores every 2 minutes in median and percentiles which are compared to a control group with subjects with no Parkinson's disease. In comparison, NeuroRPM directly outputs the presence of 3 symptom types according to Table 1, without comparison to a control group. Although the output scales and references differ, NeuroRPM outputs were validated in a clinical trial, demonstrating that the device performance is adequate to support the intended use of quantifying movement disorder symptoms. Thus, these differences in technological characteristics do not raise different questions of safety and effectiveness.

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K221772

Performance Bench Testing:

Bench testing was conducted to verify that the motion data from the Apple Watch reflected the subject's activities within the expected signal patterns and range of values, and that there were no outliers. Raw motion data from test subjects wearing Apple Watch were collected during UPDRS and AIMS evaluation and analyzed in time and frequency domains. The test results demonstrated that the motion data for all subjects were consistent and reliable.

Performance Clinical Testing:

An observational, non-intervention study in 36 subjects was conducted to evaluate NeuroRPM's ability to quantify Parkinson's symptom presence or absence. The primary endpoints for demonstrating the performance of the NeuroRPM outputs were sensitivity and specificity. Subjects who were previously diagnosed with Parkinson's disease were enrolled in the study. Scores for each subject were obtained clinical scales, the Unified Parkinson Disease Rating Scale (UPDRS) and the Abnormal Involuntary Movement Scale (AIMS). The ground truth for each sample was derived based on the majority score of an expert rater panel of 3 board-certified movement disorder specialists.

The summary of subject demographics is provided below and is from a single site with 95.5% Caucasian subjects.

Demographics	Min	Mean	Max
Age	46	67.7	85
Approx. Age at Diagnosis	35.1	59.8	81.3
Years Since Diagnosis	0.3	7.9	19
Average Total UPDRS-IIIScore	3.4	11.1	26.7
Number of Males	-	18	-
Number of Females	-	18	-

Table 2 - Summary of Subject Demographics

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Image /page/6/Figure/0 description: The image shows the alphanumeric string "K221772" in a bold, sans-serif font. The characters are arranged horizontally, with the letter "K" followed by the numbers "221772". The text is black against a white background, creating a high contrast and making it easily readable. The overall impression is clean and straightforward.

Image /page/6/Figure/1 description: This bar graph shows the number of subjects at each Hoehn and Yahr Stage. The x-axis shows the Hoehn and Yahr Stage from 0 to 5, and the y-axis shows the number of subjects from 0 to 10. The graph shows that the most subjects are at stage 1.5, with 10 subjects.

Figure 1 - Histogram of Hoehn and Yahr Stages (n=36)

The validation study was not specifically tested in the home environment; however, additional supportive data from the clinic, where subjects performed common at-home tasks and observed naturalistic behaviors, were provided to demonstrate the potential for similar performance in the home environment.

Clinical performance testing demonstrated that NeuroRPM is substantially equivalent to the predicate device. 95% confidence intervals were estimated based on the subject cluster bootstrap method.

NeuroRPM Output	Sensitivity [95% CI]	Specificity [95% CI]
Tremor	0.7176 [0.6081, 0.8172]	0.9508 [0.9119, 0.9802]
Bradykinesia	0.7143 [0.5894, 0.8332]	0.7740 [0.6787, 0.8597]
Dyskinesia	0.7123 [0.5323, 0.8652]	0.9466 [0.9069, 0.9741]

Table 3 - NeuroRPM Output Sensitivity and Specificity of the event with 95% Confidence Intervals

Sample size n = 36

The analysis is based on events instead of subjects. There are a total of 36 subjects who may have all the 3 types of events. The total number of events (from truth) for sensitivity evaluation is 170 for Tremor, and 203 for BK and 73 for DK. The number of events (from truth) for specificity evaluation is 325 for Tremor, 292 for BK, and 422 for DK.

Conclusions:

NeuroRPM is substantially equivalent to GKC's Personal Kinetigraph (PKG) System Model GKC-2000. NeuroRPM has the same intended use, technological characteristics, and principles of operation as the predicate device. The differences in indications for use do not introduce a new intended use. In addition, technological differences between NeuroRPM and the predicate device do not raise different questions of safety or effectiveness.

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K221772

Substantial equivalence comparison of the predicate device and NeuroRPM is provided in Table 2.

	Predicate Device:GKC PKG System(K161717)	Subject Device:NeuroRPM	Comparison
Indications forUse	The Personal Kinetigraph(PKG) is intended to quantifykinematics of movementdisorder symptoms inconditions such asParkinson's disease,including tremor,bradykinesia and dyskinesia.It includes a medicationreminder, an event markerand is intended to monitoractivity associated withmovement during sleep. Thedevice is indicated for use inindividuals 46 to 83 years ofage.	NeuroRPM is intended toquantify movement disordersymptoms during wakeperiods in adult patients 46to 85 years of age withParkinson's disease. Thesesymptoms include tremor,bradykinesia, anddyskinesia. NeuroRPM isintended for clinic andhome environments.	Same intended use ofquantifying movementdisorder symptoms.
WearableDevice	Proprietary watch withaccelerometer.	Apple Watch triaxial inertialmeasurement unit.	Both use wrist-worn devicesto measure movement.
Algorithm	Equation with data infrequency domain.	Machine learning model withdata in time and frequencydomain.	Both algorithms aredeterministic and generateclassifications.
SymptomMeasured	Tremor, bradykinesia anddyskinesia.	Tremor, bradykinesia, anddyskinesia.	Same symptommeasurements. The subjectdevice produces binarysymptom outputs.
Outputs	Symptom measurementevery 2 minutes in medianand percentiles which arecompared to a control groupwith subjects with noParkison's disease.	Symptom presence orabsence levels every 15-minutes.	NeuroRPM provides directsymptom measurementwithout comparison to acontrol group. 15-minuteintervals provide sufficientcharacterization of whether asymptom is present.
Output Report	PDF report with daily graphsand summary statistics ofsymptom outputs.	PDF report with daily graphsand summary statistics ofsymptom outputs.	Same output report formatswith similar symptominformation andsymptom outputs.

Medication

Reminder

Yes

Table 2 - Substantial Equivalence Comparison of Predicate Device and NeuroRPM

visualizations.

Not required for

disorder symptoms.

quantification of movement

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).