DARI Health is a computer and video system used to quantify and graphically display human movement patterns and techniques for uses such as assessment and training of limb or body motion in pre/post rehabilitation evaluation, physical therapy, and the like.

Device Description

DARI Health is a "markerless," three-dimensional human motion capture and analytical software system that uses off-the-shelf video cameras, off-the-shelf computer hardware, off-theshelf motion analysis software, and proprietary DARI Health Software (consisting of DARI Connect, DARI Capture plug-in, DARI Insight Engine, and DARI Rerort Engine) or DARA quantify, and document full-body human kinematics and kinetics during patient movement. Motions are recorded in real-time, using a digital "skeleton" to identify joint center and segment data for the cervical spine, upper extremity, trunk, and lower extremity of the paint. The captured video can be viewed after recording has ended or at some later point. During movement, the DARI Health interfaces with the capture software (off-the-shelf, Captury Live) tracks all segments and joint centers as they move in all planes of more the with resulting output is sent to The DARI Insight Engine processing software-either housed it ally on the computer used for capture or in a security-compliant, cloud-based server-where thered drant can be used to calculate all kinetic data produced during the revor d more one more one Such data is then displayed in different report formats-from large, raw datasets to simple, grahital reports that track key biomechanical metrics. Healthcare providers can access patient biomechanical data remotely through a secure webportal or locally on the computer database application to monitor patient progress and view prior or current motion analyses. There is no direct contact with the patient by the DARI Health system, and no energy is delivered to the subject at any point during the usage of the system.

AI/ML Overview

The DARI Health device is a "markerless," three-dimensional human motion capture and analytical software system that uses off-the-shelf video cameras, computer hardware, motion analysis software, and proprietary DARI Health Software to quantify and document full-body human kinematics and kinetics during patient movement.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the acceptance criteria are not explicitly stated in a defined "acceptance criteria" section with specific numerical thresholds. Instead, the document discusses the device's performance in relation to predicate devices and industry standards. Therefore, I will derive the implicit acceptance criteria from the performance claims made in the "Summary of Performance Data" section and present the reported device performance.

Acceptance Criterion (Implicitly Derived)	Reported Device Performance
Kinematic Accuracy: No statistically significant differences in clinically relevant joint angles compared to a predicate marker-based system (Vicon/Peak Motus).	Met: When compared to a predicate marker-based Vicon (Peak Motus) system, the DARI Health system showed no statistically significant differences in the clinically relevant joint angles being measured for investigation (p = 0.33).
Kinetic Accuracy: No statistically significant differences in peak force, mean force, or now force compared to industry-standard force plate output.	Met: The DARI Health system was tested against standard force plate output, and its force calculation methodology demonstrated no statistically significant differences in peak force, mean force, or now force as compared to simultaneous measurements derived from a force plate (p > 0.05). Additionally, comparison of force-time curves showed a strong correlation between modalities (r = 0.995, r^2 = 0.989, SEM = 11.1 N).
Repeatability (Segment Length & Joint Center Calculation): Ability to identify joint centers and segment lengths within a specified tolerance, exceeding predicate and industry standards.	Met: Repeatability of segment length and joint center calculation over successive scans of 9,120 bone segments demonstrated the ability to identify the joint centers and segment lengths within 0.811mm with 99% confidence, exhibiting only 1.02% total skeletal change between sessions with 0.002 mm of variance. This exceeds predicate repeatability associated with marker analysis and inter-test repeatability of goniometers claimed by predicate JRS v2.0.
Software Functionality: Software functions as intended, and all results are as expected.	Met: Software validation and testing were completed for the device and functioned as intended, and all results were those expected.
Safety: Compliance with relevant safety standards (IEC 60601-1 and IEC 60601-1-2).	Met: The DARI Health complies with IEC 60601-1 and IEC 60601-1-2. The system requires no contact with the patient and poses no electrical, chemical, mechanical, thermal, or radiation safety concerns.

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

Sample Size for Kinematic Accuracy Study: Not explicitly stated as a number of subjects or sessions. It refers to "clinically relevant joint angles being measured for investigation" in a comparison to a predicate system.
Sample Size for Kinetic Accuracy Study: Not explicitly stated as a number of subjects or sessions. It refers to a comparison to "simultaneous measurements derived from a force plate."
Sample Size for Repeatability Study: "Successive scans of 9,120 bone segments" were analyzed. This implies a significant amount of data, likely from multiple subjects and/or multiple scan sessions.
Data Provenance: The studies are described as "independent, peer-reviewed studies" and "DARI Health internal studies." The country of origin of the data is not specified, but the submission is to the U.S. FDA. The retrospective or prospective nature of these studies is not explicitly mentioned.

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

The document does not mention the use of experts to establish ground truth for the test set. Instead, the ground truth was established by:

Predicate marker-based Vicon (Peak Motus) system: For kinematic accuracy.
Industry-standard force plate output: For kinetic accuracy.
Successive scans and internal measurements: For repeatability.

Therefore, there were no human experts establishing the ground truth as described in the prompt's question for this type of objective measurement device.

4. Adjudication Method for the Test Set

Not applicable. As the ground truth was established by objective measurement systems (Vicon, force plate, internal measurements), there was no human adjudication process involved for the test set.

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

No, an MRMC comparative effectiveness study was not conducted. The studies described are focused on the technical accuracy and repeatability of the device's measurements compared to established objective methods, not on how human readers (clinicians) improve with AI assistance. The DARI Health system is a measurement and analysis tool, not one that directly assists a human reader in making a diagnostic interpretation in the same way an AI for medical imaging might.

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

Yes, the performance studies described are essentially standalone (algorithm only) performance assessments. The DARI Health system's ability to accurately capture, quantify, and analyze human movement (kinematics and kinetics) and its repeatability are evaluated as a standalone system against objective measurement standards. It does not involve human-in-the-loop performance in the context of these validation studies.

7. The Type of Ground Truth Used

Kinematic Accuracy: Reference data from a predicate marker-based Vicon (Peak Motus) system. This is an instrument-based ground truth.
Kinetic Accuracy: Reference data from industry-standard force plate output. This is also an instrument-based ground truth.
Repeatability: Internal measurements of successive scans of bone segments, indicating the device's consistency over time.

8. The Sample Size for the Training Set

The document does not provide any information regarding the sample size used for the training set. The descriptions focus on performance validation rather than the details of algorithm development or training.

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

The document does not provide any information on how the ground truth for the training set (if any specific training set was used for machine learning models, which is implied by a "markerless" system) was established. The "Summary of Performance Data" focuses solely on the validation/test datasets against established objective measures.

Summary

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March 7, 2019

Scientific Analytics, Inc. % Evan Phelps Principal OFW Law 600 New Hampshire Ave., NW Suite 500 Washington, District of Columbia 20037

Re: K180880

Trade/Device Name: DARI Health Regulation Number: 21 CFR 890.5360 Regulation Name: Measuring Exercise Equipment Regulatory Class: Class II Product Code: LXJ Dated: December 18, 2018 Received: December 18, 2018

Dear Evan Phelps:

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.

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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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Vivek J.

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) K180880

Device Name DARI Health

Indications for Use (Describe)

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

"510(k) Summary" As required by section 807.92(c) For DARI Health

February 4, 2019

Company Name and Address

a. Sponsor/Manufacturer

Scientific Analytics, Inc. 2100 Magnum Circle Suite 7 Lincoln, NE 68522

b. Consultant/Contact

Evan P. Phelps OFW Law 600 New Hampshire Ave, Ste. 500 Washington D.C. 20037 ephelps@ofwlaw.com Tel: (202) 789-1212 Fax: (202) 234-3550

Establishment Registration Number:

Not yet assigned

1. Device Name:
- a. Trade Name: DARI Health b. Common/Usual Name: Motion Measurement System System, Optical Position/Movement Recording
- c. Classification Name:

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1. Device Classification:
- a. 21 C.F.R. § 890.5360 (Class II)
- b. Product Code: LXJ
- c. Classification Panel: Physical Medicine
1. Legally Marketed Predicate Devices
- a. Peak Motus Motion Measurement System
  - i. 510(k) Owner: Peak Performance Technologies, Inc.
    - ii. 510(k) Number: K030714
    - iii. 21 C.F.R. § 890.5360 (Class II)
    - iv. Product Code: LXJ
1. Device Description

DARI's existing motion capture technology system has been utilized in non-clinical biomechanical research, fitness applications, and performance evaluation for may years. In view of experience with this technology, its numerous uses, and its demonstrated value, there's an need for the development of its use in clinical applications.

Motions are recorded in real-time, using a digital "skeleton" to identify joint center and segment data for the cervical spine, upper extremity, trunk, and lower extremity of the paint. The captured video can be viewed after recording has ended or at some later point.

During movement, the DARI Health interfaces with the capture software (off-the-shelf, Captury Live) tracks all segments and joint centers as they move in all planes of more the with resulting output is sent to The DARI Insight Engine processing software-either housed it ally on the computer used for capture or in a security-compliant, cloud-based server-where thered drant can be used to calculate all kinetic data produced during the revor d more one more one Such data is then displayed in different report formats-from large, raw datasets to simple, grahital reports that track key biomechanical metrics.

Healthcare providers can access patient biomechanical data remotely through a secure webportal or locally on the computer database application to monitor patient progress and view prior or current motion analyses.

There is no direct contact with the patient by the DARI Health system, and no energy is delivered to the subject at any point during the usage of the system.

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7. Intended Use

8. Technological Characteristics and Substantial Equivalence Evaluation

The technological characteristics of the DARI Health System device are based on the capture of three-dimensional motion information obtained from the subject under study. The video feed from the patient in motion is then recorded and stored on a computer where it is available for analysis of human motion using the DARI Health product. The DARI Insight Engine provided by DARI Health is used for data presentation to the healthcare professional. The data are accessible from a remote, security-compliant server for remote evaluations by the healthcare professional.

The DARI Health is substantially equivalent in terms of intended use, operating principles, and operational specifications to the Peak Motus Motion Measurement System (K030714) which is a legally marketable Optical Position/Movement Recording Systems classified pursuant to 21 C.F.R. §890.5360 under Product Code LXJ. As with the Peak Motus device, the DARI Health is intended to be used to quantify, analyze, document for remote access, visually display threedimensional human kinematics, kinetics, and patient performance metrics related to human movement patterns for uses such as assessment and training of limb or body motion in applications where such analysis is relevant to the clinician's decision-making processes.

This equivalency is summarized in the Tables below where Table 1 discusses the equivalency of the indications for use between the DARI device and the predicates. Table 2 discusses the technological characteristics between the DARI device and the predicates to demonstrate substantial equivalency.

Page 2

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	Substantial Equivalence to Predicate DevicesTable 1: Indications for Use
	Peak MotusK030714	DARI Health
Indicationsfor Use	Computer and video system used to quantify and graphically display human movement patterns and techniques for uses such as assessment and training of limb or body motion in gait analysis, prosthetic design, pre/post rehabilitation evaluation, physical therapy, and the like.	DARI Health is a computer and video system used to quantify and graphically display human movement patterns and techniques for uses such as assessment and training of limb or body motion in pre/post rehabilitation evaluation, physical therapy, and the like.

DARI Motion 510(k) Submission

THANN ALER LE

Page

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Table 2: Technological Characteristics Comparison
	Peak MotusK030714	DARI Health
Motion CapturePrinciplesofOperation	Optical camerasSoftware/Hardware system thatuses off-the-shelf cameras,sensors, and computers tocollect, quantify, and documenthuman movement in two-dimensional or three-dimensional space. This systemtracks and provides visualfeedback of patient movementwhile reporting on kinematicparameters such as velocity andjoint angles measured duringmovement	Optical camerasUse of off-the-shelf optical camerasor motion sensing technology, andcomputing equipment as the userinterface and software, to collect,quantify, and document humanmovement in three-dimensionalspace. The DARI Health calculatessuch outputs as validatedbiomechanics and performancemetrics vis cloud-based or localprocessing software.
AnalysisandInterface Tools	Peak Motus uses softwaremodules (Vicon) to capture,calculate, and represent patientbiomechanical data	DARI Health uses software modulesto capture, calculate, and displaypatient biomechanical data, andoffers remote access to prior analysesvia web-based portal and database.
SoftwareandHardwareCompatibility	Peak Motus uses software andhardware that are compatiblewith Microsoft Windows	DARI Health hardware and softwareare compatible with Linux operatingsystems.
Operating System	Microsoft Windows	Linux-based OS
Markerless MotionLive Capture andPost-Processing	Live capture video requires useof position markers on subject'sbody.Post-processing motion analysismay be done without positionmarkers on body.	DARI Health provides livemarkerless motion capture of thesubject and the ability to post-processvideo for motion analysis.No position markers required for livecapture or post-processing analysis.
TrajectoryReconstruction	2D and/or 3D reconstruction	3D reconstruction
Kinetic Calculations
	Requires integration with forceplates to measure kinetic datasuch as ground reaction force.	DARI Health uses subject and digitalskeleton data to perform groundreaction force calculations.
ExternalMeasurementDevice Integration	Electromyography(EMG)integration.Event synchronization units.Analog-to-digital interface (64sensors)	None
Contraindications	None	None
Electrical Safety:Energy Used /Delivered	No energy is delivered to thepatient	No energy is delivered to the patient
Biocompatibility	Not applicable	Not applicable
Mechanical,Thermal, ChemicalSafety	Safety not an issue per 510ksummary	No thermal, chemical, or safetyissues during DARI Health motionanalysis
Radiation SafetyElectromagneticCompatibility	System does not emit radiationEMC and EMI Compliant	System does not emit radiationEMC and EMI Compliant
Sterility	Non-sterile device	Non-sterile device

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9. Summary of Performance Data

DARI Health performance characteristics have been verified by independent, peerreviewed studies proving the accuracy of the system's calculations of human kinematics and kinetics as compared to both traditional, gold-standard marker-based analysis and forces plate output. Likewise, DARI Health internal studies demonstrate repeatability metrics that or or exceed predicate and motion analysis industry standards. In addition, software validation a ot testing were completed for the device and functioned as intended and all results onsemally were those expected.

a. Non-Clinical Performance Summary
Safety

DARI Health utilizes common technical equipment to execute motion analysis with demonstrated safety. The system requires no contact with the patient, and poses no electrical, chemical, mechanical, thermal, or radiation safety concerns; therefore, there are

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no safety issues associated with its use. The DARI Health complies with IEC 60601-1 and IEC 60601-1-2.

Effectiveness

Bench testing demonstrates the DARI Health motion capture methodology's accuracy in representing and tracking digital skeletal segments.

b. Clinical Performance Summary

Effectiveness

Clinical studies demonstrate the equivalency to predicate marker-based capture of human kinematics and industry-standard force plate output for evaluation of human kinetics.

Specifically, when compared to a predicate marker-based Vicon (Peak Motus) system in an independent, peer-reviewed study, the DARI Health system showed no statistically significant differences in the clinically relevant joint angles being measured for investigation (p =0.33).

The DARI Health system was also tested against standard force plate output in an independent, peer-reviewed study, where DARI's force calculation methodology demonstrated no statistically significant differences in peak force, mean force, or now force as compared to simultaneous measurements derived from a force plate (p > 0.05). Additionally, comparison of force-time curves with regression yiald ( > > 0.03). correlation between modalities (r = 0.995, 2 = 0.989, SEM = 11.1 NN.

A clinical study also supports the repeatability of the DARI Health System.

Specifically, the repeatability of segment length and joint center calculation over successive scans of 9,120 bone segments demonstrated the ability to identify the joint centers and segment lengths within 0.811mm with 99% confidence, exhibiting only 1.02% total skeletal change between sessions with 0.002 mm of variance. This exceeds prelicate repeatability associated with marker analysis and inter-test repeatability of goniometers claimed by predicate JRS v2.0.

System Validation for Software Design, Documentation, and Hazard Analysis

The DARI Health software is of "modcrate" level of concern based upon FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005). Consistent with FDA guidance and other applicable requirements, all hazards have been mitigated through appropriate controls, product labeling, while maintaining sufficient secve to may see protect the software and data.

DARI Motion 510(k) Submission

Page 24 of 217

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The DARI Health motion analysis software underwent a standardized approach consistent with the requirements of the Quality System Regulation (21 C.F.R. § 820.30) and ANSI 62304 for appropriate design, risk assessment, document, and validation control for software classed as "moderate level of concern."

DARI Health conforms to the following FDA recognized standards and associated FDA guidance documents:

Medical Device Software-Software Life Cycle Processes ANSI/AAMI/ IEC 62304: 2006 . & A1:2016
Guidance on the use of AGILE practices in the development of medical device software . AAMI TIR45:2012
1. Substantial Equivalence Conclusion

The aforementioned testing dominstrate substantial equivalence between the DARI Health System and the Peak Motus Motion Measurement System (K020214).

Regulation Number and Section

§ 890.5360 Measuring exercise equipment.

(a)
Identification. Measuring exercise equipment consist of manual devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. These devices also include instrumentation, such as the pulse rate monitor, that provide information used for physical evaluation and physical planning purposes., Examples include a therapeutic exercise bicycle with measuring instrumentation, a manually propelled treadmill with measuring instrumentation, and a rowing machine with measuring instrumentation.(b)
Classification. Class II (special controls). The device, when it is a measuring exerciser or an interactive rehabilitation exercise device for prescription use only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.