Qualisys Clinical System

K171547 · Qualisys AB · LXJ · Aug 2, 2018 · Physical Medicine

Device Facts

• Record ID: K171547
• Device Name: Qualisys Clinical System
• Applicant: Qualisys AB
• Product Code: LXJ · Physical Medicine
• Decision Date: Aug 2, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5360
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Qualisys Clinical System is a camera and computer system used to quantify and graphically display human movement patterns for adults and children. It is intended to be used for movement analysis in the fields of gait analysis, rehabilitation, sports medicine and ergonomics.

Device Story

Qualisys Clinical System (QCS) is a motion capture system for quantifying human movement. Input: IR-light reflected from markers attached to patient skin; captured by 2+ calibrated cameras. Processing: Cameras triangulate 3D marker positions; QTM software reconstructs 3D kinematics; maps markers to anatomical human models. Output: 3D positional/rotational data; graphical movement displays; MS Word/Web reports. Used in clinics/labs by clinicians for gait analysis, rehabilitation, sports medicine, ergonomics. Optional synchronized inputs include video, EMG, and force plate data. Output assists clinicians in assessing movement patterns and clinical decision-making; benefits include objective quantification of patient movement.

Clinical Evidence

Bench testing only. Software verification and validation confirmed requirements met. Hardware tested for EMC (IEC-60601-1-2) and electrical safety (ANSI AAMI ES60601-1). Metrological accuracy of 3D marker positioning verified and validated with traceability to national meter reference. Clinical Evaluation report provided to support clinical relevance of gait assessments.

Technological Characteristics

System comprises workstation, software (QTM, Qualisys Report, Clinical Gait PAF Module), and IR-tracking cameras. Cameras use 850 nm IR-light; C-mount lenses; 1216x800 to 4096x3072 resolution; 100 fps. Connectivity: Subsystems (video, EMG, force plates) connect to PC workstation. Electrical safety: ANSI AAMI ES60601-1. EMC: IEC-60601-1-2. Software: Predefined analysis protocols.

Indications for Use

Indicated for movement analysis in adults and children for gait analysis, rehabilitation, sports medicine, and ergonomics.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Smart-D (K131660)

Submission Summary (Full Text)

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August 2, 2018

Qualisys AB Nils Betzler, PhD Product Owner Kvarnbergsgatan 2 Göteborg, 411 05 Se

Re: K171547

Trade/Device Name: Qualisys Clinical System Regulation Number: 21 CFR 890.5360 Regulation Name: Measuring Exercise Equipment Regulatory Class: Class II Product Code: LXJ Dated: July 2, 2018 Received: July 5, 2018

Dear Dr. Betzler:

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.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Michael J. Hoffmann -S

Carlos L. Peña, PhD, MS for 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) K171547

Device Name Qualisys Clinical System

Indications for Use (Describe)

The Qualisys Clinical System is a camera and computer system used to quantify and graphically display human movement patterns for adults and children. It is intended to be used for movement analysis in the fields of gait analysis, rehabilitation, sports medicine and ergonomics.

Type of Use (Select one or both, as applicable)

| <div> <span> <b> ☑ </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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Image /page/3/Picture/0 description: The image shows the Qualisys logo. The logo consists of the word "QUALISYS" in bold, black letters. Above the "I" in "QUALISYS" are four circles, the first one is red and the other three are gray. Below the word "QUALISYS" is the text "Motion Capture Systems" in a smaller font.

# 5. 510(k) Summary

Submitter Name and Address Qualisys AB Kvarnbergsgatan 2, SE-411 05 Gothenburg, Sweden

Establishment registration No: N/A

# Contact

Nils Betzler Qualisys AB, Kvarnbergsgatan 2, SE-411 05 Gothenburg, Sweden Telephone: [phone] Fax: [phone] Email: [e-mail]

Date Summary Prepared August 2, 2018

Device Name Qualisys Clinical System

Common Name QCS

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Image /page/4/Picture/0 description: The image shows the logo for Qualisys Motion Capture Systems. The word "QUALISYS" is written in large, bold, black letters. Above the "S" in Qualisys are four circles, the first one is red and the other three are gray. Below the word "QUALISYS" is the phrase "Motion Capture Systems" in a smaller font.

| Classification | |
|-------------------|-------------------|
| Product Code | LXJ |
| Device Class | 2 |
| Regulation Number | 890.5360 |
| Review Panel | Physical Medicine |
| Predicate Device | |
| | Name |
| | Manufacturer |
| | |
| | 510(k) Number |
| | Product Code |
| Device Class | 2 |
| Regulation Number | 890.5360 |
| Review Panel | Physical Medicine |

## Device Description

The Qualisys Clinical System (QCS) is a camera and computer system used to quantify and graphically display human movement patterns for adults and children. It is intended to be used for movement analysis in the fields of gait analysis, rehabilitation, sports medicine and ergonomics.

In order to achieve this, the QCS utilizes data captured from image sensors (motion capture cameras) to triangulate the 3D-position of one or several reflective markers attached to the patient. This is done by two or more cameras calibrated to provide overlapping field of views from multiple angles. QCS produce data with 3 degrees of freedom for each marker, i.e. positional information. Rotational information (e.g. of a limb) may be retrieved from the relative orientation of three or more markers.

The tracking cameras may record images and identify the position of the markers with a high spatial and temporal resolution to generate high performance motion capture of the markers.

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Image /page/5/Picture/0 description: The image shows the Qualisys logo. The logo consists of the word "QUALISYS" in a bold, sans-serif font. Above the "I" and "S" are three circles, one red and two gray. Below the word "QUALISYS" is the phrase "Motion Capture Systems" in a smaller font.

The markers are usually attached directly to the skin. The markers are specially designed to reflect the IR-light flashed from the tracking cameras.

In addition, subsystems may be added to record data in synchronization with the tracking cameras to facilitate the analysis, or for pure documentation purposes. The additional subsystems may be any one of, or a combination of: 1) Ordinary video, 2) EMG data and 3) Force plate data.

# Intended Use

The Qualisys Clinical System is a camera and computer system used to quantify and graphically display human movement patterns for adults and children. It is intended to be used for movement analysis in the fields of gait analysis, rehabilitation, sports medicine and ergonomics.

## Substantial Equivalence: The Predicate

| Name: | Smart-D |
|----------------|---------------------------------------------------|
| 510(k) Holder: | BTS SPA, Via della Croce Rossa 11, PD Italy 35129 |
| 510(k) Number: | K131660 |
| Date Cleared: | April 2014 |

Substantial Equivalence: Technical and functional comparison

The proposed device, Qualisys Clinical System (QCS), is claimed to be substantially equivalent to the predicate SMART-D[K131660].

The comparison of technical and functional characteristics is presented in table 5-1 and table

5-2, respectively. Identified differences are discussed in the next section.

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Image /page/6/Picture/0 description: The image shows the Qualisys logo. The logo consists of the word "QUALISYS" in a bold, sans-serif font, with a red circle and three gray circles above the "S". Below the word "QUALISYS" is the text "Motion Capture Systems" in a smaller font.

| | | Name: Qualisys Clinical System<br>K number: 171547<br>Summary: --- | SMART-D System<br>K number: 131660<br>Summary: (Att AD) | Eq. |
|-----|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| 1 | CFR Section | 2(*) | 2(*) | Yes |
| 2 | Product code | LXJ | LXJ | Yes |
| 3 | Regulation number | 890.5360 | 890.5360 | Yes |
| 4 | Classification name | System, optical position/movement<br>recording | System, optical<br>position/movement<br>recording | Yes |
| 5 | Intended use | The Qualisys Clinical System is a<br>camera and computer system used<br>to quantify and graphically display<br>human movement patterns for<br>adults and children. It is intended<br>to be used for movement analysis<br>in the fields of gait analysis,<br>rehabilitation, sports medicine and<br>ergonomics. | SMART-D is a system for<br>motion analysis, intended<br>for the recording and<br>analysis of human<br>movement patterns in the<br>fields of rehabilitation,<br>sports medicine,<br>ergonomics. | Yes |
| 6 | System Components | Workstation + Software, Tracking<br>Cameras | Workstation + Software,<br>Tracking Cameras | Yes |
| 7 | Software Tools | QCS Software modules (QTM,<br>Qualisys Report, Clinical Gait PAF<br>Module) combined with third party<br>"off-the-shelf" software<br>(Visual3D) to achieve:<br>a) Data acquisition<br>b) 3-dimensional marker tracking<br>c) 3D kinematics reconstruction by<br>using an international scientific and<br>validated protocol<br>d) Real-time visualization<br>e) Creating MS Word or Web<br>reports | SMARTcapture,<br>SMARTtracker,<br>SMARTanalyzer,<br>SMARTclinic to achieve:<br>a) Real-time visualization of<br>signals of all integrated<br>devices,<br>b) 3D kinematics<br>reconstruction validated by<br>international scientific<br>community protocols,<br>c) Tool for easy<br>construction of analysis<br>protocols,<br>d) Multimedia customizable<br>and web reporting | No |
| 8 | Contraindications | Not needed | Not needed | Yes |
| 9 | Target population | All population | All population | Yes |
| 10 | Frame rate | 100 fps | 200 fps | No |
| 11 | Acquisition Frequencies | 500-1500 HZ<br>(dependent on source) | 250 Hz (up to 500 Hz) | No |
| 12 | Light emission | Infrared | Infrared | Yes |
| 13 | Light wave length | 850 nm | 880 nm | No |
| 14 | Output Angle | 61-42 degree (FOV) | 40 degree | No |
| ો ર | Modulation /<br>External Sync | Y | Y<br>(Square wave synchronized<br>with the acquisition<br>frequency) | Yes |
| 16 | Lens | C-mount | C-mount | Yes |
| 17 | Number of Cameras | up to 100 | up to 16 digital TVC | No |
| 18 | Camera resolution | 1216×800 - 4096×3072 | 800 H x 600 V | No |
| 19 | 3D Trajectory<br>Reconstruction | Y (QTM) | Y (SMARTtracker) | Yes |
| 20 | Customizable<br>Analysis Protocol | N (PAF) | Y (SMARTanalyzer) | No |
| 21 | Reporting | Y (Qualisys Report Generator) | Y (SMARTclinic) | Yes |
| 22 | Weight | 1 kg / camera | 20 kg | No |
| 23 | Dimension | 140*87*84 mm (camera) | 450*330*500 mm | No |
| 24 | Realtime visualization | Y | Y | Yes |
| 25 | Max input power | Max 30W / camera.<br>To be scaled accordingly to<br>number of cameras used. | 950 W | No |
| 26 | Power supply | 110 V, 60 Hz / 230 V, 50 Hz<br>Dual power. | 110 V, 60 Hz | Yes |
| 27 | Electrical Safety | ANSI AAMI ES60601-<br>1:2005/(R)2012 and A1:2012,<br>C1:2009/(R)2012 and<br>A2:2010/(R)2012 | AAMI/ANSI ES60601-<br>1:2005 and further<br>amendments | Yes |
| 28 | EMC | IEC-60601-1-2 | IEC 60601-1-2 | Yes |
| 29 | Options | None | None | Yes |

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Image /page/7/Picture/0 description: The image shows the logo for Qualisys Motion Capture Systems. The word "QUALISYS" is written in large, bold, black letters. Above the "I" and "S" are three circles, the first is red and the other two are gray. Below the word "QUALISYS" is the phrase "Motion Capture Systems" in a smaller font.

## Tabell 5-1 Technical Characteristic Comparison. Note Eq – Equivalent. * - previously unclassified

| | Functionality<br>Characteristics | Qualisys Clinical System<br>K number: 171547<br>Summary: --- | SMART-D System<br>K number: 131660<br>Summary: (Att AD) | Eq. |
|---|-------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|-----|
| 1 | Calibration and Signals<br>acquisistion | Real-time visualization of all<br>acquired data using Qualisys QTM<br>and "Clinical Gait PAF Module" | SMARTcapture: a) Real-<br>time visualization of signals<br>of all integrated devices | Yes |
| 2 | Trajectory reconstruction,<br>signal elaboration | 3D marker trajectory evaluated by<br>the Qualisys QTM software<br>module. Marker mapped to an<br>anatomical human model by a<br>scientific international validated<br>protocol | SMARTtracker: b) 3D<br>kinematics reconstruction<br>validated by international<br>scientific community<br>protocol | Yes |
| 3 | Management of acquired<br>data customizable<br>analysis protocols | Predefined analysis protocol | SMARTanalyzer: c) Tool<br>for easy construction of<br>analysis protocols | No |

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Image /page/8/Picture/0 description: The image shows the Qualisys logo. The logo consists of the word "QUALISYS" in a bold, sans-serif font. Above the "I" in "QUALISYS" is a red circle, and above the "S" are three gray circles. Below the word "QUALISYS" are the words "Motion Capture Systems" in a smaller font.

| 4 | Report drafting, data visualization | Visualization tool to verify the trajectories and anatomical mapping algorithm. Graphical presentation in Reports | SMARTclinic: d) Multimedia customizable and web reporting | Yes |
|---|-------------------------------------|-------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|-----|
|---|-------------------------------------|-------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|-----|

Tabell 5-2 Functional Characteristic Comparison. Note Eq - Equivalent.

Substantial Equivalence: Discussion of technical and functional differences

The identified technical and functional differences (table 5-2) are discussed below in table 5-3 and table 5-4, respectively.

| Technical<br>Characteristics | Qualisys Clinical System<br>K number: 171547<br>Summary: --- | SMART-D System<br>K number: 131660]<br>Summary: (Att AD) |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Software Tools | QCS Software modules (QTM, Qualisys Report, Clinical Gait PAF Module) combined with third party “off-the-shelf” software (Visual3D) to achieve:<br>a) Data acquisition<br>b) 3-dimensional marker tracking<br>c) Mapping marker movement to a body-model using a international scientific protocol.<br>d) Creating MS Word or Web reports | SMARTcapture, SMARTtracker, SMARTanalyzer, SMARTclinic to achieve:<br>a) Real-time visualization of signals of all integrated devices,<br>b) 3D kinematics reconstruction validated by international scientific community protocols,<br>c) Tool for easy construction of analysis protocols,<br>d) Multimedia customizable and web reporting |

The QCS and its predicate perform the same tasks. Acquire data, reconstruct 3D-marker positions/trajectories, mapping data to a human anatomical body to extract kinematic information and creating reports

| Frame rate | 100 fps | 200 fps |
|------------|---------|---------|
|------------|---------|---------|

Whilst all of the supported Qualisys motion capture camera models are capable of operating at higher frame rates, Qualisys recommends a frame rate of 100 fps for gait analysis. This is in line with recommendations from the scientific literature:

- Baker (2013, p. 210): "Most current systems can capture at 100 120 Hz, which is more than ● adequate for clinical gait analysis (although faster sample rates may be required for running). '
- Richards (2008, p. 108): "Cameras exist that can provide sampling frequencies up to 10 kHz, but it is well accepted that 50 Hz is adequate for studying many aspects of human walking."
- . Stergiou (2004 p. 236): recommended sampling frequencies for walking are 50 to 100 Hz for motion capture.

This will not influence intended use or reduce safety or effectiveness of the OCS compared to the predicate.

#### Full references:

Baker, Richard (2013): Measuring Walking: A Handbook of Clinical Gait Analysis: 1st Edition. London: Mac Keith Press.

> Qualisys AB • Kvarnbergsgatan 2, SE-411 05 Gothenburg • SWEDEN • www.qualisys.com • [e-mail] • [phone]

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Image /page/9/Picture/0 description: The image shows the Qualisys logo. The word "QUALISYS" is written in large, bold, black letters. Above the "ISYS" portion of the word are four circles, the first of which is red and the other three of which are gray. Below the word "QUALISYS" are the words "Motion Capture Systems" in a smaller font.

| | Richards, Jim (2008): Biomechanics in Clinic and Research. 1st Edition. London: Churchill Livingstone.<br>Stergiou, Nicholas (2004): Innovative Analyses of Human Movement. Champaign, IL: Human Kinetics. | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Acquisition<br>Frequencies | 500-2000 Hz<br>(dependent on source) | |
| | QCS will record analog data faster than the predicate. This improves the time-resolution and will therefore not influence intended use or reduce the safety or effectiveness of the QCS compared to the predicate | |
| | 250 Hz (up to 500 Hz) | |
| Light wave length | 850 nm | |
| | 880 nm | |
| The IR wavelength is close to be the same and both are well within the range of IR-light. From a practical<br>point of view, the IR-light from the two systems behave the same in terms of attenuation and scatter. Further<br>the QCS-cameras are optimized to work at this specific wavelength. There is no influence on Intended use or<br>reduction of safety and effectiveness due to the slight difference in IR wave length | | |
| Output Angle | 61-42 degree (FOV) | |
| | 40 degree | |
| The QCS has a wider Field of View (FOV) than the predicate. This allows the QCS to detect reflective<br>markers over a wider spatial region which in turn will improve marker detectability. There is no influence<br>on Intended use or reduction of safety and effectiveness due to the wider FOV | | |
| Number of Cameras | up to 100 | |
| | up to 16 digital TVC | |
| The QCS supports more cameras than the predicate. Does not influence the Intended use or reduce the<br>safety or effectiveness | | |
| Camera resolution | 1216×800 - 4096×3072 | |
| | 800 H x 600 V | |
| The QCS system has a higher image resolution than its predicate. This will improve the precision of the<br>marker detection and/or improve the detection distance from the camera compared to the predicate. Will not<br>influence the "Intended use" or reduce the safety or effectiveness | | |
| Customizable<br>Analysis Protocol | N (PAF) | |
| | Y (SMARTanalyzer) | |
| The QCS does not allow the user to modify the analysis protocol. The protocol is considered to be a crucial part of the software, requiring specific verification and validation. As such, this does not influence the "Intended use", impose any risk or reduced safety or efficiency. | | |
| Weight | 1 kg / camera | |
| | 20 kg | |
| The QCS does not require a base station, instead the sub-systems are directly connected to the PC workstation. The weight of a camera does not bring a point of non-substantial equivalence between the QCS system and its predicate. The difference in weight does no influence the "Intended use" or reduce the safety or the effectiveness | | |
| Dimension | 140*87*84 mm | |
| | 450*330*500 mm | |
| The dimensions of a camera do not constitute a point of non-substantial equivalence between the QCS system and its predicate. The difference in dimensions does no influence the "Intended use" or reduce the safety or the effectiveness | | |

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Image /page/10/Picture/0 description: The image shows the Qualisys logo. The logo consists of the word "QUALISYS" in bold, black letters. Above the "I" in "QUALISYS" are four circles, the first one is red and the other three are gray. Below the word "QUALISYS" is the text "Motion Capture Systems" in a smaller, gray font.

| Max input power | Max 30W / camera.<br>To be scaled accordingly to<br>number of cameras used. | 950 W |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|-------|
| The max input power does not constitute a point of non-substantial equivalence between the SMART-D<br>System and the predicate devices, as it does not influence the intended use, the performance, the safety and<br>effectiveness of the system than the predicate devices | | |

### Tabell 5-3 Technical Characteristic Differences Discussion.

| Functionality<br>Characteristic | Qualisys Clinical System<br>K number: 171547<br>Summary: --- | SMART-D System<br>K number: 131660<br>Summary: (Att AD) |
|----------------------------------------------------------------------|--------------------------------------------------------------|-----------------------------------------------------------------------|
| Management of<br>acquired data<br>customizable<br>analysis protocols | Predefined analysis protocol | SMARTanalyzer: c) Tool for easy construction of<br>analysis protocols |

The QCS does not allow the user to change the analysis protocol. The reason for this is that the protocol is considered to be a crucial part of the software and the corresponding verification and validation of the software. The quality of its design is considered an integral part of the system. This does not influence the "Intended use", impose any risk or reduction on safety or on efficiency

#### Tabell 5-4 Functionality Characteristic Differences Discussion.

## Performance Data

Non-clinical tests performed on the QCS include software and hardware tests. All software tests passed successfully, demonstrating that the QCS meets all specified requirements. Hardware has been tested successfully for EMC compatibility (IEC-60601-1-2), and electrical safety has been assessed and found to comply with a relevant standard (ANSI AAMI ES60601-1), which is equal to the standard used by the predicate. Metrological accuracy and reliability of the raw output of the system (three-dimensional position of reflective markers) has been verified and validated, and the dimensions of the calibration devices supplied with the system are traceable to a national meter reference. Further, a Clinical Evaluation report has been provided, supporting the clinical relevance of gait assessments.

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Image /page/11/Picture/0 description: The image shows the Qualisys logo. The logo consists of the word "QUALISYS" in bold, black letters. Above the "I" in "QUALISYS" are four circles, the first one is red and the other three are gray. Below the word "QUALISYS" is the phrase "Motion Capture Systems" in a smaller, lighter font.

# Conclusion

Based on the comparison, discussion of identified differences and test results, it is concluded that the proposed device (Qualisys Clinical System) is substantially equivalent to its predicate (SMART-D[K131660]).