(433 days)
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.
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.
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.
Here's an analysis of the acceptance criteria and study information based on the provided document:
Acceptance Criteria and Device Performance
The document does not explicitly present a table of acceptance criteria with specific performance metrics (e.g., accuracy, precision) that the Qualisys Clinical System (QCS) must meet for regulatory purposes. Instead, the acceptance criteria are implicitly tied to demonstrating substantial equivalence to a predicate device (SMART-D [K131660]) through technical and functional comparisons, along with performance data from non-clinical tests.
The reported device performance is described generally through the successful completion of software and hardware tests, and demonstration of metrological accuracy and reliability.
Table 1: Implicit Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicit) | Reported Device Performance and Discussion |
|---|---|
| Pertaining to Substantial Equivalence: Technical Characteristics | |
| Identical CFR Section, Product Code, Regulation Number, and Classification Name to Predicate | Met: All are identical to the predicate (Table 5-1, items 1-4). |
| Equivalent Intended Use to Predicate | Met: The QCS and predicate perform the same tasks for motion analysis (Table 5-1, item 5). |
| Equivalent System Components to Predicate | Met: Both consist of Workstation + Software, Tracking Cameras (Table 5-1, item 6). |
| Software Tools enable similar functions (data acquisition, 3D marker tracking, 3D kinematics, reporting) | Met with discussion: QCS software modules (QTM, Qualisys Report, Clinical Gait PAF Module) combined with third-party software (Visual3D) perform similar functions to the predicate's software (SMARTcapture, SMARTtracker, SMARTanalyzer, SMARTclinic) (Table 5-1, item 7; Table 5-3). The differences in specific software names and whether analysis protocols are customizable are discussed as not impacting safety or effectiveness. |
| Equivalent Contraindications, Target Population, Light Emission, Modulation/External Sync, and Lens | Met: All are identical to the predicate (Table 5-1, items 8, 9, 12, 15, 16). |
| Frame rate appropriate for clinical gait analysis | Met with discussion: QCS operates at 100 fps. This is discussed as being appropriate and in line with scientific literature recommendations for clinical gait analysis, even though the predicate operates at 200 fps (Table 5-1, item 10; Table 5-3). |
| Acquisition Frequencies acceptable | Met with discussion: QCS records analog data faster (500-2000 Hz) than the predicate (250 Hz, up to 500 Hz). This improves time-resolution, not reducing safety or effectiveness (Table 5-1, item 11; Table 5-3). |
| Light wavelength comparable to predicate | Met with discussion: QCS (850 nm) and predicate (880 nm) have very similar IR wavelengths, behaving the same in terms of attenuation and scatter. Optimized for QCS cameras. No influence on intended use or safety/effectiveness (Table 5-1, item 13; Table 5-3). |
| Output Angle (FOV) sufficient for marker detection | Met with discussion: QCS has a wider FOV (61-42 degrees) than the predicate (40 degrees), which improves marker detectability, not reducing safety or effectiveness (Table 5-1, item 14; Table 5-3). |
| Number of Cameras supported | Met with discussion: QCS supports up to 100 cameras, more than the predicate's 16. This does not influence intended use or reduce safety/effectiveness (Table 5-1, item 17; Table 5-3). |
| Camera Resolution sufficient for precision | Met with discussion: QCS has higher resolutions (1216x800 - 4096x3072) than the predicate (800x600), improving precision of marker detection. Not influencing intended use or safety/effectiveness (Table 5-1, item 18; Table 5-3). |
| Reporting capability equivalent | Met: Both provide reporting functionalities (Table 5-1, item 21). |
| Physical characteristics (Weight, Dimension, Max input power) not impacting safety or effectiveness | Met with discussion: Differences in weight, dimension, and max input power are discussed as not influencing intended use or reducing safety/effectiveness (Table 5-1, items 22, 23, 25; Table 5-3). |
| Equivalent Power Supply and Electrical Safety/EMC standards compliance | Met: Equivalent power supply and compliance with relevant electrical safety and EMC standards (Table 5-1, items 26, 27, 28). |
| Pertaining to Substantial Equivalence: Functional Characteristics | |
| Real-time visualization of acquired data | Met: Both support real-time visualization (Table 5-2, item 1; Table 5-1, item 24). |
| 3D marker trajectory and kinematics reconstruction | Met: Both perform 3D marker trajectory evaluation and mapping to anatomical models using validated protocols (Table 5-2, item 2). |
| Management of acquired data (analysis protocols) | Met with discussion: QCS uses predefined analysis protocols, while the predicate allows user customization. This is discussed as not influencing intended use or reducing safety/efficiency, as the QCS protocol is a crucial, verified part of the software (Table 5-2, item 3; Table 5-4). |
| Report drafting and data visualization | Met: Both offer visualization tools and reporting (Table 5-2, item 4). |
| Performance Data | |
| Software meets specified requirements | Reported: "All software tests passed successfully, demonstrating that the QCS meets all specified requirements." (Page 10) |
| Hardware complies with EMC and electrical safety standards | Reported: Hardware tested successfully for EMC (IEC-60601-1-2) and electrical safety (ANSI AAMI ES60601-1) (Page 10). |
| Metrological accuracy and reliability of 3D position of reflective markers | Reported: Verified and validated. Calibration devices traceable to a national meter reference (Page 10). |
| Clinical relevance of gait assessments supported | Reported: A Clinical Evaluation report has been provided (Page 10). |
Study Information
The document describes non-clinical tests rather than a formal clinical study with human subjects for novel device performance claims. The primary "study" is a comparative analysis demonstrating substantial equivalence to a predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not explicitly stated as a number of patients/cases. The "test set" primarily refers to software and hardware testing.
- Data Provenance: Not specified for any dataset related to the performance data. It is focused on demonstrating substantial equivalence through technical and functional comparisons and non-clinical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not applicable. The ground truth for the non-clinical tests and metrological accuracy would be established by engineering standards, calibrated instruments, and scientific literature rather than expert human interpretation of medical data.
- Qualifications of Experts: N/A.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. This concept typically applies to studies where human readers are interpreting a test set and their discrepancies need to be resolved. The document focuses on technical verification and validation against specified requirements and predicate device characteristics.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The device is a motion capture system, not an AI-assisted diagnostic tool that aids human readers in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, the described "Non-clinical tests performed on the QCS include software and hardware tests" and "Metrological accuracy and reliability of the raw output of the system (three-dimensional position of reflective markers) has been verified and validated" indicate standalone performance evaluations of the system's components and overall output. The system quantifies and displays movement patterns.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth:
- For metrological accuracy, the ground truth is established by physical standards (e.g., "dimensions of the calibration devices supplied with the system are traceable to a national meter reference").
- For software and hardware functioning, the ground truth is against predefined technical specifications and requirements.
- For the relevance of gait assessments, it refers to a "Clinical Evaluation report," implying a review against established clinical understanding and literature on gait analysis.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. The document describes a medical device for motion capture, not a machine learning or artificial intelligence system that requires a "training set" in the conventional sense.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no mention of a training set for a machine learning model.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: +46 31 336 94 34 Fax: +46 31 336 94 20 Email: nils.betzler@qualisys.com
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 SystemK number: 171547Summary: --- | SMART-D SystemK number: 131660Summary: (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/movementrecording | System, opticalposition/movementrecording | Yes |
| 5 | Intended use | The Qualisys Clinical System is acamera and computer system usedto quantify and graphically displayhuman movement patterns foradults and children. It is intendedto be used for movement analysisin the fields of gait analysis,rehabilitation, sports medicine andergonomics. | SMART-D is a system formotion analysis, intendedfor the recording andanalysis of humanmovement patterns in thefields of rehabilitation,sports medicine,ergonomics. | Yes |
| 6 | System Components | Workstation + Software, TrackingCameras | Workstation + Software,Tracking Cameras | Yes |
| 7 | Software Tools | QCS Software modules (QTM,Qualisys Report, Clinical Gait PAFModule) combined with third party"off-the-shelf" software(Visual3D) to achieve:a) Data acquisitionb) 3-dimensional marker trackingc) 3D kinematics reconstruction byusing an international scientific andvalidated protocold) Real-time visualizatione) Creating MS Word or Webreports | SMARTcapture,SMARTtracker,SMARTanalyzer,SMARTclinic to achieve:a) Real-time visualization ofsignals of all integrateddevices,b) 3D kinematicsreconstruction validated byinternational scientificcommunity protocols,c) Tool for easyconstruction of analysisprotocols,d) Multimedia customizableand 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(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 /External Sync | Y | Y(Square wave synchronizedwith the acquisitionfrequency) | 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 TrajectoryReconstruction | Y (QTM) | Y (SMARTtracker) | Yes |
| 20 | CustomizableAnalysis 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 | 1408784 mm (camera) | 450330500 mm | No |
| 24 | Realtime visualization | Y | Y | Yes |
| 25 | Max input power | Max 30W / camera.To be scaled accordingly tonumber of cameras used. | 950 W | No |
| 26 | Power supply | 110 V, 60 Hz / 230 V, 50 HzDual power. | 110 V, 60 Hz | Yes |
| 27 | Electrical Safety | ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012,C1:2009/(R)2012 andA2:2010/(R)2012 | AAMI/ANSI ES60601-1:2005 and furtheramendments | 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
| FunctionalityCharacteristics | Qualisys Clinical SystemK number: 171547Summary: --- | SMART-D SystemK number: 131660Summary: (Att AD) | Eq. | |
|---|---|---|---|---|
| 1 | Calibration and Signalsacquisistion | Real-time visualization of allacquired data using Qualisys QTMand "Clinical Gait PAF Module" | SMARTcapture: a) Real-time visualization of signalsof all integrated devices | Yes |
| 2 | Trajectory reconstruction,signal elaboration | 3D marker trajectory evaluated bythe Qualisys QTM softwaremodule. Marker mapped to ananatomical human model by ascientific international validatedprotocol | SMARTtracker: b) 3Dkinematics reconstructionvalidated by internationalscientific communityprotocol | Yes |
| 3 | Management of acquireddata customizableanalysis protocols | Predefined analysis protocol | SMARTanalyzer: c) Toolfor easy construction ofanalysis 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.
| TechnicalCharacteristics | Qualisys Clinical SystemK number: 171547Summary: --- | SMART-D SystemK number: 131660]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:a) Data acquisitionb) 3-dimensional marker trackingc) Mapping marker movement to a body-model using a international scientific protocol.d) Creating MS Word or Web reports | SMARTcapture, SMARTtracker, SMARTanalyzer, SMARTclinic to achieve:a) Real-time visualization of signals of all integrated devices,b) 3D kinematics reconstruction validated by international scientific community protocols,c) Tool for easy construction of analysis protocols,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 • sales@qualisys.com • +46 31 336 94 00
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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.Stergiou, Nicholas (2004): Innovative Analyses of Human Movement. Champaign, IL: Human Kinetics. | ||
|---|---|---|
| AcquisitionFrequencies | 500-2000 Hz(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 practicalpoint of view, the IR-light from the two systems behave the same in terms of attenuation and scatter. Furtherthe QCS-cameras are optimized to work at this specific wavelength. There is no influence on Intended use orreduction 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 reflectivemarkers over a wider spatial region which in turn will improve marker detectability. There is no influenceon 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 thesafety 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 themarker detection and/or improve the detection distance from the camera compared to the predicate. Will notinfluence the "Intended use" or reduce the safety or effectiveness | ||
| CustomizableAnalysis 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 | 1408784 mm | |
| 450330500 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.To be scaled accordingly tonumber of cameras used. | 950 W |
|---|---|---|
| The max input power does not constitute a point of non-substantial equivalence between the SMART-DSystem and the predicate devices, as it does not influence the intended use, the performance, the safety andeffectiveness of the system than the predicate devices |
Tabell 5-3 Technical Characteristic Differences Discussion.
| FunctionalityCharacteristic | Qualisys Clinical SystemK number: 171547Summary: --- | SMART-D SystemK number: 131660Summary: (Att AD) |
|---|---|---|
| Management ofacquired datacustomizableanalysis protocols | Predefined analysis protocol | SMARTanalyzer: c) Tool for easy construction ofanalysis 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]).
§ 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.