(315 days)
SMART-D is a system for motion analysis, intended for the recording and analysis of human movement patterns in the fields of rehabilitation, sports medicine, ergonomics.
SMART-D is a motion capture and analysis system. It is based on optoelectronic technology and uses passive reflective markers, infrared cameras and strobes.
SMART-D executes the three-dimensional reconstruction of trajectories of a certain number of small reflective markers on the body to be analyzed.
Using a set of cameras placed all around the volume where the action is performed, the system acquires the movement of the subject; cameras position is computed after a calibration step.
Here's a breakdown of the acceptance criteria and the study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative (numerical) acceptance criteria for device performance such as accuracy, precision, or sensitivity/specificity. Instead, the acceptance criteria are described qualitatively as meeting "appropriate device specification or expected operation results" and performing "as the predicate devices."
The reported device performance is also presented qualitatively, focusing on the system's functionalities being equivalent to the predicate devices.
| Acceptance Criteria (Qualitative) | Reported Device Performance and Compliance |
|---|---|
| Meets appropriate device specification or expected operation results | All acceptance criteria were met in testing. |
| Is as effective and performs as the predicate devices | The SMART-D System is as effective and performs as the predicate devices. |
| Compliance with Electrical Safety Standards (AAMI/ANSI ES60601-1:2005) | The SMART-D System complies with AAMI/ANSI ES60601-1:2005 and amendments. |
| Compliance with EMC Standards (IEC 60601-1-2) | The SMART-D System complies with IEC 60601-1-2. |
| Functional equivalence to predicate devices for: | |
| * Calibration and Signals acquisition | SMARTcapture: Real-time visualization of signals of all integrated devices. (Equivalent to predicate functionalities) |
| * Trajectory reconstruction, signal elaboration | SMARTtracker: 3D kinematics reconstruction, validated by international scientific community protocols. (Equivalent to predicate functionalities) |
| * Management of acquired data, customizable analysis protocols | SMARTanalyzer: Tool for easy construction of analysis protocols. (Equivalent to predicate functionalities) |
| * Report drafting, data visualization | SMARTclinic: Multimedia customizable and web reporting. (Equivalent to predicate functionalities) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a numerical sample size for the test set used in performance evaluations. It refers to "non-clinical tests performed on the SMART-D System" and concludes that "all performance requirements defined by the System Requirement Specifications" were met.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given that it's a 510(k) submission for a device manufactured in Italy (BTS SPA, Via della Croce Rossa 11, PD Italy 35129), it's plausible that testing occurred in Italy or internationally. The term "non-clinical tests" implies bench testing and verification, rather than clinical trials with patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- The document does not mention the use of experts to establish a "ground truth" for a test set in the traditional sense (e.g., radiologists interpreting images). The device is a motion capture system, and the ground truth would likely refer to the accuracy of its measurements against known physical standards or highly precise reference systems.
- The document states that "3D kinematics reconstruction" is "Validated by international scientific community protocols." This suggests that the accuracy of the reconstruction is evaluated against established scientific methods rather than expert consensus on a specific dataset.
4. Adjudication Method for the Test Set
- No adjudication method (e.g., 2+1, 3+1) is mentioned, as the study does not involve human interpretation or subjective assessments that would require such a process. The performance evaluation is based on objective technical specifications and comparisons to predicate devices.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No MRMC comparative effectiveness study was done. The device is a motion capture system, not an imaging diagnostic tool that would typically involve human readers interpreting cases.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Yes, the performance data presented appears to be a standalone evaluation of the device. The "non-clinical tests" and the verification of functionalities (SMARTcapture, SMARTtracker, SMARTanalyzer, SMARTclinic) demonstrate the system's performance independent of human intervention in the motion capture and analysis process itself. The system is designed to objectively record and analyze movement.
7. The Type of Ground Truth Used
- The document implies that the ground truth for performance validation is based on "international scientific community protocols" for 3D kinematics reconstruction. This typically involves comparing the device's measurements against:
- Known physical standards: e.g., the movement of objects with precisely known dimensions or trajectories.
- Highly accurate reference systems: comparing the SMART-D's output to that of a more established or higher-precision motion capture system.
- Mathematical/Physical models: ensuring the reconstructed movements align with validated biomechanical principles.
No specific mention of pathology or outcomes data as ground truth is made.
8. The Sample Size for the Training Set
- The document does not mention a "training set" or "sample size for the training set." This is consistent with the nature of the device as a motion capture system. Such systems are typically calibrated using known physical configurations and their performance is then validated, rather than being "trained" on a dataset in the way a machine learning algorithm would be.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as no training set is mentioned for this type of device and evaluation. The system likely uses internal calibration routines and established mathematical models for its operation rather than a machine learning training paradigm.
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510(k) NOTIFICATION
APR 1 7 2014
1 Summary of safety and effectiveness
| Company Name: | BTS SPA |
|---|---|
| Company Address: | Via della Croce Rossa 11, PD Italy 35129 |
| Company Phone: | +39 049 981 5520 |
| Company Fax: | +39 049 792 9260 |
| Contact Person: | Mr. Enrico Bisson |
|---|---|
| Title: | Quality and Regulatory Affairs Consultant |
| Email: | enrico.bisson@isoplan.org |
| Company Phone: | +39 049 981 5520 |
| Company Fax: | +39 049 792 9260 |
April 17th 2014
Date Summary Prepared:
Device Identification
| A. | Generic Device Name: | System, optical position/movement recording |
|---|---|---|
| B. | Trade/Proprietary Name: | SMART-D |
| C. | Classification: | Unclassified |
| D. | Product Code: | LXJ |
Device description
SMART-D is a motion capture and analysis system. It is based on optoelectronic technology and uses passive reflective markers, infrared cameras and strobes.
SMART-D executes the three-dimensional reconstruction of trajectories of a certain number of small reflective markers on the body to be analyzed.
Using a set of cameras placed all around the volume where the action is performed, the system acquires the movement of the subject; cameras position is computed after a calibration step.
Intended Use
SMART-D is a system for motion analysis, intended for the recording and analysis of human movement patterns in the fields of rehabilitation, sports medicine, ergonomics.
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510(k) NOTIFICATION
BTS Spa
Substantial equivalents
The SMART-D device is of comparable type and is substantially equivalent to the following predicate devices:
| Predicate Device | 510(K) Holder | 510(k) No. | Date Cleared |
|---|---|---|---|
| PEAK MOTUS | PEAK PERFORMANCETECHNOLOGIES, INC | K030714 | 16 May 2003 |
| CODA CX1 MOTIONANALYSIS SYSTEM | CHARNWOOD DYNAMICSLTD. | K033514 | 6 Jan 2004 |
In further support of a substantial equivalence determination, Section 12 provides a comparison chart of SMART-D and the predicate devices.
Technological characteristics
A comparison of the technological characteristics of SMART-D and the predicate devices has been performed. The results of this comparison demonstrate that the system for motion analysis SMART-D is equivalent to the marketed predicate devices.
The two tables below show the comparison of technical characteristics of SMART-D system compared to the characteristics of predicate devices:
- Table 1 contains the summary of the technical characteristics which are the same for both devices; ー
- Table 2 contains the summary of the different technical characteristics and provides an explanation of how they are comparable to the predicate device.
| Table 1 - Same Technical Characteristics | |||
|---|---|---|---|
| Characteristics | SMART-D System | PEAK MOTUS | CODA CX1 MOTIONANALYSIS SYSTEM |
| CFR Section | Unclassified | Unclassified | Unclassified |
| Pro-code | LXJ | LXJ | LXJ |
| Classification name | System, optical position/movementrecording | System, optical position/movementrecording | System, optical position/movementrecording |
| Intended / IndicationsFor Use | SMART-D is a system formotion analysis,intended for therecording and analysis ofhuman movementpatterns in the fields ofrehabilitation, sportsmedicine, ergonomics. | Computer and videosystem used to quantifyand graphically displayhuman movementpatterns and techniquesfor uses such asassessment and trainingof limb or body motionin gait analysis,prosthetic design,pre/post rehabilitationevaluation, physicaltherapy, and the like. | The Coda CX I MotionAnalysis System hasgeneral application tomeasurement andrecording of 3D positionand movement,including humanmovement. It isappropriate for use inassessment of the 3Dmotion of the limbs andbody of patients whohave some impairment |
| of movement functionsof either a neurologicalor orthopaedic cause. | |||
| System Components | Workstation + Cameras+ Software | Workstation + Cameras+ Software | Workstation + Cameras+ Software |
| Software tools | SMARTcapture,SMARTtracker,SMARTanalyzer,SMARTclinic to achieve:a) Real-timevisualization of signals ofall integrated devices'b) 3D kinematicsreconstructionValidated byinternational scientificcommunity protocolsc) Tool for easyconstruction of analysisprotocolsd) Multimediacustomizable and webreporting | Vicon Motusa) Advanced video or3D-optical-motion-capture moduleb) 2D and/or 3Dkinematic calculation anddisplay softwareAnalog acquisitionmodulec) 3D pan and tiltmoduleKineCalc mathematicalanalysis moduled) Peak Motus GaitAnalysis Template | a) Realtime displays toverify marker locationFully labelled dataappears immediatelyafter acquisition fromCodamotion activemarker systemb) Switch betweendifferent projects insecondsOptions for simultaneousEMG and Force VectorOverlayFull standardised gaitanalysis packageavailablec) Graphs and stickfigure displaysHighly configurableanalysis setups |
| Contraindications | Not needed | Not needed | Not needed |
| Target population | All population | All population | All population |
| Electrical Safety | AAMI/ANSI ES60601-1:2005 and furtheramendments | SAME | SAME |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 |
| Power Supply | 110 V, 60 Hz | 110 V, 60 Hz | 110 V, 60 Hz |
| Frame rate | 200 fps | VCam/SV Cam200 fps | Not available |
| AcquisitionFrequencies | 250 Hz (up to 500 Hz) | up to 250 Hz progressiveup to 500 Hz progressiveup to 1000 Hzprogressive | Sampling Rates vs.Marker Numbers100Hz for 56 markers400Hz for 12 markers |
| Light emission | Infrared | Infrared | Not available |
| Characteristics | SMART-D System | PEAK MOTUS | CODA CX1 MOTION ANALYSIS SYSTEM |
| Max Input power | 950 W | 15-20 W for single unit | Not available |
| Number of cameras | Up to 16 digital TVC | up to 12 cameras on one PC | Up to 16 digital inputs |
| Resolution (pixel) | 800 H x 600 V | MCam-2 59.94: 1272 H x 1024 VMCam-2 100: 1266 H x 1024 VMCam-2 119.88: 1266 H x 940 VMCam-2 250: 816 H x 656 VMCam-2 500: 498 H x 480 VMCam-2 1000: 498 H x 210 VVCam/SV Cam : 648 H x 493 VMCam (PAL): 1011 H x 1024 V1000 H x 972 VMCam (NTSC): 1012 H x 987 V947 H x 881 VAll Vicon MX cameras are built for speed at their full frame resolutions - 370fps for the 4 Megapixel F40, 240fps for the MX-3+ and a massive 500fps for the 2 Megapixel F20. On top of this all | 1/10th of pixel in a 5 Megapixel camera |
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Section5 Rev 4
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| run at speeds up to2000fps at reduced,windowed resolutionsparticularly highi for a |
|---|
| speed applications |
The Resolution (pixels) does not bring a point of non-substantial equivalence between the SMART-D System and the predicate devices, as it does not influence the intended use, the performance, the safety and effectiveness of the system than the predicate devices.
The only effect that this characteristic produces is a better or worse capability to detect the markers in the space and displaying them on the video.
| Acquisition Frequencies | 250 Hz (up to 500 Hz) | up to progressive | 120Hz | Sampling Rates vs. Marker Numbers |
|---|---|---|---|---|
| up to progressive | 250 Hz | 100Hz for 56 markers | ||
| up to progressive | 500 Hz | 200Hz for 28 markers | ||
| up to progressive | 1000 Hz | 400Hz for 12 markers | ||
| 800 Hz for 6 markers |
The Acquisition frequency does not bring a point of non-substantial equivalence between the SMART-D System and the predicate devices, as it does not influence the intended use, the performance, the safety and effectiveness of the system than the predicate devices.
The only effect that this characteristic produces is a different quantity of data in the time (frames in the time) to reconstruct the trajectory of the markers in the space.
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|---|---|---|---|
The weight of workstation does not bring a point of non-substantial equivalence between the SMART-D System and the predicate devices, as it does not influence the intended use, the performance, the safety and effectiveness of the system than the predicate devices.
The three devices are not portable, so the weight does not influence their use and application.
| Dimensions | 450mm long x 330mmhigh x 500 mm deep | 443.4 mm long x43.6mm high x348.2mm deep | 800mm long x 112mmhigh x 81mm deep |
|---|---|---|---|
| ------------ | ------------------------------------------ | -------------------------------------------------- | ---------------------------------------- |
The Dimensions of workstation do not bring a point of non-substantial equivalence between the SMART-D System and the predicate devices, as it does not influence the intended use, the performance, the safety and effectiveness of the system than the predicate devices.
The three devices are not portable, so the dimensions do not influence their use and application. Moreover the difference of dimensions between the three workstations is negligible respect to the environment in which they have to be placed.
| SensorTechnicalCharacteristics | Wavelength: | 880 nm | Not available | Not available |
|---|---|---|---|---|
| Outputangle | 40° | Not available | Not available | |
| Modulation | Squarewavesynchronized with theacquisition frequency,Duty Cycle 0+0.5 ms | Not available | Not available | |
| Lens | C-mount compatible(std. 8 mm) | Not available | Not available |
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The Lenses and Sensor technical characteristics do not bring a point of non-substantial equivalence between the SMART-D System and the predicate devices, as they do not influence the intended use, the performance, the safety and effectiveness of the system than the predicate devices.
The difference brouqht by those differences is in the quality of the image provided to the system.
| Options | None | SAME | Tripod Mount for cx1units |
|---|---|---|---|
| Gait Wand Set | |||
| Wired Strobe Adapterunit and Drive BoxExtension Cable | |||
| External Strobe Panelfor Active Hub or MiniHub |
The options do not bring a point of non-substantial equivalence between the SMART-D System and the predicate devices, as they do not influence the intended use, the safety and effectiveness of the system than the predicate devices.
Options are optional configurations or accessories to the main system which are not needed for its normal functioning and do not influence it.
Performance Data
The performance data indicate that the system for motion analysis SMART-D meets all specified requirements, and is substantially equivalent to the predicate device.
Conclusions
The non-clinical tests performed on the SMART-D System provided in Appendix 4, demonstrate that the SMART-D System is as effective and performs as the predicate devices. The acceptance criteria for each test item included the appropriate device specification or expected operation results. All acceptance criteria were met in the testing and the overall performance bench testing concluded that the SMART-D system had passed all the performance requirements defined by the System Requirement Specifications (provided in Appendix 2). The effectiveness and performance of the system are tested through the subtest: SMART capture, SMART tracker, SMART analyser, SMART clinic, which verify the same functionalities of the predicate devices as described in the comparison below:
| Functionality | SMART-D System | PEAK MOTUS | CODA CX1 MOTIONANALYSIS SYSTEM |
|---|---|---|---|
| Calibration and Signalsacquisition | SMARTcapture: a) Real-time visualization ofsignals of all integrateddevices | Vicon Motusa) Advanced video or3D-optical-motion-capture moduleAnalog acquisitionmodule | a) Realtime displays toverify marker locationFully labelled dataappears immediatelyafter acquisition fromCodamotion activemarker system |
| Trajectoryreconstruction, signal | SMARTtracker: b) 3D | b) 2D and/or 3D | b) Switch between |
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510(k) NOTIFICATION
| elaboration | kinematicsreconstructionValidated byinternational scientificcommunity protocols | kinematic calculation anddisplay software | different projects insecondsOptions for simultaneousEMG and Force VectorOverlayFull standardised gaitanalysis packageavailable |
|---|---|---|---|
| Management ofacquired data,customizable analysisprotocols | SMARTanalyzer: c) Toolfor easy construction ofanalysis protocols | c) 3D pan and tiltmoduleKineCalc mathematicalanalysis module | c) Graphs and stickfigure displaysHighly configurableanalysis setups |
| Report drafting, datavisualization | SMARTclinic: d)Multimedia customizableand web reporting | d) Peak Motus GaitAnalysis Template |
The EMC and Electrical Safety Tests performed on the SMART-D System and the predicate devices are the same and demonstrate that the SMART-D System complies with the AAMI/ANSI ES60601-1:2005 and further amendments and IEC 60601-1-2, and that it is as safe, as effective and performs as well as the predicate devices.
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Image /page/7/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three wavy lines representing the department's commitment to health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002
April 17, 2014
BTS Spa c/o Enrico Bisson ISO plan Via Della Croce Rossa. I I Padova, Italy. 35129
Re: K131660 Trade/Device Name: SMART-D Regulatory Class: Unclassified Product Code: 1_XJ Dated: March 12, 2014 Received: March 18, 2014
Dear Mr. Bisson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA 's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act s requirements. including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Enrico Bisson
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Felipe Aguel -S
Carlos L. Peña, Ph.D., M.S. for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known)
Device Name
SMART-D
Indications for Use (Describe)
SMART-D is a system for motion analysis, intended for the recording and analysis of human movement in the fields of rehabilitation, sports medicine, ergonomics.
Type of Use (Select one or both, as applicable)
[x] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)
Date: 2014.04.17 13:35:53 -04'00'
FORM FDA 3881 (1/14)
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§ 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.