(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.
§ 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.