(61 days)
The Coda cx1 Motion Analysis System has general application to measurement and recording of 3D position and movement, including human movement. It is appropriate for use in assessment of the 3D motion of the limbs and body of patients who have some impairment of movement functions of either a neurological or orthopaedic cause.
Coda cx1 is an optical/electronic system which measures and analyses the 3D position and movement of markers placed on the limbs of patients whose movement function is to be assessed.
Here's a summary of the acceptance criteria and study information for the Coda cx1 Motion Analysis System, based on the provided document:
1. Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative "acceptance criteria" in a typical numerical format. Instead, it frames the acceptance criteria implicitly through a comparison to a predicate device and adherence to safety standards. The core criterion is "substantial equivalence" to the predicate device in terms of measurement functions and technology, along with meeting relevant safety and effectiveness standards.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Safety: | |
| Electrical safety requirements (EN 61010) | Met: System designed and manufactured to meet EN 61010. |
| No electrical connection to the patient | Met: There is no electrical connection to the patient of any kind. |
| No localized heat sources (thermal safety) | Met: System does not produce sources of localized heat, so no thermal safety hazard arises. |
| No ionizing radiation generation | Met: System does not generate any ionizing radiation. |
| Electromagnetic compatibility (EN60601-1-2:2002) | Met: System tested to EN60601-1-2:2002. |
| Effectiveness (Substantial Equivalence to Predicate Device - CODA mpx30 K982425): | |
| Measures and analyzes 3D position and movement of markers placed on limbs for assessing movement function (general application). | Met: The Coda cx1 system has general application to measurement and recording of 3D position and movement, including human movement. It is appropriate for use in assessment of the 3D motion of the limbs and body of patients who have some impairment of movement functions of either a neurological or orthopaedic cause. It performs the same measurement functions using substantially similar technology. |
| Non-intrusive optical method using infra-red light to acquire movement data. | Met: Both systems (Coda cx1 and predicate) provide a non-intrusive optical method of measuring movements using infra-red light. |
| Acquires movement data into a host PC for analysis and display (graphs/reports). | Met: Both systems acquire movement data into a host PC which then analyzes and displays the data on graphs and printed reports. |
| Performance similar to predicate device in measuring 3D motion and producing gait/movement data. | Met: The Coda cx1 system has been tested for its effectiveness in measuring 3-D motion and producing graphical and mechanical data on gait and other movements as compared with the predicate device. All other aspects of the system performance were similar to the predicate device. (Note: Resolution and sampling duration were improved with Coda cx1, indicating it met or exceeded the predicate's performance in these areas). |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state a specific "test set" sample size or data provenance (e.g., country of origin, retrospective/prospective). The effectiveness claim is based on a comparative test against the predicate device, but the details of this test (how many subjects, what specific movements, etc.) are not provided. The phrase "the data were acquired by the Coda cx1 system and the sampling duration were significantly improved" suggests data was collected by the device.
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. The comparison is made against the predicate device's performance, implying the predicate device itself served as the reference for effectiveness.
4. Adjudication Method for the Test Set:
No information is provided regarding any adjudication method (e.g., 2+1, 3+1, none) for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No mention of an MRMC comparative effectiveness study is made. The device appears to be a motion analysis system, which typically provides objective data, rather than requiring human interpretation in the way imaging devices often do. Therefore, a study involving human readers' improvement with AI assistance would not be directly applicable to this type of device.
6. Standalone (Algorithm Only) Performance Study:
Yes, a standalone performance assessment was done. The document states: "The Coda cx1 system has been tested for its effectiveness in measuring 3-D motion and producing graphical and mechanical data on gait and other movements as compared with the predicate device." This indicates the device's inherent capability to perform its function (measure and produce data) was evaluated without human intervention in the measurement process itself.
7. Type of Ground Truth Used:
The "ground truth" for the effectiveness study was the performance of the predicate device (CODA mpx30). The Coda cx1 system's measurements and data were compared against those generated by the mpx30.
8. Sample Size for the Training Set:
The document does not mention a "training set" or any details related to machine learning or AI development that would necessitate a training set. This device is an optical/electronic system for measuring physical movement, not an AI-driven image analysis or diagnostic tool.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a training set, there is no information on how its ground truth would have been established.
§ 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.