(86 days)
The Coda mpx30 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 mpx30 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.
Dimensions: 30mm wide x 114mm high x 250mm deep Weight : 11 kg
Here's a breakdown of the acceptance criteria and study information for the CODA mpx30 Motion Analysis System based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Device | The CODA mpx30 system performs the same measurement functions using substantially similar technology as the OrthoTrak II predicate device, including general three-dimensional movement measurement (e.g., walking) and acquiring movement data into a host PC for analysis and display. |
| Improved Resolution and Sampling Rate | The resolution and sampling rate for data acquisition by the CODA mpx30 system were significantly improved compared to the predicate device. |
| Improved Data Analysis Speed | The speed with which analyzed data became available was improved due to the automatic recognition of marker identity (feature not present in predicate). |
| Electrical Safety Compliance | Designed and manufactured to meet the electrical safety requirements of EN 61010. |
| Thermal Safety | Does not produce sources of localized heat, so no thermal safety hazard arises. |
| Radiation Safety | Does not generate any ionizing radiation. |
| Overall Performance (Other Aspects) | "All other aspects of the system performance were similar to the predicate device." (This implies a baseline of acceptable performance established by the predicate device). |
| Enhanced Effectiveness (due to LED markers) | The LED markers used provide for greater effectiveness in performance (due to automatic identification), contributing to improved analysis speed. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state a sample size for the test set used to compare the CODA mpx30 with the predicate device. It refers to "effectiveness in measuring 3-D motion and producing graphical and mechanical data on gait and other movements" but doesn't quantify the number of movements, patients, or trials.
- Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document. The study primarily relies on a technical comparison to a predicate device rather than a clinical ground truth established by experts.
4. Adjudication Method for the Test Set
- An adjudication method is not mentioned in the document. Given the nature of the technical comparison, it's unlikely a human-based adjudication method (like 2+1 or 3+1) was used.
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
- No, an MRMC comparative effectiveness study was not done. This device is a motion analysis system, not an AI-assisted diagnostic tool for human readers. The comparison is between the performance of the CODA mpx30 system itself and a predicate device, focusing on technical specifications and functional equivalence.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, a standalone performance assessment was effectively done. The "effectiveness in measuring 3-D motion and producing graphical and mechanical data" was directly attributed to the CODA mpx30 system itself, comparing its capabilities to the predicate device. This is inherently a standalone assessment of the device's technical measurement capabilities.
7. The Type of Ground Truth Used
- The ground truth in this submission is implicitly the established and accepted performance of the predicate device (OrthoTrak II). The CODA mpx30's performance was compared against the predicate device's capabilities and improved upon in specific areas (resolution, sampling rate, analysis speed due to marker identification). It's a technical and functional equivalence comparison rather than a comparison to a clinical "ground truth" like pathology or outcomes data.
8. The Sample Size for the Training Set
- The document does not mention a training set as this device does not appear to use machine learning or AI algorithms that require a separate training phase. The comparison is based on the inherent design and technical performance of the device.
9. How the Ground Truth for the Training Set was Established
- Since there is no mention of a training set, the establishment of ground truth for a training set is not applicable to this submission.
§ 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.