(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.
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JAN - 6 2004
F
PREMARKET NOTIFICATION 510(K) SUMMARY
| 1. | Submitters Name: | David L Mitchelson |
|---|---|---|
| 2. | Address: | Charnwood Dynamics Limited |
| Victoria Mills | ||
| Fowke Street | ||
| Rothley | ||
| Leicestershire | ||
| LE7 7PJ | ||
| United Kingdom | ||
| 3. | Telephone No: | +44 (0) 116 230 1060 |
| Facsimile: | +44 (0) 116 230 1857 | |
| 4. | Date Prepared: | 31 st October 2003 |
| 5. | Trade Name: | Coda cx1 Motion Analysis System |
| 6. | Common Name: | Codamotion System |
| 7. | Classification Name: | System / Optical Position / Movement Recording |
| 8. | Identification of Predicate Device(s): |
CODA mpx30 (K982425)
ਹੈ. Device Description:
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.
Dimensions: 800mm long x 112mm high x 81mm deep
Weight: ર kg
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10. Intended use:
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.
11. Technological characteristics in comparison with predicate device.
The Coda cx1 system is substantially equivalent to the CODA mpx30 system as a means of measuring the general three dimensional movement of patients, including such activities as walking. Both systems provide a non-intrusive optical method of measuring the movements using infra-red light. Both systems acquire the movement data into a host PC which then analyses and displays the data on graphs and printed reports.
l 2. Safety and Effectiveness Summary:
The Coda cx1 system is designed and manufactured to meet the electrical safety requirements of EN 61010. There is no electrical connection to the patient of any kind. The system does not produce sources of localised heat so no thermal safety hazard arises. The system does not generate any ionising radiation.
The Coda cx1 system has been tested to EN60601-1-2:2002, the Medical electrical equipment - electromagnetic compatibility standard.
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. The resolution at which the data were acquired by the Coda cx1 system and the sampling duration were significantly improved. All other aspects of the system performance were similar to the predicate device.
- 510 (K) Number: Not assigned at the time of submission
14. Conclusion
The Coda cx1 system performs the same measurement functions using substantially similar technology as the predicate device and meets all relevant safety standards. Consequently it is substantially equivalent to the predicate device.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 6 2004
Mr. David L. Mitchelson Managing Director Charnwood Dynamics Ltd Unit 2, Victoria Mills Fowke Street Rothley, Leicestershire United Kingdom LE7 7PJ
Re: K033514
Trade/Device Name: Coda cx1 Motion Analysis System Regulatory Class: Unclassified Product Code: LXJ Dated: October 31, 2003 Received: November 6, 2003
Dear Mr. Mitchelson:
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). and Oosmetter fore, 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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 - Mr. David L. Mitchelson
This letter will allow you to begin marketing your device as described in your Section 510(k) rms letter natification. The FDA finding of substantial equivalcnce of your device to a legally premated predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, Connect the Office of Companise notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
R. Mark A. Milkenson
Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K033514
Device Name: Coda cx1 Motion Analysis System
Indications For Use:
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.
Prescription Use (Part 21 CFR 80) Subpart D) AND/OR
Over-The-Counter-Use
(21 CFR 807 Subpart C) ✓
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Mark A. Millerson
al. Restorative and Neurolo
510(k) Number: K033574
§ 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.