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.

Device Description

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

AI/ML Overview

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.

Summary

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K/82425

PREMARKET NOTIFICATION 510(K) SUMMARY

1.	Submitters Name:	David L Mitchelson
2.	Address:	Charnwood Dynamics Limited17 South Street, Barrow Upon Soar,Leicestershire, LE12 8LY,United Kingdom
3.	Telephone No:Facsimile:	+44 (0) 1509 620 388+44 (0) 1509 416 791
4.	Date Prepared:	24th June 1998
5.	Trade Name:	CODA mpx30 Motion Analysis System
6.	Common Name:	Motion Analysis System
7.	Classification Name:	System / Optical Position / Movement Recording
8.	Identification of Predicate Device(s):
		OrthoTrak II (K 890076)

ರು. Device Description:

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

Intended use: 10.

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Technological characteristics in comparison with predicate device: l 1 .

The Coda mpx30 system is substantially equivalent to the Ortho Trak 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.

The Coda system provides the advantages of LED markers which are automatically identified, whereas the Ortho Trak system uses reflective markers which have no intrinsic identity.

12. Safety and Effectiveness Summary:

The Coda 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 mpx30 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 and sampling rate at which the data were acquired by the CODA mpx30 system were significantly improved. Also the speed with which the analysed data became available was improved due to the automatic recognition of marker identity. All other aspects of the system performance were similar to the predicate device.

13. 510 (K) Number: Not assigned at the time of submission.

14. Conclusion:

The CODA mpx30 system performs the same measurement functions using substantially similar technology as the predicate device.

The LED markers used provide for greater effectiveness in performance and the CODA mpx30 system meets all relevant safety standards. Consequently it is substantially equivalent to the predicate device.

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Image /page/2/Picture/2 description: The image shows a circular logo with text around the perimeter and a stylized eagle-like symbol in the center. The text around the perimeter appears to be part of a government agency or organization's name, possibly related to health and human services. The eagle-like symbol is abstract, with three curved lines forming the body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 7 1998

Mr. Lee A. Barnes President Pinsco, Inc. dba B & L Engineering 3002 Dow Avenue, Suite 416 Tustin, California 92780

K982425 Re: CODA mpx30 Motion Analysis System Trade Name: Requlatory Class: Unclassified Product Code: LXJ Dated: June 24, 1998 Received: July 13, 1998

Dear Mr. Barnes:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. ਚ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M

ria M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Fvaluation Center for Devices and Radiological Health

Enclosure

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STATEMENT OF INDICATIONS FOR USE

Over-the-Counter Use X

Signature

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K982425

Regulation Number and Section

§ 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.