The CMAP Pro™ is a stand-alone, battery operated dynamic muscle function monitoring system, with a number of surface electromyography (sEMG) sensors connected to various parts of the subject's body for data collection. The data are then directly fed into a system for conditioning, acquiring, and transmitting sensor data. Analyzed signals include sEMG readings, motion detection, and muscle strength measurements. The system acquires continuous analog signals and then digitizes these signals by sampling at a rate of 2kHz. These data are then transferred wirelessly to an all-in-one PC for processing using software.. The system is capable of monitoring and video recording data from (SEMG) sensors connected to various muscle groups in the human body. During the acquisition of sEMG signals, the system will simultaneously acquire motion tracking of the body, isometric functional testing and pinch and grip strength measuring.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the CMAP Pro™ device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Accuracy of ROM sensors	Validated to capture data accurately.
Repeatability of ROM sensors	Validated to capture data repeatably.
Accuracy of FCE sensor	Validated to capture data accurately.
Repeatability of FCE sensor	Validated to capture data repeatably.
Accuracy of EMG leads	Validated to capture data accurately.
Repeatability of EMG leads	Validated to capture data repeatably.
Compliance with IEC 60601-2-40	Device complies with this standard.
Overall functionality compared to predicate device	Identical from a black box perspective; underlying technology enhancements are transparent to the user.
Safety comparison to predicate device	As safe as the predicate device.
Effectiveness comparison to predicate device	As effective as the predicate device.
Performance comparison to predicate device	Performs the same as the predicate device.

2. Sample Size for the Test Set and Data Provenance

The provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "validation tests were performed."

3. Number of Experts Used to Establish Ground Truth and Qualifications

The provided text does not specify the number or qualifications of experts used to establish ground truth for the test set.

4. Adjudication Method for the Test Set

The provided text does not specify any adjudication method used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The provided text does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it provide information on the effect size of human readers improving with AI vs. without AI assistance. The CMAP Pro™ is described as a diagnostic device, not one that directly assists human readers in interpreting images or data in an "AI-assisted" context. Its comparisons are against a previous version of the company's own device.

6. Standalone Performance Study (Algorithm Only)

Yes, a standalone performance evaluation was conducted for the device's components. The document states:

"validation tests were performed to validate the accuracy and repeatability of the range of motion (ROM) sensors, the FCE sensor, and the EMG leads."
"It was shown through the validation tests that the ROM sensors, FCE sensor, and EMG test leads captured data accurately and repeatably."

This indicates that the device's ability to accurately and repeatably acquire data was tested independently of a human operator making interpretations. The "algorithm only" aspect would refer to the device's internal processing and measurement capabilities.

7. Type of Ground Truth Used

The ground truth used for performance testing was likely:

Reference measurements/standards for accuracy and repeatability: For the ROM, FCE, and EMG leads, the validation would have involved comparing the device's measurements against established, more precise, or gold-standard methods or known physical properties to determine accuracy and consistency (repeatability).

The text doesn't specifically use terms like "expert consensus" or "pathology," but rather implies instrumental validation against known benchmarks or highly accurate measurement techniques.

8. Sample Size for the Training Set

The provided text does not specify the sample size for any training set. Given that this is a 510(k) for a hardware-based diagnostic electromyograph, and not an AI/machine learning algorithm, the concept of a "training set" in the context of machine learning is unlikely to apply in the same way. The device's functionality is based on direct signal acquisition and processing, not learning from a dataset.

9. How the Ground Truth for the Training Set Was Established

As noted above, the concept of a "training set" as typically understood in machine learning is not explicitly applicable or mentioned for this device. Therefore, the method for establishing ground truth for a training set is not provided. The validation focused on the intrinsic performance of the sensors and data acquisition.

Summary

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Image /page/0/Picture/1 description: The image contains a logo for Med-Tek Medical Technologies Unlimited. The logo consists of a circular graphic on the left and the text "MED-TEK" in bold, uppercase letters to the right. Below "MED-TEK" is the text "MEDICAL TECHNOLOGIES UNLIMITED" in a smaller font size.

FEB - 2 2012

510(k) Summary for K113074

Medical Technologies Unlimited, Inc. (MED-TEK)

Comprehensive Muscular Activity Profiler Pro (CMAP Pro™)

1. Submitter Information

Submitter's Name and Address:

Medical Technologies Unlimited, Inc. (Med-Tek) 2665 S. Bayshore Drive #502 Coconut Grove, FL 33133

Submitter's Telephone and fax numbers:

Phone: 866-930-2627 Fax: 866-980-2627

Contact Person:

Marco Vitiello, M.D. Medical Director Medical Technologies Unlimited, Inc. (Med-Tek) 2665 S. Bayshore Drive #502 Coconut Grove, FL 33133

Date this 510(k) summary was prepared: January 9, 2012.

2. General Device Information

Comprehensive Muscular Activity Profiler Pro (CMAP Pro TM) Trade Name of Device: Diagnostic Electromyograph ( 21 CFR 890.1375) Classification Name:

Predicate Device: Medical Technologies Unlimited Comprehensive Neuromuscular Profiler (CNMP)

Predicate Device 510(k) number K031995

3. Device Description:

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connected to various muscle groups in the human body. During the acquisition of sEMG signals, the system will simultaneously acquire motion tracking of the body, isometric functional testing and pinch and grip strength measuring.

Image /page/1/Figure/2 description: The image shows a diagram of a process flow. The process starts with a subject, then goes to sensors, then to signal conditioning, and finally to PC processing. Each step is represented by a square box with text inside, and the steps are connected by arrows.

4. Intended Use of Device:

The CMAP Pro is indicated for surface electromyography with video recording, range of motion tracking, isometric functional testing and pinch and grip strength measuring.

5. Comparison to Predicate Device:

The CMAP Pro and the predicate systems, our CNMP, both use a range of motion device in combination with functional capacity evaluation devices and surface EMG electrodes to obtain similar data. Instead of the electromagnetic field-based range-of-motion unit of the predicate device, the CMAP Pro uses gyroscopic sensors to detect motion. Instead of the 3 off-the-shelf functional capacity evaluation devices of the predicate system, the CMAP Pro uses a Med-Tek proprietary, integrated functional capacity evaluation (FCE) sensor. Both devices utilize surface EMG electrodes. The signal conditioning in the CMAP Pro takes place in two stages, one outside the POD and close to the sEMG sensor leads and the other inside the POD itself. In the predicate device, all signal conditioning took place inside the main unit. The CMAP Pro POD is smaller and thinner than the predicate, and it is battery powered rather than AC powered. The CMAP Pro transmits all data wirelessly via an ad hoc wireless network while the predicate device transmits data via USB 2.0.

6. Performance Testing:

The CMAP Pro complies with IEC 60601-2-40 and all applicable performance tests in that standard. Additionally, validation tests were performed to validate the accuracy and repeatability of the range of motion (ROM) sensors, the FCE sensor, and the EMG leads. It was shown through the validation tests that the ROM sensors, FCE sensor, and EMG test leads captured data accurately and repeatably.

In conclusion, the functionality of the new device is identical to the predicate device from a black box perspective. The underlying technology enhancements used to collect data using the range of motion (ROM) sensors, the FCE sensor, and the EMG leads are transparent to the user in terms of device functionality. Therefore the device is as safe, as effective, and performs the same as our predicate device and is therefore substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Medical Technologies Unlimited, Inc. % Underwriters Laboratories, Inc. Mr. Casey Conry 1285 Walt Whitman Road Melville, New York 11747

FEB -2 2012

Re: K113074

Trade/Device Name: CMAP Pro Regulation Number: 21 CFR 890.1375 Regulation Name: Diagnostic electromyograph Regulatory Class: II Product Code: IKN Dated: January 17, 2012 Received: January 18, 2012

Dear Mr. Conry:

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). You may, therefore, 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. Casey Conry

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Indications for Use Section 3:

KII 3074 510(k) Number (if known):

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

Surface electromyography with video recording, range of motion tracking, isometric functional testing and pinch and grip strength measuring.

Prescription Use xi (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) .

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

(Division Sign of Surgical, Ofthopedic, and Restorative Devices

510(k) Number K113074

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3.1

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Regulation Number and Section

§ 890.1375 Diagnostic electromyograph.

(a)
Identification. A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.(b)
Classification. Class II (performance standards).