The Intended Use Section is identical to the original device PMRU (K022719) To provide non-invasive muscle testing integrating with range of motion, functional capacity of lifting, pulling, pushing, pinching and gripping. To pinpoint muscle activity during movement objectively isolating abnormal movements with abnormal muscle patterns. To establish relative functioning of muscle in any specific anomaly that may occur due to muscle damage, muscle fatigue, hypertonicity or stress. To pinpoint referred pain pattern associated with cervical, thoracic, lumbosacral upper and lower extremities, and refer pain sources. To evaluate a baseline muscle activity for preemployment screening, sport medicine. To look at chronic vs. acute muscle function and range of motion to ascertain good effort with FCE, range of motion, and gripping, and pinch. To ascertain the ischemic activity of muscles. To ascertain chronic damage to muscles. To monitor the frequency range for cardiac muscle.

Device Description

The Physical Monitoring Registration Unit-S, (PMRU-S) like the legally cleared PMRU combines surface EMG with functional capacity sensors range of motion, grip and pinch strength sensors. This integration allows for a reproducible, objective interpretation of muscle function and effort via the range of motion, fce, pinch and grip. All muscle groups of the body from cervical (to mid back, low back and extremities can be monitored with the device). Bilateral muscle testing is done to compare antagonist muscle groups. The devices monitors bilateral muscle activity with the force produced by the patient while he or she pulls on the strain gauge, with the range of motion. is to provide non-invasive muscle testing integrating with range of motion, functional capacity of lifting, pulling, pushing, pinching and gripping. To measure surface emg along the spine, extremities or cervical region. To measure the EMG with functional tasks, to measure the EMG with range of motion, to measure the EMG with pinch and or grip. This this is identical to the already cleared PMRU.

AI/ML Overview

Here's an analysis of the provided text regarding the PMRU-S device, focusing on acceptance criteria and supporting studies:

It's important to note that the provided document is a 510(k) Summary for substantial equivalence, not a detailed clinical study report. Therefore, some information, particularly regarding specific performance metrics and detailed study methodologies, might be summarized or omitted in comparison to a full scientific publication.

Acceptance Criteria and Device Performance

The document doesn't explicitly state quantitative acceptance criteria or a specific study designed to prove the device meets these criteria in a broad sense. Instead, it focuses on demonstrating substantial equivalence to a predicate device (PMRU K022719). The primary "acceptance criteria" presented are implied through this comparison, meaning the PMRU-S must perform at least as well as the predicate device in its fundamental functions.

The validation testing described focuses on accuracy and repeatability of individual sensor components.

Implied Acceptance Criteria and Reported Device Performance (Based on Substantial Equivalence and Validation Testing)

Acceptance Criteria (Implied)	Reported Device Performance
Functional Equivalence: Same intended use as predicate (PMRU).	"PMRU-S has the same intended use as the predicate"
Technological Equivalence: Same fundamental technological characteristics as predicate (PMRU) for core functionalities (EMG, strain gauge, grip, pinch sensors).	"The PMRU-S uses all the same technological characteristics, it uses the same strain gage, grip, pinch and EMG sensors." Differences are: data transmission (Bluetooth vs. USB/PCMCI), power source (battery vs. 110V AC), and DAQ location (in each sensor vs. main circuit board). These changes are asserted not to alter fundamental scientific technology or safety/efficacy.
EMG Sensor Accuracy and Repeatability	"It was show [shown] through validation using... Signal Generator for EMG Sensors. It was shown through this validation testing that all sensors captured data accurately and repeatability."
Range of Motion Sensor Accuracy and Repeatability	"It was show [shown] through validation using... inclinometer testing for Range of Motion... It was shown through this validation testing that all sensors captured data accurately and repeatability."
FCE (Functional Capacity Evaluation) Sensor Accuracy and Repeatability	"It was show [shown] through validation using weights for FCE... It was shown through this validation testing that all sensors captured data accurately and repeatability."
Pinch Strength Sensor Accuracy and Repeatability	"It was show [shown] through validation using weights for... Pinch... It was shown through this validation testing that all sensors captured data accurately and repeatability."
Grip Strength Sensor Accuracy and Repeatability	"It was show [shown] through validation using weights for... Grip... It was shown through this validation testing that all sensors captured data accurately and repeatability."
Electrical Safety/EMC: Conformity to 60601 standard.	"Both PMRU and PMRU-s conform to 60601."

Study Details

The document describes validation tests rather than a traditional clinical study with human subjects, given that the changes are primarily related to wireless data transmission and power.

Sample size used for the test set and the data provenance:
- The document does not specify a sample size for the "validation tests." It refers to "weights" for FCE, Pinch, and Grip, "inclinometer testing" for Range of Motion, and a "Signal Generator" for EMG. This suggests a laboratory-based testing environment with physical standards or simulated inputs, not a human patient test set.
- Data Provenance: Not explicitly stated, but the nature of the tests (using signal generators, weights, inclinometers) suggests it was in-house (e.g., at the manufacturer's facility) and not from human subjects in a clinical setting. It would be considered prospective as it was conducted specifically for this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" for these validation tests was established by objective physical standards (e.g., known weights, known angles from an inclinometer, specified signals from a signal generator). Human experts were not involved in establishing this type of ground truth.
Adjudication method for the test set:
- Not applicable. Since the ground truth was based on objective physical standards, there was no need for human expert adjudication. The device's measurements would be compared directly to the known values of the standards.
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:
- Not applicable. This device (PMRU-S) is a diagnostic measurement tool (EMG, ROM, strength) and not an AI-powered image analysis or diagnostic support system that would typically be evaluated with an MRMC study involving human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The validation tests described (using signal generators, weights, inclinometers) represent a form of standalone performance evaluation, as they assess the sensor's ability to accurately capture physical parameters without human interpretation of the device's output in a diagnostic context. The device itself (the sensors and data acquisition) is being tested in a "standalone" fashion against known inputs.
The type of ground truth used:
- Physical Standards/Calibration References: Known weights for FCE, Pinch, and Grip; inclinometer readings for Range of Motion; and signal generator outputs for EMG.
The sample size for the training set:
- Not applicable. This device is described as operating on established physical principles (EMG, strain gauges) and is demonstrating equivalence to a predicate. There is no mention of machine learning or AI algorithms that would require a "training set" in the conventional sense. The device's calibration and underlying algorithms would likely have been developed and tested on previous data, but not in the context of a "training set" for this specific 510(k) submission.
How the ground truth for the training set was established:
- Not applicable for the reasons outlined in point 7.

Summary

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K123902

PMRU-S 510(k) Application

Section F 510(k) Summary

Submitted by: MaryRose Cusimano-Reaston, Ph.D. and Phil Reaston

7225 S. 85th E. Ave. Suite 300

Tulsa, OK 74133

Telephone: 702-234-1014

Date Prepared: December 7, 2012

SEP 1 3 2013

Contact: MaryRose Cusimano-Reaston, Ph.D. mreaston@emergedx.com 702-234-1014

Trade Name: Physical Monitoring Registration Unit -S (PMRU-S)

Common Name: EMG

Classification Name: Diagnostic Electromyography (890.1375)

Product code: IK N

Class II

Legally Marketed Predicate Device to which we are claiming equivalence. Physical Monitoring Registration Unit (PMRU) K022719, Class II

Description of Device:

The PMRU-S

has the same intended use as the predicate;
Page 1

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technological characteristics the predicate; has the same as . has the same intended use as the predicate;
The PMRU-S uses all the same technological characteristics, it uses the same strain . gage, grip, pinch and EMG sensors. The only difference from a technological characteristic is the data is transmitted via Bluetooth.

Indications For Use:

Surface Electromyography with range of motion functional capacity assessment grip and pinch strength.

Intended Use

PMRU	PMRU-S
EMG leads	6" clip to snap	6"clip to snap
Straingagepinch/fce	Force measuring platform	Force measuring platform
grip	Jamar dynamometer	Jamar dynamoter
Sample rate	1000 HZ	1024 HZ
CMRR	>90db (at 10 hz)	>90db (at 10hz)
Filters	Current limiting	Current Limiting
EMG	The instrumentationamplifiers stage detectsthe voltage difference	The instrumentation amplifiers stagedetects the voltage difference between thetwo (2) points of electrodes on the

System Comparisons

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	between the two (2) patients skin with ground on each EMGpoints of electrodes onthe patients skin with 1universal ground	patients skin with ground on each EMGsensor
DAQ	The DAC moduleconverts analog voltageto a digital value, whichis then passed through anoptical isolation deviceand is then available forprocessing by the lap topcomputer. The DAQ ishoused in the main circuitboard and box for allsensors	The DAC module converts analog voltageto a digital value. This DAQ module ishoused in each individual sensor. Sincethe patient is not connected to a powersource no optical isolation is needed.
Power Source	110V AC power fromany conventional outlet.	Battery Operated
Datatransmission	USB or PCMCI cable	Bluetooth

The PMRU-S is substantially equivalent to the PMRU cleared in K022719 based on the following similarities:

A laptop computer to acquire data

Surface electrodes with range of motion. functional grip and pinch sensors

Data acquisition converting analog to digital signals.

There has been a change to the original device. This is a change for the data transfer to a wireless (Bluetooth) platform. None of these modifications including the Bluetooth data transfer, which is the subject of this submission lead to a change in the indications or intended use of the original device nor do they alter the fundamental scientific technology or introduce a fundamentally new scientific technology. Furthermore, none of these modifications poses an new issues with safety or efficacy. The design change which is the is to transfer the data to host computer without a cable and to further increase the device's safety through use of a battery operated wireless sensors and Bluetooth wireless technology to eliminate any possible connection between the patient and line voltage.

Both PMRU and PMRU-s conform to 60601. In addition, validation tests were performed to validate the accuracy and repeatability of the EMG, Range of Motion, FCE, Pinch and Grip Sensors. It was show through validation using weights for FCE, Pinch, and Grip, inclinometer testing for Range of Motion, and Signal Generator for EMG Sensors. It was

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shown through this validation testing that all sensors captured data accurately and repeatability.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, which is a symbol often associated with healthcare.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

September 13, 2013

OKTX, LLC c/o Ms. MaryRose Cusimano-Reaston 7225 S 85th E. Ave. Suite 300 Tulsa, OK 74137

Re: K123902

Trade/Device Name: Physical Monitoring Registration Unit-S (PMRU-S) Regulation Number: 21 CFR 890.1375 Regulation Name: Diagnostic Electromyograph Regulatory Class: Class II Product Code: IKN Dated: August 9, 2013 Received: August 12, 2013

Dear Ms. MaryRose Cusimano-Reaston:

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 - Ms. MaryRose Cusimano-Reaston

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Joyce M. Whang -S

for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K123902

Device Name: PMRU-S (Physical Monitoring Registration Unit-S)

Indications For Use:

Surface Electromyography with range of motion.functional capacity assessment.grip and pinch strength.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

e M. Whang -

Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)

K123902 510(k) Number

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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).