To record electrical activity of 2 muscles of the stomatognathic system, especially temporalis or masseter
To clinically monitor 2 different muscles as an aid in the diagnosis and treatment evaluation by recording the electrical activity of muscles of the stomatognathic system
To determine the degree of relaxation (intra-patient) of 2 muscles at rest
To measure relative (intra-patient) levels of activity of 2 muscles during a function act

Device Description

The M-Scan is a 2-channel, portable, battery operated electromyographic amplifier which includes: a) two (2) identical high-gain differential input amplifiers, b) two (2) buffer amplifiers, c) two (2) full wave rectifiers, and d) two (2) integrators. The overall amplification of the M-Scan is calibrated to 2500. The bandwidth filtering is set (fixed) from 30 Hz to 1000 Hz (± 3dB). The common mode rejection ratio is ≥ 130 dB at the power line frequency (50/60 Hz). The M-Scan does not include isolated power converter since it is battery operated, portable, and does not interface with any external equipment (it is never connected to the a-c line). Only three (3) functions are provided by the M-Scan: 1) amplification, 2) bandwidth limiting, and 3) integration of the signal for the integrated display.

AI/ML Overview

Here's an analysis of the provided text regarding the M-Scan device, focusing on acceptance criteria and study details.

Important Note: The provided text is a 510(k) summary for a medical device (M-Scan). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed performance study with explicit acceptance criteria for a new clinical claim. Therefore, much of the requested information (like specific acceptance criteria values, sample sizes for deep learning models, expert qualifications, etc.) is not present in this type of document because it's not a clinical effectiveness study. The "study" described here is a non-clinical performance comparison to a legally marketed predicate device.

Acceptance Criteria and Device Performance

There are no explicitly stated numerical acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy) in this 510(k) summary, as it's not a clinical performance study aiming to prove a specific diagnostic efficacy. Instead, the acceptance criteria implicitly involve demonstrating that the M-Scan's electrical characteristics are comparable or substantially equivalent to its predicate device (BioEMG III).

Acceptance Criteria (Implied)	Reported Device Performance
Overall amplification comparable to predicate (2500)	"overall amplification of the M-Scan is calibrated to 2500"
Bandwidth filtering comparable to predicate (30 Hz to 1000 Hz ± 3dB)	"bandwidth filtering is set (fixed) from 30 Hz to 1000 Hz (± 3dB)"
Common mode rejection ratio (CMRR) comparable to predicate (≥ 130 dB)	"common mode rejection ratio is ≥ 130 dB at the power line frequency (50/60 Hz)"
Waveforms and frequency response characteristics comparable to predicate	"comparable graphic plots of the waveforms and the frequency response characteristics of both instruments" (in Appendix E, not provided here)
"retained comparable levels of amplification and band-pass filtering as used in the BioEMG III predicate device."

Study Details

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of human patient or imaging data. The "test set" consisted of artificial signals generated by a calibrated function generator. The number of such test signals or their variations is not specified.
- Data Provenance: Not applicable as it's not real-world patient data. The "data" was synthetically generated using a function generator.
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 the instrument's electrical performance was established by objective measurements using a calibrated function generator and oscilloscope, not clinical experts.
Adjudication method for the test set:
- Not applicable. The "test" involved direct electrical measurement and comparison to the predicate device's measured characteristics, not a human reader adjudication process.
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 MRMC study was done. This device is an electromyograph (EMG) amplifier, not an AI-powered diagnostic tool interpreting complex data. There is no AI component mentioned that would assist human readers, or any reader component at all other than clinical interpretation of the EMG signals generated.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a measurement instrument. Its "performance" is its ability to accurately amplify and filter EMG signals, not to provide a diagnostic interpretation that could be done "standalone." Software validation testing was performed on the device's software (likely firmware controlling components and display logic), but not a standalone 'algorithm' in the sense of AI.
The type of ground truth used:
- Objective electrical measurements: The ground truth for the M-Scan's performance was established by applying known, calibrated electrical signals from a function generator and measuring the output with an oscilloscope. This allowed for direct comparison of amplification, bandwidth, and waveform characteristics against the predicate device.
The sample size for the training set:
- Not applicable. This device does not use machine learning or AI that would require a "training set."
How the ground truth for the training set was established:
- Not applicable, for the same reason as above.

Summary

{0}------------------------------------------------

510(k) Summary

BioResearch Associates, Inc. 9275 North 49th Street Suite 150 Brown Deer, WI 53223 Phone: (414) 357-7525 Fax: (414) 357-7545 Official Correspondent: John Radke 24 July 2013

Trade Name: M-Scan

Common Name: 2-channel, portable, battery operated electromyography

Regulation Number: 21 CFR 890.1375

Regulation Name: Diagnostic Electromyography

Regulatory Class: Class II

Product Code: KZM

Equivalent Device: BioEMG III (K082927)

Previous submissions: None

Product Description:

Intended Use of electromyography: (same as for the BioEMG III - K082927)

1. To record electrical activity of 2 muscles of the stomatognathic system, especially temporalis or masseter
in To clinically monitor 2 different muscles as an aid in the diagnosis and treatment evaluation by recording the electrical activity of muscles of the stomatognathic system
1. To determine the degree of relaxation (intra-patient) of 2 muscles at rest
To measure relative (intra-patient) levels of activity of 2 muscles during a functional act 4.

JUL 2 5 2013

{1}------------------------------------------------

Technological Characteristics:

The technological advantages of the M-Scan (compared to the predicate device) include:

The M-Scan is a portable, self contained, battery operated unit with no requirement for any 1. external connections.
The M-Scan is dedicated to simple tests comparing two muscles at rest or in function. 2.
Due to its simplicity and low-power electronic components, the M-Scan will use less energy than 3. the predicate device.
The functional characteristics of the M-Scan amplifiers are essentially identical to those of the 4. BioEMG III (K082927); literally the same I.C. components are used. See Appendix G.
1. New features of the M-Scan include: a) miniaturized, self contained operation, b) built-in rectification and averaging filter hardware, and c) built-in digital display

Non-Clinical Test Data:

Utilizing a calibrated function generator and oscilloscope we have applied test signals to both instruments. In Appendix E we have supplied comparable graphic plots of the waveforms and the frequency response characteristics of both instruments. In the M-Scan it is clear that we have retained comparable levels of amplification and band-pass filtering as used in the BioEMG III predicate device. EMG testing was performed on the M-Scan. Software validation testing was performed on the software for the M-Scan. This submission does not contain clinical data.

Conclusion:

Based on the information provided concerning the M-Scan is substantially equivalent to the declared predicate of the BioEMG III (K082927).

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white and appears to be a scanned image.

Public Health Service

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

July 25, 2013

BioResearch Associates, Incorporated C/O Mr. John Radke President 9275 North 49th Street, Suite 150 BROWN DEER WI 53223

Re: K130158

Trade/Device Name: M-Scan Regulation Number: 21 CFR 890.1375 Regulation Name: Diagnostic Electromyography Regulatory Class: II Product Code: KZM Dated: June 25, 2013 Received: June 28, 2013

Dear Mr. Radke:

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. Ilsting 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.

{3}------------------------------------------------

Page 2 - Mr. Radke

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 devicerelated 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.

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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): K | 30 15 8

M-Scan Device Name:

Indications for Use:

Indications for use; 2 channel, hand held, mobile EMG amplifier

1. To record electrical activity of 2 muscles of the stomatognathic system, especially temporalis or masseter
1. To clinically monitor 2 different muscles as an aid in the diagnosis and treatment evaluation by recording the electrical activity of muscles of the stomatognathic system
1. To determine the degree of relaxation (intra-patient) of 2 muscles at rest
1. To measure relative (intra-patient) levels of activity of 2 muscles during a function act

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ Yes (Pat 21 CFR 801 subpart D) AND/OR

Over-the-counter Use (Part 21 CFR 801 subpart D) Andrew I. Steen -S Andrew I. Steen -5

(Division Sign-Off) (Olvision of Anesthesiology, General Hospital Infection Control, Dental Devices

KISOIS

610{k) Number:

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).