The MLS Electromyographic preamplifier enables researchers and clinicians to acquire EMG signals from active subjects. It is intended to be used in hospital, university and other research facilities to acquire EMG signals for display and analysis by, or under the direction of, a health care professional.

Device Description

The purpose of the MLS Electromyographic preamplifier is to amplify the myoelectric signals that are generated by muscles when they contract.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define "acceptance criteria" in a quantitative sense that the MLS Electromyographic Preamplifier must meet to be cleared. Instead, it demonstrates "substantial equivalence" to a predicate device by comparing key specifications. Therefore, the "acceptance criteria" can be inferred as matching or being acceptably similar to the predicate device's performance.

Characteristic	Predicate Device (B&L Active Electrode) Specification (Implied Acceptance Criteria)	Proposed Device (MLS Electromyographic Preamplifier) Reported Performance
Intended Use	Ambulatory myoelectric EMG monitoring.	Ambulatory myoelectric EMG monitoring.
Power Source	Isolated external source.	Isolated external source.
Materials / Construction	Styrene case with stainless steel sensor pads.	Polyethylene case with stainless steel sensor pads.
CMRR	95 dB	90 dB
Input Impedance	Greater than 100 MΩ	Greater than 100 MΩ
Power requirements	Not stated	500 uA
Signal Bandwidth	20 Hz to 2,000 Hz	DC to 2,000 Hz
Gain	330	20

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: "A sample of both the predicate B&L Active Electrode and the proposed MLS Electromyographic preamplifier were tested." The exact number of units or recordings in this sample is not specified.
Data Provenance: The location or country of origin of the data is not specified. The study is prospective in the sense that the testing was performed specifically for this submission to compare the devices, but no further details on the study design or subject population are provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The study report mentions "myographic recordings... were found to be substantially identical," implying an expert evaluation, but no details are given.

4. Adjudication Method for the Test Set

Adjudication method: Not specified.

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

MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is an EMG preamplifier, a hardware component, not an AI-powered diagnostic tool for human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance Study: No, a standalone algorithm performance study was not done. This is a hardware device; thus, performance is characterized by its signal amplification and filtering properties rather than algorithmic output. The study focused on comparing the amplified signal characteristics from two devices.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" was established by direct comparison of the electrical signals generated by both devices from a single muscle. The primary criterion was that "Myographic recordings from the skin surface over a single muscle were found to be substantially identical in frequency content and power spectrum for both devices." This represents a direct experimental comparison to an already legally marketed device, rather than an independent "ground truth" derived from pathology or clinical outcomes.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This device is a hardware component and does not utilize a "training set" in the context of machine learning or AI algorithms.

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

Ground Truth Establishment for Training Set: Not applicable. As above, there is no training set for this type of device.

Summary

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510(k) Marketing Clearance Application

510(k) Summary

Premarket Notification [510(k)] summary prepared on November 14, 1997

Establishment Information

Manufacturer/Summiteer:

Motion Lab Systems, Inc. 4326 Pine Park Drive, Baton Rouge, LA 70809

Contact Name/Phone #

Edmund Cramp Motion Lab Systems, Inc. (504) 928-4248 Phone: (504) 928-0261 Fax:

General Device Information

Common/Usual Name	EMG Electrode
Trade/Proprietary Name	MLS Electromyographic preamplifier
Classification Name	Electromyography, Diagnostic - 21 CFR 890.1375
Device Classification	Class II
Performance Standards	None established under section 514

Substantial Equivalence:

The MLS Electromyographic preamplifier is substantially equivalent to the B&L Electrode which is currently legally manufactured under 510(k) K952655

Device Description:

The purpose of the MLS Electromyographic preamplifier is to amplify the myoelectric signals that are generated by muscles when they contract.

Intended Use:

Testing:

A sample of both the predicate B&L Active Electrode and the proposed MLS Electromyographic preamplifier were tested to determine substantial equivalence and relative performance. Myographic recordings from the skin surface over a single muscle were found to be substantially identical in frequency content and power spectrum for both devices.

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510(k) Summary

Comparison to legally marketed predicate device:

Characteristic	B&L Active Electrode	Proposed MLS device
Intended Use	Ambulatory myoelectric EMG monitoring.	Ambulatory myoelectric EMG monitoring.
Power Source	Isolated external source.	Isolated external source.
Materials / Construction	Styrene case with stainless steel sensor pads.	Polyethylene case with stainless steel sensor pads.
CMRR	95 dB	90 dB
Input Impedance	Greater than 100 MΩ	Greater than 100 MΩ
Power requirements	not stated	500 uA
Signal Bandwidth	20 Hz to 2,000 Hz	DC to 2,000 Hz
Gain	330	20

Conclusion:

Testing done on the MLS Electromyographic preamplifier and the predicate B&L Electrode indicates the proposed MLS Electromyographic preamplifier is as safe and effective and performs a substantially equivalent function to the predicate B&L Electrode.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 9 1998

Mr. Edmund Cramp President Motion Lab Systems, Inc. 4326 Pine Park Drive Baton Rouge, Louisiana 70809

Re : K974385 Trade Name: MLS Electromyographic Preamplifier Regulatory Class: II Product Code: IKN Dated: November 18, 1997 Received: November 21, 1997

Dear Mr. Cramp:

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 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 (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. A substantially equivalent determination-assumes compliance-with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (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 action. In addition, FDA may publish further announcements 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 regulations.

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Page 2 - Mr. Edmund Cramp

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) 594-4595. 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,

2Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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にとができる。 1つ・ささ

Page 1 of 1 .

510(k) Number (if known):_____K974385

Device Name: MLS Electromyographic preamplifier

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division (Sign-On)
Division of General Restorative Devices
510(k) Number K974365

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use_

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).