MED-4000 by MICRO CURRENT TECHNOLOGY, INC.

The MED 4000 is a dual channel device that produces constant micro ampere currents with the selected envelopes, waveforms, frequencies, and polarity, with a maximum voltage of 30 volts.

AI/ML Overview

The provided documents are a 510(k) clearance letter and an "Indications For Use" statement for the MED 4000 Transcutaneous Electrical Nerve Stimulator (TENS) device. This type of regulatory document does not typically include detailed studies with acceptance criteria, sample sizes, expert qualifications, or detailed performance metrics as would be found in a later clinical trial or a more recent AI/ML device submission.

The 510(k) clearance process focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving efficacy and safety through comprehensive studies for novel devices.

Therefore, the specific information requested cannot be extracted directly from these documents. Here's why and what can be inferred:

A table of acceptance criteria and the reported device performance: Not provided. The 510(k) essentially states the device is "substantially equivalent" to predicate devices for the given indications. No quantitative performance metrics or specific acceptance criteria are listed in this document.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided. A 510(k) submission for a TENS device from 1999 would likely rely on existing data and performance of predicate devices, or potentially very limited non-clinical testing if specified. No details about a specific test set, its size, or provenance are in this letter.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable or provided. This type of information is relevant for studies involving subjective assessment (e.g., image interpretation), which is not the primary focus of a TENS device submission for chronic pain relief.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or provided. Similar to point 3, this is for assessments needing expert consensus.
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. The MED 4000 is a TENS device, not an AI/ML diagnostic tool or an AI-assisted device for human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The MED 4000 is a physical medical device, not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not explicitly stated in the provided documents. For TENS devices, "ground truth" for chronic pain relief would typically be patient-reported outcomes or pain scales, observed through clinical studies. However, the 510(k) itself does not detail such studies or their ground truth methodologies.
The sample size for the training set: Not applicable. This refers to machine learning models, which the MED 4000 is not.
How the ground truth for the training set was established: Not applicable.

Summary based on the provided documents:

The documents confirm the MED 4000 TENS device received 510(k) clearance (K993823) from the FDA on November 19, 1999. This clearance signifies that the device was deemed "substantially equivalent" to a predicate device marketed prior to May 28, 1976, or reclassified devices. The stated "Indications For Use" are for the symptomatic relief of chronic intractable pain by sending electrical impulses to block pain messages to the brain.

The 510(k) process in 1999 primarily required demonstrating that the new device was as safe and effective as a legally marketed predicate device, often by showing it had the same technological characteristics and indications for use, or that any new technological characteristics did not raise new questions of safety or effectiveness. It did not require the detailed performance studies, specific acceptance criteria, or AI/ML-related information requested in the prompt.

Summary

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Image /page/0/Picture/2 description: The image shows a seal for the Department of Health & Human Services. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 9 1999

Mr. Robert M. Boonstra Underwriters' Laboratories and Testing Representing Micro Current Technology, Inc. 2600 NW Lake Road 98607 Camas, Washington

K993823 Re: MED 4000 Trade Name: Regulatory Class: II GZJ : Product Code: Dated: November 9, 1999 Received: November 12, 1999

Dear Mr. Boonstra:

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 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 requlations 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 General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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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Page 2 - Mr. Robert M. Boonstra

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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,

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment 1 b

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510(k) Number (if known):	K993827
Device Name:	Med 4000

Indications For Use:

INTENDED USE STATEMENT

The MED 4000 Transcutaneous Electrical Nerve Stimulator (TENS) device is intended to by used by physicians or licensed practitioners for symptomatic relief of chronic intractable pain by sending electrical impulses through the skin to the nerves lying directly beneath the skin suarane impulses help to block the body's ability to send a pain message to the brain, thereby reducing the pair. sensation. The MED 4000 is a dual channel device that produces constant micro ampere currents with the selected envelopes, waveforms, frequencies, and polarity, with a maximum voltage of 30 volts.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Use (Per 21 CFR 801.109) OR

Over-the Counter-

(Optional Format 1-2-96)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K993823

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).