The provided text describes a 510(k) summary for the "CARE IFC plus™" interferential stimulator. This device is a portable interferential device for pain control, and its 510(k) submission relies on demonstrating substantial equivalence to a predicate device (HMP4000 Interferential Stimulator, K924961) through bench testing. This means that no clinical studies were conducted to establish acceptance criteria or device performance based on human data.

Therefore, the requested information, which pertains to clinical study design and results, cannot be provided directly from the given text.

Here's a breakdown of why each point cannot be addressed:

A table of acceptance criteria and the reported device performance: This document explicitly states "Clinical Testing: Not applicable." The "acceptance criteria" here would be related to electrical output characteristics, and the "reported device performance" would be comparing those electrical characteristics to the predicate device. The document states: "Bench testing demonstrated that the output characteristics or CARE IFC plus™ are substantially equivalent to that of the predicate device."
Sample size used for the test set and the data provenance: Not applicable as no clinical test set was used.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no ground truth was established by experts for clinical performance.
Adjudication method for the test set: Not applicable as no clinical test set was used.
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 as this is not an AI device, and no MRMC study was conducted.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an AI device. The "standalone" performance here would refer to the bench testing of the device's electrical output.
The type of ground truth used: For regulatory purposes of substantial equivalence in this context, the "ground truth" was the electrical output characteristics of the predicate device. The CARE IFC plus™ device was tested to ensure its electrical output matched these characteristics within acceptable parameters.
The sample size for the training set: Not applicable as no training set (in the machine learning sense) was used.
How the ground truth for the training set was established: Not applicable as no training set was used.

In summary: The submission for the CARE IFC plus™ relied on demonstrating substantial equivalence in technological characteristics (specifically, electrical output) through bench testing against a legally marketed predicate device, rather than through clinical studies with human participants. Therefore, the detailed information requested about clinical acceptance criteria, study populations, expert ground truth, and AI performance metrics is not contained within this 510(k) summary.

Summary

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MAY 1 6 2002

K020516

13 Appendix G: 510 (k) Summary

510(k) Summary

Submitter's Information:	Christian E. HuntCare Rehab®1124 Dominion CtMcLean, VA 22102	Phone: 1-703-448-9644FAX: 1-703-356-2182.
Date of preparation:	May 14, 2002
Proprietary Name:	CARE IFC plus™
Common Name:	Interferential Stimulator (LIH)
Classification Name:	Stimulator Interferential (LIH); Unclassified
Device Classification:	Unclassified
Predicate Device:	HMP4000 Interferential Stimulator (K924961)
Description of Device:	A portable Interferential device for pain control
Intended Use:	Interferential treatment is used for symptomatic relief of chronicintractable pain and/or as an adjunctive treatment in the management ofpostsurgical and posttraumatic acute pain.
Technological Comparison:	The CARE IFC plus™ has technological characteristics that aresubstantially equivalent to those of the predicate device, as determinedby bench testing.
Labeling Comparison:	The labeling of the CARE IFC plus™ is substantially equivalent to thatof the predicate device.
Nonclinical Testing:	Bench testing demonstrated that the output characteristics or CAREIFC plus™ are substantially equivalent to that of the predicate device.
Clinical Testing:	Not applicable.
Conclusions from Testing:	The CARE IFC plus™ is substantially equivalent in electrical output tothe predicate device and any differences between the devices do not posenew questions of safety and effectiveness.

ર I

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle. The logo is rendered in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 6 2002

Mr. Christian E. Hunt Care Rehab 1124 Dominion Ct. McLean, VA 22102

Re: K020516

Trade/Device Name: CARE IFC plus Regulatory Class: Unclassified Product Code: LIH Dated: February 14, 2002 Received: February 15, 2002

Dear Mr. Hunt:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); 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. This letter will allow you to begin marketing your device as described in your Section 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.

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Page 2 - Mr. Christian Hunt

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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

Enclosure

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4 Indications for Use

510(k) Number:

Device Name: CARE IFC plus™

Indications for Use:

Symptomatic relief of chronic intractable pain, post-traumatic and post-surgical pain

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K0205/6

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).