RICH-MAR THERASOUND 6.5 THERAPEUTIC ULTRASOUND by RICH-MAR CORP.

The provided text is a 510(k) premarket notification approval letter for the Rich-Mar Therasound 6.5 Therapeutic Ultrasound device. It does not contain information about acceptance criteria, study details, performance metrics, ground truth, sample sizes, or expert qualifications as typically found in a clinical study report or a more detailed technical submission.

The letter simply states that the FDA has reviewed the submission and determined that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. It lists the "Indications For Use" which are the conditions for which the device is intended (relief of pain, muscle spasms, joint contractures, but not for the treatment of malignancies), but these are not acceptance criteria in the sense of performance thresholds.

Therefore,Based on the provided document, the following information cannot be extracted:

A table of acceptance criteria and the reported device performance: This document is an FDA approval letter, not a study report. It does not contain specific acceptance criteria for device performance or reported performance metrics.
Sample sized used for the test set and the data provenance: No study details are provided, so sample size and data provenance are unknown.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no specific test set or ground truth establishment method is described.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No such study is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this device is a therapeutic ultrasound, not an AI algorithm.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

The document is a regulatory approval notice based on substantial equivalence to existing devices, not a scientific study detailing device performance against specific criteria.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SFP 1 3 2002

Ken Coffey President/CEO Rich-Mar Corporation P.O. Box 879 Inola. Oklahoma 74036

Re: K021483

Trade/Device Name: Rich-Mar Therasound 6.5 Therapeutic Ultrasound Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasonic Diathermy Regulatory Class: Class II Product Code: IMI Dated: August 20, 2002 Received: August 21, 2002

Dear Mr. Coffey:

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.

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Page 2 – Mr. Ken Coffey

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.

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) 594-4659. 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" (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 vours,

L. Mark N. Millman

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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Rich-Mar 510(k) for Therasound 6.5

of 1 Page }

510(k) Number (if known):

Device Name: Rich-Mar Therasound 6.5

Indications For Use:

Rich-Mar ultrasound devices are indicated to produce therapeutic deep heat for the following conditions:

Relief of pain ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Muscle spasms 2.
Joint contractures 3.

But NOT for the treatment of malignancies

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Mark N. Milliken

(Division Sign-Off Division of Gener estorative .nd Neurological l . Pres

K021483
510(k) Number

Section 14 - Required Certification Statements 14.4

Regulation Number and Section

N/A