ARP RX100 by ARP MANUFACTURING, INC

The system consists of a table top electrical generator producing optimal continuous or interrupted electrical impulses through patient electrodes. Control parameters are software controlled through an LCD touch screen.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device, the ARP Rx100 Powered Muscle Stimulator. It details the device's intended use and claims substantial equivalence to a predicate device, the TheraStim Muscle Stimulator (K893851).

However, the document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria beyond safety testing. The "Test Data" section only states: "The ARP Rx100 has been demonstrated safe by testing to IEC 60601-2-10. The Device compared to the Predicate is substantially equivalent, safe and as effective." This indicates electrical safety and a claim of equivalence based on comparison, not a direct performance study with defined acceptance criteria.

Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria and a study proving the device meets them, as this information is not present in the provided text.

Here's what I can extract and state based on the provided document:

1. A table of acceptance criteria and the reported device performance

Information Not Found: The document does not specify performance-based acceptance criteria (e.g., target accuracy, sensitivity, specificity, or specific physiological outcomes) for the ARP Rx100 or its reported performance against such criteria. The only "test data" mentioned refers to safety testing and a general claim of substantial equivalence.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Information Not Found: The document does not describe any specific test set for performance, nor does it mention sample size, country of origin, or whether any data was retrospective or prospective. The "Test Data" section refers to safety testing to a standard (IEC 60601-2-10), which typically involves device-level testing, not patient-level data.

3. 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)

Information Not Found: This information is not relevant or present as there is no described test set or ground truth establishment related to clinical performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Information Not Found: This information is not relevant or present as there is no described test set.

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

Information Not Found: This is a powered muscle stimulator, not an AI-assisted diagnostic device. Therefore, an MRMC study or AI-related metrics are not applicable and are not mentioned.

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

Information Not Found: This is a powered muscle stimulator, not an algorithm-only device. Therefore, standalone algorithm performance is not applicable and is not mentioned.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Information Not Found: There is no mention of a performance study requiring ground truth data.

8. The sample size for the training set

Information Not Found: The document does not describe any training set, as it is related to a physical device rather than a machine learning model.

9. How the ground truth for the training set was established

Information Not Found: Not applicable as there is no training set described.

Summary

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1093259

Submitted by:	ARP Manufacturing7200 E. Dry Creek Road, Suite G-102Centennial, CO 80112
Contact Person	Lewis WardL.W. Ward and Associates, Inc.4655 Kirkwood CourtBoulder, CO 80301
	DEC 1 7 2009
Date Prepared:	September 3, 2009
Product:	Trade Name: ARP Rx100Common Name: Powered Muscle Stimulator
Classification Name:	Stimulator, Muscle, Powered, 890.5850, Product Code IPF
Intended Use:	The ARP Rx100 is intended for the following applications:Relaxation of muscle spasmsPrevention or retardation of disease atrophyIncreasing local blood circulationMuscle re-educationMaintaining or increasing range of motion
Technological Characteristics:	The system consists of a table top electrical generator producing optimal continuous or interrupted electrical impulses through patient electrodes. Control parameters are software controlled through an LCD touch screen.
Substantial Equivalence:	The Rx100 Powered Muscle Stimulator is substantially equivalent to the TheraStim Muscle Stimulator, K893851. The modes, frequency, output, and indications for use are substantially equivalent.
Test Data:	The ARP Rx100 has been demonstrated safe by testing to IEC 60601-2-10. The Device compared to the Predicate is substantially equivalent, safe and as effective.

September 1999 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1999 - 1999 -

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a human figure embracing a bird, which is a symbol of care and protection.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

ARP Manufacturing, Inc. % Regulatory Technology Services LLC Mr. Mark Job 1394 25th Street NW Buffalo, MN 55313

Re: K093259

Trade/Device Name: ARP Rx100 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator. Regulatory Class: Class II Product Code: IPF Dated: November 28, 2009 Received: December 2, 2009

Dear Mr. Job:

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 idications for use stated in the enclosure) to legally marketed predicate devices marketed in intestate 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, Dr to 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 additional controls. Existing major regulations affecting your devine (1 m he found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, PDA 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); medical device reporting (reporting of medical device-related 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.

DEC 1 7 2009

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Page 2- Mr. Mark Job

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark A Millman

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known):

Device Name: ARP Rx100

Indications for Use:

The ARP Rx100 is indicated for the following applications:

. Relaxation of muscle spasms
Prevention or retardation of disuse atrophy .
Increasing local blood circulation .
Muscle re-education ●
Maintaining or increasing range of motion .

AND/OR Prescription Use X (Part 21 CFR 801 Subpart D)

Over-the-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

FOR M. MELKERSON

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093259

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).