(225 days)
The ARP POV Sport is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.
The ARP POV Sport is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. The ARP POV Sport is not designed for use on injured or ailing muscles and its use on such muscles is contraindicated.
The POV Sport's electrical impulses allow triggering action potential on motoneurones of motornerves (excitations). These excitations of motoneurones are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.
The various types of muscle work that the POV Sport can impose on the stimulated muscles are able to improve or facilitate muscle performance.
The ARP POV Sport is considered a technique of muscle training.
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.
The provided text is a 510(k) summary for the ARP POV Sport, a powered muscle stimulator. It focuses on demonstrating substantial equivalence to predicate devices for safety and effectiveness rather than presenting a study with specific acceptance criteria for performance.
Therefore, many of the requested details, such as a table of acceptance criteria with reported device performance, sample sizes for test sets, expert-established ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not available in the provided document.
The document primarily states that the device's safety has been demonstrated through compliance with electrical safety standards and that its modes, frequency, output, and indications for use are substantially equivalent to predicate devices.
Here's an attempt to answer the questions based only on the provided text, acknowledging the limitations:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The document primarily focuses on regulatory compliance and substantial equivalence to predicate devices rather than specific performance metrics against pre-defined acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. The "Test Data" section only states that "The ARP POV Sport has been demonstrated safe by testing to IEC 60601-2-10, IEC 60601-1-1:2000, IEC 60601-1-2:2008, and IEC 60601-1-4:2000." These are electrical safety standards, not a clinical performance study involving a patient test set.
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)
This information is not provided as there is no described clinical performance study with a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided as there is no described clinical performance study with a 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
An MRMC study is not mentioned in the document. This device is a powered muscle stimulator, not an AI-assisted diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable as the device is a physical powered muscle stimulator, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided as there is no described clinical performance study with a ground truth. The "ground truth" for this type of device's safety and effectiveness determination is typically established by compliance with recognized standards and demonstration of similar operational parameters to legally marketed predicate devices.
8. The sample size for the training set
This information is not provided as there is no mention of an algorithm or a training set.
9. How the ground truth for the training set was established
This information is not provided as there is no mention of an algorithm or a training set.
Summary of the Study and Acceptance Criteria from the Text:
The document describes the ARP POV Sport as a powered muscle stimulator. The "study" mentioned for demonstrating its safety and effectiveness is primarily regulatory.
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Acceptance Criteria (Implied):
- Compliance with electrical safety standards: IEC 60601-2-10, IEC 60601-1-1:2000, IEC 60601-1-2:2008, and IEC 60601-1-4:2000.
- Substantial equivalence to predicate devices (Compex Sport K011880, TheraStim Muscle Stimulator K893851, and Endurance Therapeutics Model T1040 K060846) in terms of modes, frequency, output, and indications for use.
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Reported Device Performance (from the text):
- "The ARP POV Sport has been demonstrated safe by testing to IEC 60601-2-10, IEC 60601-1-1:2000, IEC 60601-1-2:2008, and IEC 60601-1-4:2000."
- "The device compared to the predicate is substantially equivalent, safe and as effective."
It's important to understand that this 510(k) summary is for a traditional medical device (a muscle stimulator), not an AI/ML-driven diagnostic or treatment device, which is why much of the requested information (related to AI performance studies) is not present.
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510(k) Summary
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| Submitted by: | ARP Manufacturing7200 E. Dry Creek Road, Suite g-102Centennial, CO 80112 |
|---|---|
| AUG 10 2010 | |
| 1K093999 | |
| Contact Person | Lewis WardL.W. Ward and Associates, Inc.4655 Kirkwood CourtBoulder, CO 80301 |
| Date Prepared: | 5-27-10 |
| Product: | Trade Name: ARP POV SportCommon Name: Powered Muscle Stimulator, OTC |
| Classification Name: | Stimulator, Muscle, Powered, 890.5850, Product Code NGX |
| Intended Use: | The ARP POV Sport is intended for the following: |
| The ARP POV Sport is intended to stimulate healthy muscles in order toimprove or facilitate muscle performance. | |
| The ARP POV Sport is not intended to be used in conjunction withtherapy or treatment of medical diseases or medical conditions of anykind. The ARP POV Sport is not designed for use on injured or ailingmuscles and its use on such muscles is contraindicated. | |
| The POV Sport's electrical impulses allow triggering action potential onmotoneurones of motornerves (excitations). These excitations ofmotoneurones are transmitted to the muscle fibers via the motor endplatewhere they generate mechanical muscle fiber responses that correspond tomuscle work. Depending on the parameters of the electrical impulses(pulse frequency, duration of contraction, duration of rest, total sessionduration), different types of muscle work can be imposed on thestimulated muscles. | |
| The various types of muscle work that the POV Sport can impose on thestimulated muscles are able to improve or facilitate muscle performance. | |
| The ARP POV Sport is considered a technique of muscle training. |
.
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| TechnologicalCharacteristics: | The system consists of a table top electrical generator producing optimalcontinuous or interrupted electrical impulses through patient electrodes.Control parameters are software controlled through an LCD touch screen. |
|---|---|
| SubstantialEquivalence: | The POV Sport Powered Muscle Stimulator is substantially equivalent tothe Compex Sport K011880, the TheraStim Muscle Stimulator K893851,and Endurance Therapeutics Model T1040 K060846. The modes,frequency, output, and indications for use are substantially equivalent. |
| Test Data: | The ARP POV Sport has been demonstrated safe by testing to IEC 60601-2-10, IEC 60601-1-1:2000, IEC 60601-1-2:2008, and IEC 60601-1-4:2000. The device compared to the predicate is substantially equivalent,safe and as effective. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is positioned around the upper half of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
ARP Manufacturing, Inc. % L.W. Ward and Associates, Inc. Mr. Lewis Ward 4655 Kirkwood Court Boulder, Colorado 80301
Re: K093999
Trade/Device Name: ARP POV Sport Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: NGX Dated: August 4, 2010 Received: August 6, 2010
AUG 1 0 2010
Dear Mr. Ward:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Lewis Ward
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.
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/ReportalProblem/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 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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16093999
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: ARP POV Sport
AUG10 2010
Indications for Use:
The ARP POV Sport is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.
The ARP POV Sport is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind: The ARP POV Sport is not designed for use on injured or ailing muscles and its use on such muscles is contraindicated.
The POV Sport's electrical impulses allow triggering action potential on motoneurones of motornerves (excitations). These excitations of motoneurones are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.
The various types of muscle work that the POV Sport can impose on the stimulated muscles are able to improve or facilitate muscle performance.
The ARP POV Sport is considered a technique of muscle training.
Prescription Use AND/OR (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)
__, and I'm not sure how to handle the signature.
(Division Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093999
N/A