OrthoCor Knee System is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue. Temporary relief of minor muscular and joint aches and pains associated with over-exertion, strains, sprains, and arthritis.

Device Description

The OrthoCor Active Knee System is a portable (battery operated) non-invasive shortwave diathermy medical device which applies electromagnetic energy at a radio frequency (RF) of 27.12 MHz for the treatment of medical conditions by means other than the generation of deep heat within body tissues, i.e., by athermal means. The OrthoCor Knee System delivers the pulsed RF signal of 6.5±0.5µWs/cm to the tissue target via the inductive coupling with an applicator coil. The system also includes disposable, single-use, air activated OrthoPods that provide heat. The OrthoPods are snapped into medial and lateral slots on the knee wrap. Treatment may occur directly through dressings, clothing, casts, compression garments or supports.

AI/ML Overview

The provided text describes a 510(k) submission for the OrthoCor Active Knee System, a medical device for pain and edema. The submission primarily focuses on establishing substantial equivalence to predicate devices through technical comparisons and adherence to safety standards, rather than conducting a detailed clinical study with acceptance criteria for device performance in a clinical context.

Therefore, many of the requested categories related to clinical performance studies, ground truth establishment, expert adjudication, and sample sizes for training/test sets are not applicable or not provided in this document.

Here's the information that can be extracted based on the provided text:

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

Acceptance Criteria (Predicate Device Specification)	Reported Device Performance (OrthoCor Active Knee System)
Technology: Deposit athermal RF energy in tissue	Technology: Deposit athermal RF energy in tissue
Anatomical sites: Superficial soft tissues	Anatomical sites: Superficial soft tissues (knee)
Practitioner: Licensed physician/chiropractor	Practitioner: Licensed physician/chiropractor
Portable: Yes	Portable: Yes
How Energy Deposited: Induction (coil applicator)	How Energy Deposited: Induction
Carrier Frequency: 27.12 MHz	Carrier Frequency: 27.12 MHz ± 5%
Burst duration: 2msec	Burst duration: 2msec
Burst frequency: 2Hz	Burst frequency: 2Hz
Energy Deposited Per Pulse: 6.5 µWs/cm³	Energy Deposited Per Pulse: 6.5 µWs/cm³
Electrical safety: Conforms with IEC 60601-1	Electrical safety: Conforms with IEC 60601-1
Electromagnetic safety: Conforms with IEC 60601-1-2	Electromagnetic safety: Conforms with IEC 60601-1-2
Power required: Battery or Mains	Power required: 3V-4.2V DC (battery)

Study that proves the device meets the acceptance criteria:

The document states that "Equivalence was based on bench testing that showed the device produces the same outputs as the predicate as shown in the table below." This implies a bench testing study was conducted to compare the technical specifications and outputs of the OrthoCor Active Knee System against its predicate device (Ivivi Torino II K070541).

2. Sample size used for the test set and the data provenance: Not applicable. The submission relies on bench testing for technical equivalence, not clinical data sets with "test sets" in the context of AI/diagnostic device performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This pertains to clinical studies, not technical equivalence bench testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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: Not applicable. This is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" in this context is the technical specifications and measured outputs of the predicate device (Ivivi Torino II K070541), which the OrthoCor Active Knee System aimed to match. The assessment was based on objective physical measurements during bench testing.

8. The sample size for the training set: Not applicable. This is not a machine learning device that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

Summary

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K092044

DEC 1 8 2009

510(k) Summary

SUBMITTED BY:	ORTHOCOR MEDICAL, Inc.1000 Westgate Drive, Suite 243,Minneapolis, MN 55114Registration: Awaiting Assignment
DATE PREPARED:	June 22, 2009
CONTACT:	Advanced Medical Consortium9907 Oakleaf WayMcCordsville, IN 46055Tel: 651-641-2829
TRADE NAME:	OrthoCor Active Knee System
COMMON NAME:	Shortwave Diathermy
CLASSIFICATION NAME:	Diathermy, Shortwave, For Use Other Than ApplyingTherapeutic Deep HeatHot or cold disposable pack
DEVICE CLASS:	Class III
PRODUCT CODE:	ILX, 21 CFR 890.5290(b)IMD, 21 CFR 890.5710
PREDICATE:	Ivivi K070541 (Torino II)OrthoCor K091640

DEVICE DESCRIPTION

INTENDED USE

. Adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue.
. Temporary relief of minor muscular and joint aches and pains associated with overexertion, strains, sprains, and arthritis

DETERMINATION OF SUBSTANTIAL EQUIVALENCE

Equivalence was based on bench testing that showed the device produces the same outputs as the predicate as shown in the table below.

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COMPARISON TO PREDICATE DEVICES(s)

The OrthoCor Medical, OrthoCor Active Knee System has the same intended use, target population, clinical setting, and technology as its predicate devices.

Device Features	PredicateIVIVI Torino II K070541	OrthoCor Active Knee System
Technology	Deposit athermal RF energy in tissue	Deposit athermal RF energy intissue
Anatomical sites	Superficial soft tissues	Superficial soft tissues (knee)
Practitioner	Licensed physician/chiropractor	Licensed physician/chiropractor
Portable	Yes	Yes
How Energy Deposited	Induction (coil applicator)	Induction
Carrier Frequency	27.12 MHz	27.12 MHz ± 5%
Burst duration	2msec	2msec
Burst frequency	2Hz	2Hz
Energy Deposited Per Pulse	6.5 µWs/cm³	6.5 µWs/cm³
Electrical safety	Conforms with IEC 60601-1	Conforms with IEC 60601-1
Electromagnetic safety	Conforms with IEC 60601-1-2	Conforms with IEC 60601-1-2
Power required	Battery or Mains	3V-4.2V DC (battery)

STANDARDS MET

IEC 60601-1 Medical Electrical Equipment Part I: General Requirements for Basic . Safety and Essential Performance
IEC 60601-1-2 Medical Electrical Equipment- Part 2: General Requirements for Safety-. Collateral Standard: Electromagnetic Compatibility- Requirements and Tests

CONCLUSION

OrthoCor Medical, Inc. believes that the OrthoCor Active Knee System Basic is substantially equivalent to the predicate device based on intended usage, technology comparison and system performance.

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

DEC 1 8 2009

OrthoCor Medical, Inc. % Advanced Medical Consortium Ms. Ines Burgos 9907 Oakleaf Way McCordsville, IN 46055

Re: K092044

Trade/Device Name: OrthoCor Knee System Regulation Number: 21 CFR 890.5290 Regulation Name: Shortwave diathermy Regulatory Class: Class III Product Code: ILX, IMD Dated: November 27, 2009 Received: December 3, 2009

Dear Ms. Burgos:

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 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 - Ms. Ines Burgos

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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely vours.

Sincerely yours,

Mark A. Milliken

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 Form

510(k) Number:

Device Name: OrthoCor Knee System

Indications for Use:

OrthoCor Knee System is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue.

Temporary relief of minor muscular and joint aches and pains associated with over-exertion, strains, sprains, and arthritis.

Prescription Use X 21CFR 801, Subpart D

OR Over-the-Counter Use _ 21CFR 801.109

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

FOR M.MELKERSON

Sigingical, Orthopedic, Division on of the Device

510(k) Number K092044

Regulation Number and Section

§ 890.5290 Shortwave diathermy.

(a)
Shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. A shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body electromagnetic energy in the radiofrequency (RF) bands of 13.56 megahertz (MHz) or 27.12 MHz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.(2)
Classification. Class II (performance standards).(b)
Nonthermal shortwave therapy —(1)Identification. A nonthermal shortwave therapy is a prescription device that applies to the body pulsed electromagnetic energy in the RF bands of 13.56 MHz or 27.12 MHz and that is intended for adjunctive use in the palliative treatment of postoperative pain and edema of soft tissue by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.(2)
Classification: Class II (special controls). The device is classified as class II. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible.
(ii) Appropriate analysis/testing must demonstrate that the device is electrically safe and electromagnetically compatible in its intended use environment.
(iii) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Non-clinical performance testing must characterize the output waveform of the device and demonstrate that the device meets appropriate output performance specifications. The output characteristics and the methods used to determine these characteristics, including the following, must be determined:
(A) Peak output power;
(B) Pulse width;
(C) Pulse frequency;
(D) Duty cycle;
(E) Characteristics of other types of modulation that may be used;
(F) Average measured output powered into the RF antenna/applicator;
(G) Specific absorption rates in saline gel test load or other appropriate model;
(H) Characterization of the electrical and magnetic fields in saline gel test load or other appropriate model for each RF antenna and prescribed RF antenna orientation/position; and
(I) Characterization of the deposited energy density in saline gel test load or other appropriate model.
(iv) A detailed summary of the clinical testing pertinent to use of the device to demonstrate the effectiveness of the device in its intended use.
(v) Labeling must include the following:
(A) Output characteristics of the device;
(B) Recommended treatment regimes, including duration of use; and
(C) A detailed summary of the clinical testing pertinent to the use of the device and a summary of the adverse events and complications.
(vi) Nonthermal shortwave therapy devices marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with these special controls.