The OrthoCor General Use Device (marketed as the OrthoCor Active Device) is a portable (battery operated) non-invasive shortwave diathermy medical device. Through the use of resonators and two applicator coils, the device applies electromagnetic energy at a radio frequency (RF) of 27.12MHz 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 General Use Device delivers the pulsed RF signal of 6.5±0.5µWs/cm³ to the tissue target via inductive coupling using two applicator coils. It is a general use device and can be positioned on the body with a wrap designed to hold the device in place at the location that requires treatment.

AI/ML Overview

The provided document is a 510(k) summary for the OrthoCor Active Device, a nonthermal shortwave therapy (SWT) device. It reclassifies the device from Class III to Class II and details the substantial equivalence to a predicate device, the OrthoCor Active Knee System (K091996).

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define "acceptance criteria" in the traditional sense of a clinical trial's primary endpoints. Instead, the focus is on demonstrating substantial equivalence to a predicate device. The performance is assessed by comparing technical specifications and intended use.

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (OrthoCor Active Device)
Indications for Use: Adjunctive use in the palliative treatment of postoperative edema and pain in superficial soft tissue.	Meets: "Adjunctive use in the palliative treatment of postoperative edema and pain in superficial soft tissue" (Matches predicate)
Exposure Duration: 30 minutes.	Meets: 30 minutes (Matches predicate)
Anatomical site: General Use.	Achieved: General Use (Broader than predicate's "Knee")
Peak Power: 0.5W.	Meets: 0.5W (Matches predicate)
Average Output Power (over 1 second): 2mW.	Meets: 2mW (Matches predicate)
Energy Density (µ): 6.5.	Meets: 6.5 (Matches predicate)
Voltage: 3V.	Meets: 3V (Matches predicate)
Therapy control burst width: 2ms/PPR 2±.03Hz.	Meets: 2ms/PPR 2±.03Hz (Matches predicate)
Burst frequency: 2Hz.	Meets: 2Hz (Matches predicate)
Duty Cycle (%): 0.4%.	Meets: 0.4% (Matches predicate)
Current: 10mA.	Meets: 10mA (Matches predicate)
Frequency - short wave: 27.12 MHz.	Meets: 27.12 MHz (Matches predicate)
Peak B Field (T): 0.004042 T.	Meets: 0.004042 T (Matches predicate)
Output impedance: 50 Ohm.	Meets: 50 Ohm (Matches predicate)
Applicator Size, Coil perimeter: 108.6cm.	Meets: 108.6cm (Matches predicate)
Applicator Type: Induction coil.	Meets: Induction coil (Matches predicate)
Safety and Effectiveness (Bench Testing): As safe and effective as the predicate device.	Meets: "The results of the bench and safety testing indicated that the new device is as safe and as effective as the predicate device. The energy/area is the most relevant measure because it is the total energy deposited into the body per specific area. The OrthoCor device and the predicate device all have similar energy/area measurements."
Conformity to Standards: IEC 60601-1, IEC 60601-1-2.	Meets: Conformity to these standards is implied by the document listing them under "Conformity to Standards".

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document explicitly states "Clinical data submitted: No" for both the OrthoCor General Use Device and the predicate device (K091996). This indicates that no clinical test set (human subjects) was used for this 510(k) submission.
Data Provenance: Not applicable, as no clinical data was submitted. The data primarily consists of bench testing results and technical specifications.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable, as no clinical test set requiring expert ground truth was used for this 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication was used for this 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states "Clinical data submitted: No."
Effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is a medical device and not an AI-assisted diagnostic tool, and no clinical studies were performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable, as this is a medical device (nonthermal shortwave therapy) and not an algorithm or AI system. Its performance is evaluated based on its physical and electrical properties.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on engineering specifications and bench testing measurements that demonstrate the device's adherence to its design parameters and its equivalence in those parameters to a legally marketed predicate device.

8. The Sample Size for the Training Set

Not applicable, as this submission is not for an AI/machine learning device. There is no concept of a "training set" in the context of this 510(k).

9. How the Ground Truth for the Training Set was Established

Not applicable, as this submission is not for an AI/machine learning device.

Summary

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A final order reclassifying shortwave diathermy (SWD) 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, a preamendments Class III device, into class II, and renaming the device "nonthermal shortwave therapy" (SWT), was published on October 13, 2015. See here: https://www.federalregister.gov/documents/2015/10/13/2015-

25923/physical-medicine-devices-reclassification-of-shortwavediathermy-for-all-other-uses-henceforth-to

While the device submitted and cleared through K121702 may serve as a valid predicate device for a new SWT device, please refer to the aforementioned final order for current regulatory requirements for this device type.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The text is in all caps and is smaller than the caduceus symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 6, 2013

OrthoCor Medical % MEDicept, Inc. . Mr. David Rothkopf President 200 Homer Avenue Ashland, MA 01721

Re: K121702

Trade/Device Name: OrthoCor Active Device Regulation Number: 21 CFR 890.5290(b) Regulation Name: Shortwave Diathermy for All Other Uses Regulatory Class: Class III Product Code: ILX Dated: April 17, 2013 Received: April 18, 2013

Dear Mr. Rothkopf:

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. Iisting 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. David Rothkopf

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address:

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

Joyce M. Whang -ś

for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K121702

Device Name: OrthoCor Active Device

Indications for Use:

The device is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue.

Prescription Use & 21CFR 801, Subpart D OR Over-the-Counter Use _ 21 CFR 876.1500

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Joyce M. Whang -S

Division Sign Off Office of Device Evaluation

K121702

510 (K) ______________________________________________________________________________________________________________________________________________________________________

OrthoCor Medical

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K 121702

510(k) Summary of Safety and Effectiveness in accordance with 21 CFR 807.92(a)(1) Date this 510(k) Summary was prepared: May 2, 2013

A) Manufacturer: OrthoCor Medical, Inc. 4848 IDS Center 80 8th Street Minneapolis, MN 55402 Contact: John Dinusson Contact: MEDIcept, Inc. 200 Homer Ave Ashland, MA 01721 Telephone: 508-231-8824 Fax: 508-231-8861 Contact: F. David Rothkopf B) Trade Name OrthoCor Active Device Common Name: Shortwave Diathermy Classification Name: Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat. Device Regulations: 21 CFR 890.5290(b) Class: III Product Code: ILX C) Predicate: K091996 - OrthoCor Active Knee System

D) Device Description:

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E) Intended Use:

The device is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue.

F) Substantial Equivalence Summary

	OrthoCor General Use Device	OrthoCor Active Knee System
	TBD	K091996
Indication for Use	Adjunctive use in the palliativetreatment of postoperative edemaand pain in superficial soft tissue	Adjunctive use in the palliativetreatment of postoperative edemaand pain in superficial soft tissue
Exposure	30 minutes	30 minutes
Anatomical site	General Use	Knee
Clinical data submitted	No	No
Electrical Specifications
Peak Power	0.5W	0.5W
Average Output Power(over 1 second)	2mW	2mW
Energy Density (μ)	6.5	6.5
Voltage	3V	3V
Therapy control burst width	2ms/PPR 2±.03Hz	2ms/PPR 2±.03Hz
Burst frequency	2Hz	2Hz
Duty Cycle (%)	0.4%	0.4%
Current	10mA	10mA
Frequency - short wave	27.12 MHz	27.12 MHz
Peal B Field (T)	0.004042 T*	0.004042 T*
Output impedance	50 Ohm	50 Ohm
Physical Specifications
Applicator Size,Coil perimeter	108.6cm	108.6cm
Applicator Type	Induction coil	Induction coil

Value calculated by: B=V(u 2μο), u = Energy Density , μο= Magnetic Constant = 4π107

G) Conformity to Standards

There were no FDA guidance documents identified for this device.

IEC 60601-1 Medical Electrical Equipment Part I: General Reguirements 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

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H) Performance Testing

The results of the bench and safety testing indicated that the new device is as safe and as effective as the predicate device. The energy/area is the most relevant measure because it is the total energy deposited into the body per specific area. The OrthoCor device and the predicate device all have similar energy/area measurements.

Conclusion

OrthoCor Medical, Inc. believes that based on the indications for use, technological characteristics, and comparison to predicate devices, the OrthoCor General Use Device has been shown to be substantially equivalent to the predicate and safe and effective for its intended use.

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.