The Empi Phoenix is a multifunctional electrotherapy device indicated for retarding or preventing disuse atrophy, maintaining or increasing range of motion, and re-educating muscles. The Empi Phoenix device provides two channels of neuromuscular electrical stimulation (NMES), transcutaneous electrical stimulation (TENS) for pain management, and a pulsed DC Edema program to increase local blood circulation and reduce edema (swelling). These programs allow the patient to receive electrotherapy throughout the recovery cycle using a single device.

Its simplified programming makes the Empi Phoenix device convenient for home use: after placing the electrodes and selecting the program as prescribed by a healthcare professional, the patient only needs to increase the intensity to begin therapy. The device may be used with conventional leadwires and electrodes. For NMES treatment, it also may be paired with the Empi Phoenix™ Thigh Garment (provided as an accessory), which is designed to make electrode placement and treatment of the knee/quadriceps easier for the patient and clinician.

AI/ML Overview

The provided text describes the Empi Phoenix, a multifunctional electrotherapy device. However, it does not contain the specific details about acceptance criteria, a comprehensive study proving device performance against those criteria, or most of the requested information regarding sample sizes, expert involvement, and ground truth establishment.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, rather than providing a detailed clinical study report with acceptance criteria.

Here's what can be extracted and what is missing:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance	Comments
Software Validation: Meets design requirements.	"The device's software has been validated in accordance with the requirements set forth in the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005). The software validation tests demonstrated that the software version meets its design requirements."	This is a general statement of compliance, not specific performance metrics or thresholds.
Usability/Human Factors: Allows successful use in home environment; risks acceptable.	"A Human Factors and Usability Study was conducted to validate the usability of the Empi Phonix device in the home environment. The results of the Summative Validation support the instructions for successfully using the device as intended. The result of the Human Factors and Usability Study substantiates the acceptability of the risks identified during the risk assessment activities."	This is a general statement of compliance, not specific performance metrics or thresholds.
Safety and Essential Performance: Compliance with IEC 60601-1	"The Empi Phoenix was tested and found to comply with the following standards: . IEC 60601-1 for basic safety and essential performance"	General compliance statement.
Electromagnetic Compatibility: Compliance with IEC 60601-1-2	"The Empi Phoenix was tested and found to comply with the following standards: . IEC 60601-1-2 for electromagnetic compatibility"	General compliance statement.
Home Healthcare Environment: Compliance with IEC 60601-1-11	"The Empi Phoenix was tested and found to comply with the following standards: . IEC 60601-1-11 for use in a home healthcare environment"	General compliance statement.
Nerve and Muscle Stimulators Performance: Compliance with IEC 60601-2-10	"The Empi Phoenix was tested and found to comply with the following standards: . IEC 60601-2-10 for performance of nerve and muscle stimulators"	General compliance statement.
EMPI Phoenix and Compex Rehab Equivalence (NMES): Tech/Performance characteristics similar, 2 channels vs 4, simpler interface, same warm-up/work/cool-down progression.	"The Empi Phoenix and the Compex Rehab have the same NMES indications for use. Both are hand-held devices... The Empi Phoenix is a simpler form of the Compex Rehab... The progression of warm-up, work (contraction alternating with active rest), and cool down is the same on the two devices."	This section describes technological comparisons, not performance against specific clinical acceptance criteria.
EMPI Phoenix and Empi Continuum Equivalence (TENS & Pulsed DC): Tech/Performance characteristics similar, 2 channels, removable AA batteries, optional remote switch, simpler interface for Phoenix.	"The Empi Phoenix and Empi Continuum devices both provide TENS and Pulsed DC treatments. Both are 2-channel devices using two removable AA batteries... The Phoenix is more convenient for home use because the user only needs to select the program and the intensity."	This section describes technological comparisons, not performance against specific clinical acceptance criteria.
TENS Modulation Equivalence: Both types of modulation (Continuum's intensity or SMP; Phoenix's frequency modulation) aim to reduce body acclimation.	"The type of modulation is different between the two devices... The purpose of modulation in a TENS treatment is to reduce the body's acclimation to the signal, and either type of modulation can do this effectively."	This states the purpose is achieved, but does not provide quantitative data of how effectively or a specific acceptance criterion for it.
Pulsed DC Current Equivalence: Both provide 266 uA of DC current.	"For PDC, the Continuum and the Phoenix both provide 266 uA of dc current regardless of the amplitude."	This is a specific performance characteristic, but not an acceptance criterion in the traditional sense of a study endpoint.

Missing Information:

The provided document is a 510(k) summary and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a clinical study with detailed performance metrics against pre-defined acceptance criteria. Therefore, most of the requested information about a specific study proving the device meets acceptance criteria is not available in this document:

Sample size used for the test set and the data provenance: Not mentioned for any clinical performance testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
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 as this is not an AI-based diagnostic device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable as this is not an AI-based diagnostic device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not mentioned for any clinical performance claims. The "performance testing" described primarily refers to software validation and compliance with safety and compatibility standards, not clinical efficacy or diagnostic accuracy.
The sample size for the training set: Not applicable as this is not an AI-based device and no such training set would exist in this context.
How the ground truth for the training set was established: Not applicable.

Summary of what the document does provide regarding "studies":

The document mentions three types of "performance testing":

Software Validation: "The device's software has been validated... The software validation tests demonstrated that the software version meets its design requirements." This confirms internal software functionality but doesn't relate to clinical outcomes.
Human Factors and Usability Study: "A Human Factors and Usability Study was conducted to validate the usability of the Empi Phonix device in the home environment. The results of the Summative Validation support the instructions for successfully using the device as intended." This relates to user interaction and safety in the intended environment.
Compliance with Standards: The device was tested and found to comply with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 60601-2-10. These are engineering and safety standards, not clinical efficacy studies.

The document does not detail any clinical studies (e.g., randomized controlled trials, prospective observational studies) to prove the device's clinical efficacy (e.g., specific reductions in pain or edema, or improvements in muscle function) against quantifiable acceptance criteria for its intended use indications. The basis for effectiveness appears to be primarily through substantial equivalence to predicate devices that already have established clinical use and regulatory clearance for similar indications.

Summary

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Section 5 510(k) Summary

MAY 0 6 2013

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

The assigned 510(k) number is: K124016

Submitted by:

DJO, LLC 1430 Decision Street Vista, CA 92081 .

Contact Person:

Maria Pronina Regulatory Affairs Specialist Phone: 760-734-3047 Fax: 760-734-5694

Date Summary Prepared: December 21, 2012

Trade Name:

Empi Phoenix

NMES; TENS

Class II

Common/Usual Name:

Classification Name:

Powered muscle stimulator (21 CFR 890.5850); Transcutaneous electrical nerve stimulator for pain relief (21 CFR 882.5890)

Product Code:

IPF, Powered muscle stimulator GZJ, Transcutaneous electrical nerve stimulator for pain relief NYN, Stimulator, electrical, transcutaneous, for arthritis

Regulatory Class:

Predicate Device(s):

Compex® Rehab (K090632) EMPI Continuum (K093324)

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Device Description:

Intended Use:

As an NMES device, indications are for the following conditions:

Retarding or preventing disuse atrophy -
Maintaining or increasing range of motion -
Re-educating muscles -
Relaxation of muscle spasms ・
Increasing local blood circulation -

As a TENS device, indications are for the following conditions:

Symptomatic relief and management of chronic, intractable pain -
Adjunctive treatment for post-surgical and post-trauma acute pain -
Relief of pain associated with arthritis -

As a pulsed current device, indications are for the following conditions:

-Reduction of edema (under negative electrodes)
Reduction of muscle spasm -
Influencing local blood circulation (under negative electrode) -
Retardation or prevention of disuse atrophy ー
Facilitation of voluntary motor function -
Maintenance of increase of range of motion -

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Technological Comparison to Predicate Devices:

The Empi Phoenix device is technologically equivalent to Compex® Rehab (K090632) and EMPI Continuum (K093324) with respect to technical and performance characteristics.

The Empi Phoenix and the Compex Rehab have the same NMES indications for use. Both are hand-held devices. The Empi Phoenix uses two AA batteries that must be removed from the device for recharging. The Compex Rehab uses one 4.6 V NiMH battery that is charged in the device. The Empi Phoenix is a simpler form of the Compex Rehab. The Phoenix provides two channels of stimulation instead of four. For the Phoenix, the user only needs to select the desired program and adjust the intensity. On the Compex Rehab, the user has several display options and must choose the appropriate body part before selecting the program. The progression of warm-up, work (contraction alternating with active rest), and cool down is the same on the two devices.

The Empi Phoenix and Empi Continuum devices both provide TENS and Pulsed DC treatments. Both are 2-channel devices using two removable AA batteries. Both have an optional remote switch. The Phoenix is more convenient for home use because the user only needs to select the program and the intensity. The Continuum can be locked by the clinician so that the user only has these options, but if the device is not locked, the Continuum has more display and parameter choices for the user.

For TENS, the Continuum offers five body-part specific programs and one custom program. All programs have adjustable treatment time and frequency, and the custom program also allows the selection of type and degree of modulation and cycling time. Both devices use a fixed pulse duration of 300 us. The type of modulation is different between the two devices. Continuum uses either intensity modulation or a simple modulated pulse (SMP) which modulates both frequency and intensity. The Phoenix uses frequency modulation. The purpose of modulation in a TENS treatment is to reduce the body's acclimation to the signal, and either type of modulation can do this effectively.

For PDC, the Continuum and the Phoenix both provide 266 uA of dc current regardless of the amplitude. The Continuum does this by mixing triphasic (2 positive 60 usec pulses and one negative one) and biphasic (one positive and one negative pulse) waveforms. The Phoenix achieves the same result by adjusting the pulse width of the positive waveform compared to the set 60 usec negative pulse width. On the Continuum, the user selects between acute or chronic edema and the software provides net positive or net negative dc waveforms. The Phoenix always generates a net positive waveform, and the user connects the leadwires to the electrodes differently for acute or chronic edema.

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The Phoenix and both predicate devices use a microprocessor and a transformer to generate symmetrical square biphasic waveforms for NMES and TENS. All devices use an LCD to display the selected program, remaining time, and channel intensity, and to show open load and low battery icons.

Performance Testing:

. The device's software has been validated in accordance with the requirements set forth in the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005). The software validation tests demonstrated that the software version meets its design requirements.
하 A Human Factors and Usability Study was conducted to validate the usability of the Empi Phonix device in the home environment. The results of the Summative Validation support the instructions for successfully using the device as intended. The result of the Human Factors and Usability Study substantiates the acceptability of the risks identified during the risk assessment activities.
The Empi Phoenix was tested and found to comply with the following standards: .
- . IEC 60601-1 for basic safety and essential performance
- IEC 60601-1-2 for electromagnetic compatibility
- 루 IEC 60601-1-11 for use in a home healthcare environment
- IEC 60601-2-10 for performance of nerve and muscle stimulators .

Conclusion:

Based on the performance testing and the supporting documentation, it can be concluded that the Empi Phoenix device is safe, effective and substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

May 6, 2013

DJO, LLC Attention: Ken Fisher SVP Quality Assurance and Regulatory Affairs 1430 Decision Street Vista, CA 92081

Re: K124016

Trade/Device Name: Empi Phoenix Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, GZJ, NYN Dated: March 13, 2013 Received: March 27, 2013

Dear Mr. Fisher:

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

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Page 2 - Mr. Ken Fisher

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.

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 -S

for V

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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Section 4 Indications for Use

K124016 510(k) Number (if known):

Device Name: _________________________________________________________________________________________________________________________________________________________________

The Empi Phoenix is a multifunctional electrotherapy device with various treatment modes that allow for neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS) and pulsed current stimulation (PCS).

As an NMES device, indications are for the following conditions:

Retarding or preventing disuse atrophy -
Maintaining or increasing range of motion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Re-educating muscles
Relaxation of muscle spasms -
-Increasing local blood circulation

As a TENS device, indications are for the following conditions:

-Symptomatic relief and management of chronic, intractable pain
-Adjunctive treatment for post-surgical and post-trauma acute pain
Relief of pain associated with arthritis -

As a pulsed current device, indications are for the following conditions:

-Reduction of edema (under negative electrode)
Reduction of muscle spasm -
Influencing local blood circulation (under negative electrode) -
Retardation or prevention of disuse atrophy -
Facilitation of voluntary motor function -
-Maintenance of increase of range of motion

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

Over-the-Counter Use (Part 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)

Joyce M. Whang -S

Page 1 of 1

K124016 Empi Phoenix Abbreviated 510(k): New Device

Page 14 of 714

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).