(130 days)
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
- Facilitation of voluntary motor function
- Maintenance of increase of range of motion
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.
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.
§ 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).