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510(k) Data Aggregation
(83 days)
Compex Wireless USA
The Compex Wireless USA is an Over-The-Counter device intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only.
The Compex Wireless USA is not intended for adjunctive therapy in the treatment of medical diseases and conditions of any kind. None of the Compex Wireless USA stimulation programs are designed for injured or disease afflicted muscles. Its use on such muscles is contraindicated. The work imposed on the muscles by the Compex Wireless USA programs is definitely not suitable for rehabilitation and physiotherapy.
The Compex Wireless USA electrical impulses allow the triggering of action potentials on motoneurones of motor nerves (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 Compex Wireless USA may therefore be considered a technique of muscle training.
Compex Wireless USA as a TENS device is used for:
- temporary relief of pain associated with sore and aching muscles due to strain from exercise or . normal household and work activities.
- the symptomatic relief and management of chronic, intractable pain and relief of pain associated ● with arthritis.
The Compex Wireless USA employs programs for neuromuscular electrical stimulation (NMES) and transcutaneous electrical stimulation (TENS).
TENS (Transcutaneous Electrical Nerve Stimulation) and NMES (NeuroMuscular Electrical Stimulation) target different nerve groups of the body. TENS is specifically targets the sensory nerves, which are responsible for sending pain signals to the brain. NMES targets the muscle itself, specifically through the motor nerves. This allows the NMES machine to create a muscle contraction to recruit more muscle fibers when training; warming up or recovering.
The Compex Wireless USA device stimulates nerve fibers by means of electrical impulses transmitted by electrodes. The electrical pulses generated by the Compex Wireless USA stimulate motor nerves to stimulate a muscular response. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, and total session duration), different types of muscle work can be imposed on the stimulated muscles. The Compex Wireless USA may therefore be considered a technique of muscle training.
The device system is made up of a remote control. 4 stimulation modules, and electrodes, which are stored and shipped within the docking station which is used to recharge the remote and the modules. The docking station is powered by an AC-DC adapter.
The remote control is the interface between the stimulation modules and the user. It sends and receives information to and from the modules via a wireless network. The remote control allows the user to navigate through the user interface (UI), select stimulation program or objectives, set desired options and control the four (4) module intensities independently. The remote control is powered by a rechargeable battery.
The Compex Wireless USA stimulation module set is composed of 4 independent stimulation modules that are controlled via the remote control by a wireless connection. Each module is composed of two "pods" (1 battery "pod" and one stimulation "pod") linked by an electrical connection (cable). Two proprietary Compex standard snap gel electrodes are also needed to connect each "pod" to the body. The modules are powered by a Lithium Polymer (LiPo) rechargeable 3.7[V] /> 450 [mAh] battery.
The wireless protocol of the Compex Wireless USA Device is a proprietary design of a Radio-Frequency protocol operating the 2.4 GHz ISM band.
It is used to 1) Send particular information from remote control to stimulation modules (stimulation settings)
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Send particular information from stimulation modules to remote control. like current stimulation level and stimulation module subsystem status,
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Transfer binary data to stimulation modules, and
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Allow synchronization from stimulation modules to remote control clocks.
The provided document is a 510(k) Summary for the Compex Wireless USA, a powered muscle stimulator. It details the device's characteristics, indications for use, and a comparison to predicate devices, along with performance testing conducted. However, it explicitly states, "This submission does not contain clinical data." This means there is no study described in this document that proves the device meets specific acceptance criteria based on clinical outcomes or efficacy in human subjects.
Therefore, the response below will focus on the technical and safety acceptance criteria demonstrated by the performance testing, as clinical efficacy data is not present in the provided text.
Acceptance Criteria and Device Performance for Compex Wireless USA (K170903)
The Compex Wireless USA device, a powered muscle stimulator, demonstrates its compliance with acceptance criteria primarily through non-clinical performance testing related to electrical safety, electromagnetic compatibility, software validation, usability, and wireless coexistence. There is no clinical study information provided in this document to demonstrate the device meets acceptance criteria related to its intended physiological effects (e.g., muscle performance improvement or pain relief).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with AAMI/ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance (IEC 60601-1, Mod.). | "The Compex Wireless USA was tested and found to comply with… standards for electrical safety." (Implies successful adherence to the standard's requirements for basic safety and essential performance). |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 Edition 3:2007-03, Medical Electrical Equipment - Part 1 -2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests. | "The Compex Wireless USA was tested and found to comply with… standards for… electromagnetic compatibility." (Implies successful adherence to the standard's requirements for EMC, ensuring it operates without undue interference and is not unduly affected by other electromagnetic phenomena). |
| FCC Radio Frequency | Compliance with 47 CFR 15.249. | "The Compex Wireless USA was tested to FCC requirements and found to comply with the requirements of 47 CFR 15.249." (Indicates successful compliance with regulations for operating in the 2.4 GHz ISM band.) |
| Software Validation | Verification in accordance with FDA's guidance document: General Principles of Software Validation, January 11, 2002. | "The software testing demonstrated that the software meets its design requirements." (Indicates the software functions as intended and is validated for its specified purpose.) |
| Usability/Human Factors | Established requirements for usability met, and device design appropriate for intended users and use environment. | "Usability/Human Factors testing was performed, which demonstrated that the established requirements for usability were met, and the device's design is appropriate for the intended users and use environment. The result of this study substantiates the acceptability of the use-related risks identified during the risk assessment activities." (Confirms the device is user-friendly and safe in practical use.) |
| Wireless Coexistence | Performance in an environment with other Compex Wireless USA devices and with other types of 2.4 GHz wireless devices (Bluetooth and Wi-Fi) met specific requirements. | "The device met all specified requirements." (Ensures the device can operate effectively without interference in a typical wireless environment.) |
| Risk Management | Compliance with ISO 14971 Second Edition 2007-03-01. Medical Devices - Applications of Risk Management to Medical Devices. | The document states conformance to ISO 14971, implying that risks were identified, analyzed, evaluated, controlled, and monitored in accordance with the standard. |
| Software Life Cycle Processes | Compliance with AAMI /ANSI /IEC 62304:2006, Medical Device Software - Software Life Cycle Processes. | The document states conformance to IEC 62304, indicating that the software development followed recognized life cycle processes for medical device software. |
| Particular Requirements for Nerve and Muscle Stimulators | Compliance with IEC 60601-2-10 Edition 2.0 2012-06, Medical Electrical Equipment - Part 2-10: Particular Requirements for the Basic Safety and Essential Performance of Nerve and Muscle Stimulators. | The document states conformance to IEC 60601-2-10, demonstrating adherence to specific safety and performance standards for its device type. |
| Home Healthcare Environment | Compliance with IEC 60601-1-11 Edition 1.0 2010-04, Medical Electrical Equipment Part 1-11: General Requirements - Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment. | The document states conformance to IEC 60601-1-11, indicating its suitability and safety for use in home healthcare settings. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not provide details on the sample sizes for the test sets used in the performance testing (Electrical Safety, EMC, FCC, Software, Usability, Wireless Coexistence). It also does not specify the country of origin of the data or whether the data was retrospective or prospective. These are typically technical bench tests or simulations rather than human subject studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since the "studies" described are technical performance tests (e.g., electrical safety, EMC, software validation, usability), the concept of "ground truth" established by human experts in a clinical context is not applicable. For these technical tests, compliance is typically determined by accredited testing laboratories and engineers following the specifications of the relevant international and national standards. While these individuals are "experts" in their respective fields (e.g., electrical engineering, software engineering, human factors engineering), they are not referred to in the context of clinical ground truth or adjudication.
4. Adjudication Method for the Test Set
Not applicable, as the "studies" are technical performance tests based on compliance with established standards, not diagnostic or outcome-based clinical evaluations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "This submission does not contain clinical data." Therefore, there is no information on human readers, AI assistance, or effect sizes related to clinical performance. The focus of this submission is on demonstrating substantial equivalence based on technical specifications and non-clinical performance and safety.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
The device is a physical powered muscle stimulator with TENS and NMES capabilities, not an algorithm, AI, or diagnostic software. Therefore, the concept of "standalone (algorithm only)" performance is not applicable in this context. The document describes the technical performance and safety of the device itself and its integrated software.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests described is compliance with established engineering and medical device standards (e.g., IEC 60601 series, ISO 14971, FCC regulations). This is a form of technical or regulatory compliance ground truth, rather than expert consensus, pathology, or outcomes data related to clinical efficacy.
8. The Sample Size for the Training Set
Not applicable. The device is not an AI/ML algorithm that requires a "training set" in the conventional sense. The "training" for such a device involves its design, manufacturing, and calibration processes, guided by engineering principles and standards, not a data-driven machine learning approach.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the reasons stated in point 8.
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(134 days)
Compex Wireless USA
The Compex Wireless USA is an Over-The-Counter device intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only.
The Compex Wireless USA is not intended for adjunctive therapy in the treatment of medical diseases and conditions of any kind. None of the Compex Wireless USA stimulation programs are designed for injured or disease afflicted muscles. Its use on such muscles is contraindicated. The work imposed on the muscles by the Compex Wireless USA programs is definitely not suitable for rehabilitation and physiotherapy. The Compex Wireless USA electrical impulses allow the triggering of action potentials on motoneurones of motor nerves (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 Compex Wireless USA may therefore be considered a technique of muscle training.
The Compex Wireless USA is a neuromuscular electrical stimulation (NMES) device, which stimulates nerve fibers by means of electrical impulses transmitted by electrodes. The electrical pulses generated by the Compex Wireless USA stimulate motor nerves to stimulate a muscular response. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, and total session duration), different types of muscle work can be imposed on the stimulated muscles. The Compex Wireless USA may therefore be considered a technique of muscle training.
The device system is made up of a remote control, 4 stimulation modules, and electrodes, which are stored and shipped within the docking station which is used to recharge the remote and the modules. The docking station is powered by an AC-DC adapter.
The remote control is the interface between the stimulation modules and the user. It sends and receives information to and from the modules via a wireless network. The remote control allows the user to navigate through the user interface (UI), select stimulation program or objectives, set desired options and control the four (4) module intensities independently. The remote control is powered by a rechargeable battery.
The Compex Wireless USA stimulation module set is composed of 4 independent stimulation modules that are controlled via the remote control by a wireless connection. Each module is composed of two "pods" (1 battery "pod" and one stimulation "pod") linked by an electrical connection (cable). Two proprietary Compex standard snap gel electrodes are also needed to connect each "pod" to the body. The modules are powered by a Lithium Polymer (LiPo) rechargeable 3.7[V] /> 450 [mAh] battery.
The wireless protocol of the Compex Wireless USA Device is a proprietary design of a Radio-Frequency protocol operating the 2.4 GHz ISM band. It is used to 1) Send particular information from remote control to stimulation modules (stimulation settings) 2) Send particular information from stimulation modules to remote control, like current stimulation level and stimulation module subsystem status, 3) Transfer binary data to stimulation modules, and 4) Allow synchronization from stimulation modules to remote control clocks.
The provided text describes the Compex Wireless USA device, its indications for use, and a comparison to a predicate device (Compex Sport Elite) for 510(k) clearance. However, it does not contain the acceptance criteria or results of a study that proves the device meets specific performance criteria in terms of accuracy, sensitivity, specificity, or other clinical efficacy metrics as would be expected for an AI/ML or diagnostic device.
The document focuses on demonstrating substantial equivalence to a predicate device through:
- Identical Indications for Use.
- Similar technological characteristics in terms of basic device attributes and output specifications.
- Performance testing related to electrical safety, electromagnetic compatibility, FCC radio frequency, software verification, usability/human factors, and wireless coexistence, all against applicable standards.
Therefore, for the information requested in your prompt, I can only provide what is available in the text, which mainly pertains to regulatory compliance and safety/performance against engineering standards, not clinical performance or artificial intelligence specific metrics.
Here's an analysis of the provided text in response to your questions:
1. A table of acceptance criteria and the reported device performance
The document does not present clinical acceptance criteria (e.g., accuracy, sensitivity, specificity) for a specific diagnostic task or AI performance. Instead, the "acceptance criteria" are implied by compliance with various regulatory and engineering standards, and performance testing confirming functionality and safety.
| Acceptance Criteria (Implied by Standards & Testing) | Reported Device Performance (Summary from text) |
|---|---|
| Electrical Safety & Essential Performance | Complied with AAMI/ANSI ES 60601-1:2005(R)2012 and C1:2009/(R)2012 and A2:2010/(R)2012 for medical electrical equipment. |
| Electromagnetic Compatibility (EMC) | Complied with IEC 60601-1-2 Ed. 3:2007-03. |
| FCC Radio Frequency Requirements | Complied with 47 CFR 15.249. |
| Software Verification | Software was verified in accordance with FDA's guidance document "General Principles of Software Validation, January 11, 2002." Demonstrated that the software meets its design requirements. Compliance with IEC 62304. |
| Usability/Human Factors | Usability/Human Factors testing was performed, demonstrating that established requirements for usability were met and the design is appropriate for intended users and use environment. Results substantiate acceptability of use-related risks. Compliance with IEC 60601-1-6 and IEC 62366 and AAMI/ANSI HE75:2009. |
| Wireless Coexistence | Evaluated in environments with other Compex Wireless USA devices and other 2.4 GHz wireless devices (Bluetooth and Wi-Fi). Device met all specified requirements. |
| Risk Management | Compliance with ISO 14971:2007. |
| Muscle Stimulation Performance | The device's electrical impulses allow triggering of action potentials on motoneurones of motor nerves, leading to mechanical muscle fiber responses. Parameters allow different types of muscle work. (This is a description of how NMES works and the intended physiological effect, not a specific performance metric against a benchmark). The 9 NMES programs are identical to the predicate device. Minor differences in maximum output voltage/current, pulse width, and phase duration are noted but not presented as failing or meeting a specific performance threshold. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not describe a clinical test set or data provenance in the context of typical AI/ML or diagnostic device studies (i.e., patient data, images, etc.). The mention of "Performance Testing" refers to engineering and software validation, not clinical validation on a patient cohort.
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 is not applicable as the document does not describe a clinical study involving experts establishing ground truth for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable as there is no described clinical test set or adjudication process.
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
A multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This device is a muscle stimulator, not a diagnostic imaging device with human readers.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
This is not applicable in the sense of an AI algorithm making a diagnosis or prediction. The device itself is "standalone" in its operation of muscle stimulation, controlled by the user.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the engineering and software validation tests performed, the "ground truth" would be the expected behavior and specifications defined by the design requirements and industry standards. For example, for "Software Verification," the ground truth is that the software performs its functions as designed. For "Electrical Safety," the ground truth is that the device passes specific tests outlined in the relevant IEC/AAMI standards. These are not clinical ground truths like pathology or outcomes data.
8. The sample size for the training set
This is not applicable. The device is not an AI/ML algorithm that requires a "training set" in the common sense of machine learning.
9. How the ground truth for the training set was established
This is not applicable.
In summary: The provided FDA 510(k) clearance document for the Compex Wireless USA is for a traditional medical device (a powered muscle stimulator). It demonstrates substantial equivalence to a predicate device and compliance with safety and performance standards through engineering tests. It does not present clinical performance data, AI/ML algorithm validation, or studies involving human readers, test sets, or ground truth establishment in the context of diagnostic or AI-powered devices.
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