(189 days)
For Microcurrent and IFC (Premodulated Interferential) electrical stimulation using models 314A, 314B, 314C, 314F and 314G:
- Symptomatic relief and management of chronic intractable pain
- Adjunctive treatment in the management of post-surgical and post-traumatic pain.
For VMS Burst, Russian and Biphasic Symmetrical Pulses electrical stimulation using models 314F and 314G: - Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Maintaining or increasing range of motion
- Prevention of venous thrombosis of the calf muscles immediately after surgery
For Hot/Cold therapy using models: 314A, 314B, 314C, 314D, 314E: - Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and/or surgical conditions.
- Temporary relief of minor aches and pains and muscle spasms
The ELFcare™ device is a lightweight hand held battery operated unit which employs a combination application of previously well known electrical and temperature treatment modalities for pain relief and rehabilitation. The system is based on a combination of thermal transfer and conventional transcutaneous electrical stimulation therapy.
The ELFcare™ device makes use of an electronically controlled thermoelectric electrode unit that can be operated in cooling or heating modes. The thermoelectric electrode unit is controlled by the hand-held control unit.
Cooling: In the cooling mode, the thermoelectric electrode unit produces continuous and accurately controlled cold therapy to the treated area.
Heating: When operated in heating mode, well-controlled heat therapy is introduced to the treated area.
Electrotherapy: The unit incorporates a 4-head electrode for localized electrotherapy. Electrical and temperature calibrated modalities are applied in pre-programmed sequences and combinations
The ELFcare™ device combines electrical and temperature calibrated modalities by means of an electronically controlled thermoelectrode, as described above. The thermoelectrode is placed on the affected area. The thermoelectrode unit is connected to the ELFcare" Control Unit. The treatment programs and treatment parameters are controlled and operated via the ELFcare™ Control Unit.
The provided text describes the ELFcare™ device, which is a combination of TENS/EMS and hot/cold therapy. It mentions "Performance data: Safety Testing" and states that "Testing was carried out to assure compliance with recognized electrical safety standards. Mediseb has certified compliance with the IEC 60601-1 standard for electrical safety and compliance with the IEC 60601-1-2 standard for electromagnetic compatibility."
However, the document does not contain information about studies related to clinical performance or effectiveness data for the device's therapeutic claims (e.g., pain relief, muscle relaxation, or hot/cold therapy). It primarily focuses on electrical safety and electromagnetic compatibility to support its substantial equivalence to predicate devices.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and reported device performance related to therapeutic efficacy.
- Sample size used for the test set and data provenance related to therapeutic efficacy.
- Number of experts used to establish ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- Multi reader multi case (MRMC) comparative effectiveness study or its effect size.
- Standalone (algorithm only) performance study.
- Type of ground truth used related to therapeutic efficacy.
- Sample size for the training set.
- How the ground truth for the training set was established.
Based on the provided text, the acceptance criteria and study information are limited to safety and electrical standards:
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Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criteria Reported Device Performance Compliance with IEC 60601-1 (Electrical Safety) Mediseb certified compliance with IEC 60601-1 standard. Compliance with IEC 60601-1-2 (EMC) Mediseb certified compliance with IEC 60601-1-2 standard. -
Sample size used for the test set and the data provenance: Not specified for safety testing, nor for any clinical effectiveness.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or specified for hardware electrical safety testing.
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Adjudication method: Not applicable or specified for hardware electrical safety testing.
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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. The ELFcare™ device is a physical therapy device (TENS/EMS/Hot/Cold pack), not an AI diagnostic or assistance tool for human readers.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The ELFcare™ device is a physical therapy device, not a software algorithm for standalone performance evaluation in the context of device effectiveness.
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The type of ground truth used: For safety testing, the "ground truth" would be established by the specifications and test procedures outlined in the IEC 60601-1 and IEC 60601-1-2 standards.
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The sample size for the training set: Not applicable (referring to software/AI). For hardware safety testing, it would involve testing a representative sample of the devices.
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How the ground truth for the training set was established: Not applicable (referring to software/AI). For hardware safety, compliance is established by testing against the defined electrical safety and EMC standards.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).