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510(k) Data Aggregation

    K Number
    K131159
    Device Name
    SMARTRELIEF
    Manufacturer
    CHATTEM, INC.
    Date Cleared
    2013-07-25

    (92 days)

    Product Code
    NUH,NYN
    Regulation Number
    882.5890
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K113037
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHATTEM, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To be used for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities. To be used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

    Device Description

    The SmartRelief is a transcutaneous electrical nerve stimulator for relief of muscular pain and sold without prescription. Key to its use are specially shaped electrodes that allow an untrained person to properly place them on the body. The device consists of a microprocessor and associated components powered by a coin cell and housed in a small plastic case. The controls for the device consist of three buttons: A power button which turns the device on and off, an intensity increase button, and an intensity decrease button. This simple user interface is further augmented by distinctive shapes to allow the user to identify the controls even if they cannot see the device. Contact to the body is made through self-adhesive electrodes. Electrical connection from the device to the electrode is made directly through snaps on the device and the electrode; no leadwires are used. The electrodes are designed with both conductive surfaces combined into a single piece. These electrodes are manufactured in various shapes to facilitate proper placement on the body.

    AI/ML Overview

    The provided summary describes the SmartRelief device, a transcutaneous electrical nerve stimulator, and its substantial equivalence to a predicate device (PDI Works Pain-Aid, K113037). The acceptance criteria and the study proving the device meets them are based on this substantial equivalence.

    Here's the breakdown of the information requested:

    1. Table of Acceptance Criteria and Reported Device Performance

    The core acceptance criterion for the SmartRelief device is its substantial equivalence to the predicate device, the PDI Works Pain-Aid (K113037). This equivalence is based on identical technological characteristics, intended use, and safety/effectiveness profiles.

    Acceptance Criteria (based on Predicate Device Equivalence)Reported Device Performance (SmartRelief)
    Intended Use: Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities; symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.Identical: The SmartRelief has the exact same intended use as the predicate device, as explicitly stated in the 510(k) summary and the "Indications for Use" section.
    Technological Characteristics: Power Source, Number of Outputs, Number of Output Modes, Treatment Timer, Output Waveform, Shape, Housing Materials, Weight, Dimensions, Max Pulse Freq., Pulse Width, Technology/Control System, Patient Connection, Safety.Identical: The table in Section 6 explicitly details that all these technological characteristics (e.g., 3V lithium battery, 1 output, 30-minute fixed timer, asymmetrical biphasic waveform, 100 Hz max pulse frequency, 30-220 µsec pulse width, microprocessor control, self-adhesive electrodes, limited power/simple user interface) are the same as the predicate device. The text further states: "Comparison of actual output under various loads and operating parameters shows no difference in the SmartRelief and the predicate device." And "The electrical design, output, function and safety characteristics are exactly the same."
    Safety and Effectiveness: Compliance with voluntary standards (EN60601-1, EN60601-1-2), no differences in safety or effectiveness.Identical: The SmartRelief also complies with EN60601-1 and EN60601-1-2. The conclusion explicitly states: "Because the SmartRelief is only different from the predicate, cleared Pain-Aid device by cosmetic details in the plastic enclosure, no differences in safety or effectiveness exist." Testing confirmed equivalence in performance, including output waveform.

    2. Sample size used for the test set and the data provenance

    • Sample size: Not explicitly mentioned as a clinical test set for performance comparison in the traditional sense. The comparison is primarily based on technical specifications and output measurements rather than patient outcomes. If output measurements are considered as a "test set" for technical characteristics, the sample size would refer to the number of devices tested and the conditions under which the output was measured. This detail is not provided.
    • Data provenance: Not applicable in the context of a clinical study. The data is based on the technical specifications and output testing of the SmartRelief device in comparison to the predicate device. It's an engineering and design comparison rather than a human clinical trial.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

    • Number of experts and qualifications: Not applicable. The "ground truth" for this substantial equivalence submission is the technical specifications and verified performance of the predicate device (K113037), which has already been cleared by the FDA. The comparison is against established device parameters, not adjudicated expert interpretations of clinical data.

    4. Adjudication method for the test set

    • Adjudication method: Not applicable. There was no clinical test set requiring expert adjudication. The comparison is based on objective technical measurements and design specifications.

    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

    • MRMC study: No, an MRMC comparative effectiveness study was not done. This device is a transcutaneous electrical nerve stimulator, not an imaging or diagnostic AI device that would typically involve human readers.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

    • Standalone performance study: Not applicable. This device is a physical electromedical device, not an algorithm, and it is designed for direct patient use. Its "performance" is its ability to generate electrical pulses according to specifications, which was confirmed to be equivalent to the predicate device.

    7. The type of ground truth used

    • Type of ground truth: The ground truth used for the comparison is the engineering specifications, technical performance, and previously established safety and effectiveness of the predicate device (PDI Works Pain-Aid, K113037). The SmartRelief device is considered equivalent because its physical and electrical characteristics match those of the legally marketed predicate.

    8. The sample size for the training set

    • Sample size for training set: Not applicable. This device is not an AI/machine learning algorithm, so there is no concept of a "training set" in the context of this 510(k) submission.

    9. How the ground truth for the training set was established

    • Ground truth for training set establishment: Not applicable, as there is no training set for this device.
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