LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K014019
    Device Name
    NEUROTECH MEDISTIM PLUS, TYPE 291
    Manufacturer
    BIO-MEDICAL RESEARCH, LTD.
    Date Cleared
    2002-07-11

    (217 days)

    Product Code
    IPF
    Regulation Number
    890.5850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    NEUROTECH MEDISTIM PLUS, TYPE 291

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

    The MediStim PLUS is indicated for:

    • Relaxation of muscle spasms .
    • Prevention or retardation of disuse atrophy
    • Increasing local blood circulation
    • Muscle re-education .
    • Immediate post-surgical stimulation of calf muscles to prevent . venous thrombosis
    • Maintaining or increasing range of motion.
    Device Description

    The MediStim PLUS is a portable two-channel battery operated neuromuscular electrical stimulator. The device is intended for prescriptive use per 21 CFR 801,109. It comprises of the device and two colour differentiated lead wires. which connect to four skin surface electrodes. The device is powered by a 9-volt (type 6/22) battery located in a compartment to the rear of the device with a detachable batterv cover. The device is supplied with a set of adhesive electrodes, a carrying case, the user instruction manual and a battery.

    AI/ML Overview

    The provided text describes a powered muscle stimulator, the MediStim PLUS, and its regulatory submission (510(k)). However, the document does not contain specific acceptance criteria or details of a study that proves the device meets such criteria.

    Here's an analysis based on the information provided, highlighting what's present and what's missing:

    1. A table of acceptance criteria and the reported device performance

    • Missing. The document details the device's technical specifications and safety standards it was tested against (IEC 601-1, IEC 601-2-10, IEC 601-1-2), but it does not specify clinical "acceptance criteria" (e.g., a certain percentage of muscle re-education success) or comparative performance data against these criteria.

    2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

    • Missing. The document mentions "non-clinical tests" and adherence to "recognised and established industry practices" for final performance testing, but it does not describe any clinical test sets, their sample sizes, or data provenance.

    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)

    • Missing. No information on expert involvement for establishing ground truth is provided, as no clinical test set details are available.

    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

    • Missing. No information on any adjudication method is provided.

    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

    • Not applicable. This device is a powered muscle stimulator, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to "human readers" or "AI assistance" is not relevant to this product.

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

    • Not applicable. This is a hardware medical device with no mention of an algorithm or AI component for standalone performance evaluation in the context of what is typically considered "AI device" standalone performance.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

    • Missing. As no clinical test data or methodology is described, the type of ground truth used is not mentioned. The document primarily focuses on electrical safety and performance standards.

    8. The sample size for the training set

    • Not applicable / Missing. There is no mention of a "training set" as this is not an AI/machine learning device.

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

    • Not applicable / Missing. Correspondingly, no information on establishing ground truth for a training set is provided.

    Summary of available information regarding compliance:

    The document states that the MediStim PLUS:

    • Was designed to and independently tested to:
      • IEC 601-1: 1998 +A1: 1991+ A2: 1995 (General requirements for safety)
      • IEC 601-2-10:1987 (Particular requirements for the safety of nerve and muscle stimulators)
      • IEC 601-1-2:1993 (Electromagnetic compatibility issues)
    • Adheres to recognized and established industry practices.
    • Is subject to final performance testing.
    • Underwent Hazard analysis, risk analysis, and failure mode effects analysis.

    These are non-clinical performance and safety criteria that the device aims to meet. The study proving these were met is the independent testing to the listed IEC standards, along with internal final performance testing and risk analyses. However, the exact data from these tests (e.g., specific measured voltage outputs, current limits, EMI resilience levels) are not provided in this summary. The FDA's 510(k) clearance (K014019) confirms their review of this evidence and a determination of substantial equivalence to a predicate device (Staodyn EMS +2), implying these non-clinical criteria were satisfactorily addressed for market clearance.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1