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510(k) Data Aggregation

    K Number
    K203337
    Device Name
    PainTB, PainTJ
    Manufacturer
    Ptech Co., Ltd.
    Date Cleared
    2022-02-11

    (456 days)

    Product Code
    NHN
    Regulation Number
    890.5500
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K030226
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Pain TB and Pain TJ Laser systems are indicated for adjunctive use in the temporary relief of low-back pain and wrist pain associated with Carpal Tunnel Syndrome.

    Device Description

    PainTB and PainTJ can be used repeatedly and uses semiconductor lasers to generate three wavelengths of light at 670nm, 830nm and 910nm. In general, this device irradiates to the pain area with a laser beam to relieve pain. It can also be controlled via a dedicated app on your smartphone, allowing you to monitor when and how much you have used it.

    AI/ML Overview

    The information provided describes the PainTB/PainTJ Laser systems. Here's a breakdown of the acceptance criteria and study details based on the input:

    1. Table of Acceptance Criteria and Reported Device Performance:

    The document doesn't explicitly list specific numerical acceptance criteria for performance like a certain percentage reduction in pain score with a corresponding confidence interval. Instead, it relies on demonstrating statistical significance in pain reduction compared to a mock device and claiming substantial equivalence to a predicate device.

    Acceptance Criteria (Implied)Reported Device Performance
    SafetyNo adverse effects observed during the clinical study. Complies with general safety, EMC, usability, home healthcare, medical laser equipment, and laser product safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 60601-2-22, IEC 60825-1). Biological evaluation (cytotoxicity, skin sensitization, skin irritation) meets ISO 10993 standards.
    Effectiveness for Pain Relief (Low-back pain)The difference in VAS scores before and after treatment for Group B (Active Laser + exercise treatment) and Group C (Mock Laser + exercise treatment) was statistically significant (p-value < 0.05).
    Technical Equivalence to PredicateWavelength: While the predicate (THØR DDII 830CL3) used 830nm, PainTB/PainTJ uses 670nm, 830nm, and 910nm. The 830nm wavelength in PainTB/PainTJ (24.1mW) is within the acceptable range compared to the predicate's 30mW. The other wavelengths are considered "supporting performance."
    Indications for Use (IFU): Both the predicate and PainTB/PainTJ are indicated for adjunctive use in the temporary relief of wrist pain associated with Carpal Tunnel Syndrome. PainTB/PainTJ also includes low-back pain.
    Device Class/Regulation/Product Code: All are Class II, 21 CFR 890.5500, NHN.
    Clinical Equivalence to PredicateThe predicate device was used for pain treatment and reduced pain, similar to PainTB/PainTJ. The clinical study further supports the effectiveness for low back pain, addressing the expanded IFU.

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

    • Sample Size for Test Set: 60 adult patients
    • Data Provenance: Single-center study conducted in South Korea. The study was prospective and randomized.

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

    The document does not explicitly state the number of experts or their qualifications for establishing ground truth regarding the patients' pain levels. It mentions "VAS measurement has used as pain level scale," which is a subjective patient-reported outcome. The study was "rater blind," meaning the individuals assessing the VAS scores were unaware of the treatment group, but it doesn't specify if these "raters" were experts.

    4. Adjudication method for the test set:

    Not explicitly mentioned. The study likely relied on patient-reported VAS scores as the primary outcome.

    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:

    This is not applicable to the described device. PainTB/PainTJ is a therapeutic laser system, not an AI-powered diagnostic imaging tool involving human readers.

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

    Not applicable. The PainTB/PainTJ is a medical device that delivers laser therapy; it is not an algorithm that performs a task autonomously. Its performance is evaluated through patient outcomes and safety.

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

    The primary ground truth for effectiveness was outcomes data, specifically:

    • Patient-reported Visual Analog Scale (VAS) scores for pain relief.
    • Observation for adverse effects.

    8. The sample size for the training set:

    Not applicable. The PainTB/PainTJ device is a physical laser therapy system and does not involve AI or machine learning models that require a "training set."

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

    Not applicable, as there is no training set for this type of device.

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