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510(k) Data Aggregation

    K Number
    K200926
    Device Name
    OrthoGold 100
    Manufacturer
    Tissue Regeneration Technologies, LLC
    Date Cleared
    2020-08-28

    (143 days)

    Product Code
    PZL
    Regulation Number
    878.4685
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K191961
    Predicate For
    K231710
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The OrthoGold 100™ is indicated to provide acoustic pressure shockwaves in the treatment of superficial partial thickness second degree burns in adults (22 years and older). The OrthoGold 100 is indicated for use in conjunction with standard of care burn treatment(s).

    Device Description

    The OrthoGold 100™ is a pulsed acoustic wave device. It includes an electrically powered generator to generate transient compressed air that rapidly expands to create the acoustic waves, which in turn are propagated through a water-filled coupling membrane attached to the hand-held applicator. The hand-held applicator reflects the acoustic waves towards the treatment area through a silicone membrane and ultrasound transmission gel.

    AI/ML Overview

    The provided document describes the FDA 510(k) clearance for the OrthoGold 100 device, an extracorporeal shock wave device. The information details the device's indications for use, a comparison to a predicate device, and performance data including non-clinical, animal, and clinical studies.

    Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

    Acceptance Criteria and Reported Device Performance

    The acceptance criteria are implicitly demonstrated through the clinical study's primary endpoint, which showed a statistically significant improvement in the time to epithelialization. The safety was also assessed by monitoring adverse events.

    Acceptance Criteria (Implicit)Reported Device Performance
    Efficacy: Show significant reduction in wound healing time for superficial partial thickness second-degree burns.Efficacy Met: Mean time to ≥95% epithelialization was significantly shorter for the ESWT group (9.6 ± 1.7 days) vs. control (12.5 ± 2.2 days), with p<0.0005. This demonstrates a clear improvement in wound healing time.
    Safety: No significant increase in adverse events (e.g., cardiac, neurological, dermal, allergic reactions, infections) compared to standard of care.Safety Met: "There were no reported cardiac, neurological, dermal, or allergic reactions." Clinically apparent burn wound infection (9% ESWT vs. 14% control, p=0.99) and postburn bacteremia/other nosocomial infections (8% ESWT vs. 16% control) did not differ significantly between groups. This indicates a comparable safety profile to standard of care.
    Biocompatibility/Electrical Safety/EMC: Meet relevant performance standards.Met: "The OrthoGold 100™ was tested for electrical safety and electromagnetic compatibility and pressure field measurements. In addition, probe cover testing and transport verification and validation was also conducted. The testing demonstrated that the OrthoGold 100™ met performance requirements..."

    Study Details:

    1. Sample Size Used for the Test Set and Data Provenance:

      • Test Set Sample Size: A prospective randomized controlled study with 44 patients in each group (treatment and control).
      • Data Provenance: The document does not explicitly state the country of origin. It was a prospective study.

    2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

      • The document describes a clinical trial evaluating the device's effect on wound healing (epithelialization). The "ground truth" here is the clinical outcome (time to 95% epithelialization and occurrence of adverse events), which would have been assessed by treating physicians and study personnel. The document does not specify the number or qualifications of experts involved in establishing this clinical "ground truth" beyond implying that qualified medical professionals conducted the study.

    3. Adjudication Method for the Test Set:

      • The document describes a clinical trial measuring objective outcomes (time to epithelialization, infection rates). It does not explicitly mention an adjudication method for subjective assessments, as the primary endpoint (epithelialization time) is a measurable clinical outcome.

    4. 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:

      • No. This device is an extracorporeal shock wave device for treating burns, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.

    5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

      • Not applicable. This device is a physical therapy device; it does not have an "algorithm-only" mode of operation in the context of AI. Its "performance" is its therapeutic effect, which is measured clinically.

    6. The Type of Ground Truth Used:

      • The primary ground truth for efficacy was clinical outcomes data related to wound healing, specifically the mean time to ≥95% epithelialization.
      • For safety, the ground truth was recorded adverse events (cardiac, neurological, dermal, allergic reactions, infections).

    7. The Sample Size for the Training Set:

      • The document does not mention a "training set" in the context of machine learning. The clinical study described is a traditional randomized controlled trial to assess the device's efficacy and safety for its intended use, not to train a machine learning algorithm.

    8. How the Ground Truth for the Training Set Was Established:

      • Not applicable, as there was no mention of a machine learning training set for this device. The clinical study design serves as the primary evidence for its performance.
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