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510(k) Data Aggregation

    K Number
    K250519
    Device Name
    Lap.Ox™ Laparoscopic Tissue Oximeter
    Manufacturer
    ViOptix, Inc.
    Date Cleared
    2025-06-26

    (125 days)

    Product Code
    MUD
    Regulation Number
    870.2700
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K233488
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Lap.Ox™ Laparoscopic Tissue Oximeter is intended to estimate the percent oxygen saturation (StO2) in a volume of tissue, including bowel tissue, during laparoscopy.

    The Lap.Ox™ Laparoscopic Tissue Oximeter is indicated for use in monitoring patients during circulatory or perfusion assessment during laparoscopy.

    The Lap.Ox™ Laparoscopic Tissue Oximeter is intended to be used by physicians, surgeons, nurses, or other skilled users in a medical environment.

    The Lap.Ox™ Laparoscopic Tissue Oximeter should only be used on adult patients.

    Device Description

    The proposed Lap.Ox™ Laparoscopic Tissue Oximeter ("Lap.Ox" or "Device") is a cordless, battery-powered device that estimates the percent oxygen saturation (StO2) in a volume of tissue, including bowel tissue. The device includes two components:

    • a Reusable Main Unit that shows a digital readout of percent oxygen saturation (StO2) when the system is in contact with tissue (also denoted as "main unit" or "durable"); and
    • a Disposable Kit that contains two AA batteries and a sterile single-use disposable consisting of sources, detectors, a laparoscopic tube, and a sheath that is placed around the Reusable Main Unit (denoted as "Disposable").

    The Device uses spatially-resolved optical measurements at three wavelengths. The Device displays the StO2 estimate on the built-in screen. The Device is constructed from biocompatible materials that can tolerate bodily fluids. The basic principle of operation of the Lap.Ox Laparoscopic Tissue Oximeter is spectrophotometric oximetry which entails utilizing red and near-infrared light to measure the color of blood and determine an oxygen saturation value.

    AI/ML Overview

    The provided FDA 510(k) clearance letter for the Lap.Ox™ Laparoscopic Tissue Oximeter details aspects of its regulatory review, including its intended use, technological characteristics, and a summary of performance testing. However, the document does not provide specific acceptance criteria or detailed results of a study proving the device meets those criteria, particularly in the context of clinical performance or accuracy of StO2 measurements with numerical values.

    The letter broadly states that "The verification and validation studies demonstrated that Lap.Ox performs as intended" and "ViOptix conducted a clinical study... The results demonstrated that the performance of the Lap.Ox Laparoscopic Tissue Oximeter, on human subjects, is comparable to the predicate device."

    Without the actual study report or more detailed submission information, it's impossible to explicitly fill out the table and answer all questions with specific numerical values for device performance and study details.

    Based on the provided text, here is what can be inferred and what information is missing:

    Acceptance Criteria and Device Performance (Inferred/Missing)

    Given the device is an oximeter, typical acceptance criteria would involve accuracy and precision compared to a reference method (e.g., arterial blood gas analysis, or the predicate device's measured values). However, these specific criteria and the measured performance are not detailed in the provided text.

    Acceptance Criteria CategorySpecific Acceptance Criteria (Inferred/Expected, but NOT explicitly stated in text)Reported Device Performance (NOT explicitly stated in text)
    StO2 Measurement Accuracye.g., Mean Absolute Error (MAE) < X% or Agreement within Y% of reference/predicateNot provided in the document
    StO2 Measurement Precisione.g., Standard Deviation of differences < Z%Not provided in the document
    Comparability to PredicatePerformance "comparable" to predicate device"results demonstrated that the performance...on human subjects, is comparable to the predicate device." (No quantitative data)
    Functional as IntendedDevice operates reliably and displays StO2"tests demonstrated that the proposed device functions as intended for its proposed intended use"
    SafetyNo new safety concerns compared to predicate"do not raise different questions of safety or effectiveness"

    Study Details (Based on provided text and general knowledge of FDA submissions for this type of device)

    1. Sample Size and Data Provenance for Test Set:

      • Sample Size: Not specified. The document mentions "a clinical study...on human subjects."
      • Data Provenance: Conducted by ViOptix. The specific country of origin is not stated, but given the FDA clearance, it would likely adhere to US regulatory standards for clinical trials. The study was a "clinical study," implying it was prospective data collection.

    2. Number of Experts and Qualifications for Ground Truth of Test Set:

      • Number of Experts: Not specified.
      • Qualifications of Experts: Not specified. For an oximeter, ground truth might be derived from direct physiological measurements rather than expert interpretation of images.

    3. Adjudication Method for Test Set:

      • Not applicable/Not specified. Given the device measures a physiological parameter (StO2), "adjudication" (as typically used for image-based diagnostics) is not directly relevant in the same way. The ground truth source would be a reference standard for oxygen saturation. If it involved comparing to the predicate, then the predicate's reading would be the comparator, not an "adjudication."

    4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

      • No. This device is a physiological measurement device, not an AI-assisted diagnostic imaging device that involves human readers interpreting images. Therefore, an MRMC study is not applicable in this context. The study mentioned is a "clinical study" comparing the device's performance to a predicate.

    5. Standalone (Algorithm-only) Performance:

      • Yes, implicitly. The device itself is a standalone oximeter that provides an StO2 reading. The "clinical study" would have evaluated this device's performance (i.e., its algorithm's output) compared to a reference or the predicate. The device doesn't have a "human-in-the-loop" in the sense of an AI assisting a human to make a diagnosis; it directly provides a measurement.

    6. Type of Ground Truth Used:

      • Implicitly, a reference standard for tissue oxygen saturation. This would likely be derived from a validated method of measuring tissue perfusion or oxygen saturation, or comparison to the predicate device, which is already cleared. The text states "comparison to the predicate device," which implies the predicate serves as the comparative "ground truth" for showing substantial equivalence.

    7. Sample Size for Training Set:

      • Not specified. The document mentions "development" and "bench testing data" to demonstrate performance, but does not explicitly detail a separate "training set" in the context of an algorithm's development (which is more common for machine learning/AI algorithms). For a traditional oximeter, calibration data might be used, but not typically referred to as a "training set" in the same way.

    8. How Ground Truth for Training Set Was Established:

      • Not specified. If a "training set" was used for algorithm development (e.g., calibrating the optical model), the ground truth would have been established through controlled experiments with known oxygen saturation levels or comparison to established gold standard oximetry methods. This detail is not provided.
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