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510(k) Data Aggregation

    K Number
    K963541
    Device Name
    SIGMA DIAGNOSTICS CO2 ACID REAGENT
    Manufacturer
    SIGMA DIAGNOSTICS, INC.
    Date Cleared
    1996-10-24

    (50 days)

    Product Code
    JFL
    Regulation Number
    862.1160
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K963541
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Used to measure carbon dioxide concentrations in serum or plasma on the SYNCHRON CX®3 System.

    Device Description

    CO2 Acid Reagent, Procedure Number C7558

    AI/ML Overview

    This document is a 510(k) Notification for a diagnostic medical device, specifically the Sigma Diagnostics CX®3 CO2 Acid Reagent. It is not based on AI/ML; it's a traditional chemical reagent for measuring carbon dioxide. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC studies, training set details) are not applicable to this type of device and study.

    However, I can extract the information relevant to its performance and acceptance criteria based on the provided text.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Implied)Reported Device Performance
    Substantial equivalency to predicate deviceCorrelation coefficient: 0.992
    Regression equation: y = 0.95x + 1.54
    Within-run precision (Implied %CV target)%CV < 6.5%
    Total precision (Implied %CV target)%CV < 6.5%
    Linearity (Implied acceptable range)Linear from 5.0 to 40.0 mmol/L
    Identical reaction principlesReaction principles are identical to predicate device

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

    • Sample size: Not explicitly stated. The text mentions "serum samples" were used in comparison studies, but the exact number is not provided.
    • Data provenance: "Serum samples." The country of origin is not specified, but the submission is to the FDA in the US. The study is retrospective in the sense that existing serum samples would have been used.

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

    • Not applicable. This is a chemical reagent. "Ground truth" would be established by the reference method or the predicate device's accepted performance, not by expert interpretation.

    4. Adjudication method for the test set

    • Not applicable. This is a chemical reagent. Data comparison would involve statistical analysis against the predicate device, not expert adjudication.

    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 not AI-based, nor does it involve human readers interpreting images or data in the context of AI assistance.

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

    • Not applicable. This device is a chemical reagent, not an algorithm. Its performance is inherent in its chemical reaction.

    7. The type of ground truth used

    • The "ground truth" or reference for comparison was the Beckman CO2 Acid Reagent Kit, Part No. 443330. The study aimed to demonstrate substantial equivalence to this predicate device rather than an absolute biological truth established by, for example, pathology or outcomes data.

    8. The sample size for the training set

    • Not applicable. This is a chemical reagent, not an AI/ML algorithm that requires a training set.

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

    • Not applicable. No training set was used.
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