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510(k) Data Aggregation

    K Number
    K992431
    Device Name
    NEO-2 METER
    Manufacturer
    AUTOMATA INSTRUMENTATION, INC.
    Date Cleared
    1999-10-13

    (84 days)

    Product Code
    FIZ
    Regulation Number
    876.5820
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    NEO-2 METER

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

    The NEO-2 Meter may be used by hemodialysis personnel to test conductivity, temperature, pressure, and pH of the dialysate solution used with hemodialysis delivery systems. The NEO-2 Meter may also be used to test the conductivity/temperature and pH of acid and sodium bicarbonate dialysate concentrates and water used in hemodialysis applications.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device called the "NEO-2 Meter". It indicates that the device has been found substantially equivalent to a predicate device. However, the provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria.

    The text only states:

    • Device Name: NEO-2 Meter
    • Intended Use: To test conductivity, temperature, pressure, and pH of the dialysate solution used with hemodialysis delivery systems, and the conductivity/temperature and pH of acid and sodium bicarbonate dialysate concentrates and water used in hemodialysis applications.
    • Regulatory Class: II (21 CFR §876.5820/Product Code: 78 FIZ)
    • Date of Clearance: October 13, 1999

    Therefore, I cannot provide the requested information regarding acceptance criteria and studies because it is not present in the provided text. The output will reflect this lack of information for each requested point.

    Acceptance Criteria and Study Information for NEO-2 Meter

    Based on the provided document, the following information regarding acceptance criteria and supporting studies for the NEO-2 Meter is not available:

    1. Table of acceptance criteria and reported device performance:

      • No acceptance criteria are mentioned in the document.
      • No device performance data is reported.

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

      • No information about a test set or its sample size is provided.
      • No data provenance (country of origin, retrospective/prospective) is mentioned.

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

      • No information regarding experts or ground truth establishment is provided.

    4. Adjudication method for the test set:

      • No information regarding a test set or adjudication method is provided.

    5. Multi-reader multi-case (MRMC) comparative effectiveness study and effect size:

      • No MRMC study or comparative effectiveness data is mentioned.

    6. Standalone (algorithm-only) performance:

      • The NEO-2 Meter is a physical measurement device, not an AI/algorithm-based device in the context typically described by "standalone performance." Therefore, this question is not applicable, and no such study is mentioned anyway.

    7. Type of ground truth used:

      • No information about the type of ground truth is provided.

    8. Sample size for the training set:

      • This question is typically relevant for machine learning models. As the NEO-2 Meter is a measurement device, a "training set" in this context is not applicable. No information about any training data is provided.

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

      • As with point 8, this is not applicable for this type of device, and no relevant information is provided.
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