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510(k) Data Aggregation

    K Number
    K193441
    Device Name
    Aqua Naina Sterile Saline Solution
    Manufacturer
    Chemtex USA, Inc.
    Date Cleared
    2020-05-26

    (167 days)

    Product Code
    LPN
    Regulation Number
    886.5928
    Type
    Traditional
    Panel
    Ophthalmic (OP)
    Reference & Predicate Devices
    K110221,K002319
    Why did this record match?
    Device Name :

    Aqua Naina Sterile Saline Solution

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

    Aqua Naina Sterile Saline Solution is indicated only for rinsing soft contact lenses after cleaning and disinfection before use.

    Device Description

    Aqua Naina Sterile Saline Solution is a sterile, preservative-free, buffered, isotonic, clear colorless aqueous solution containing isotonic solution of sodium chloride, boric acid and sodium borate in purified water USP. Aqua Naina Sterile Saline Solution has pH of 6.30 to 7.80 and Osmolality of 280 to 320 mOsmol/kg The Sterile Saline Solution is packed in 4 fl oz (118ml) high density polyethylene (HDPE) container with a tamper evident seal.

    AI/ML Overview

    The provided text describes the 510(k) Premarket Notification for Aqua Naina Sterile Saline Solution and its substantial equivalence to predicate devices. It focuses on the chemical composition, intended use, and various safety tests (sterility, biocompatibility, ocular irritation, cytotoxicity).

    However, this document does not describe acceptance criteria, performance data, or study details relevant to a machine learning or AI device. The device in question is a sterile saline solution, which is a chemical product, not a medical imaging or AI diagnostic device. Therefore, the requested information about test sets, data provenance, expert consensus, MRMC studies, or training sets is not applicable to this submission.

    The "study that proves the device meets the acceptance criteria" in this context refers to a series of chemical and biological tests conducted on the saline solution to demonstrate its safety and performance, as outlined in section (7) "PERFORMANCE STSTANDARDS APPLIED".

    Here's a breakdown of what is provided and why it doesn't fit the typical AI/ML device study format:

    • Device: Aqua Naina Sterile Saline Solution (a chemical product for contact lens care).

    • Acceptance Criteria & Reported Performance: These are presented implicitly through the successful completion of various tests against established standards for saline solutions.

      • Sterility: USP
      • Bacteriostasis: USP
      • Ocular irritation: Tested per ISO 10993-10:2010
      • Cytotoxicity (Direct contact test & MEM Elution test): Tested per ISO 10993-5:2009
      • Biocompatibility: Tested per ISO 10993-1:2009
      • pH: 6.30 to 7.80 (reported in description)
      • Osmolality: 280 to 320 mOsmol/kg (reported in description)
        The document states: "Results of all testing demonstrate the solution is non-toxic, is comparable to other currently marketed soft contact lens solution and is substantially equivalent to legally marketed predicates." This is the reported device performance meeting the acceptance criteria set by these standards.

    • Sample Size for Test Set and Data Provenance: Not applicable. This refers to chemical and biological samples, not image datasets. The tests are laboratory-based, not based on patient data in the sense of AI/ML.

    • Number of Experts, Qualifications, Adjudication Method: Not applicable. These relate to human interpretation of diagnostic data, which is not relevant for testing a saline solution.

    • MRMC Comparative Effectiveness Study: Not applicable. This is for evaluating AI assistance in diagnostic tasks.

    • Standalone Performance (algorithm only): Not applicable, as there is no algorithm.

    • Type of Ground Truth: Not applicable in the AI/ML sense. Ground truth here is established by laboratory measurements and biological assays, comparing results against defined pass/fail criteria from recognized standards (e.g., USP, ISO).

    • Sample Size for Training Set & How Ground Truth for Training Set was Established: Not applicable. There is no machine learning model involved, therefore no training set. The "training" of the product is its formulation and manufacturing process, and its "ground truth" is its chemical and physical properties verified through standard laboratory testing.

    In summary, the provided document details the regulatory clearance of a contact lens saline solution, not an AI/ML-based medical device. Therefore, the questions posed regarding AI/ML device acceptance criteria and study methodology cannot be answered from this information.

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