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510(k) Data Aggregation

    K Number
    K021937
    Device Name
    TGDC-01 PRA
    Manufacturer
    TRUEVISION INSTRUMENTS
    Date Cleared
    2002-10-11

    (121 days)

    Product Code
    HKX
    Regulation Number
    886.1930
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    K981432,K943939
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRUEVISION INSTRUMENTS

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

    The TGDC - 01 PRA Tonometer is used to measure ocular pressure (IOP) in the diagnosis for use. The intended device is 0, 1101.

    Device Description

    The TGDc-01 "PRA" is a portable tonometer that measures IOP through the eyelid in the sclera area. It has a measurement range of 5-60 mm Hg, a single measurement time of not more than 3 seconds, and uses 2 CR2032 batteries. It weighs not more than 79 g and has dimensions of 173.5 x 25.5 x 19.5 mm. It displays the IOP measurement on an LCD screen.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Tonometer TGDc-01 "PRA", based on the provided 510(k) summary:

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided document does not explicitly state quantitative acceptance criteria or a formal study with statistical targets for performance. Instead, it relies on a qualitative comparison to predicate devices and highlights the device's technological characteristics.

    However, based on the narrative, the implicit acceptance criteria are that the TGDc-01 "PRA" performs equivalently to the predicate devices (Goldmann Tonometer and Canon T-2 Non-Contact Tonometer) in terms of IOP measurement, particularly demonstrating "high coincidence degree in the whole range."

    Acceptance Criteria (Inferred from Narrative)Reported Device Performance
    IOP Measurement Equivalence to Predicate Devices"high coincidence degree in the whole range with the compared devices."
    Measurement Range: 5-60 mm Hg5-60 mm Hg
    Single Measurement Time: = 15001500 (not less)
    Serviceability: >= 8 years8 years (not less)
    Weight:
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