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510(k) Data Aggregation

    K Number
    K963334
    Device Name
    JAMIESON MODEL 2100 CINE FILM PROCESSOR AND KODAK CINEFLURE PROCESSOR MODEL 2100
    Manufacturer
    JAMIESON FILM CO.
    Date Cleared
    1996-09-11

    (16 days)

    Product Code
    IXX
    Regulation Number
    892.1900
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    IXX

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

    Not Found

    Device Description

    The Model 2100 is a leader card black-and-white 35 mm cine film processor, most commonly used for developing cineangiogram films. The Model 2100 has four (4) tanks, the developer, fixer, wash, and dryer tanks. The Model 2100 is 58.5 inches long, 17 inches wide, and 43 inches high.

    AI/ML Overview

    This document is a 510(k) Summary for a film processor (Jamieson Model 2100 Cine Processor and Kodak Cineflure Processor Model 2100). It describes the device, its intended use (developing cine angiogram films), and states that it has been altered to meet electrical and safety requirements and customer preferences.

    However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies pertaining to AI or algorithmic performance.

    The document is a safety and efficacy summary for a physical medical device (film processor), not a software or AI-driven diagnostic device. Therefore, the questions posed in the prompt (which are typically relevant for AI/ML-based medical devices) are not applicable to the information provided in this 510(k) summary.

    In summary:

    1. A table of acceptance criteria and the reported device performance: Not found.
    2. Sample sized used for the test set and the data provenance: Not found.
    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not found.
    4. Adjudication method for the test set: Not found.
    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, no AI component.
    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, no algorithm.
    7. The type of ground truth used: Not applicable.
    8. The sample size for the training set: Not applicable.
    9. How the ground truth for the training set was established: Not applicable.
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