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510(k) Data Aggregation

    K Number
    K961464
    Device Name
    SELECT/SP
    Manufacturer
    ELSCINT, INC.
    Date Cleared
    1996-07-03

    (77 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K884667,K954678,K930090
    Why did this record match?
    Device Name :

    SELECT/SP

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

    Not Found

    Device Description

    The SeleCT/SP is a cost effective spiral scanner, with compact siting requirements and real-time image processing functions.

    AI/ML Overview

    The provided text describes a CT scanner (SeleCT/SP) and establishes its substantial equivalence to a predicate device (HeliCAT, K930090) based on safety and effectiveness. However, it does not contain specific acceptance criteria, performance metrics, or details of a study as requested in your prompt.

    Therefore, I cannot fill in the table or provide information for most of your numbered points. The document focuses on regulatory equivalence rather than a detailed performance study against specific acceptance criteria.

    Here's what I can extract and what is missing:

    1. Table of acceptance criteria and the reported device performance

    Acceptance CriteriaReported Device Performance
    Not specified in the documentNot specified in the document
    Implied/General: Safety not significantly different from predicate device (HeliCAT)"The SeleCT/SP complies with IEC601-1 safety standard. Its safety is not significantly different from the predicate device."
    Implied/General: Effectiveness not significantly changed in respect to predicate device (HeliCAT)"The effectiveness of SeleCT/SP is not significantly changed in respect to the predicate device. HeliCAT..."
    Detail (effectiveness comparison to another device): Lower spatial resolution and X-ray power similar to Exel 905 GT."the lower spatial resolution and X-ray power are similar to those of Exel 905 GT."

    2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

    • Not provided. The document does not describe any specific test set or data. It relies on a comparison to predicate devices.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

    • Not applicable. No test set or ground truth establishment process is described.

    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

    • Not applicable. No test set or adjudication process is described.

    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

    • No. This document is for a CT scanner, not an AI-assisted device. No MRMC study is mentioned.

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

    • No. This is for a CT scanner.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

    • Not applicable. No test set or ground truth establishment process is described. The "ground truth" for this submission appears to be regulatory compliance and comparison to existing, approved devices.

    8. The sample size for the training set

    • Not applicable. This document describes a medical imaging device, not a machine learning model that would require a training set.

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

    • Not applicable. As above, no training set is relevant to this submission.
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