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510(k) Data Aggregation

    K Number
    K140680
    Device Name
    LEADPOINT FOCUS WORKSTSTION, LEADPOINT FOCUS NOTEBOOK SYSTEM
    Manufacturer
    ALPINE BIOMED APS
    Date Cleared
    2014-12-12

    (269 days)

    Product Code
    GZL
    Regulation Number
    882.1330
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K071364
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Leadpoint Focus microelectrode targeting system is intended to assist in neurosurgical procedures where recording of neuronal activity and stimulation of brain neurons will aid in the placement of depth electrodes.
    The Leadpoint Focus microelectrode targeting system is intended to be used in the operating room by a neurosurgeon, neurologist, or clinical neurophysiologist.

    Device Description

    Intraoperative microelectrode recording (MER) has been introduced to improve the target localization during stereotactic surgery. The Leadpoint Focus is a MER system which consists of the Leadpoint Focus Software, Focus Hardware, a Macro Stimulator, a MER amplifier and a sterile interconnection cable (MER Cable) that connects the system to a Microelectrode. The Microelectrode is supplied by another manufacturer and is not part of the Leadpoint Focus system.

    AI/ML Overview

    The provided text describes the Leadpoint Focus Microelectrode Targeting System, its intended use, and a comparison to a predicate device (FHC, Inc. Guideline 4000). It also mentions performance data related to software and electrical safety/EMC testing, but it does not contain information about studies measuring device performance against acceptance criteria in a clinical context.

    Therefore, I cannot populate many of the requested fields as detailed clinical study information is absent from the provided document.

    Here's what can be extracted based on the document:

    1. Table of acceptance criteria and the reported device performance:

    The document describes technical compliance rather than clinical performance criteria.

    Acceptance Criteria (Technical/Compliance)Reported Device Performance
    Software Compliance:
    FDA guidance: "The content of premarket submissions for software contained in medical devices, 11 May 05"Tested in accordance with this guidance.
    FDA guidance: "Off-the-shelf software use in medical devices, 09 Sep 99"Tested in accordance with this guidance.
    Electrical Safety:
    IEC 60601-1:1988 + A1:1991 + A2:1995Complies with this standard.
    Electromagnetic Compatibility (EMC):
    EN/(IEC) 60601-1-2:2007 (3rd edition)Complies with this standard.
    EN/(IEC) 60601-2-40:1998, section 5Complies with this standard.
    EN/(IEC) 61000-3-2:2006+A1+A2Complies with this standard.
    EN/(IEC) 61000-3-3:2008Complies with this standard.

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

    No information provided. The document focuses on technical compliance and comparison to a predicate device, not clinical validation with a test set of data.

    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):

    No information provided. (Not applicable as no clinical test set is described).

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

    No information provided. (Not applicable as no clinical test set 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 information provided. This device is a microelectrode targeting system, not an AI-assisted diagnostic tool that would typically involve a multi-reader multi-case study in the context of "human readers improving with AI."

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

    No information provided. The device is intended to "assist in neurosurgical procedures" and be "used in the operating room by a neurosurgeon, neurologist, or clinical neurophysiologist," inherently indicating human-in-the-loop operation.

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

    No information provided about clinical ground truth. The "ground truth" demonstrated here is compliance with technical and safety standards.

    8. The sample size for the training set:

    No information provided. (Not applicable as the document describes a medical device, not an AI/ML model requiring a training set in the conventional sense).

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

    No information provided. (Not applicable).

    Summary of available information regarding the "study that proves the device meets the acceptance criteria":

    The document primarily describes various technical compliance tests (software, electrical safety, EMC) to demonstrate that the Leadpoint Focus system adheres to established industry standards. These tests serve as the "study" proving it meets the technical acceptance criteria. The specific methodologies mentioned are in accordance with the listed FDA guidances and IEC/EN standards. The conclusion states that the comparison to the predicate device and these performance data demonstrate the system is "safe and effective for its intended use and is substantially equivalent to the predicate devices." No clinical performance study with patient data or expert assessments is provided in this summary.

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