LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K171519
    Device Name
    FLXfit™
    Manufacturer
    Expanding Orthopedics, Inc.
    Date Cleared
    2017-09-15

    (114 days)

    Product Code
    MAX
    Regulation Number
    888.3080
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K133813,K080537
    Why did this record match?
    Reference Devices :

    K133813, K080537

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

    The EOI FLXfit™ 15 and FLXfit™ Intervertebral body fusion device is indicated for interbody fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. The EOI FLXfit™ 15 and FLXfit™ devices are intended to be used with supplemental spinal fixation system and with autogenous bone graft.

    Important: FLXfit™ 15 must be applied in combination with posterior fusion system such as the EOI Spinal System.

    Device Description

    EOI FLXfit15 Intervertebral Body Fusion Device is made from titanium (Ti6Al4V-ELI per ASTM F136). This is an articulated-expanded device with height ranges from 8mm through 13mm. The device also expands in height to provide lordosis angle correction of up to 15°.

    AI/ML Overview

    This document describes a 510(k) premarket notification for the FLXfit™ 15 intervertebral body fusion device. While it details the device and its intended use, it does not contain information about a study that assesses its performance against specific acceptance criteria in a clinical or AI-related context. Instead, it focuses on the device's mechanical properties and its substantial equivalence to a predicate device.

    Therefore, I cannot fulfill your request for:

    • A table of acceptance criteria and reported device performance (in a clinical/AI sense).
    • Sample size used for the test set and data provenance.
    • Number of experts used to establish ground truth and their qualifications.
    • Adjudication method for the test set.
    • MRMC comparative effectiveness study results.
    • Standalone (algorithm only) performance.
    • Type of ground truth used.
    • Sample size for the training set.
    • How ground truth for the training set was established.

    The document primarily discusses performance testing summary which refers to mechanical testing of the device, not clinical performance or an AI study.

    Here's what the document does provide regarding performance testing:

    1. Acceptance Criteria and Reported Device Performance (Mechanical Testing):

    Acceptance Criteria (Test)Reported Device Performance (Implied Meeting of Standards)
    Dynamic and static compression per ASTM F2077The document states that testing was conducted to "demonstrate that the modifications... provide adequate and substantially equivalent mechanical strength for their intended use." Implies the device met the standards of ASTM F2077.
    Dynamic and static shear compression per ASTM F2077The document states that testing was conducted to "demonstrate that the modifications... provide adequate and substantially equivalent mechanical strength for their intended use." Implies the device met the standards of ASTM F2077.
    Subsidence per ASTM F2267The document states that testing was conducted to "demonstrate that the modifications... provide adequate and substantially equivalent mechanical strength for their intended use." Implies the device met the standards of ASTM F2267.

    2. Sample Size Used for the Test Set and Data Provenance:
    * Test Set Sample Size: Not specified for mechanical testing.
    * Data Provenance: Not applicable in the context of clinical or AI data. The tests are physical mechanical tests conducted on device prototypes.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
    * Not applicable as this is mechanical testing to ASTM standards, not clinical ground truth established by experts.

    4. Adjudication Method for the Test Set:
    * Not applicable.

    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 does not describe an MRMC study or any AI component.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
    * No, this document does not describe any standalone algorithm performance.

    7. The type of ground truth used:
    * For mechanical testing, the "ground truth" is defined by the specific performance parameters and thresholds outlined in the referenced ASTM standards (F2077, F2267).

    8. The sample size for the training set:
    * Not applicable. There is no AI model or training set discussed.

    9. How the ground truth for the training set was established:
    * Not applicable.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1