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510(k) Data Aggregation

    K Number
    K201391
    Device Name
    Easytech® Anatomical Shoulder System
    Manufacturer
    FX Shoulder USA, Inc.
    Date Cleared
    2021-02-16

    (265 days)

    Product Code
    PKC
    Regulation Number
    888.3660
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K143552,K163669,K183194
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Easytech® Anatomical Shoulder System is in total shoulder repacement to treat a severely painf il and/or disabled joint resulting from osteoarthritis.

    The humeral stemless of the Easytech® Anatomical Shoulder is intended for cementless use only. The glencid components of the Easytech® Anatomical Shoulder System are intended for cemented use only.

    The patient's joint must be anatomically suited to receive the selected implants and a functional rotator cuff is necessary to use the device.

    Device Description

    The Easytech® Anatomical Shoulder is an anatomical shoulder prothesis designed for use in patients with a functional rotator cuff. The Easytech® humeral stemless (Anchor base) is used with a connector, a centered or offset humeral head, and a glenoid for use in an anatomical shoulder configuration.

    This system is designed to articulate with a glenoid component for total shoulder arthroplasty. Subject of this submission is the cementless, stemless Humeral Anchor base that is part of the Easytech® Anatomical Shoulder System. The compatible components to complete the system have been cleared previously in K111097, K123814, and K163669.

    The Easytech® Anchor base is a stemless prosthesis. The cementless Anchor base is available in diameters of 30 to 38 mm. The Anchor base has a main central post with striaes. In the periphery of the Anchor base, five retentives striaes are positioned to help with the primary fixation. The undersurface of the Anchor base, including the central post and retentive striaes, has a plasma sprayed CPTitanium and Hydroxyapatite coating without the superior surface and the female taper. The Anchor base incorporates a female taper for attachment of compatible components. This component is manufactured in Ti-6AI-4V ELI allov conforming to ISO 5832-3.

    The Anchor base can be used with a straight taper connector or a centered spacer manufactured from Ti-6Al-4V ELI alloy conforming to ISO 5832-3, a centered or offset humeral head manufactured from wrought Co-Cr-Mo alloy conforming to ISO 5832-12 and a 2 pegs or 3 or 4 pegs cemented glenoid manufactured from ultra high molecular weight polyethylene (UHMWPE) conforming to ISO 5834-2 for use in an anatomical shoulder configuration.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

    Acceptance Criteria and Device Performance

    Acceptance CriteriaReported Device Performance
    Primary Endpoint (Clinical Success at 24+ Months): Percentage of subjects where: - Adjusted Constant Score >54 AND improved from baseline >10 - No migration or subsidence - No radiolucencies of the humeral or glenoid components - Implant integrity maintained - No revision surgery - No serious adverse device event91.7% (with a lower two-sided 90% confidence bound of 87.3%). This is compared to a performance goal for the predicate device of 92.3% and a reference margin of 10%. The lower bound (87.3%) being greater than (92.3% - 10% = 82.3%) indicated success.
    Adjusted Constant Score Improvement: Clinically significant improvement in Adjusted Constant Score from preoperative baseline.Average Month 24+ Adjusted Constant Score: 99.14 (SD 18.73). Clinically significant improvement (p < 0.0001) from preoperative baseline of 55.68 (SD 18.50). 99.0% of patients achieved Adjusted Constant Score success.
    Range of Motion Improvement: Significant improvement from preoperative to postoperative.Showed significant improvement from preoperative to postoperative (p < 0.0001).
    Radiographic Findings: No migration or subsidence of humeral or glenoid components, no radiolucencies, no anatomic fractures, and no issues with implant integrity (as reported by independent radiograph review).Independent radiograph review reported no migration or subsidence of humeral or glenoid components, no radiolucencies, no anatomic fractures, and no issues with implant integrity.
    Clinical Success of Anchor Base: (Implicit, based on SADE analysis)99.2%
    Device Survivorship: (Implicit, based on long-term performance)95% survivorship at an average 3 years follow-up.
    Safety Profile: Equivalent to other total anatomic shoulder devices regarding potential risks and adverse event rates.The overall adverse event rate was low. The stemless humeral design did not create an increased risk for loosening or revision. The device has an equivalent safety profile and is at least as safe as other total anatomic shoulder arthroplasty systems. Eight (8) serious adverse device effects (SADE) in 8 patients were reported (4 instability, 3 dislocation, 1 glenoid loosening). Seven resulted in secondary surgical procedures, five of which converted to reversed shoulder without removal of the well-fixed Anchor base. One dislocation was reduced, and one required Anchor base revision.

    Study Details

    1. Sample size used for the test set and the data provenance:

      • Sample Size: 129 patients (from an initial 141; 7 refused data sharing, 5 had non-osteoarthritis diagnoses).
      • Data Provenance: Retrospective, multi-center study conducted at 5 sites in France. This is described as "real-world evidence" reflecting clinical experience by orthopedic surgeons in community and clinic-based practices.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

      • The document mentions "Independent radiograph review" was conducted, but does not specify the number of experts or their qualifications.

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

      • The document does not specify an adjudication method for the test set. It mentions "Independent radiograph review," suggesting individual assessment, but no mechanism for resolving discrepancies is detailed.

    4. 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 MRMC comparative effectiveness study was done. This study is a clinical efficacy and safety study of a medical device (shoulder prosthesis) in patients, not an AI diagnostic tool's performance with human readers.

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

      • No standalone algorithm performance study was done. This is a study of a physical medical device.

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

      • The ground truth for the clinical success criteria was established using a combination of:
        • Clinical Outcomes Data: Adjusted Constant Score (a standardized patient outcome measure), Range of Motion measurements.
        • Radiographic Review: For migration, subsidence, radiolucencies, and implant integrity.
        • Event-Based Data: Absence of revision surgery, absence of serious adverse device events.

    7. The sample size for the training set:

      • Not applicable/Not provided. This refers to a clinical study of a physical medical device, not a machine learning model that requires a training set. The "training" here would be general surgical training and experience.

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

      • Not applicable/Not provided. As above, this is for a physical device, not an AI/ML system.
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