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510(k) Data Aggregation

    K Number
    K203634
    Device Name
    BioPoly Great Toe Hemiarthroplasty Implant
    Manufacturer
    BioPoly, LLC
    Date Cleared
    2021-02-02

    (53 days)

    Product Code
    KWD
    Regulation Number
    888.3730
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K781870,K070052,K190543
    Why did this record match?
    Device Name :

    BioPoly Great Toe Hemiarthroplasty Implant

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

    The BioPoly Great Toe Hemiarthroplasty implant is intended to replace the distal metatarsal surface of the great toe of patients with degenerative and post-traumatic arthritis in the presence of good bone stock along with the following clinical conditions: hallux limitus, hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The device is a single use implant intended to be used with bone cement.

    Device Description

    The BioPoly Great Toe Hemiarthroplasty Implant is a hemi-arthroplasty device specifically designed to restore the articular surface of the first metatarsal bone in patients with degenerative and post-traumatic arthritis.

    The implant is comprised of BioPoly (UHMWPE/hyaluronic acid) direct compression molded onto a Ti-6Al-4V stem. A porous stem option is available, which additionally contains OsteoSync™ Ti, a porous titanium (CP Ti) material.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for the BioPoly Great Toe Hemiarthroplasty Implant. This document focuses on the substantial equivalence of the device to existing predicate devices, rather than an AI/ML medical device. Therefore, a table for "acceptance criteria and reported device performance" as typically understood for AI/ML devices (e.g., sensitivity, specificity, AUC) and other details about an AI/ML study are not applicable or extractable from this document.

    However, I can extract the performance testing summaries for the device as described, which demonstrate its mechanical and material properties.

    Performance Testing Summary for BioPoly Great Toe Hemiarthroplasty Implant (Not an AI/ML device)

    Test CategoryAcceptance Criteria (General Description)Reported Device Performance (Summary)
    Mechanical Testing
    Initial FixationMeet predetermined acceptance criterion & exceed predicate strengthMet the predetermined acceptance criterion and exceeded the predicate fixation strength.
    Shear TestingMeet predetermined acceptance criterionMet the predetermined acceptance criterion.
    Fatigue TestingMeet predetermined acceptance criterionMet the predetermined acceptance criterion.
    Wear TestingMeet predetermined acceptance criterionSignificantly less wear of the BioPoly material compared to predicate materials (CoCrMo and Silastic) against cartilage. Significantly less cartilage wear when articulating with BioPoly than with CoCrMo or Silastic.
    BioPoly Material Testing
    Tensile & Impact StrengthMeet or exceed ASTM F648 Type 1 (impact) and Type 2/3 (tensile) requirementsMet or exceeded the Type 1 (impact strength) and Type 2 / 3 (tensile) requirements per ASTM F648.
    Fatigue Crack Propagation(No specific criterion mentioned, but conducted)Conducted per ASTM E647.
    Density TestingMeet ASTM F648 Type 1 requirementsMet the Type 1 requirements per ASTM F648.
    Oxidative Index Testing(No specific numerical criterion)Showed no measurable oxidative index ("non-detectable") per ASTM F2102.
    Morphology Testing(No specific criterion mentioned, but for full consolidation)Showed full consolidation of the BioPoly material per ASTM F648.
    Creep Testing(No specific criterion, but for consistency with control)Showed no difference between BioPoly material and UHMWPE control creep strain and creep modulus per ASTM D2990.
    Coefficient of Friction (against cartilage)(No specific numerical criterion)Significantly lower than that of CoCrMo, silicone, and UHMWPE.
    Pin on Disc (POD) Testing(No specific criterion, but for wear rate)Wear rate of BioPoly material against cobalt chrome is significantly less than that of UHMWPE control.
    Enzyme Degradation Testing(No specific criterion, but for stability)BioPoly material in its final form is not degraded in the presence of hyaluronidase enzyme.
    Bacterial EndotoxinMeet predetermined acceptance criteria (LAL method)Measured levels were , USP , EP 2.6.14, and JP 4.01).

    Non-Applicable Sections for this Device (as it is not an AI/ML medical device):

    The following information is specifically requested for Artificial Intelligence/Machine Learning (AI/ML) medical devices and is not applicable to the BioPoly Great Toe Hemiarthroplasty Implant, which is a physical implant, not a software device that relies on AI/ML algorithms for its function. Therefore, the document does not contain information on these points:

    1. Sample size used for the test set and the data provenance: Not applicable.
    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
    3. Adjudication method for the test set: Not applicable.
    4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
    5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
    6. The type of ground truth used: Not applicable.
    7. The sample size for the training set: Not applicable.
    8. How the ground truth for the training set was established: Not applicable.
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