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510(k) Data Aggregation

    K Number
    K152267
    Device Name
    Remedy® Shoulder Spacer
    Manufacturer
    Osteoremedies LLC
    Date Cleared
    2015-12-15

    (126 days)

    Product Code
    KWS,MBB
    Regulation Number
    888.3660
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K131135,K042021,K061454,K140063,K040432,K071032,K103466,K062273,K062274,K112470,K060535,K112983
    Why did this record match?
    Device Name :

    Remedy**®** Shoulder Spacer

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

    The Remedy® Shoulder Spacer, which consists of a modular head and stem, is indicated for temporary use (maximum 180 days) as an adjunct to total or hemi-shoulder replacement in skeletally mature patients undergoing a two-stage procedure due to a septic process and where gentamicin is the most appropriate antibiotic based on the susceptibility pattern of the infecting micro-organisms.

    The head and stem components are inserted into the glenoidal cavity and humeral medullary canal, respectively, following removal of the existing prosthetic components and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

    The Remedy® Shoulder Spacer is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion etc.).

    Device Description

    The Remedy® Shoulder Spacer is a sterile, single-use device intended for temporary use (maximum 180 days) as shoulder replacement.

    The Remedy® Shoulder Spacer is composed of two components (a head and a stem) that are intended to be used together to form a temporary shoulder spacer; the components are available in a range of sizes.

    The device is made of fully formed polymethylmethacrylate (PMMA), which is radioopaque and contains gentamicin. The stem component has also an inner stainless steel reinforcing structure.

    The Remedy® Shoulder Spacer provides a functional-mechanical mode of action; it provides patients a temporary implant allowing for a natural range of motion and partial weight-bearing during treatment. It is designed to preserve soft tissue to prevent further complications, such as muscular contraction, and to facilitate the subsequent joint replacement procedure.

    AI/ML Overview

    This document appears to be a 510(k) Summary for a medical device called the "Remedy® Shoulder Spacer." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study designed to meet specific acceptance criteria in the way one would for an AI/ML powered device.

    Therefore, many of the requested categories for AI/ML device studies (like sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this document as it describes a physical orthopedic implant, not a software algorithm.

    Below is an attempt to map the available information to the closest relevant categories, with explanations for why certain sections are not applicable.

    1. Table of Acceptance Criteria and Reported Device Performance

    As this is not an AI/ML device, the concept of "acceptance criteria" for diagnostic performance metrics (e.g., sensitivity, specificity, AUC) is not present. Instead, the document discusses performance testing designed to demonstrate safe and effective mechanical function and material properties, and equivalence to a predicate device. The "acceptance criteria" would be compliance with relevant standards and demonstration of properties comparable to the predicate.

    Acceptance Criteria (Implied)Reported Device Performance
    Sterilization: Compliance with international standards.Sterilization cycles validated following international standards.
    Shelf Life: Established through stability testing.Established through stability studies. Shelf life is 5 years, same as predicate.
    Biocompatibility: Safe, biocompatible materials for intended use, compliant with ISO 10993 and FDA Draft Guidance.Biocompatibility evaluation performed, showing device materials are safe, biocompatible, and suitable for intended use, taking into account ISO 10993 and FDA Draft Guidance.
    Mechanical Performance: Static and fatigue performance acceptable and comparable to predicate.Performance testing included evaluation of static and fatigue performances. (The document states "The performance data demonstrate that the new devices are substantially equivalent to the predicate device Tecres' Interspace Shoulder" implies these tests met the necessary benchmarks for equivalence).
    Surface Roughness: Acceptable and comparable to predicate.Performance testing included evaluation of surface roughness. (Implied acceptability and equivalence to predicate). Reference devices for surface roughness: Tecres InterSpace Knee (K062273 and K062274) and OsteoRemedies Knee Modular Spacer (K112470).
    Disassembling: Acceptable performance.Performance testing included evaluation of disassembling. (Implied acceptability and equivalence to predicate).
    Antibiotic Elution: Gentamicin elution effective and comparable to predicate.Performance testing included antibiotic (gentamicin) elution testing. (Implied acceptability and equivalence to predicate). The device is made of PMMA containing gentamicin, and the predicate also contains gentamicin. The indications for use specify "where gentamicin is the most appropriate antibiotic."
    Material Composition: Same as predicate.Main Components: Polymethylmethacrylate (PMMA), Methylmethacrylate (MMA), Barium Sulphate (Same as predicate).
    Other Components: Benzoyl peroxide, N,N-Dimethyl-p-toluidine, Hydroquinone (Same as predicate).
    Antibiotics: Gentamicin Sulphate (Same as predicate).
    Inner core: Stainless Steel (AISI 316 ESR) (Same as predicate).
    Design (Shape): Different but functionally equivalent.Design is Head + Stem (separated) for Remedy® vs. Head + Stem (monoblock) for predicate. This is a "Different" characteristic, but the overall performance data is presented to show substantial equivalence.
    Modularity: Different from predicate.Remedy® has 3 heads, 3 stems, offset adjustment vs. None for predicate. This is a "Different" characteristic, but the overall performance data is presented to show substantial equivalence, suggesting the modularity does not negatively impact safety or efficacy.
    Sizes: Different but comparable range.Head Size: Ø: 40 – 45 – 50 mm (Remedy®) vs. Ø: 41 – 46 mm (Predicate).
    Stem Size: L: 101 mm Ø: 7 mm, L: 116 mm Ø: 10.5 mm, L: 131 mm Ø: 14 mm (Remedy®) vs. L: 99 mm Ø: 7 mm, L: 125 mm Ø: 11 mm (Predicate). While "Different," the sizes are intended to cover most shoulder prosthesis configurations currently available, indicating a functional expansion rather than a deviation in core performance.
    Stem-neck angle: Same as predicate.130° (Same as predicate).
    X-ray visibility: Yes (Same as predicate).Yes (Same as predicate).
    Single-use device: Yes (Same as predicate).Yes (Same as predicate).
    Provided Sterile: Yes (Same as predicate).Yes (Same as predicate).
    Sterilization Method: Ethylene Oxide (Same as predicate).Ethylene Oxide (Same as predicate).
    Sterility Assurance Level (SAL): 10-6 (Same as predicate).10-6 (Same as predicate).

    2. Sample size used for the test set and the data provenance

    This is not applicable for a physical device 510(k) submission in the context of diagnostic "test sets." The performance data is based on laboratory testing of the device itself and its components, according to established engineering and material science protocols. There is no biological "data" in the sense of patient images or clinical outcomes that would have "provenance."

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

    This is not applicable. "Ground truth" in this context refers to a standard of truth for diagnostic or clinical outcome data, which is not evaluated here. The "truth" for device performance is established through physical and chemical testing against engineering standards and comparison to a predicate device.

    4. Adjudication method for the test set

    This is not applicable. There is no clinical "test set" requiring adjudication by experts.

    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

    This is not applicable as this is not an AI/ML device or a diagnostic device involving "human readers."

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

    This is not applicable as this is not an AI/ML device.

    7. The type of ground truth used

    This is not applicable in the AI/ML sense. The "ground truth" for the device's acceptable performance is defined by:

    • Compliance with recognized standards: e.g., ISO for biocompatibility, sterilization standards.
    • Engineering and material science principles: for mechanical strength, fatigue, material composition.
    • Comparative data to a legally marketed predicate device: demonstrating that the new device is "substantially equivalent" in terms of safety and effectiveness.

    8. The sample size for the training set

    This is not applicable as this is not an AI/ML device. There is no concept of a "training set" for a physical orthopedic implant.

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

    This is not applicable as this is not an AI/ML device.

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