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SmartSet MV Endurance Bone Cement is indicated for the fixation of prostheses to living bone in orthopaedic musculoskeletal surgical procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions, and revision of previous arthroplasty.

SmartSet GMV Endurance Gentamicin Bone Cement is indicated for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.

SmartMix Cemvac is a vacuum mixing and syringe delivery system pre-packed with bone cement powder and liquid. The device is for single use only and reduces exposure to monomer fumcs and cement porosity during preparation and avoids handling of bone cement during cement delivery. The device is available in a single 60g or 100g unit. Each unit pack consists of the following:
. A syringe barrel assembly pre-packed with bone cement powder.
. A monomer cartridge pre-loaded with two ampoules of bone cement liquid.
= Accessories consisting of a disposable mixing stand, a vacuum hose with filter attached, a vacuum tube adaptor and a central mixing rod.

SmartMix Bowl is a vacuum mixing system pre-packed with bone cement powder and liguid. The device is for single us only and reduces exposure to monomer fumes and cement porosity during preparation. The device is available in single 80g units. Each unit pack consists of the following:
. A bowl base pre-packed with bone cement powder.
T A monomer cartridge pre-loaded with two ampoules of bone cement liquid.
. Accessories consisting of a bowl lid with vacuum hose and filter attached, a vacuum tube adaptor and a spatula.

The provided text is a 510(k) premarket notification for a medical device called the "SmartMix Pre-filled Mixing System." This document primarily focuses on demonstrating substantial equivalence to already approved predicate devices and does not contain information about specific acceptance criteria, device performance, or a clinical study in the format requested.

The document discusses the device's design, materials, intended use, and states that "On testing, the pre-packed bone cements have been found to be stable on storage in both systems and when mixed in SmartMix Cemvac and SmartMix Bowl, the physicomechanical properties and elution profile (for the medicated bone cement) have shown to be equivalent to mixing by the conventional bowl and spatula technique." However, it does not provide:

• A table of acceptance criteria and reported device performance: The document only makes a general statement about equivalence regarding physicomechanical properties and elution profiles. It does not quantify these properties or define specific thresholds for acceptance.
• Details of a study: There is no description of a study design, sample sizes, data provenance, ground truth establishment, or expert involvement. The testing mentioned appears to be bench testing rather than a clinical study evaluating diagnostic performance.
• Information related to AI or a "multi-reader multi-case (MRMC) comparative effectiveness study": This device is a bone cement mixing system, not an AI-powered diagnostic tool. Therefore, these sections are not applicable.
• Sample size for training set or how ground truth was established for a training set: Again, this relates to AI/machine learning studies, which is not what this document describes.

In summary, the provided text does not contain the information necessary to fulfill the request as it describes a non-AI medical device and a regulatory submission focused on substantial equivalence rather than a detailed performance study with acceptance criteria and clinical outcomes.

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