(85 days)
The Quantum Cement Restrictor is indicated for use as a cement restrictor in the femur, tibia, or humerus. This device is not intended for spinal indications. The safety and effectiveness of this device when implanted in the spine have not been established.
The Quantum Cement Restrictor is a generally box-shaped device with various holes located throughout its geometry to hold bone cement. The exterior surface of the device has teeth to help keep the device from migrating once placed in its desired location. It is available in a multitude of sizes to suit the individual pathology and anatomic condition of the patient. The device may be made from titanium, polyetheretherketone (PEEK), or ceramic materials.
This 510(k) summary describes a traditional medical device (cement restrictor), not an AI/ML-enabled device. Therefore, the information requested, such as acceptance criteria, performance metrics, sample sizes for test/training sets, expert involvement, and comparative effectiveness studies, which are standard for AI/ML device evaluations, are not applicable to this submission.
The 510(k) submission for the Quantum Cement Restrictor focuses on demonstrating substantial equivalence to previously cleared predicate devices based on indications for use, design, function, and materials. It does not involve a performance study with acceptance criteria in the way an AI/ML device would.
Here's an breakdown of why the requested information doesn't apply based on the provided document:
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Acceptance Criteria and Reported Device Performance: Not applicable. For a traditional device like this, the "performance" is primarily assessed through design, materials, and functional equivalence to predicates, not through quantitative metrics against a defined acceptance threshold in a clinical or retrospective study. The submission asserts substantial equivalence, which is the "performance" goal for 510(k) devices of this type.
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Sample Size for Test Set and Data Provenance: Not applicable. There is no "test set" in the context of an AI/ML study. The evaluation is based on product specifications and comparison to predicates.
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Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable. There is no ground truth establishment in the context of an AI/ML study. The determination of substantial equivalence is made by the FDA based on the provided documentation and comparison to predicate devices.
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Adjudication Method: Not applicable. There is no data to adjudicate.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is not an AI/ML device, so no such study would be conducted.
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Standalone Performance Study: Not applicable. "Standalone performance" in the AI/ML context refers to the algorithm's performance without human intervention. This is a physical device, so the concept does not apply.
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Type of Ground Truth Used: Not applicable.
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Sample Size for the Training Set: Not applicable. There is no training set for a traditional medical device.
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How the Ground Truth for the Training Set was Established: Not applicable.
Summary of Device Evaluation in the Provided Document:
The FDA determined that the Quantum Cement Restrictor is substantially equivalent to legally marketed predicate devices. This determination was based on:
- Indications for Use: As a cement restrictor in the femur, tibia, or humerus.
- Design: Generally box-shaped with various holes and exterior teeth.
- Function: To hold bone cement and resist migration.
- Materials: Titanium, PEEK, or ceramic.
A key part of the FDA's review was to add a warning to the labeling: "THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS. THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED." This indicates specific boundaries of the device's acceptable use and indirectly highlights that performance for unintended uses was not established (and explicitly stated could cause harm).
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.