(89 days)
The Theken Large Cement Restrictor is designed to occlude the medullary canal before the introduction of acrylic cement during surgeries such as total hip arthroplasty, as well as prevent cement from flowing down the diaphysis thereby facilitating cement pressurization. The Theken Large Cement Restrictor is NOT intended for any spinal indications.
The Theken Large Cement Restrictor is titanium, hollow, rectangular frame with The Thelions and radii on all sides and toothed spikes on opposite sides. The device is intended to be used in conjunction with standard PMMA cement.
The provided text is a 510(k) summary for the Theken Large Cement Restrictor, an orthopedic surgical device. It does not contain information about acceptance criteria or a study proving that the device meets such criteria.
The document primarily focuses on establishing substantial equivalence to previously marketed predicate devices (Signus Medizintechnik GmbH Rabea™ Cement Restrictor Device and Medtronic Sofamor Danek Titanium Cement Restrictor Device) for regulatory approval.
Here's a breakdown of why the requested information is absent based on the provided text:
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Acceptance Criteria and Reported Device Performance:
- The document states "Static evaluation was performed and the strength of the device was characterized." However, it does not provide specific quantitative acceptance criteria for strength, nor does it present the numerical results ("reported device performance") from this characterization.
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Sample Size for Test Set and Data Provenance:
- No information about a "test set" in the context of device performance testing is provided. The static evaluation mentioned is a non-clinical test, not a clinical study on a patient sample.
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Number of Experts and Qualifications:
- This information is relevant for studies involving human interpretation (e.g., image-based diagnostics) or clinical ground truth establishment. This device's evaluation did not involve such expert review.
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Adjudication Method:
- Not applicable as there's no expert-based ground truth establishment mentioned.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not applicable. This is an orthopedic implant, not an AI-assisted diagnostic tool.
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Standalone Performance:
- The "Static evaluation" is a standalone test of the device's physical properties. However, as noted in point 1, the specific performance metrics and acceptance criteria are not detailed.
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Type of Ground Truth Used:
- For the static evaluation, the "ground truth" would be the engineering specifications and test standards for material strength and mechanical properties. These are not explicitly detailed in the summary.
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Sample Size for Training Set:
- Not applicable. This is not an AI/ML device that requires a training set.
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How Ground Truth for Training Set was Established:
- Not applicable.
In summary, the provided 510(k) document is a regulatory submission for a physical medical device, not an AI/ML-based diagnostic or prognostic tool. Therefore, much of the requested information, which pertains to clinical studies, human expert involvement, and AI model evaluation, is not present in this type of document. The only performance data mentioned is a non-clinical "static evaluation," but the specifics of that evaluation (criteria and results) are not elaborated.
§ 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.