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The Tornier Cement restrictor is a diaphyseal plug designed to occlude the medullary cavity before the introduction of acrylic cement during joint arthroplasty. The Tornier Cement restrictor prevents the cement from flowing down the diaphysis and therefore facilitates cement pressurisation when the implant is introduced.

The Tornier Cement Restrictor is a diaphyseal plug for orthopedic use. It is designed to occlude the medullary cavity before the introduction of acrylic cement. The Tornier Cement Restrictor is used to prevent the cement progression in the diaphysis and therefore facilitate the cement pressurization during the introduction of the implant. Its flexible mechanism makes it adaptable to different diameters of medullary canal to be occluded. The present device modification submission consists in the addition of a small diaphyseal plug and an extension of the indication for use.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) premarket notification for the Tornier Cement Restrictor and primarily discusses its description, materials, indications for use, and its substantial equivalence to predicate devices. It does not include details on clinical studies, performance metrics, ground truth establishment, or expert reviews as requested in your prompt.

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• 1. Total Shoulder Arthroplasty
• 2. Total Hip Arthroplasty
• 3. Intramedullary Occlusion
• 4. Cement Pressurization

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The provided text is a summary of safety and effectiveness information for the Tornier Cement Restrictor, submitted as a premarket notification (510(k)) to the FDA. It does not contain information about acceptance criteria for a device's performance, nor does it describe any study proving the device meets particular acceptance criteria.

The document primarily focuses on:

• Device Identification: Name (Tornier Cement Restrictor), common name (Canal Plug, Cement Restrictor), classification name (Cement Obturator).
• Regulatory Classification: Class II device under 21 CFR §878.3300 (Surgical mesh), product code 87LZN.
• Intended Use/Indications For Use: Total Shoulder Arthroplasty, Total Hip Arthroplasty, Intramedullary Occlusion, Cement Pressurization.
• Regulatory Correspondence: An FDA letter confirming substantial equivalence to devices marketed prior to May 28, 1976.
• General Controls: Mentions requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

Therefore, I cannot provide the requested information from the given text as it does not contain details regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes, data provenance, or study design for test sets.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication method.
5. MRMC comparative effectiveness study, including effect size.
6. Standalone algorithm performance.
7. Type of ground truth used (pathology, outcomes data, etc.).
8. Sample size for the training set.
9. How ground truth for the training set was established.

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