(89 days)
The CEMSTOP Cement Restrictor is a diaphyseal plug designed to occlude the medullary cavity before the introduction of acrylic cement during total hip arthroplasty. The CEMSTOP restrictor prevents the cement from flowing down the diaphysis and therefore facilitates cement pressurization.
The CEMSTOP Cement Restrictor is inserted into the femoral canal prior to introduction of bone cement during total hip arthroplasty. It occludes the medullary canal and prevents the cement from flowing down the diaphysis and aids in cement pressurization. It is available in sizes. It is fabricated from gelatin and glycerol and is completely resorbed within a few days of implantation. The gelatin is porcine based.
This document is a 510(k) premarket notification for a medical device called the "CEMSTOP Cement Restrictor." It's a regulatory document from the FDA, not a study report. Therefore, it does not contain the acceptance criteria or a study proving the device meets those criteria in the format you requested.
The document states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use and technological characteristics to devices already approved by the FDA. This substantial equivalence is based on comparisons, not necessarily on a novel clinical trial or performance study against specific acceptance criteria.
Therefore, I cannot provide the information you requested about acceptance criteria and a study from this document.
Here's what the document does provide, which might be helpful in understanding why your request cannot be fulfilled by this particular text:
- Device Name: CEMSTOP Cement Restrictor
- Intended Use: A diaphyseal plug designed to occlude the medullary cavity before the introduction of acrylic cement during total hip arthroplasty. It prevents cement from flowing down the diaphysis and facilitates cement pressurization.
- Material: Fabricated from gelatin and glycerol, completely resorbed within a few days of implantation. (Porcine-based gelatin).
- Predicate Devices: Exactly the same as cleared on K993841 by Encore Medical. Equivalent to BIOSTOP (Landos) cleared on K943727.
- Basis for Equivalence: Design, manufacturing method and facilities, packaging and sterilization are performed by the same company as the Encore Medical device.
To obtain the kind of performance data and acceptance criteria you're looking for, you would typically need to consult a clinical trial report, a risk assessment, or a specific performance testing document, not a 510(k) clearance letter.
§ 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.