(29 days)
The CEMENT RESTRICTOR (CR) is intended for use as a cement restrictor in orthopedic surgeries in the femur and tibia in hip and knee replacement.
The CEMENT RESTRICTOR (CR) is NOT intended for any spinal indications.
The subject CEMENT RESTRICTOR is a tapered block that is made from POLYETHERETHERKETONE (PEEK). The device is intended to be used in conjunction with standard PMMA cement.
Implants are manufactured out of medical-grade titanium alloy such as described by ASTM F136 or ISO 5832-3. The CEMENT RESTRICTOR implants may also be manufactured from 70:30 Polylactic Acid (Poly (L-lactide-co-D, L -lactide) 70:30, amorphous). Alternatively, the entire system may be made out of POLYETHERETHERKETONE (PEEK) as described by standards such as ASTM F-2026.
The provided document is a 510(k) summary and FDA clearance letter for a medical device called the "CEMENT RESTRICTOR (CR)". It describes the device, its intended use, and its substantial equivalence to previously cleared devices. Crucially, this document is a regulatory submission for a physical medical device (an implantable cement restrictor), not an AI/ML powered device.
Therefore, most of the requested information about acceptance criteria, study design, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance does not apply to this type of submission. The FDA clearance for this device hinges on its substantial equivalence to predicate devices, focusing on materials, design, and intended use, rather than a performance study of an algorithm.
Here's a breakdown of why the requested information isn't present in the provided text:
- No AI/ML Component: The device is a physical "tapered block" made of specific materials (PEEK, titanium alloy, polylactic acid). It does not involve any software, algorithms, or AI/ML for diagnosis, prognosis, or treatment.
- Substantial Equivalence Pathway: The clearance is based on demonstrating "substantial equivalence" to existing, legally marketed predicate devices (K013014 and K010528). This typically involves comparing design, materials, manufacturing processes, and intended use, rather than extensive performance studies in the way an AI/ML device would require.
- Focus on Material and Intended Use: The "purpose of this submission is to obtain clearance for the alternative material." This indicates the primary focus was on the safety and compatibility of the new material, not the performance of a diagnostic or predictive algorithm.
Therefore, I cannot provide the requested information in the format of acceptance criteria and study data for an AI/ML device because the provided document does not pertain to such a device.
If you have a document related to an AI/ML powered device, I would be happy to analyze it for the requested information.
§ 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.