(412 days)
The acetabular cup is indicated for cemented use in skeletally mature individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDID) or its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
ZCA is an acetabular cup prosthesis intended for use in total hip arthroplasty. It is manufactured from conventional Ultra-High Molecular-Weight Polyethylene (UHMWPE). The current submission is a retrospective 510(k) for devices that are currently marketed in the U.S. Through a review of the changes to the device system based on the current FDA Guidance document "Deciding When to Submit a 510(k) for a Change to an Existing Device" (October 25, 2017), Zimmer Inc. has decided to submit a 510(k) for the cumulative changes.
This document is a 510(k) summary for the "ZCA All-Poly Acetabular Cups." It is a premarket notification to the FDA to demonstrate the substantial equivalence of this device to previously cleared predicate devices.
Based on the provided document, there is no information regarding acceptance criteria for device performance related to a study proving the device meets those criteria, expert ground truth, sample sizes for test/training sets, or MRMC studies.
This document specifically states under "Summary of Performance Data (Nonclinical and/or Clinical)":
- "Clinical Tests: Clinical test data is not provided for the subject o device." (page 4)
Instead, the submission relies on:
- "Non-Clinical Tests:
- Performance Evaluation: Performance testing was completed on the line extension to determine equivalence to legally marketed devices.
- Shelf Life: Accelerated and real time aging testing conducted shows the sterile devices included in this submission have a shelf life of eight years.
- Compatibility: Functional Relationship Analysis, wear performance, range of motion, and lever-out pull-through strength evaluation conducted shows the implants in this submission are compatible with femoral heads." (page 4)
- Comparison of Intended Use, Indications for Use, Materials, Design Features, and Sterilization to predicate devices. (page 4)
Therefore, I cannot provide details on the requested points because the submission explicitly states that clinical test data (which would typically involve the elements you've asked about, such as acceptance criteria, ground truth, expert review, and sample sizes for performance evaluation studies) was not provided for the subject device. The clearance is based on non-clinical performance and a comparison to predicate devices, asserting that the changes do not affect safety and effectiveness.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.