(29 days)
Total hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis and diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; non-union; femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.
Reflection® Cross-linked UHMWPE Acetabular Components are designed for single use only.
The intended use, type of interface, and design features of the Reflection® Cross-linked UHMWPE Acetabular Components are identical to Smith and Nephew, Inc. predicate counterparts cleared for market under K002747.
This Special 510(k) premarket notification is requesting approval for use of Reflection® 10 Mrad . Cross-Linked UHMWPE Acetabular Components with zirconia ceramic femoral heads.
This document is a 510(k) summary for the Reflection® Cross-linked UHMWPE Acetabular Components. It is a premarket notification for a medical device trying to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission focuses on comparing the new device to existing ones rather than presenting de novo clinical study results for acceptance criteria.
Therefore, the document does not contain the information requested in points 1-9 regarding acceptance criteria and a study proving device conformance based on a clinical trial with specific performance metrics, sample sizes, expert ground truth, adjudication methods, or MRMC studies.
Instead, the document states:
- Performance characteristics: "Test data indicate that the Reflection® Cross-linked UHMWPE Acetabular Components meet the requirements of draft Guidance Document for Testing Acetabular Cup Prostheses, dated 05-01-95. The subject devices are identical to predicate devices cleared under K002747."
- Wear claims (marketing claims, not acceptance criteria from a clinical study):
- No detectable wear as measured gravimetrically.
- Generation of 84% fewer particles compared to conventional, non-irradiated UHMWPE used against CoCr femoral heads.
- Generation of 79% fewer particles compared to conventional, non-irradiated UHMWPE used against zirconia ceramic femoral heads.
- Generation of 41% fewer particles compared to Cross-Linked UHMWPE used against CoCr femoral heads.
Summary of missing information:
- Table of acceptance criteria and reported device performance: Not provided in the context of a clinical study. The document lists "wear claims" which are marketing claims based on testing, but not formal acceptance criteria from a clinical trial.
- Sample size for test set and data provenance: Not applicable as no such clinical test set is described.
- Number of experts and qualifications for ground truth: Not applicable.
- Adjudication method for test set: Not applicable.
- MRMC comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for training set: Not applicable as this is not an AI/algorithm-based device and no such training set is mentioned.
- How ground truth for training set was established: Not applicable.
This 510(k) is primarily based on the device's substantial equivalence to previously cleared devices (predicate devices K002747) and in vitro testing against established guidance documents, rather than a clinical study with detailed acceptance criteria as one might find for a novel AI or diagnostic device.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.