(101 days)
CPT Hip System: The CPT Hip System is indicated for cemented use in: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur. Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis. Patients suffering from disability due to previous fusion. Patients with previously failed endoprostheses and/or total hip components in the affected extremity. Patients with acute femoral neck fractures.
Epsilon Acetabular System: Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., osteoarthritis, posttraumatic arthritis, or avascular necrosis and inflammatory degenerative joint disease (IJD), e.g., rheumatoid arthritis. Those patients with failed previous surgery where pain, deformity, or dysfunction persists. Revision of previously failed hip arthroplasty. Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. This includes severely crippled patients with multiple joint involvement, for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives.
Epsilon Acetabular System Constrained: Primary or revision total hip arthroplasties where is a high risk of hip dislocation due to a history of instability, bone loss, joint, muscle or tissue laxity, or disease condition. This device is intents for whom all other options to constrained acetabular components have been considered. The acetabular components with which this device is intended to be used is porous cementless with supplemental screws, and the fixation method of the femoral components with which this device is intended to be used is cementless, or non-porous cementless fixation, as indicated for use by each respective femoral component.
Trabecular Metal Acetabular Revision System Cage: This device is indicated for patients with conditions of, but not limited to: Acetabular dysplasia, osteoporosis, protrusio acetabuli, cystic acetabular roof, reconstruction in cases of defects after fracture, acetabular loosening, tumors or revision surgery. Advanced joint destruction resulting from degenerative, post-traumatic, or rheumatoid arthritis. Failed previous surgery, e.g., osteosynthesis, joint reconstruction, arthrodesis, hemi-arthroplasty, or total hip replacement.
Trabecular Metal Primary Hip Prosthesis: Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures. Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.
Zimmer Biomet Ceramic Heads: The Zimmer Biomet Ceramic Heads are indicated for the following conditions: (1) a severely painful and/or disabled hip joint as a result of osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia, (2) avascular necrosis of the femoral head, (3) acute traumatic fracture of the femoral head or neck, (4) failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement, (5) certain cases of ankylosis, (6) nonunions, correction of functional deformity, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. When used with constrained acetabular liners, the Zimmer Biomet Ceramic Heads are intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered.
Zimmer Continuum and Trilogy IT Acetabular System: The system is indicated for primary or revision surgery in skeletally mature individuals for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. The system is intended for use either with or without bone cement in total hip arthroplasty.
Zimmer Continuum and Trilogy IT Longevity IT Constrained Liners: The Longevity IT Constrained Liner is indicated as a component of a total hip prosthesis in primary or revision total hip arthroplasties where there is a high risk of hip dislocation due to a history of instability, bone loss, joint, muscle or tissue laxity, or disease condition. This device is intended for patients for whom all other options to constrained acetabular components have been considered.
Zimmer M/L Taper Hip Prosthesis: Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures. Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected. The M/L Taper femoral stem is for cementless use only.
ZMR Hip System: The ZMR Hip System is indicated for cementless revision hip arthroplasty. Arthroplasty should be performed only when more conservative methods of treatment have failed to provide symptomatic relief or when there is progressive disability.
Zimmer Hip Joint Prostheses are hip replacement system components. The devices are modular and consist of femoral stems, femoral heads, acetabular shells, acetabular liners, and other ancillary components. The purpose of this submission is the addition of MR conditional labeling to the IFU and device package label of the subject devices. The addition of MR labeling to the subject devices does not impact indications, materials, design features or dimensions of the components, compatibility, packaging, or sterilization.
This document, K200823, is a 510(k) premarket notification for Zimmer, Inc. Hip Joint Prostheses MR Labeling I. It is not an AI/ML device, but rather a submission for adding MR conditional labeling to existing hip joint replacement prostheses. Therefore, the request for information regarding acceptance criteria and studies proving the device meets those criteria, specifically concerning AI/ML performance metrics, is not applicable to this document.
The document primarily focuses on demonstrating substantial equivalence by showing that the addition of MR labeling does not impact the indications, materials, design features, dimensions, compatibility, packaging, or sterilization of the components. The performance data provided is non-clinical, related to Magnetic Resonance Imaging (MRI) compatibility testing.
Let's break down why an answer to your specific questions about AI/ML device performance cannot be extracted from this document:
- AI/ML Device: This is not an AI/ML device. It's a medical device (hip prostheses) with an updated label for MRI compatibility.
- Acceptance Criteria & Performance: The "acceptance criteria" here are related to MRI safety standards (e.g., ASTM F2503-13, F2182-11a, F2119-07, F2052-14) for the physical implants, not AI performance metrics like sensitivity, specificity, or AUC. The "reported device performance" refers to the successful testing against these MRI safety standards, confirming the device is MR Conditional.
- Sample Size (Test Set), Data Provenance, Experts for Ground Truth, Adjudication, MRMC Study, Standalone Performance, Type of Ground Truth, Training Set Size & Ground Truth Establishment: All these questions are specific to the validation of an AI/ML algorithm. Since this document is for a physical orthopedic implant and its MR labeling, these AI/ML-centric details are not present. The studies conducted are physical bench tests on the implants in an MRI environment to confirm their safety and compatibility.
In summary, as this document relates to the MR labeling of hip joint prostheses and not an AI/ML-driven medical device, the detailed information requested about acceptance criteria, study findings, and ground truth establishment for an AI system is not available within the provided text.
The document states:
- Non-Clinical Tests: "Zimmer has performed non-clinical Magnetic Resonance Imaging (MRI) studies on implants which are determined to be MR Conditional in accordance to ASTM F2503-13 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment. MR Tests included the following: RF-induced heating (ASTM F2182-11a) Image Artifact (ASTM F2119-07) Magnetic Displacement (ASTM 2052-14)."
- Clinical Tests: "Clinical test data is not provided for the subject device."
- Substantial Equivalence Conclusion: "Non-clinical tests provided in this Traditional 510(k) establish the conditional safety and compatibility of the passive implants in a magnetic resonance (MR) environment. The subject devices are substantially equivalent to the legally marketed predicated devices."
Therefore, the device "meets the acceptance criteria" by demonstrating compliance with established ASTM standards for MRI safety of implants, as proven through non-clinical bench testing. There is no AI component to this device or its regulatory clearance.
§ 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.