(26 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; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion; femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. The Total Hip Femoral Heads & Liners are designed for single use only and may be used as part of cemented total hip arthroplasty.
The Total Hip Femoral Heads are zirconium alloy or alumina ceramic devices designed for use with both titanium and cobalt chromium alloy femoral components with a 12/14 taper. These heads are to be used with the appropriate sized crosslinked polyethylene Total Hip Liners. Total Hip Liners are to be used with corresponding titanium acetabular shells.
This document describes the Summary of Safety and Effectiveness for Total Hip Femoral Heads & Liners (K022958).
Based on the provided text, the device is a Class II medical device that is asserting substantial equivalence to predicate devices, rather than establishing performance against specific acceptance criteria in a clinical study. The document explicitly states:
"A review of the mechanical and wear test data indicated that the Total Hip Femoral Heads and Liners are equivalent to devices currently on the market and are capable of withstanding expected in vivo loading without failure."
Therefore, the information regarding acceptance criteria and a detailed study proving the device meets those criteria for clinical performance (as would be typical for an AI/ML device) is not available in this document. The provided text focuses on regulatory substantial equivalence based on material, design, mechanical, and wear test data, rather than a clinical effectiveness study.
Here's a breakdown of why many of your requested points cannot be answered from the provided text:
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Acceptance Criteria & Reported Performance Table: Not applicable. The document does not define specific clinical acceptance criteria or report clinical performance metrics for the device against such criteria. Instead, it relies on demonstrating equivalence to predicate devices through mechanical and wear testing.
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Sample Size (Test Set) & Data Provenance: Not applicable. The device's safety and effectiveness are established through reference to existing predicate devices and in vitro mechanical/wear testing, not a clinical test set.
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Number of Experts & Qualifications (Ground Truth): Not applicable. Ground truth, in the context of clinical performance evaluation, is not established or discussed.
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Adjudication Method: Not applicable.
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MRMC Comparative Effectiveness Study: Not applicable. This type of study relates to human reader performance with and without AI assistance, which is not relevant to this orthopedic implant's regulatory submission.
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Standalone Performance: Not applicable as this is a physical medical device, not an algorithm/AI.
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Type of Ground Truth Used: Not applicable in the context of clinical performance evaluation. The "ground truth" for this submission is related to the established performance of predicate devices and the results of in-vitro mechanical and wear tests.
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Sample Size (Training Set): Not applicable. There is no "training set" for this type of device.
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How Ground Truth for Training Set was Established: Not applicable.
Summary of Device Equivalence (from the text):
The regulatory submission for the Total Hip Femoral Heads & Liners (K022958) establishes substantial equivalence to existing predicate devices based on:
- Intended Use: Similar to currently marketed femoral heads and liners.
- Material: Similar to currently marketed femoral heads and liners (zirconium alloy or alumina ceramic for heads, crosslinked polyethylene for liners).
- Design Features: Similar to currently marketed femoral heads and liners.
- Mechanical and Wear Test Data: "A review of the mechanical and wear test data indicated that the Total Hip Femoral Heads and Liners are equivalent to devices currently on the market and are capable of withstanding expected in vivo loading without failure."
Predicate Devices for Substantial Equivalence:
- Total Hip Femoral Heads:
- Total Hip Liners:
§ 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.