(206 days)
This device is indicated in partial hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- Inflammatory degenerative joint disease such as rheumatoid arthritis;
- Correction of function deformity;
- Revision procedure where other treatments or devices have failed; and
- Treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
The U1 Hip system - Bipolar is designated as a hemiarthroplasty component and is to be used with United U1 hip stem (K994078) and U2 hip stem (K003237) of total hip replacement. It is a modular type of product system. The U1 Hip system - Bipolar has 23 sizes (40-62 mm in 1 mm increments) of option with a hemispherical design, easy snap-in and take out mechanism. The metallic outer shell is produced from casting Co-Cr-Mo alloy (ASTM F75). The plastic liner with a 26 mm inner diameter is machined from extruded UHMWPE bars (ISO 5834/1). The U1 26 mm femoral head (K994078) has four different neck lengths (+0, +3, +6, +9 mm), which can meet the various needs of patient. The inner femoral head will be pressed into the polyethylene liner firstly, and then the polyethylene liner with inner head will be pressed into the outer shell using a bipolar head assembly device in the operating room.
The provided document (K050269) is a 510(k) summary for a medical device (U1 Hip system - Bipolar) and does not contain detailed information about a clinical study with acceptance criteria, sample sizes, expert ground truth, or MRMC studies.
Instead, the document states in the "Performance" section: "A review of the mechanical test data indicated that the locking strength of this Bipolar system is strong enough to prevent locking mechanism failure in clinical use." This suggests that the device's performance was evaluated through mechanical testing rather than a clinical study involving human subjects or AI algorithms.
Therefore, I cannot provide the requested information from the given text as it only describes the device, its intended use, and a general statement about mechanical test data, not a study that fits the criteria you've outlined.
Summary of unavailable information from the provided text:
- Acceptance Criteria and Reported Device Performance: No specific acceptance criteria or quantitative performance metrics from a clinical study are provided. The statement about "locking strength" is qualitative.
- Sample Size for Test Set and Data Provenance: No clinical test set data or provenance is mentioned.
- Number of Experts and Qualifications: Not applicable as no expert-derived ground truth for a test set is discussed.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: No such study is mentioned.
- Standalone Performance Study (Algorithm Only): Not applicable, as this is a physical medical device, not an AI algorithm.
- Type of Ground Truth Used: Not applicable, as no ground truth for a clinical study is discussed.
- Sample Size for Training Set & How Ground Truth Was Established: Not applicable, as no training set for an AI algorithm is relevant here.
§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.