(260 days)
For Locking Cage
- Revision of previous unsuccessful acetabular replacement.
- Class III segmental and/or cavitary acetabular defects which make it difficult to achieve satisfactory results while using standard total hip replacement acetabular components and procedures.
For Full XPE Cup
- Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, and painful hip dysplasia;
- Inflammatory degenerative joint disease such as rheumatoid arthritis;
- Correction of function deformity;
- Revision procedures where other treatments or devices have failed;
- Treatment of nonunion and femoral neck fractures of the proximal femur with head involvement that is unmanageable using other techniques.
This device is a single use implant and intended for cemented use only.
"United" Locking Cage
The "United" Locking Cage is designed to achieve stable and lasting fixation of the severely deficient acetabulum. The "United" Locking Cage includes locking cage and several accessory components including: ischial flange, hook, cancellous locking screw and auto break-off locking nut. They are all manufactured from Ti6A14V which confirms to ASTM F136-13.
"United" Full XPE Cup
The "United" Full XPE Cup is designed for cemented use and assembled with a PMMA Spacer and an X-ray marking wire. The Full XPE Cup is manufactured from highly cross-linked UHMWPE which conforms to ASTM F2565-06. The UHMWPE raw material is in accordance with ASTM F648-14 and ISO 5834-1:2005. The PMMA Spacer and X-ray marking wire are made of PMMA (Medical Grade) and Co-20Cr-15W-10Ni alloy (ASTM F90-14), respectively. The X-ray marking wire is designed for X-ray image identification purpose. The "United" Full XPE Cup is available in a range of sizes to fit varying anatomical requirements.
The "United" Locking Cage can be used with correspondent sizes of "United" Full XPE Cup with bone cement. The "United" Full XPE Cup is also compatible with "United" Metal Femoral Head (K994078, K022520, K111546 and K122504) and "United" Ceramic Femoral Head (K103497) in correspondent sizes. The "United" Femoral Heads can be used with various types of "United" hip stems (K003237, K062978, K111546, K123550, K132207, K151316 and K152530).
The provided text is a 510(k) premarket notification for a medical device (Locking Cage, Full XPE Cup). It details the device description, indications for use, and a comparison to predicate devices, along with performance data. However, this document does not contain the acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner requested by your prompt.
The performance data section (page 6) states:
● Non-clinical Performance
Tests as follows were conducted to evaluate the safety and effectiveness of the subjected device:
- a. Structural compression stiffness of locking cage
- b. ROM for Full XPE Cup
- c. Bending fatigue testing of flanges
- d. Locking strength of locking cage and cemented cup
- e. Endurance testing
- f. Bacterial endotoxin testing was conducted and met the endotoxin limit as specified in USP .
Performance data demonstrate the device is as safe and effective and is substantially equivalent to the legally marketed predicate devices.
● Clinical Performance Data/Information
None provided as a basis for substantial equivalence.
This indicates that the manufacturer performed non-clinical (benchtop) tests to demonstrate substantial equivalence to predicate devices, rather than establishing specific acceptance criteria for a novel AI/software performance as implied by your prompt's questions (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance).
The "acceptance criteria" here implicitly refer to the device performing as safely and effectively as the predicate devices based on these engineering tests, but no specific numerical criteria (e.g., sensitivity, specificity, or specific threshold values for fatigue testing) are provided or explicitly referred to as "acceptance criteria" in this document.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: No explicit numerical acceptance criteria or detailed performance metrics are listed in this document in the format appropriate to an AI/software device. The document only lists the types of non-clinical tests performed.
- Sample sized used for the test set and the data provenance: Not applicable, as this is a mechanical device, not an AI/software device with test sets of data. The "tests" are engineering evaluations (e.g., fatigue, compression).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical properties is established by physical measurement and engineering standards, not expert adjudication of images or data.
- Adjudication method: Not applicable.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. This is for AI-assisted human reading, not a mechanical implant.
- Standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used: For mechanical tests, the "ground truth" is the physical property being measured (e.g., stiffness, strength), and the measurement itself is the truth, often against an industry standard.
- The sample size for the training set: Not applicable. This is a physical device, not an AI model requiring a training set.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document pertains to a mechanical orthopedic implant, not an AI or software as a medical device (SaMD). The regulatory approval is based on "substantial equivalence" to existing predicate devices through non-clinical (benchtop) engineering tests, not clinical studies or AI performance evaluations against expert-adjudicated ground truth.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.