(260 days)
The device is used for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- Correction of functional deformity.
- Treatment of nonunion femoral neck and trochanteric fracture of the proximal femur with head involvement that is unmanageable using other techniques.
This device is a single use implant and intended for cementless use only.
The subject device, U-Motion II Acetabular System—Extension line, is an extension in terms of additional size to the previously cleared U-Motion II Acetabular System (K122185, K132455, K170089 and K172833). The subject device includes two components: U-Motion II Cup and U-Motion II XPE Cup liner. The indication, design rationale, material, major manufacture process and sterilization method of these two components are identical to the cleared U-Motion II Cup (K122185, K132455, K170089, and K172833) and U-Motion II XPE Cup Liner (K122185 and K170089), except for the dimension.
U-Motion II Cup
The cleared U-Motion II Cup is available from 44 through 80 mm outer diameter (O.D.) in 2 mm increments. The subject U-Motion II Cup is available in 48 mm O.D. and 54 mm O.D. and the compatible liner diameter is 36 mm and 40 mm, respectively, which is larger than the cleared cups. It is designed to only be compatible with the subject cup liner.
U-Motion II XPE Cup Liner
The cleared U-Motion II XPE Cup Liner is available in 28 mm, 32 mm, 36 mm, and 40 mm inner diameter (I.D.). The subject XPE Cup Liner is available in 36 mm I.D. and 40 mm I.D., and is compatible with the subject 48 mm O.D. cup. and 54 mm O.D. cup, respectively.
This document is a 510(k) premarket notification for the "U-Motion II Acetabular System-Extension line," a hip joint prosthesis. It outlines the device description, indications for use, technological characteristics, and performance analysis used to establish substantial equivalence to existing predicate devices.
Here's an analysis of the provided information, identifying what's present and what's missing, especially regarding the acceptance criteria and study details you requested:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a specific table of acceptance criteria with quantitative thresholds for each test. Instead, it lists the types of tests conducted and states that "the test results indicated that this device is safe and effective."
| Test Conducted | Result/Comment |
|---|---|
| Impingement analysis | "Indicated that this device is safe and effective." (Implicitly, the device met impingement analysis requirements) |
| Range of motion | "Indicated that this device is safe and effective." (Implicitly, the device met range of motion requirements) |
| Jumping distance analysis | "Indicated that this device is safe and effective." (Implicitly, the device met jumping distance analysis requirements) |
| Wear simulation test | "Indicated that this device is safe and effective." (Implicitly, the device met wear simulation test requirements) |
| Locking strength test | "Indicated that this device is safe and effective." (Implicitly, the device met locking strength test requirements) |
| Cup deformation test | "Indicated that this device is safe and effective." (Implicitly, the device met cup deformation test requirements) |
| Cup fatigue test | "Indicated that this device is safe and effective." (Implicitly, the device met cup fatigue test requirements) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state the sample sizes used for each of the performance tests (Impingement analysis, Range of motion, Jumping distance analysis, Wear simulation test, Locking strength test, Cup deformation test, Cup fatigue test). These generally involve a certain number of specimens for mechanical testing.
- Data Provenance: The studies are described as "Verification activities on subject devices" and "tests were conducted to evaluate the safety and effectiveness of the subjected device." This indicates the studies were prospective in nature, specifically conducted for this submission. There's no explicit mention of the country of origin of the data, but the manufacturer (United Orthopedic Corporation) is located in Taiwan.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not applicable as the device is a medical implant (hip prosthesis), and the studies described are mechanical performance tests, not analyses requiring ground truth established by medical experts (like in AI/diagnostic device studies).
4. Adjudication Method for the Test Set:
This information is not applicable for the same reason as point 3. Mechanical tests do not typically involve adjudication by experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This information is not applicable. The device is a physical implant, not a diagnostic or AI-assisted system that would involve human readers interpreting cases. Therefore, no MRMC study or effect size comparing human readers with and without AI assistance was performed.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
This information is not applicable. The device is a physical implant, not an algorithm.
7. Type of Ground Truth Used:
This information is not applicable. As mentioned above, the tests are mechanical performance evaluations of a physical device, and the "ground truth" is defined by established engineering standards and biomechanical principles for joint prostheses.
8. Sample Size for the Training Set:
This information is not applicable. There is no "training set" as this is a physical medical device, not an AI/machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as point 8.
Summary of what's provided and what's missing for the requested information:
- Acceptance Criteria & Performance: A list of tests is provided, with a general statement of "safe and effective" results. However, specific quantitative acceptance criteria and the numerical results against these criteria are not detailed in this document.
- Sample Size (Test Set) & Data Provenance: Sample size is not explicitly stated. Data provenance is implied to be prospective mechanical testing, likely conducted in association with the Taiwanese manufacturer.
- Experts for Ground Truth & Qualifications: Not applicable (physical device, not diagnostic AI).
- Adjudication Method: Not applicable.
- MRMC Study: Not applicable.
- Standalone Study: Not applicable.
- Type of Ground Truth: Mechanical testing against established engineering/biomechanical standards.
- Training Set Sample Size: Not applicable.
- Training Set Ground Truth Establishment: Not applicable.
The document primarily focuses on establishing "substantial equivalence" of the new sizes of the U-Motion II Acetabular System to previously cleared versions and predicate devices based on identical intended use, materials, design rationale, and various mechanical performance tests. The detailed data and specific acceptance thresholds for these tests would typically be found in the full 510(k) submission, not necessarily summarized in this high-level FDA letter or 510(k) summary.
§ 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.