(90 days)
This device is indicated for use in total hip replacement undergoing primary and revision surgery for the following conditions:
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Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia.
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Inflammatory degenerative joint disease such as rheumatoid arthritis.
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Correction of functional deformity.
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Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement. unmanageable using other techniques.
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Revision procedures where other treatments or devices have failed.
This device is designed for cementless use.
UTS Stem is a modular, wedge-shaped stem with 12/14 neck taper and 130° neck angle, which is made from forging Ti-6Al-4V alloy (ASTM F136-13) and the proximal part of each femoral stem is coated with CP Ti powder (ASTM F1580-12) provides biological fixation. UTS Stem is available with standard offset and high offset to restore hip biomechanics. The standard offset is available in sizes #00~#14; the high offset is available in sizes #1~#14.
The company, United Orthopedic Corporation, submitted a 510(k) premarket notification for their UTS Stem, a hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it describes a series of performance tests conducted to evaluate the safety and effectiveness of the UTS Stem. These tests are implicitly the acceptance criteria for mechanical and material performance.
| Acceptance Criteria (Implied from Performance Tests) | Reported Device Performance |
|---|---|
| Mechanical Properties | |
| Stem Fatigue Test Performance | Data demonstrated the device is as safe and effective as predicate devices. |
| Neck Fatigue Test Performance | Data demonstrated the device is as safe and effective as predicate devices. |
| Range of Motion (ROM) Performance | Evaluation conducted. |
| Disassembly Force and Fretting Corrosion (Femoral Head & Stem) | Evaluation conducted. |
| Material/Surface Properties | |
| Modified Surface Treatment Evaluation | Evaluation conducted. |
| Biocompatibility/Sterilization | |
| Bacterial Endotoxin Testing ( USP Standard) | Met the endotoxin limit as specified in USP . |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document does not specify the exact sample sizes (number of stems tested) for each individual mechanical or material test (e.g., Stem Fatigue Test). It only states that the tests "were conducted to evaluate the safety and effectiveness."
- Data Provenance: The studies are non-clinical (laboratory-based) performance tests. The document does not specify the country of origin where these tests were performed beyond the company's location in Taiwan. These are prospective tests conducted on newly manufactured devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
This information is not applicable and not provided in the document. The "ground truth" for the non-clinical performance tests is based on established engineering and material science standards (e.g., ASTM F136-13, ASTM F1580-12, USP ) and comparative analysis with predicate devices. Expert consensus or qualifications for establishing "ground truth" in this context would typically refer to clinical studies or pathological analyses, which are not detailed for the acceptance criteria mentioned.
4. Adjudication Method for the Test Set:
This information is not applicable. Adjudication methods (like 2+1, 3+1) are relevant for clinical studies involving human interpretation or subjective assessments, where disagreements among experts need a resolution process. The performance tests described are objective, laboratory-based measurements against established standards or comparative benchmarks.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable as the device (UTS Stem) is a hip implant, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study involving human readers and AI assistance was conducted or would be relevant for this type of medical device submission.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
This is not applicable. The UTS Stem is a physical implant, not an algorithm. Standalone performance refers to the accuracy of an AI algorithm without human intervention, which is irrelevant for this product.
7. The Type of Ground Truth Used:
The ground truth for the non-clinical performance tests is based on:
- Engineering Standards: Adherence to established ASTM (American Society for Testing and Materials) standards for material composition (e.g., Ti-6Al-4V alloy, CP Ti powder) and performance.
- Pharmacopoeia Standards: Compliance with USP (United States Pharmacopeia) standards for biocompatibility (e.g., bacterial endotoxin testing).
- Comparative Performance: The device's safety and effectiveness were demonstrated by showing that its performance in the conducted tests was "as safe and effective as" the legally marketed predicate devices. This implies that the performance of the predicate devices under similar conditions serves as a benchmark or "ground truth" for acceptable performance.
8. The Sample Size for the Training Set:
This information is not applicable. There is no concept of a "training set" in the context of this device's non-clinical performance testing. Training sets are relevant for machine learning algorithms or AI models. This submission focuses on physical and mechanical properties of a medical implant.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reasons as point 8.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.