(205 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.
This subject device is a size extension of the cleared "UNITED" UTF Stem - reduced (K123550, K132207). The indications, materials, design of this subject device are identical to the cleared "UNITED" UTF Stem - reduced (K123550, K132207) except for size distribution. "UNITED" UTF Stem - reduced is a modular, wedge-shaped stem with 12/14 neck taper and 130° neck angle, which is indicated for use in primary or revision hip arthroplasty. UTF Stem - reduced is available with standard offset and high offset options to restore hip biomechanics.
The provided document is a 510(k) premarket notification for a medical device, specifically a hip joint prosthesis. It addresses a size extension for an already cleared device. As such, the document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel device through a new comprehensive study.
Therefore, much of the information requested in your prompt regarding specific acceptance criteria, detailed study design for proving device performance, sample sizes for test/training sets, expert adjudication methods, and MRMC studies, is not present in this type of regulatory submission. This document highlights that the new device shares the same indications, materials, and design (with minor modifications) as previously cleared devices.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with numerical targets and reported performance in the way one might expect for a new device study. Instead, it relies on demonstrating that the new size extension performs "as safe and effective as the predicates" by conducting specific mechanical tests required for orthopedic implants.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Performance | |
| Stem Fatigue Test | Conducted and demonstrated substantial equivalence to predicates. |
| Neck Fatigue Test | Conducted and demonstrated substantial equivalence to predicates. |
| Biocompatibility | |
| Bacterial Endotoxin Test | Conducted and met the endotoxin limit as specified in USP . |
| Functionality | |
| Range of Motion | Test conducted (implies satisfactory results to achieve equivalence). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated as a "test set" in the context of a clinical or image-based AI study. The "test set" here refers to the actual physical devices (UTF Stem, reduced, #0, #00) subjected to mechanical and biocompatibility testing. The exact number of units tested for each mechanical test is not specified in this summary.
- Data Provenance: The document does not specify the country of origin for the mechanical testing data. The manufacturer, United Orthopedic Corporation, is based in Hsinchu, Taiwan. The type of testing is non-clinical (laboratory-based mechanical and biocompatibility tests). These are prospective tests performed on the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to the type of device and submission. This is a mechanical/biocompatibility evaluation of a physical orthopedic implant, not an AI or image analysis device that requires expert ground truth labeling.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no human adjudication process described for the mechanical and biocompatibility tests performed on the physical device. The tests have predefined pass/fail criteria based on engineering standards and regulatory guidelines (e.g., USP for endotoxin limits), not expert consensus.
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
Not applicable. This is not an AI-assisted device or an imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI-driven algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance relies on established engineering principles, international standards for mechanical testing of implants, and biological safety standards (e.g., USP for endotoxins). Performance is measured against these objective standards and comparison to the predicate device's known performance, not against expert consensus, pathology, or outcomes data in the way an AI diagnostic device would.
8. The sample size for the training set
Not applicable. This is not an AI device, so there is no training set in that context.
9. How the ground truth for the training set was established
Not applicable. There is no training set.
Summary of what the document does communicate:
- Purpose of Submission: This 510(k) is for a "size extension" of an already cleared hip stem (UTF Stem, reduced, #0, #00).
- Demonstration of Safety and Effectiveness: The primary method is demonstrating substantial equivalence to previously cleared predicate devices (K123550, K132207, K110245).
- Key Argument for Equivalence: The subject device shares identical indications for use, materials, and design (except for size distribution and minor design modifications that "do not change the intended use or fundamental scientific technology") with the predicates.
- Non-Clinical Performance Data: To support equivalence, the following tests were conducted:
- Stem Fatigue Test
- Neck Fatigue Test
- Range of Motion
- Bacterial Endotoxin Testing (met USP limits)
- Clinical Performance Data: "None provided as a basis for substantial equivalence." This is common for minor modifications or size extensions of already cleared devices, as new human clinical trials are typically not required if substantial equivalence can be demonstrated through non-clinical means.
§ 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.