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This device is indicated for use in total hip replacement or bipolar hip replacement undergoing primary and revision surgery for the following conditions: non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia; inflammatory degenerative joint disease such as rheumatoid arthritis; correction of functional deformity; treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; revision procedures where other treatments or devices have failed.

This device is designed for cementless use.

This subject device is a size extension to the cleared "UNITED" UTF Stem-Reduced (K123550). The indications, materials, design of this subject device are identical to the cleared "UNITED" UTF Stem-Reduced except for its large size. As the same as the cleared UTF Stem-reduced (K123550), the subjected device forged from Ti-6A1-4V alloy (ASTM F136), is a modular, wedge-shaped stem with 12/14 neck taper. The proximal part of each femoral stem is plasma coated with CP Ti powder (ASTM F1580).

The provided text describes a 510(k) summary for a medical device called "UTF Stem-reduced, Additional Sizes," which is a hip stem. The submission is for a size extension to an already cleared device.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. A table of acceptance criteria and the reported device performance

   Acceptance Criteria	Reported Device Performance
   Mechanical properties of the device are adequate.	"The mechanical properties of this device have been evaluated, and the analysis results shown that this subjected device (#12~#14) is not the worst case within all sizes of UTF Stem-reduced (#1~#14)."
   Device modification does not affect safety and effectiveness.	"This device modification would not affect the safety and effectiveness."
   Substantial Equivalence to Predicate Device.	The subject device is deemed "substantially equivalent" to the predicate "UNITED" UTF Stem-Reduced (K123550). This implies it meets similar performance and safety standards as the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   The submission does not provide details on a specific "test set" in the context of clinical data or a test group of patients. The performance data is based on a mechanical evaluation of the device sizes #12-#14.

   • Sample size for test set: Not applicable in the context of clinical data. The mechanical evaluation was performed on device sizes #12-#14.
   • Data provenance: Not applicable. The performance data is from a mechanical evaluation rather than patient data.

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)

   Not applicable. The study is a mechanical evaluation and does not involve establishing ground truth from expert clinical review.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   Not applicable. The study is a mechanical evaluation.

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

   No MRMC comparative effectiveness study was done. This device is a hip stem, a physical implant, not an AI or imaging device that would typically involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   Not applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   The "ground truth" in this context is the mechanical performance standards for hip stems, which the device's mechanical properties were evaluated against. This is not clinical ground truth (like pathology or outcomes data) but rather engineering and material science standards for device integrity and function.

8. The sample size for the training set

   Not applicable. There is no training set mentioned, as this is not a machine learning or AI device.

9. How the ground truth for the training set was established

   Not applicable. There is no training set for a physical medical implant.

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