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This device is indicated for use in total hip replacement undergoing primary and revision surgery for the following conditions:

1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia.

2. Inflammatory degenerative joint disease such as rheumatoid arthritis.

3. Correction of functional deformity.

4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

5. 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.

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.

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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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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 modification and an additional size extension to the previously cleared "UNITED" UTF Stem (K110245). The materials, safety and effectiveness of this subject device are identical to "UNITED" UTF Stem (K110245). Compared with the UTF Stem (K110245), the distal width of UTF Stem-reduced is reduced to provide more selection for clinical demand, and the thread diameter of impact hole of UTF Stem-reduced is enlarged to increase the mechanical strength of stem holder which is locked with impact hole.

As the same as UTF Stem (K110245), UTF Stem-reduced, forged from a Ti-6A1-4V alloy (ASTM F136), is a modular, wedge-shaped stem with 12/14 neck taper and 130° neck angle. The proximal part of each femoral stem is plasma coated with CP Ti powder (ASTM F1580) in thickness 500±127μm. UTF Stem-reduced is available with standard and high offset options, and each,type is available in sizes #111. The specifications of UTF Stem-reduced in size #16 and #9 are identical with UTF Stem (K110245) in size #7.5, 9, 10, 11, 12, 13, 16.5, respectively, while size #7, 8, 10 and 11 are new items which is between size # 13 and #22 in UTF Stem (K110245). These modifications will not affect its safety and effectiveness.

For total hip replacement, UTF Stem-reduced can be used in conjunction with UNITED Femoral Head (K994078, K022520, K111546 and K122504), Ceramic Femoral Head (K103497, K112463), U2 Acetabular Cup Liner (K050262), XPE Cup Liner (K111546), U2 HA/Ti Plasma Spray Cup (K050262, K12177), U2 Ti Plasma Spray Cup (K050262, K121777) and U2 Ti Porous Coated Cup (K111546). As using with U2 Acetabular Cup Liner (K050262), UTF Stem-reduced can be used with 26 mm and 28 mm metal Femoral Head (K994078, K022520, K122504) and 28 mm Ceramic Femoral Head (K103497). As using with XPE Cup Liner (K111546), UTF Stem can be used with 28 mm, 32 mm and 36 mm metal Femoral Head (K022520, K111546, K122504) and 28 i mm, 32 mm and 36 mm Ceramic Femoral Head (K103497, K112463).

For bipolar hip replacement, UTF Stem-reduced also can be used in conjunction with 26 mm, 28 mm, 32mm and 36mm metal Femoral Head (K994078, K022520, K111546, K122504), 28 mm, 32 mm and 36 mm Ceramic Femoral Head (K103497, K112463) and Bipolar implants (K101670). UNITED Femoral Head and Bipolar Cap are made of Co-Cr-Mo alloy, while Ceramic Femoral Head is manufactured from alumina. Acetabular Cup Liner and Bipolar Cap Liner are made of UHMWPE, while U2 Acetabular Cup shells are manufactured from forged Titanium alloy.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Study Information

This submission is for a medical device (UTF Stem, reduced) and does not involve an AI/ML-based diagnostic or prognostic device, therefore many of the typical questions related to such studies (sample size for test/training sets, ground truth establishment, MRMC studies) are not applicable. The provided document is a 510(k) summary for a modified orthopedic implant. The "study" described is primarily non-clinical engineering analysis and refers to previous testing of a predicate device.

1. Sample size used for the test set and the data provenance: Not applicable. No specific "test set" in the context of image-based or data-driven AI diagnostics is mentioned. The non-clinical testing involved mechanical testing of the predicate device and engineering analysis of the modifications to the subject device.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth in the context of expert review for diagnostic accuracy is mentioned.
3. Adjudication method for the test set: Not applicable.
4. 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 study was done, as this is not an AI/ML-based device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML-based device.
6. The type of ground truth used: For the non-clinical testing of the predicate device, the "ground truth" was defined by international standards (ISO 7206-4 and ISO 7206-6) for mechanical performance criteria. For the modified coating, it was conformance to FDA Guidance.
7. The sample size for the training set: Not applicable. No training set for an AI/ML model is mentioned.
8. How the ground truth for the training set was established: Not applicable.

Summary of the "Study" and Basis for Acceptance

The submission is for a modification and size extension to a previously cleared hip stem ("UNITED" UTF Stem, K110245). The core argument for acceptance is substantial equivalence to the predicate device.

• Non-Clinical Testing of Predicate Device: The predicate device (UTF Stem K110245) had its stem fatigue test completed according to ISO 7206-4 and its neck fatigue test according to ISO 7206-6. These tests established the performance benchmarks for the original design.
• Engineering Analysis for the Subject Device (UTF Stem, reduced): For the new "UTF Stem, reduced" device, no additional non-clinical mechanical testing was performed on the stem itself. Instead, the manufacturer relied on Finite Element Method (FEM) analysis. This analysis concluded that the modifications (reduced distal width and enlarged thread diameter of the impact hole) did not decrease the stem fatigue strength or neck fatigue strength compared to the predicate device.
• Materials Testing: For the modified coating, chemical analysis, microstructural characterization, and mechanical strength were evaluated. The results were found to conform to the requirements of the FDA Guidance, "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements."
• Clinical Testing: No clinical testing was required or performed for this submission, further indicating the reliance on substantial equivalence and non-clinical data.
• Conclusion: Based on the engineering analysis of the design modification and the materials testing, the manufacturer determined that the "UTF Stem, reduced" is substantially equivalent to legally marketed predicates, meaning it is considered "as safe, as effective, and performs at least as safely and effectively."

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