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• 1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia.
• Inflammatory degenerative joint disease such as rheumatoid arthritis. 2.
• 3. Correction of function deformity.
• 4. Revision procedures where other treatments or devices have failed.
• 5. Treatment of nonunion, femoral neck and trochanteric fractures 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 except cemented stem which is designed for cemented use only.

The U2 Ti Porous Coated Matrix Stem is single use component intended for cementless fixation within the prepared femoral canals of patients requiring hip arthroplasty. U2 Ti Porous Coated Matrix Stem, made from a Ti-6Al-4V alloy conforming to ASTM F136-13/ISO 5832-3:1996, is a modular stem with 12/14 neck taper and 130° neck angle. The proximal part of each femoral stem is coated with porous coating in thickness 600±100 um using -45+60 mesh of CP Ti powder (ASTM F1580-12). The bulleted geometry stem tip of U2 Ti Porous Coated Matrix Stem helps reduce distal point loading while creating a smooth transition zone for load transfer. This stem system is available in thirteen sizes. U2 Ti Porous Coated Matrix Stem can be used with U1, U2 Acetabular components (K994078, K050262, K12177, K111546), U-Motion II Acetabular System components (K122185, K132455) and UNITED Femoral Head (K994078, K022520, K122504, K103497, K111546, K112463, K122185) for total hip replacement. For hip hemi-arthroplasty, U2 Ti Porous Coated Matrix Stem can be used in conjunction with Bipolar products (K101670).

The provided text describes a medical device, the U2 Hip Stem, Ti Porous Coated, Matrix, and its 510(k) summary, but it does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically understood for AI/algorithm-based devices. This document is for a physical orthopedic implant.

Therefore, I cannot fulfill the request as it pertains to AI device acceptance criteria and studies. The document describes:

1. Device Type: A hip stem (orthopedic implant).
2. Regulatory Pathway: 510(k) premarket notification, indicating substantial equivalence to a predicate device.
3. Non-clinical Performance Data: Mentions stem fatigue, neck fatigue, and mechanical properties of the porous coating surface. These tests comply with FDA guidance for femoral stem prostheses.
4. Clinical Performance Data: Explicitly states "None provided as a basis for substantial equivalence."

Key points missing (and why they are missing based on the document):

• Acceptance Criteria Table: Not applicable as this is a physical implant, not an AI/algorithm with performance metrics like sensitivity, specificity, etc.
• Sample Size for Test Set, Data Provenance, Experts for Ground Truth, Adjudication, MRMC Study, Standalone Performance, Ground Truth Type, Training Set Sample Size, Ground Truth for Training Set: All these points are relevant to AI/algorithm performance studies and are not found in this document because it concerns a physical medical device (hip stem). The "studies" mentioned are mechanical tests, not clinical evaluations or algorithm performance assessments.

If you have a document describing an AI/algorithm-based medical device, I would be happy to analyze it according to your requested format.

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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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The device is used for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
2. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
3. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
4. Correction of functional deformity.
5. Treatment of nonunion femoral neck and trochanteric fracture of the proximal femur with head involvement that is unmanageable using other techniques.
   The device is intended for cementless use.

The subject device designed for total hip arthroplasty includes acetabular components and femoral components. The acetabular components are composed of a highly crosslinked ultra - high - molecular - weight - polyethylene articulating bearing surface fixed in a metal shell acetabular cup, while metal shell could be fixed with acetabulum by Ti Cancellous Screw and optional screw hole cover. The femoral component is composed of a ceramic femoral head.
U-Motion II Acetabular Cup includes U-Motion II HA Cup and U-Motion II PS Cup. It is manufactured from titanium alloy forging (ASTM F620) which are forged by titanium alloy bars conforming to ASTM F136. The outer surface of U-Motion II HA Cup is coated with dual coatings, CP Ti powder (ASTM F1580) for the inner layer and HA (ASTM F1185) for the outer layer. The materials of substrate and coating layers are identical to previous cleared "UNITED" U2 Acetabular Component (K050262, K12177). The outer surface of U-Motion II PS Cup is coated with CP Ti power. There are nineteen sizes of acetabular shell available, ranging from 44 through 80 mm outer diameter in 2 mm increments. U-Motion II Cup has a snap fit locking groove for acceptance of the U-Motion II XPE Cup Liner.
Clustered-hole and multi-hole series of U-Motion II Cup have shell holes for Ti Cancellous Screw fixation to the acetabulum. Ti Cancellous Screw are self tapping and in a 6.5 mm diameter with length of 15 to 60 mm in 5 mm increments. The designs of screw are identical with the cleared screws (K050262), except for the design of screw head. This subject device also has screws and hole covers available to cover the shell holes if desired. Screw and hole covers are manufactured from Ti-6Al-4V bar (ASTM F136).
U-Motion II XPE Cup Liner is manufactured from highly crosslinked UHMWPE which conforms to ASTM F2565 and the UHMWPE raw material is in accordance with ASTM F648 and ISO 5834. The materials are identical to previous cleared "UNITED" XPE liners of U2 Hip System (K111546). U-Motion II XPE Cup Liner includes 0° and 20° hood designs, which are available in 28 mm. 32 mm. 36 mm and 40 mm inside diameter (ID), The 28 mm inserts fit the acetabular shells with outer diameter (OD) ranging from 44-80 mm, the 32 mm inserts fit the acetabular shells ranging from 48-80 mm, the 36 mm inserts fit the acetabular shells ranging from 52-80 mm, and the 40 mm inserts fit the acetabular shells ranging from 56-80 mm.
40 mm Ceramic Femoral Head - Delta is an additional size extension to the previously cleared "UNITED" Ceramic Femoral Head--Delta (K103497, K112463). The materials, design, safety and effectiveness of this subject are identical to the previously cleared device (available in sizes 28 mm, 32 mm and 36 mm), except for its larger diameter. 40 mm Ceramic Femoral Head - Delta, developed by CeramTec AG, is made from an alumina matrix composite in accordance with ISO 6474-2 and is available in -3, +1, +5 and +9 mm of neck length.
U-Motion II Cup will be used with U-Motion II XPE Cup Liner, 40 mm Ceramic Femoral Head - Delta, previously cleared 28 mm, 32 mm metal Femoral Head (K022520, K111546) and Ceramic Femoral Head (K103479, K112463) in corresponding size. This device should not be used with those of another manufacturer's hip components since the articular and dimensional compatibility cannot be assured. The 40 mm Ceramic Femoral Head may be used with UTF Stem (K110245) and the stems made of titanium alloy in U2 Hip Stem series (K003237, K062978, K111546).

Here's a breakdown of the acceptance criteria and the study information for the U-Motion II Acetabular System, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The provided document describes a bench performance testing approach to demonstrate the device's safety and effectiveness. The acceptance criteria are implicitly met by showing that the device is "capable of withstanding expected in vivo loading without failure" and that "there are no new issues related to the safety and effectiveness" as confirmed by these tests. The device performance is deemed satisfactory if it passes these tests.

No explicit quantitative acceptance criteria (e.g., a specific threshold for shear strength, a maximum wear rate) are provided in this summary section, nor are specific reported performance values for each test type. Instead, the document states generally that a "review of the mechanical data indicates that the U-Motion II Acetabular System is capable of withstanding expected in vivo loading without failure."

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated as a numerical count of individual devices tested. The document refers to "the U-Motion II Acetabular System" and its components being evaluated against various ASTM and ISO standards for mechanical testing. These standards typically specify sample sizes for such tests.
   • Data Provenance: The studies were bench tests (laboratory simulations), not clinical data from patients. The document does not specify the country of origin for the data; however, the manufacturer is in Taiwan.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This question is not applicable to this type of study. For bench testing of medical devices like an acetabular system, the "ground truth" is defined by established engineering and materials science standards (ASTM, ISO), and the performance is evaluated by engineers/technicians against these predefined criteria, not by medical experts establishing a diagnostic ground truth.

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

   • This is not applicable as there was no expert adjudication process for this type of bench test. The results are based on objective measurements and adherence to specified test methods.

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:

   • This is not applicable. This submission is for a physical orthopedic implant (hip replacement components), not a diagnostic imaging AI device. Therefore, no MRMC study was performed.

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

   • This is not applicable. This is a physical device, not an algorithm. However, the bench tests performed are akin to "standalone" performance evaluations in that they assess the device's inherent mechanical properties and durability without human interaction (beyond setting up and running the tests).

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

   • The "ground truth" for this device's performance relies on compliance with recognized international and national standards for medical device mechanical testing (ASTM F1854, F1160, F1044, F1147, F1978, F1820, F2759, ISO 14242-1, ISO 6474-2). These standards define the acceptable mechanical properties and testing methodologies for such implants. There is no biological or diagnostic "ground truth" in this context.

7. The sample size for the training set:

   • This is not applicable. This filing is for a physical medical device (orthopedic implant), not a machine learning or AI algorithm. Therefore, there is no "training set."

8. How the ground truth for the training set was established:

   • This is not applicable as there is no training set for a physical medical device.

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This device is indicated in hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

For use as a Total Hip Replacement

1. Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
2. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
3. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

For use as a Bipolar Hip Replacement

1. Femoral head/neck fractures or non-unions.
2. Aseptic necrosis of the femoral head.
3. Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.

Cemented stem is designed for cemented use only.

This device manufactured from CoCrMo alloy (ASTM F1537) is an extension of cleared "UNITED" U2 Acetabular Cup and Femoral Head (K022520) and "UNITED" U2 Hip System (K111546). The material, design, safety and effectiveness of this subject are identical to the previously cleared femoral heads except for its offset. The previously cleared femoral head offsets for the U2 Hip System are -3, +0, +5, and +10 mm. This submission adds +7.5 and +2.5 mm offset heads for 28, 32 and 36 mm diameter sizes. This device is intended to be used with the previously cleared U2 Acetabular Cup Liner (K050262), U2 XPE Liner (K111546), U2 bipolar implant (K101670), Revision Stem (K062978), HA/Ti Plasma Spray Stem (K003237), Ti Porous Coated Stem (K003237), UTF Stem (K110245), Press-fit Stem (K111546) and Cemented Stem (K111546) in corresponding size. The differences of femoral head offset do not affect the intended use of the device or alter the fundamental scientific technology of the device.

The provided text describes a Special 510(k) submission for "Femoral Heads, +2.5 and +7.5 mm Offset," which are extensions of previously cleared femoral head prostheses. This submission focuses on the addition of new offset sizes.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

The document does not specify a distinct "test set" in the sense of a clinical or imaging dataset with a specific sample size. The evaluation for this device appears to be based on mechanical testing and design assurance processes, not human clinical data or imaging studies that would typically involve a "test set" of patients or scans.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The evaluation is based on mechanical testing and engineering principles, not expert interpretation of clinical data or images.

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

Not applicable. There is no mention of a test set requiring adjudication in the context of this device's 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:

Not applicable. This device is a mechanical implant (femoral head) and does not involve AI or human readers for diagnostic interpretation.

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

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

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

The "ground truth" for this device's acceptance stems from established engineering standards and regulatory guidance documents related to the safety and mechanical performance of hip implant components. Specifically, it relies on:

• Design Assurance Process Results: Demonstrating that the new offset configurations maintain the safety and effectiveness established for the predicate devices.
• Compliance with Guidance Documents: Adherence to "Class II Special Controls Guidance Document- Hip Joint Metal Polymer Constrained Cemented or Uncemented Prosthesis" and "Guidance Document for Testing Non-Articulating, 'Mechanically Locked', Modular Implant Components."
• Mechanical Testing Results: "Femoral Head Disassembly loads for the stems" were explicitly mentioned as being completed as part of the design assurance process to show safety and effectiveness.

8. The sample size for the training set:

Not applicable. This device is a mechanical implant and does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. As there is no training set for this mechanical device, the concept of establishing ground truth for it does not apply.

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The devise is used for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
2. Inflammatory degenerative joint disease such as rheumatoid arthritis;
3. Correction of function deformity;
4. Revision procedures where other treatments or devices have failed; and
5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that is unmanageable using other techniques.
   The devise is intended for uncemented use and is single use only.

"UNITED" U2 Acetabular Cup - Plasma Spray is an extension of cleared "UNITED" U2 Acetabular Component (K050262). The materials, safety and effectiveness of this subject are identical to the previously cleared U2 Acetabular Cup (K050262), except for adding sizes and multi-hole cup design. The extension of each coating type is described as following:

1. U2 Acetabular Cup Ti Plasma Spray Coating: This submitted device adds the clustered-hole and multi-hole designs in sizes 44 ~ 80 mm and extends the size of no-hole design to #80. The catalog numbers of the cleared no-hole design are shifted to be used by clustered-hole, and the no-hole design is given new catalog numbers and extends its size to # 80. They are coated with CP Ti powder (ASTM F1580) to form a rough surface.
2. U2 Acetabular Cup -- HA/Ti plasma spray Coating: This submitted device extends cup size to #80 and increase the no-hole and multi-hole cup design for alternative. They are coated with dual coatings, which are CP Ti powder (ASTM F1580) for the inner layer and HA (ASTM F1185) for the outer layer.
   This device is intended to be used with the previously cleared U2 Acetabular cup liner (K050262), U2 XPE liner (K111546), "UNITED" Femoral head (K994078, K022520), "United" Ceramic Femoral Head (K103497, K112463) and Titanium cancellous bone screw (K050262) in corresponding size. The modifications of Acetabular cup do not affect the intended use of the device or alter the fundamental scientific technology of the device.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the "U2 Acetabular Cup, Plasma Spray" device:

Acceptance Criteria and Device Performance

Study Information:

Please note that the provided 510(k) summary is for a medical device (hip prosthesis) and not an AI/software as a medical device (SaMD). Therefore, many of the requested points related to AI/SaMD studies (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details) are not applicable to this type of submission.

The "study" referenced in this document is primarily a mechanical performance study and demonstrating substantial equivalence to previously cleared predicate devices.

Non-Applicable / Not Provided for this Device Type:

• Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to mechanical testing, not a clinical data set.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical properties is established through standardized testing methods, not expert clinical consensus.
• Adjudication method for the test set: Not applicable.
• 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 a hardware implant, not an AI-assisted diagnostic tool.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: For mechanical tests, the "ground truth" is typically the established standard (e.g., ASTM standards) that the device must meet, measured by laboratory instruments.
• The sample size for the training set: Not applicable. There is no AI training set for this device.
• How the ground truth for the training set was established: Not applicable.

Summary of the "Study" and Justification:

The "study" or rather, the basis for clearance, relies on:

1. Mechanical Performance Testing: The device underwent testing to ensure its mechanical properties conform to the FDA's "Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis." This includes a "locking strength test."
2. Substantial Equivalence: The primary strategy for regulatory clearance (510(k)) is to demonstrate that the new device is "substantially equivalent" to legally marketed predicate devices. The modifications introduced (additional sizes and multi-hole cup designs) were assessed and determined not to affect the intended use or fundamental scientific technology.
3. Predicate Devices:
   • "United" U2 Acetabular Component (K050262) - This is the primary predicate, with the new device being an "extension" of it.
   • "ENCORE MEDICAL, L.P." FMP Acetabular Shell (K063257)
   • "Depuy" Pinnacle® Duofix® HA Shells (K031495)
   • "BIOMET®" Universal® Acetabular Component (K921301)

The "Performance Data" section explicitly states that the mechanical properties of the modified surface were "evaluated to conform" to the FDA guidance and that the "locking strength test demonstrated that this device is safe and effective and is substantially equivalent to the predicate device." This is the core of the evidence presented for this type of medical device submission.

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This device is indicated for use in total hip arthroplasty for the following conditions: painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis; correction of functional deformity; treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques; revision procedures where other treatment or devices have failed arthroplasty or other procedure.

"UNITED" 36 mm Ceramic Femoral Head – Delta is an additional size extension to the previously cleared "UNITED" Ceramic Femoral Head (K103497). The materials, design, safety and effectiveness of this subject are identical to the previously cleared Ceramic Femoral Head - Delta Components (available in sizes 28 mm and 32 mm), except for its larger diameter (available in sizes 36 mm). 36 mm Ceramic Femoral Head - Delta manufactured from zirconia-toughened alumina ceramic is available in -3, +1, +5 and +9 mm of neck length. This device is intended to articulate against XPE cup liners (K111546) and can be used in conjunction with U2 Acetabular Cups and U2 Hip Stem made of titanium. U2 Acetabular Cups include U2 HA/Ti Plasma Spray Cup (K050262). U2 Ti Plasma Spray Cup (K050262) and U2 Ti Porous Cup (K111546), while U2 Hip Stem include HA/Ti Plasma Spray Stem (K003237), Ti Porous Coated Stem (K003237), Ti Plasma Spray Revision Stem (K062978), Ti Press-fit Stem (K111546) and UTF Stem (K110245). The size extension does not affect the intended use of the device or alter the fundamental scientific technology of the device.

This document describes the acceptance criteria and the study conducted for the "36 mm Ceramic Femoral Head, Delta" device (K112463).

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly detail specific quantitative acceptance criteria or a performance table for the "36 mm Ceramic Femoral Head, Delta" device in terms of clinical outcomes or specific thresholds for mechanical tests. Instead, it relies on demonstrating substantial equivalence to predicate devices through various tests.

The performance data section states: "This 510(k) was prepared in accordance with 'Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems'. Burst test, fatigue test, burst test for post-fatigue, rotational resistance test and pull-off test. completed as part of the design assurance process demonstrated that this device is safe and effective and is substantially equivalent to the predicate device."

This implies that the acceptance criteria for each of these tests were met by comparing the results to those of the predicate devices or to established industry standards outlined in the referenced guidance document. Without the specific guidance document or detailed test reports, the precise numerical acceptance criteria and the exact reported performance cannot be extracted from the provided text.

However, based on the text, the following can be inferred:

2. Sample Size Used for the Test Set and Data Provenance

The text does not specify the exact sample sizes used for each of the "burst test, fatigue test, burst test for post-fatigue, rotational resistance test and pull-off test." The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective, beyond being "completed as part of the design assurance process." Given the nature of these tests for an orthopedic implant, they would typically be laboratory-based mechanical tests performed 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 study described is a mechanical performance study, not one requiring expert human interpretation for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document. The study described is a mechanical performance study, not one requiring adjudication by human experts.

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 information is not applicable and not provided in the document. The device is a physical orthopedic implant, not an AI or imaging diagnostic tool that would involve human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable and not provided in the document. The device is a physical orthopedic implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the mechanical performance tests (burst, fatigue, rotational resistance, pull-off) would be the objective, quantitative measurements derived from the tests themselves, as compared against established engineering standards and performance of legally marketed predicate devices. It is based on objective physical properties and not on expert consensus, pathology, or outcomes data in the context of this specific 510(k) submission for mechanical properties.

8. The Sample Size for the Training Set

This information is not applicable and not provided in the document. The described study is a mechanical performance evaluation of an orthopedic implant, not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and not provided in the document, as there is no training set mentioned.

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This device is indicated for use in total hip arthroplasty or bipolar arthroplasty 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

UTF Stem is designed for cementless use.

UTF Stem is a modular, wedge-shaped stem with 12/14 neck taper, which is made from forging Ti-6A1-4V alloy conforming to ASTM F 620 and the proximal part of each femoral stem is coated with CP Ti plasma spray. The net-shape of stem was forged by the titanium bar (ASTM F136). Circumferential titanium plasma coating sprayed with CP Ti powder (ASTM F1580) provides biological fixation. This device is collarless to allow for self-seating of the implant between the lateral and medial cortices of the femoral canal. UTF Stem is available with standard offset and high offset options to restore hip biomechanics. Each type of offset is available in 10 sizes ranging.

For total hip replacement, UTF Stem can be used in conjunction with UNITED Femoral Head (K994078, K022520 and K111546), U2 Acetabular Cup Liner (K050262), XPE Cup Liner (K111546), U2 HA/Ti Plasma Spray Cup (K050262), U2 Ti Plasma Spray Cup (K050262) and U2 Ti Porous Coated Cup (K111546). As using with the U2 Acetabular Cup Liner (K050262), UTF Stem can be used with 26 mm and 28 mm Femoral Head (K994078 and K022520) and 28 mm ceramic Femoral Head (K103479). 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), and 28 mm and 32 mm Ceramic Femoral Head (K103479). Only U2 Ti Porous Coated Cup (K111546) and XPE Cup Liner (K111546) can be used in conjunction with the 32 mm and 36 mm Femoral Head (K111546, K103479). For bipolar hip replacement, UTF Stem also can be used in conjunction with 26 mm. 28 mm. 32mm and 36mm Femoral Head (K994078, K022520, K111546) and Bipolar implants (K050269, K101670). UNITED Femoral Head and Binolar 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.

The provided text describes a 510(k) summary for the "UTF Stem" total hip prosthesis. The acceptance criteria and supporting studies are limited to bench testing to demonstrate substantial equivalence to predicate devices. It does not contain information about clinical studies with human participants, expert review processes, or multi-reader multi-case studies.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the 510(k) was prepared in accordance with several guidance documents, including "Class II Special Controls Guidance Document-Hip Joint Metal Polymer Constrained Cemented or Uncemented Prosthesis" and "Guidance for Non-clinical Information for Femoral Stem Prostheses." This implies that the tests performed adhered to the acceptance criteria outlined in these guidance documents, even if the specific numerical thresholds are not explicitly listed in this summary. The successful clearance by the FDA (K110245) indicates that the device was deemed to meet these criteria.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified. The document only mentions that the listed tests "have been performed." For bench testing, the sample size would typically refer to the number of physical samples of the device components tested for each specific test.
• Data Provenance: Not applicable in the context of clinical data. For bench testing, the data would originate from laboratory experiments conducted by the manufacturer or a contracted lab. The manufacturer is United Orthopedic Corporation, located in Hsinchu, Taiwan.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

• Not applicable. This summary only describes non-clinical, bench testing. There is no indication of a "ground truth" established by human experts for these mechanical or material property tests. The "ground truth" for bench tests is typically defined by engineering specifications, material standards (e.g., ASTM), and regulatory guidance documents.

4. Adjudication Method for the Test Set

• Not applicable. This summary pertains to non-clinical bench testing, where adjudication by multiple experts is not typically a component of determining test outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. This document focuses solely on the substantial equivalence through bench testing (mechanical and material properties) of a hip prosthesis. It does not involve human readers or image interpretation, thus no MRMC study was conducted.

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

• Not applicable. This device is a physical medical implant, not a software algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

• Engineering Specifications and Standardized Test Methods: The "ground truth" for the bench tests would be the established performance criteria and thresholds defined in relevant ASTM standards (e.g., ASTM F 620, ASTM F136, ASTM F1580), FDA guidance documents (e.g., "Guidance for Non-clinical Information for Femoral Stem Prostheses"), and the manufacturer's internal design specifications for a hip prosthesis.

8. The Sample Size for the Training Set

• Not applicable. This report describes the performance of a physical device, not an AI or machine learning model that would require a training set.

9. How the Ground Truth for the Training Set was Established

• Not applicable. As above, there is no training set for a physical medical device.

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This device is indicated in hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

For use as a Total Hip Replacement

1. Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
2. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
3. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

For use as a Bipolar Hip Replacement

1. Femoral head/neck factures or non-unions.
2. Aseptic necrosis of the femoral head.
3. Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.
   Cemented stem is designed for cemented use only.

The U2 Hip System for hip arthroplasty is a metal/polymer/metal semi-constrained prosthesis with femoral components and acetabular components. The femoral components are composed of a ball mechanical locked with a stem by means of a Morse taper, while the acetabular components are composed of an highly crosslinked ultra - high - molecular - weight - polyethylene articulating bearing surface fixed in a metal shell. Components of this premarket notification include the following components:

• Ti Porous Coated Cup
• XPE Cup Liner
• 32 mm and 36 mm Femoral Head
• U2 Hip Stem, Press-fit
• U2 Hip Stem, Cemented

The titanium bar (ASTM F136) was forged into a net-shape of acetabular cup and then the forged part was machined into the final shape of Ti Porous Coated Cup. The outer surface is porous coated with three layers of CP Ti beads (ASTM F1580). XPE Cup Liner is manufactured from highly crosslinked UHMWPE which conform to ASTM F2565 and the UHMWPE raw material is in accordance with ASTM F648 and ISO 5834. The first series of XPE Cup Liner with the sizes of 44 to 80 mm has an inner diameter of 28 mm. The second series with the sizes of 50 to 80 mm have an inner diameter of 32 mm. The third series with the sizes from 54 to 80 mm have an inner diameter of 36 mm. The 32 and 36 mm Femoral Head is manufactured from CoCrMo alloy (ASTM F1537) with neck length of -3, +0, +5, and +10 mm. U2 Press-fit Stem is manufactured from titanium alloy (ASTM F620) which is intended for cementless fixation within the prepared femoral canals of patients requiring hip arthroplasty. U2 Cemented Hip Stem manufactured from forging CoCrMo alloy (ASTM F799) is intended for cement fixation. Moreover, this device is available to use with an accessory, called "Cement Restrictor, Full PE" made of Ultra-High Molecular Weight Polyethylene (ASTM F648).

The Ti Porous Coated Cup will be used with 510k cleared cup liner of the U2 Acetabular Component (K050262) and currently submission XPE Cup Liner. As using with the existing cup liner (K050262), the Ti Porous Coated Cup may be used with 26 mm and 28 mm Femoral Head (K994078 and K022520) and 28 mm Ceramic Femoral Head (K103479). As using with currently submission XPE Cup Liner, this component may be used with currently submission 32 mm and 36mm Femoral Head, the 28 mm Femoral Head (K022520) and 28 mm and 32 mm Ceramic Femoral Head (K103479). Besides, XPE Cup Liner may also be used with existing U2 Acetabular Cup (K050262). The 32 mm and 36 mm Femoral Head may also be used with U2 Bipolar Implant (K101670), Revision Stem (K062978) and current submission Cemented Stem and Press-fit Stem.

The Press-fit Stem and Cemented Stem will be used with currently submission 32mm and 36 mm metal Femoral Head and may be used with 26 mm and 28 mm metal Femoral Head (K994078 and K022520). The Press-fit Stem which made from Ti alloy can also be used with Ceramic Femoral Head (K103479).

The provided text describes the U2 Hip System, a semi-constrained hip prosthesis. It details the device components, materials, and indications for use. The document focuses on demonstrating substantial equivalence to predicate devices through comparisons of design, operational principles, material composition, and extensive bench performance tests. There is no information about acceptance criteria or a study proving the device meets acceptance criteria in the sense of clinical performance or diagnostic accuracy. Instead, the "performance test - bench" section outlines mechanical tests conducted to ensure the device's safety and effectiveness regarding its physical properties and mechanical integrity.

Here's an analysis based on the provided text, addressing the user's questions where applicable, and noting where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as pass/fail thresholds for clinical performance or diagnostic accuracy. Instead, it describes mechanical tests performed to demonstrate the device's ability to withstand expected in vivo loading. The "reported device performance" is that these tests were performed and a "review of the mechanical data indicates that the U2 Hip System is capable of withstanding expected in vivo loading without failure." No specific numerical results of these tests and their comparison against predefined limits are provided in this summary.

Here's a summary of the tests performed and the general conclusion:

The document states: "A review of these tests has demonstrated that there are no new issues related to the safety and effectiveness of the subject devices."

2. Sample size used for the test set and the data provenance

Not applicable. The study described is a series of bench performance tests on the device's components, not a clinical trial or a study involving human subjects or data. Therefore, there is no "test set" in the context of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a medical device (hip prosthesis), and the "study" involves mechanical testing, not interpretation of data by experts for ground truth establishment.

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

Not applicable. This is a medical device (hip prosthesis) and the "study" involves mechanical testing.

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 document pertains to a medical device (hip prosthesis), not an AI algorithm or a diagnostic tool that would involve human readers.

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

Not applicable. This document pertains to a medical device (hip prosthesis), not an algorithm.

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

Not applicable in the conventional sense of diagnostic accuracy studies. For mechanical tests, the "ground truth" is defined by the objective physical properties and performance characteristics as measured against established ASTM and ISO standards for medical implants. The tests themselves are designed to evaluate whether the components meet these engineering standards for safety and effectiveness.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning algorithm.

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

Not applicable. There is no "training set" as this is not an AI/machine learning algorithm.

Additional Information from the document:

• Clinical Data: "Clinical data was not needed to support the safety and effectiveness of the subject devices." This implies that the substantial equivalence argument was entirely based on non-clinical (bench) testing and comparison to predicate devices.
• Regulatory Basis: The 510(k) was prepared in accordance with several FDA guidance documents for hip joint prostheses and orthopedic implants, reinforcing that the testing conducted (as detailed in the "Performance Test - Bench" section) is the accepted method for demonstrating safety and effectiveness for this type of device.

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