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The device is indicated for use in hip arthroplasty in skeletally mature patients with the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement or total hip replacement.
5. Certain cases of ankylosis.
   Conformity stem is for cementless use only.

The subject device is an extension line of 510(K) cleared device Conformity stem, cementless (K183312, K242249), which introduces four new variations: (1) Conformity stem, #0; (2) Conformity stem, collared, #0; (3) Conformity stem, coxa vara, 125° STD, collared, #0; and (4) Conformity stem, short neck, collared #0. The indications, design rationales, materials, manufacturing process, and sterilization method of the subject devices are identical to the 510(k) cleared Conformity Stem, cementless (K183312, K242249).
Conformity Stem can collocate with “United” metallic femoral heads (K994078, K022520, K111546, K122504, K152439, K162957, K221675) or ceramic femoral heads (K103497, K112463, K122185).

• Conformity stem, #0
  Conformity stem, #0 is an extension in terms of sizes to 510 (k) cleared device Conformity stem, #1-11 (K183312). The material, coating thickness, neck angle (135°), and neck length (35.5mm) design are identical to 510 (k) cleared device Conformity Stem, #1, #11 (K183312)The only differences in the items are the offset specifications and stem length.
• Conformity stem, collared, #0
• Conformity stem, collared, #0 is an extension in terms of sizes to 510 (k) cleared device Conformity stem, collared, #1-11 (K183312). The material, coating thickness, neck angle (135°), and neck length (35.5mm) design are identical to 510 (k) cleared device Conformity stem, collared, #1, #11 (K183312).The only differences in the items are the offset specifications and stem length.
• Conformity Stem, coxa vara, 125° STD, collared, #0
• Conformity Stem, coxa vara, 125° STD, collared, #0 is an extension in terms of sizes to 510 (k) cleared device Conformity stem, coxa vara 125° STD, collared, #1-7 (K242249). The material, coating thickness, neck angle (125°), and neck length (32.5mm) design are identical to 510 (k) cleared device Conformity stem, 125° STD, collared, #1, #7 (K242249). The only differences in the items are the offset specifications and stem length.
• Conformity Stem, short neck, collared #0
• Conformity Stem, short neck, collared #0 is an extension in terms of sizes to 510 (k) cleared device Conformity Stem, short neck, collared, #1-7 (K183312 and K242249). The material, coating thickness, neck angle (135°), and neck length (28.5mm) design are identical to 510 (k) cleared device Conformity Stem, short neck, collared, #1, #7 (K183312 and K242249). The only differences in the items are the offset specifications and stem length.

The provided text is a 510(k) summary for a medical device (hip stem extension line). It details the device's identity, intended use, and comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria, especially not in the context of an AI/ML-driven device.

The document primarily focuses on demonstrating substantial equivalence to existing legally marketed devices based on:

1. Identical Indications for Use: The new device has the same indications as the predicate devices.
2. Similar Technological Characteristics: The material, principle of operation, regulation number, product code, risk class, intended users, fixation method, surface coating, locking mechanism, and sterilization method are the same as the predicate device.
3. Non-Clinical Performance Data: The submission includes tests like Range of Motion, Neck Fatigue Assessment, Stem Fatigue Test, Characterization of HA Plasma Spray Coating, and Usability Evaluation. These are standard engineering and material tests for orthopedic implants, not AI/ML performance metrics.

Therefore, I cannot extract the requested information regarding:

• A table of acceptance criteria and reported device performance (for AI/ML).
• Sample size and data provenance for a test set (for AI/ML).
• Number and qualifications of experts for ground truth (for AI/ML).
• Adjudication method (for AI/ML).
• MRMC comparative effectiveness study or human reader improvement with AI.
• Standalone algorithm performance.
• Type of ground truth (expert consensus, pathology, outcomes data, etc.) for AI/ML validation.
• Sample size for the training set (for AI/ML).
• How ground truth for the training set was established (for AI/ML).

The document is about a physical orthopedic implant and its substantial equivalence based on mechanical and material testing, not an AI/ML diagnostic or assistive device.

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The device is indicated for use in hip arthroplasty in skeletally mature patients with the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement or total hip replacement.
5. Certain cases of ankylosis.
   Conformity stem is for cementless use only.

The "United" Conformity Stem cementless type (K183312) is designed for cementless use in hip arthroplasty. The Conformity Stem cementless type is a proximal trapezoid and distal quadrangular stem with 12/14 neck taper, 135° and 125° neck angle. It is manufactured from Ti-6Al-4V alloy, which conforms to ASTM F136-13 and the distal part of each femoral stem is coated with hydroxyapatite (HA) (ASTM F1185-03) to provide biological fixation. The "United" Conformity Stem cementless is available in various sizes with collarless and collared types to accommodate various hip surgical requirements.
For the subject device, it's an extension line of the 510(K) cleared device Conformity Stem cementless type (K183312), which introduces two new variations: (1) Conformity stem, coxa vara, 125° STD, collared, #1-7; and (2) Conformity stem, short neck, #4-7. The indications, design rationales, materials, major manufacturing process, and sterilization method of the subject devices are identical to the 510(k) cleared Conformity Stem, cementless (K183312).
Conformity Stem can collocate with "United" metallic femoral heads (K994078, K022520, K111546, K122504, K152439, K162957, K221675) or ceramic femoral heads (K103497, K112463, K122185).

• Conformity stem, coxa vara, 125° STD, collared
  Conformity stem, coxa vara, 125° STD, collared is a new coxa vara type variation of 510(k) cleared Conformity stem, coxa vara (1110-52XX, K183312). The same as this 510(k) cleared device, it's also made of Ti-6Al-4V alloy (ASTM F136), and the distal part is coated with hydroxyapatite(HA) (ASTM F1185). In addition, the subject device is also a collared stem with a 125° neck angle. The only difference is the offset design. The subject device is standard offset, while the 510(k) cleared coxa vara collared stem (110-52XX) is high offset
• Conformity Stem, short neck, #4-7
  Conformity stem, short neck, #4-7 is an extension in terms of sizes to 510 (k) cleared device Conformity stem, short neck, #1-3 (K183312). The design, material, coating thickness, geometrical characteristics, neck angle (135°), and neck length (28.5mm) design are identical to 510 (k) cleared device Conformity Stem, short neck, #1-3 (K183312). The only different is the stem length sizes.

This is an FDA 510(k) clearance letter for a medical device called "Conformity Stem Extension Line." This document does not describe acceptance criteria for an AI/ML device or a study proving that an AI/ML device meets those criteria. Instead, it describes mechanical analyses performed on a physical orthopedic implant.

Therefore, I cannot extract the requested information regarding acceptance criteria and study details for an AI/ML device from this document. The document pertains to a hip joint prosthesis, which is a physical implant, not a software device.

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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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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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