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The U2 Total Knee system is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee cannot be satisfactorily balanced and stabilized at the time of surgery.

For cemented femoral components, patellar components, tibial baseplate components and tibial inserts components: This device is a single use implant and intended for cemented use only.

For porous coated femoral component: This device is a single use implant and intended for cementless use only.

U2 Cemented Femoral Component-CR Type is manufactured from cast Co-Cr-Mo alloy confirming to ASTM F75. It is available in seven proportional sizes (#1~ #7, AP/ML ranging from 52mm/ 56mm to 76mm/ 80mm) and is provided in left and right configurations. The femoral component is the same as that of cleared U2 Total Knee System (K051640), except adding size #7. Fixation of the femoral component to the femur is achieved using bone cement.

1. Table of acceptance criteria and reported device performance:

Note: The document states that the submission was prepared in accordance with the "Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA." The specific quantitative acceptance criteria are not explicitly detailed in this summary but are implied to be those outlined in this guidance document.

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

• Sample size for the test set: Not applicable. The "Performance Data" section explicitly states "None provided as a basis for substantial equivalence" for clinical performance data. The device's safety and effectiveness were evaluated through non-clinical (bench) testing.
• Data provenance: Not applicable. No clinical data (which would have provenance) was provided.

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

• Not applicable. The study relies on non-clinical performance data (bench testing) rather than clinical data requiring expert review for ground truth.

4. Adjudication method for the test set:

• Not applicable. The study relies on non-clinical performance data (bench 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 is a medical device (femoral component for knee replacement) and not an AI-powered diagnostic or assistive tool for human readers.

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

• Not applicable. This is a medical device and does not involve an algorithm. The "standalone" performance here would refer to the physical device's mechanical performance, which was assessed through bench testing as described in the "Non-clinical Performance" section.

7. The type of ground truth used:

• Bench Testing Standards: The ground truth for the non-clinical tests would be defined by established engineering and biomechanical standards (e.g., ASTM standards, or those referenced in the FDA's "Class II Special Controls Guidance Document") for the performance metrics being evaluated (e.g., range of motion, contact pressure, fatigue strength). The device's performance was compared against these predefined physical and mechanical thresholds for safety and effectiveness.

8. The sample size for the training set:

• Not applicable. This is a medical device, not an AI model.

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

• Not applicable. This is a medical device, not an AI model.

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The U2 Total Knee system is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee cannot be satisfactorily balanced and stabilized at the time of surgery.

For cemented femoral components, patellar components, tibial baseplate components and tibial inserts components: This device is a single use implant and intended for cemented use only.

For porous coated femoral component: This device is a single use implant and intended for cementless use only.

U2 Porous Coated Femoral Component-CR Type is manufactured from Co-Cr-Mo alloy confirming to ASTM F75. The inner surface is porous coated with Co-Cr-Mo beads (ASTM F75) to provide a porous surface for enhanced fixation. It is available in seven proportional sizes (#1~ #7, AP/ML ranging from 52mm to 76mm/ 80mm) and is provided in left and right configurations. The femoral component is the same as that of cleared U2 Total Knee System (K051640), except adding size #7.

The provided text describes a 510(k) submission for a medical device, the "U2 Femoral Component, CR, Porous Coated." This is a premarket notification to demonstrate that the device is substantially equivalent to a predicate device, and it primarily focuses on non-clinical performance data.

Therefore, the requested information regarding acceptance criteria, study details for AI performance, sample sizes for test/training sets, expert qualifications, ground truth establishment methods, and MRMC studies is not applicable or not provided in this type of submission. These details are typically associated with studies evaluating the performance of AI/CADe devices, which this document is not.

The device in question is a physical orthopedic implant, not a software or AI-based diagnostic tool. The performance data presented refers to mechanical and design-based tests.

Here's a breakdown of why each point of your request cannot be fully answered based on the provided document:

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

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds against specific numerical values. The document states that "Tests as follows were conducted to evaluate the safety and effectiveness of the subjected device, and the test results demonstrated that this device is safe and effective." This implies all tests met their inherent safety and effectiveness requirements, but specific performance metrics and their acceptance benchmarks are not detailed.
• Reported Device Performance: The document lists the types of non-clinical tests performed, but does not provide the results or specific performance metrics from these tests. It only states that the tests "demonstrated that this device is safe and effective."

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

• Sample Size: Not applicable. The tests performed are non-clinical (e.g., mechanical tests on the implant itself), not involving human or clinical data.
• Data Provenance: Not applicable.

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

• Number of experts and qualifications: Not applicable. There is no "ground truth" to be established by experts as this is not a diagnostic device involving interpretation of data.

4. Adjudication method for the test set

• Adjudication method: Not applicable.

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

• MRMC study: No, this device is an orthopedic implant, not an AI or diagnostic tool. Thus, no MRMC study was performed.

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

• Standalone performance: No, this is not an algorithm or AI device.

7. The type of ground truth used

• Type of ground truth: Not applicable. For devices like this, safety and effectiveness are confirmed through established engineering and materials testing standards (e.g., ASTM F75 for Co-Cr-Mo alloy).

8. The sample size for the training set

• Training set sample size: Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Ground truth establishment for training set: Not applicable.

Summary of Relevant Information from the Document:

• Device Type: U2 Femoral Component, CR, Porous Coated - a femoral component for total knee replacement, made from Co-Cr-Mo alloy and porous coated.
• Purpose of Submission: Demonstrate substantial equivalence to predicate devices (K051640 and K030612) by showing similar materials, design, manufacturing, and intended use, and adding a new size (#7).
• Performance Data: Non-clinical tests were conducted according to the "Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA."
• Specific Tests Performed (Non-clinical):
  • Range of Motion
  • Contact Area and Contact Pressure on Femorotibial Joint
  • Contact Area and Contact Pressure on Femoropatellar Joint
  • Subluxation of Femorotibial Joint
  • Fatigue Compression Test of Femoral Component
• Clinical Performance Data: "None provided as a basis for substantial equivalence." This further confirms that no studies involving human subjects or clinical outcomes were part of this specific 510(k) submission.

This 510(k) focuses on mechanical and physical properties of an implant, rather than the diagnostic accuracy or performance of a digital health or AI-driven device.

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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.

U-Motion II PS Cup is an extension of cleared "UNITED" U-Motion II Acetabular System (K122185). The indications, major design features, materials, major manufacture processing and methods, size distribution of this subject are identical to the cleared U-Motion II Acetabular System (K122185). This device is manufactured from titanium alloy forging (ASTM F620) which are forged by titanium alloy bars (ASTM F136). The outer surface of U-Motion II PS+ Cup is coated with CP Ti power (ASTM F1580), and the coating layer is thicker than the cleared U-Motion II PS Cup (K122185). U-Motion II PS* Cup includes cluster-holed, no-hole and multi-hole series, and there are nineteen sizes of acetabular shell available, ranging from 44 through 80 mm outer diameter in 2 mm increments.

The provided text is a 510(k) Summary for the "U-Motion II PS+ Cup" acetabular cup, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the context of a clinical trial or AI model validation.

Therefore, many of the requested elements (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, etc.) are not applicable in this regulatory submission for a orthopedic implant.

Here's an analysis based on the available information:

Description of Acceptance Criteria and Proving Device Meets Them

The "acceptance criteria" in this context are for demonstrating substantial equivalence to a legally marketed predicate device, as required for 510(k) clearance by the FDA. The study proving the device meets these criteria is the comparison presented in the 510(k) summary, specifically focusing on physical and mechanical properties.

The core "acceptance criteria" are that the device shares the same intended use, materials, basic design features, and performs at least as safely and effectively as the predicate device, or any differences do not raise new questions of safety and effectiveness.

The document states:
"The mechanical properties of the modified surface have been evaluated to conform to FDA guidance: 'Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis; Guidance for Industry and FDA' and 'Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement.' The analysis results demonstrate that the coating layer thickness increase would not affect the safety and effectiveness."

This indicates that the acceptance criteria for the device involved adherence to specific FDA guidance documents for mechanical property testing of orthopedic implants with modified metallic surfaces. The "study" proving this was the mechanical property evaluation of the modified surface.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) for an orthopedic implant extension, specific numerical performance metrics like sensitivity, specificity, accuracy (which would be common for AI/diagnostic devices) are not presented in this summary. Instead, the "performance" is about meeting safety and effectiveness standards through material and mechanical testing.

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 used for the test set: Not applicable in this context. The "test set" here refers to physical components undergoing mechanical testing, not patient data or images. The specific number of physical samples tested is not disclosed in the summary.
• Data provenance: Not explicitly stated for the mechanical testing. This would typically be generated by the manufacturer's R&D or an accredited testing lab.

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)

• Number of experts: Not applicable. Ground truth in this context refers to the results of mechanical and material property tests (e.g., tensile strength, fatigue resistance), which are objectively measured, not subject to expert consensus in the same way as diagnostic image interpretation.
• Qualifications of experts: N/A.

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

• Adjudication method: Not applicable. This concept pertains to resolving discrepancies in expert interpretations, which is not relevant for physical product 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

• MRMC study: No, this is not an AI/diagnostic device. This is a medical implant (acetabular cup).

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

• Standalone performance: Not applicable. This is not an AI algorithm.

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

• Type of ground truth: The "ground truth" for this device revolves around objective engineering and material science measurements, such as:
  • Material composition analysis (e.g., ASTM F620, ASTM F136, ASTM F1580 standards).
  • Dimensional accuracy checks.
  • Mechanical strength tests (e.g., fatigue, static strength), as per the specified FDA guidance documents.
  • Verification of coating thickness and adhesion.

8. The sample size for the training set

• Sample size for the training set: Not applicable. This is not an AI/machine learning device.

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

• How ground truth was established: Not applicable. This is not an AI/machine learning device.

Ask a specific question about this device

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 knee arthroplasty in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion contraction. This device is intended for use in patients who require augmentation and/or stem extensions due to inadequate bone stock and/or require increased stabilization for tibiofemoral joint due to soft tissue imbalance. The femoral and tibial augments are to be attached to their respective components with a fixation screw or screws. Note: In the US, this device is for cemented use only.

"UNITED" Augment and Screw - PSA Type, including femoral augments - distal only and tibial augments, is an extension of cleared "UNITED" U2 Total Knee System -PSA Type (K082424). The raw materials, safety and effectiveness of this subject device are identical to the "UNITED" U2 Total Knee System - PSA Type (K082424), except for increasing their thickness and modifying the shape to mimic anatomy. Femoral augment - distal only made of Co-Cr-Mo alloy (ASTM F75 or ASTM F1537) are available in 12 mm and 16 mm thickness and can be positioned on either side of femoral component. This component is only available distally. Tibial augments are made of Ti-6Al-4V alloy (ASTM F136/ISO 5832-3) and with 15 mm thickness. The periphery of the distal end of tibial augments is larger than that of the proximal end. It is left/right specific. The femoral augments and tibial augments are sized to match the femoral components and tibial base plates, respectively. There are 6 sizes (sizes #1 through 6) to match the corresponding augmentable femoral components - PSA type and tibial baseplates - PSA type (K082424). The augments are affixed to the tibial and femoral components with screw fixation and that the implant construct as a whole is to be fixed with cement. This device should not be used with another manufacturer's total knee systems since dimensional compatibility cannot be assured. It also should not be used with U2 Total Knee System - PS Type and CR Type. For total knee replacement, "UNITED" patella components (K021657, K051640, K082469, and K103733) are intended to be used with U2 Total Knee System - PSA Type (K082424) and the subject device.

The provided text is a 510(k) summary for the "Augment and Screw, PSA Type" knee system. This document focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering and manufacturing comparisons rather than clinical performance data typical of AI/ML devices. Therefore, many of the requested fields are not applicable to this type of submission.

Here's an analysis of the provided information relative to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document states, "The locking strength evaluation between femoral component and femoral augment, as well as tibial baseplate and tibial augment completed as part of the design assurance process, demonstrated that this device is substantially equivalent to the predicate device." Acceptance criteria for "locking strength" are not explicitly quantified (e.g., minimum Newtons of force, cycles endured), but the conclusion is that the new device performs equivalently to established predicate devices.

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

• Sample Size: Not explicitly stated. The performance data section refers to "locking strength evaluation," implying mechanical testing rather than a clinical dataset. The number of samples tested for this evaluation is not provided.
• Data Provenance: Not applicable in the traditional sense of clinical data. This is a mechanical engineering evaluation of a physical device.

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

• Not Applicable. Ground truth, in the context of AI/ML, refers to human annotations or confirmed diagnoses used for model training and validation. For this mechanical device, "ground truth" would be the measured physical properties during testing, likely assessed against engineering specifications by qualified engineers or technicians, though their qualifications are not detailed.

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

• Not Applicable. Adjudication methods are typically used to resolve discrepancies among expert opinions in clinical ground truth establishment. This document describes 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:

• No. This is a hardware device (knee augment and screw) and not an AI/ML-driven device that assists human readers. Therefore, an MRMC study is not relevant to this submission.

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

• No. This is a hardware device. "Standalone performance" in the context of AI/ML refers to the algorithm's performance without human intervention. This concept does not apply here.

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

• Mechanical Test Results/Engineering Specifications. The "ground truth" for this device's performance would be the direct measurements from mechanical tests (e.g., force required for failure, displacement under load) compared against established engineering standards or the performance of predicate devices.

8. The sample size for the training set:

• Not Applicable. There is no "training set" in the context of an AI/ML model for this hardware device. The device's design is based on engineering principles and iterative design assurance processes, not machine learning.

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

• Not Applicable. See point 8.

Ask a specific question about this device

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 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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This device is intended for use in combination with UNITED Femoral System for cemented or cementless hip replacement in skeletally mature patients with the following conditions: 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; correction of function deformity; revision procedures where other treatments or devices have failed; treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

"UNITED" U2 Bipolar Implant, designed with a simple one-step assembly interface between femoral head and U2 Bipolar Implant, is a hemiarthroplasty design. U2 Bipolar Implant consists of an outer shell into which a bearing insert has been permanently assembled. The bearing insert has a factory assembled stopper ring and metal wire. The assembled prosthesis provides for primary articulation at the femoral head/inner polyethylene bearing interface and secondary articulation at the outer shell/acetabulum interface. The internal aspect of the shell is designed to lock the polyethylene liner. The outer metal surfaces of the bipolar hip prosthesis are highly polished for articulation with the patient's acetabulum. Components are available in a range of sizes to fit varying anatomical requirements. U2 Bipolar Implant are offered in 41-73 mm outer diameters and is designed to be used with either 26mm, 28mm, or 36 mm femoral heads, depending on the inner diameter liner. The minimum thickness of the polyethylene at its thinnest point at a load bearing area of the liner is at lest 5.mm in U2 Bipolar Implant.

The provided 510(k) summary for the U2 Bipolar Implant (K101670) does not contain the detailed information requested regarding specific acceptance criteria, study designs, sample sizes for test sets, expert qualifications, or ground truth establishment.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices (U1 Hip System - Bipolar (K050269) and "Wright" GLADIATOR Bipolar System (K062693)) through device description, intended use, and a limited set of performance bench tests.

Here's a breakdown of what can be extracted and what is missing based on your request:

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

Note: The document only lists the types of performance tests performed, not specific quantitative acceptance criteria or the numerical results of those tests. The basis for acceptance appears to be substantial equivalence to predicate devices, meaning the U2 Bipolar Implant performs similarly to the U1 Hip System - Bipolar and the "Wright" GLADIATOR Bipolar System for these tests.

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

The document only mentions "Performance Test - Bench" and lists two tests. It does not specify any sample sizes for these tests or the data provenance (e.g., country of origin, retrospective/prospective). These were likely conducted in vitro (bench tests) rather than using patient data.

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

This information is not provided as the tests described are bench tests and do not involve human expert assessment for ground truth.

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

This information is not applicable and not provided as the tests described are bench tests and do not involve human adjudication.

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. This submission is for a physical orthopedic implant, not an AI-assisted diagnostic device or software that would involve human readers.

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

This information is not applicable and not provided. This submission is for a physical orthopedic implant, not an algorithm or software.

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

For the bench tests mentioned, the "ground truth" would be the engineering specifications and design requirements for the locking mechanism and range of motion for hip implants, which are typically established through industry standards, regulatory guidance, and comparisons to predicate devices. The document does not explicitly state the type of ground truth used but implies adherence to established engineering principles for orthopedic devices.

8. The sample size for the training set

This information is not applicable and not provided. The device is a physical hip implant, not an AI 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. The device is a physical hip implant, not an AI model.

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Stem - PSA Type is included in U2 Total Knee System-PSA type. U2 Total Knee System-PSA type is indicated for use in skeletally mature patients with severe knee pain and disability undergoing surgery for knee arthroplasty due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion contraction. This device is intended for use in patients who require augmentation and/or stem extensions due to inadequate bone stock and/or require constrained stabilization for tibiofemoral joint due to soft tissue imbalance. U2 Total Knee System-PSA type is designed for cemented use only.

"UNITED Stem-PSA Type is an additional size extension of stem to the existing, previously cleared "UNITED" U2 Total Knee system product line (K082424). The materials, design, safety and effectiveness of this subject are identical to the previously cleared U2 Total Knee system. The only difference from the existing products is the length of stem. This subject stem made of Ti-6A1-4V alloy and will be offered in two types which include straight stem and curved stem. The length of extended straight stem distribute to 150, 200 and 240mm, while the curved stem has 240mm only. Each size of stem has fifteen options in diameter which ranging from 10mm to 24mm. Canal filling stems with spline and flute design provide immediate rigid fixation and resistance to torsional movements. Distal taper is designed to address the problems associated with proximal stress shielding, resulting from distal fixation.

The provided text describes a 510(k) premarket notification for a medical device called "Stem, PSA Type" (K100981). This document primarily focuses on establishing substantial equivalence to existing devices rather than presenting a performance study with detailed acceptance criteria and testing methodology as one might find for a novel diagnostic or AI-driven device.

Therefore, many of the requested elements (sample size of test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details, etc.) are not applicable or not provided in this type of submission.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Not applicable/not provided. This submission is for a new size extension of an existing mechanical implant, relying on substantial equivalence to predicates, not a clinical trial or performance study requiring a test set of patient data.
• Data Provenance: Not applicable/not provided. There are no patient data used for "testing" in the traditional sense. The data relates to mechanical property testing.

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

• Not applicable/not provided. Ground truth, in the context of patient data, is not established for this type of submission. The evaluation is based on engineering principles and comparison to predicate devices.

4. Adjudication Method for the Test Set

• Not applicable/not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not applicable. This device is a mechanical implant, not an AI-assisted diagnostic tool or an imaging reader.

6. Standalone (Algorithm Only) Performance Study

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

7. Type of Ground Truth Used

• Not applicable in the conventional sense. The "ground truth" here is the established safety and effectiveness of the predicate devices based on their prior clearances and the engineering standards applied to their design, materials, and manufacturing. For the specific performance data mentioned (locking strength), the ground truth would be established mechanical engineering standards for such components.

8. Sample Size for the Training Set

• Not applicable/not provided. There is no "training set" as this is not an AI/ML device.

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

• Not applicable/not provided.

Summary of the Study (Performance Data):

The "study" referenced in the 510(k) is a locking strength test of the Morse Taper. This mechanical test was performed as part of the design assurance process. The purpose was to demonstrate that the expanded stem sizes maintain similar safety and effectiveness characteristics to the predicate devices. The document states that this test demonstrated the device is safe and effective and is substantially equivalent to the predicate device in this regard. No specific acceptance values or detailed test results are provided in this summary, but the conclusion of substantial equivalence is drawn based on these tests.

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