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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.
   This device is a single use implant and intended for cementless use only.

The subject device, U-Motion II Acetabular System—Extension line, is an extension in terms of additional size to the previously cleared U-Motion II Acetabular System (K122185, K132455, K170089 and K172833). The subject device includes two components: U-Motion II Cup and U-Motion II XPE Cup liner. The indication, design rationale, material, major manufacture process and sterilization method of these two components are identical to the cleared U-Motion II Cup (K122185, K132455, K170089, and K172833) and U-Motion II XPE Cup Liner (K122185 and K170089), except for the dimension.
U-Motion II Cup
The cleared U-Motion II Cup is available from 44 through 80 mm outer diameter (O.D.) in 2 mm increments. The subject U-Motion II Cup is available in 48 mm O.D. and 54 mm O.D. and the compatible liner diameter is 36 mm and 40 mm, respectively, which is larger than the cleared cups. It is designed to only be compatible with the subject cup liner.
U-Motion II XPE Cup Liner
The cleared U-Motion II XPE Cup Liner is available in 28 mm, 32 mm, 36 mm, and 40 mm inner diameter (I.D.). The subject XPE Cup Liner is available in 36 mm I.D. and 40 mm I.D., and is compatible with the subject 48 mm O.D. cup. and 54 mm O.D. cup, respectively.

This document is a 510(k) premarket notification for the "U-Motion II Acetabular System-Extension line," a hip joint prosthesis. It outlines the device description, indications for use, technological characteristics, and performance analysis used to establish substantial equivalence to existing predicate devices.

Here's an analysis of the provided information, identifying what's present and what's missing, especially regarding the acceptance criteria and study details you requested:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a specific table of acceptance criteria with quantitative thresholds for each test. Instead, it lists the types of tests conducted and states that "the test results indicated that this device is safe and effective."

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

• Sample Size: The document does not explicitly state the sample sizes used for each of the performance tests (Impingement analysis, Range of motion, Jumping distance analysis, Wear simulation test, Locking strength test, Cup deformation test, Cup fatigue test). These generally involve a certain number of specimens for mechanical testing.
• Data Provenance: The studies are described as "Verification activities on subject devices" and "tests were conducted to evaluate the safety and effectiveness of the subjected device." This indicates the studies were prospective in nature, specifically conducted for this submission. There's no explicit mention of the country of origin of the data, but the manufacturer (United Orthopedic Corporation) is located in Taiwan.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable as the device is a medical implant (hip prosthesis), and the studies described are mechanical performance tests, not analyses requiring ground truth established by medical experts (like in AI/diagnostic device studies).

4. Adjudication Method for the Test Set:

This information is not applicable for the same reason as point 3. Mechanical tests do not typically involve adjudication by experts.

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

This information is not applicable. The device is a physical implant, not a diagnostic or AI-assisted system that would involve human readers interpreting cases. Therefore, no MRMC study or effect size comparing human readers with and without AI assistance was performed.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

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

7. Type of Ground Truth Used:

This information is not applicable. As mentioned above, the tests are mechanical performance evaluations of a physical device, and the "ground truth" is defined by established engineering standards and biomechanical principles for joint prostheses.

8. Sample Size for the Training Set:

This information is not applicable. There is no "training set" as this is a physical medical device, not an AI/machine learning algorithm.

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

This information is not applicable for the same reason as point 8.

Summary of what's provided and what's missing for the requested information:

• Acceptance Criteria & Performance: A list of tests is provided, with a general statement of "safe and effective" results. However, specific quantitative acceptance criteria and the numerical results against these criteria are not detailed in this document.
• Sample Size (Test Set) & Data Provenance: Sample size is not explicitly stated. Data provenance is implied to be prospective mechanical testing, likely conducted in association with the Taiwanese manufacturer.
• Experts for Ground Truth & Qualifications: Not applicable (physical device, not diagnostic AI).
• Adjudication Method: Not applicable.
• MRMC Study: Not applicable.
• Standalone Study: Not applicable.
• Type of Ground Truth: Mechanical testing against established engineering/biomechanical standards.
• Training Set Sample Size: Not applicable.
• Training Set Ground Truth Establishment: Not applicable.

The document primarily focuses on establishing "substantial equivalence" of the new sizes of the U-Motion II Acetabular System to previously cleared versions and predicate devices based on identical intended use, materials, design rationale, and various mechanical performance tests. The detailed data and specific acceptance thresholds for these tests would typically be found in the full 510(k) submission, not necessarily summarized in this high-level FDA letter or 510(k) summary.

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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 pervious 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 function 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.

This device is an extension in terms of additional size to the previously cleared U-Motion II Acetabular System (K122185) and U-Motion II PS+ Cup (K132455). U-Motion II acetabular component includes U-Motion II Cup and U-Motion II XPE Cup Liner. The indications, materials, design, safety and effectiveness of U-Motion II Cup and Cup Liner are identical to the cleared U-Motion II Acetabular System (K122185) and U-Motion II PS* Cup (K132455) except the dimension. The subject U-Motion II Cups are available in size Ø 50 mm and Ø 46 mm O.D. and the subject U-Motion II Cup Liners are available in 32 mm and 36 mm I.D. The 32 mm and 36 mm inserts fit the acetabular shells with 46 mm O.D. and 50 mm O.D., respectively.

I am sorry, but the provided text does not contain the information required to answer your request. The text describes a 510(k) premarket notification for a medical device (U-Motion II Acetabular System- Additional Sizes), focusing on its substantial equivalence to previously cleared predicate devices.

The document discusses:

• Device name and regulation
• Indications for use
• Device description, including materials and design
• Comparison to predicate devices

However, it does not contain any information regarding acceptance criteria, study methodologies (like sample sizes, data provenance, expert usage, adjudication methods, MRMC studies, standalone performance), or ground truth establishment related to a study proving the device meets acceptance criteria. It only states, "The mechanical properties of this device have been evaluated, and the analysis results shown that this subjected device is not the worst case within all sizes of U-Motion II Acetabular System. These adding sizes would not affect the safety and effectiveness." This sentence indicates that some evaluation was done, but does not provide the specific details requested in your prompt.

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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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