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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 indicated for use in hip arthroplasty in patients with the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatoid 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.

This device is a single use implant and intended for cemented stem which is designed for cemented use only.

UNITED U2 femoral head is a modification of the cleared UNITED femoral head (K994078, K022520, K111546, K122504 and K152439) which is intended to use in primary or revision total/hemi hip arthroplasty. U2 femoral heads include three series of products: U2 Femoral head, U2 Femoral head, 3/4 polished and U2 Femoral head, 4/5 polished.

U2 femoral heads provide five different diameters of 22 mm, 26 mm, 32 mm and 36 mm. 22 mm is available in +0, +3, +6 and +9 mm of neck length, 26 mm is available in -2, +0. +3, +6 and +9 mm of neck length and 28 mm to 36 mm are available in -3, +0, +2.5. +5, +7.5 and +10 mm of neck length. A variety of diameters and neck lengths are available for various patient anatomies, adjustment of the tension of the ligaments, and reconstruction of the center of the physiological head of the femur.

U2 femoral heads is design for compatibility with various types of UNITED Hip Stem (K062978, K003237, K003237, K151316, K111546, K111546, K152530, K123550, K132207). For total hip replacement, U2 femoral heads can be used in conjunction with U2 Acetabular Cup Liner (K050262), XPE Cup Liner (K111546), U2 HA/Ti Plasma Spray Cup (K050262, K121777), U2 Ti Plasma Spray Cup (K050262, K121777), U2 Ti Porous Coated Cup (K111546) and U-Motion II Acetabular System (K122185, K132455). For hemi hip arthroplasty, U2 femoral heads can be used with U2 Bipolar Implant (K152439).

The provided document describes the FDA 510(k) summary for the U2 Femoral Head prosthesis. This document does not describe the acceptance criteria and study proving device meets the acceptance criteria for an AI/ML device. Instead, it focuses on the substantial equivalence of a physical medical device (a femoral head implant) to previously cleared predicate devices.

Therefore, the requested information elements (acceptance criteria, device performance table, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC study, standalone performance, training set details) are not available in the provided text.

The document only states the following:

Performance Data:

• Non-clinical Performance:
  • Tests were conducted to evaluate safety and effectiveness.
  • Tests included:
    • Disassembly force between U2 femoral head and stem component.
    • Range of Motion.
    • Bacterial endotoxin testing, which met the endotoxin limit specified in USP .
  • The performance data demonstrated the device is as safe and effective and is substantially equivalent to the legally marketed predicate devices.
• Clinical Performance Data/Information: None provided as a basis for substantial equivalence.

This information pertains to the physical and biological properties of the implant, not to the performance of an AI/ML algorithm.

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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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