Search Results

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.

Ask a specific question about this device

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:

• · 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; and
• · Treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

The U2 Acetabular Cup and Femoal Head are designated as an acetabular component and femoral head and are to be used with United U1 hip stem (K994078) and U2 hip stem (K003237) of total hip replacement. It is a modular type of product system. The U2 Acetabular Cup has ten sizes of options, hemispherical design, porous-coated surface on the metallic shell, clustered bone screw holes, spherical screw holes for variable screw locking angle, PMMA cement plug, easy snap-in and take out mechanism, 12 options for angle adjustment, minimum 6.9 mm thickness of UHMWPE liner. The metallic shell is produced from cast Co-Cr-Mo alloy (ASTM F75). The plastic liner is machined from extruded UHMWPE bars (ISO 5834/I). The U2 28 mm femoral head is aimed to providing more choice for orthopaedic surgeon to perform total hip arthroplasty. The taper angle of 28 mm femoral head is identical with U1 26. mm femoral head (K994078). Therefore, U2 28 mm femoral head can be used wath our Ul and U2 hip stems. The U2 28 mm femoral head is available in -3, +0, +5, and +10 mm of neck length.

The provided text describes a 510(k) premarket notification for the U2 Acetabular Cup and Femoral Head, and therefore it is a submission to demonstrate substantial equivalence to a predicate device, rather than a study proving the device meets specific acceptance criteria through clinical trials or software validation.

Here's an analysis of what is and isn't present in the document based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present "acceptance criteria" in the typical sense of a clinical study (i.e., specific sensitivity, specificity, accuracy targets). Instead, it presents test results for biomechanical properties and states that the device is substantially equivalent to a predicate device.

Explanation of "Acceptance Criteria" in this context: For a 510(k) submission, the primary "acceptance criterion" is demonstrating substantial equivalence to a legally marketed predicate device. The performance metrics presented are compared against the predicate device or industry standards to support this claim.

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

• Sample Size for Test Set: The document does not specify a distinct "test set" in terms of patient data or clinical samples. The testing described (static tensile/shear strength, porosity, range of motion, biomechanical tests) refers to physical testing of the device components. The number of units tested for each biomechanical or material property is not provided.
• Data Provenance: The testing appears to be laboratory-based physical/mechanical testing of the device components. It is not patient data. The manufacturer is located in Hsinchu, Taiwan, suggesting the testing was likely conducted by or for the manufacturer.

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

This is not applicable as the study described is physical product testing, not an assessment requiring expert adjudication of "ground truth" using imaging or clinical data.

4. Adjudication Method for the Test Set

This is not applicable for the reasons stated above.

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

No, an MRMC study was not done. The document describes physical and biomechanical testing of the device, not a comparative effectiveness study involving human readers or AI.

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

This is not applicable. The device is a physical medical implant (hip prosthesis components), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to engineering specifications, material science standards (e.g., ASTM F75 for Co-Cr-Mo alloy, ISO 5834/I for UHMWPE), and the performance characteristics of the predicate device (UNITED U1 Hip Prosthesis K994078). The physical properties and biomechanical performance of the U2 Acetabular Cup and Femoral Head were measured and compared against these established benchmarks.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical medical implant, not a machine learning model requiring a training set.

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

This is not applicable.

Ask a specific question about this device