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

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

The "United" Conformity Stem cementless type is design for cementless use in hip arthroplasty. The Conformity Stem cementless type is a proximal trapezoid and distal quadrangular stem with 12/14 neck taper, 135° and 125° neck angle. It is manufactured from Ti-6A1-4V alloy which conform to ASTM F136-13 and the distal part of each femoral stem is coated with hydroxyapatite (HA) (ASTM F1185-03) to provide biological fixation. The subject device is available in various sizes with collarless and collared types to accommodate various hip surgical requirements.

The provided text describes a 510(k) premarket notification for a medical device called "Conformity Stem," a hip stem for hip arthroplasty. The document asserts the device's substantial equivalence to a legally marketed predicate device.

However, the content does not contain any information related to an AI/ML-driven medical device, nor does it discuss acceptance criteria, device performance metrics (like accuracy, sensitivity, specificity, AUC), sample sizes for test or training sets, ground truth establishment by experts, adjudication methods, or MRMC studies.

The document focuses on the mechanical and material performance of the hip stem, including tests like stem fatigue, neck fatigue, range of motion, and fretting corrosion, all of which are standard engineering and biocompatibility evaluations for an implantable orthopedic device. It explicitly states "Clinical Performance Data/Information: None provided as a basis for substantial equivalence."

Therefore, I cannot fulfill the request as the provided text does not contain the necessary information about an AI/ML device study.

To answer your request, the input text would need to describe an AI/ML device, its intended use for diagnostic or prognostic purposes, and the clinical study conducted to validate its performance according to the specified criteria.

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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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This device is indicated for use in total hip replacement undergoing primary and revision surgery for the following conditions:

1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia.

2. Inflammatory degenerative joint disease such as rheumatoid arthritis.

3. Correction of functional deformity.

4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

5. Revision procedures where other treatments or devices have failed.

This device is designed for cementless use.

This subject device is a size extension of the cleared "UNITED" UTF Stem - reduced (K123550, K132207). The indications, materials, design of this subject device are identical to the cleared "UNITED" UTF Stem - reduced (K123550, K132207) except for size distribution. "UNITED" UTF Stem - reduced is a modular, wedge-shaped stem with 12/14 neck taper and 130° neck angle, which is indicated for use in primary or revision hip arthroplasty. UTF Stem - reduced is available with standard offset and high offset options to restore hip biomechanics.

The provided document is a 510(k) premarket notification for a medical device, specifically a hip joint prosthesis. It addresses a size extension for an already cleared device. As such, the document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel device through a new comprehensive study.

Therefore, much of the information requested in your prompt regarding specific acceptance criteria, detailed study design for proving device performance, sample sizes for test/training sets, expert adjudication methods, and MRMC studies, is not present in this type of regulatory submission. This document highlights that the new device shares the same indications, materials, and design (with minor modifications) as previously cleared devices.

Here's an analysis based on the information available:

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

The document does not provide a table of acceptance criteria with numerical targets and reported performance in the way one might expect for a new device study. Instead, it relies on demonstrating that the new size extension performs "as safe and effective as the predicates" by conducting specific mechanical tests required for orthopedic implants.

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 for Test Set: Not explicitly stated as a "test set" in the context of a clinical or image-based AI study. The "test set" here refers to the actual physical devices (UTF Stem, reduced, #0, #00) subjected to mechanical and biocompatibility testing. The exact number of units tested for each mechanical test is not specified in this summary.
• Data Provenance: The document does not specify the country of origin for the mechanical testing data. The manufacturer, United Orthopedic Corporation, is based in Hsinchu, Taiwan. The type of testing is non-clinical (laboratory-based mechanical and biocompatibility tests). These are prospective tests performed on the device.

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)

This is not applicable to the type of device and submission. This is a mechanical/biocompatibility evaluation of a physical orthopedic implant, not an AI or image analysis device that requires expert ground truth labeling.

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

Not applicable. There is no human adjudication process described for the mechanical and biocompatibility tests performed on the physical device. The tests have predefined pass/fail criteria based on engineering standards and regulatory guidelines (e.g., USP for endotoxin limits), not expert consensus.

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 not an AI-assisted device or an imaging diagnostic device.

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

Not applicable. This is not an AI-driven algorithm.

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

The "ground truth" for this device's performance relies on established engineering principles, international standards for mechanical testing of implants, and biological safety standards (e.g., USP for endotoxins). Performance is measured against these objective standards and comparison to the predicate device's known performance, not against expert consensus, pathology, or outcomes data in the way an AI diagnostic device would.

8. The sample size for the training set

Not applicable. This is not an AI device, so there is no training set in that context.

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

Not applicable. There is no training set.

Summary of what the document does communicate:

• Purpose of Submission: This 510(k) is for a "size extension" of an already cleared hip stem (UTF Stem, reduced, #0, #00).
• Demonstration of Safety and Effectiveness: The primary method is demonstrating substantial equivalence to previously cleared predicate devices (K123550, K132207, K110245).
• Key Argument for Equivalence: The subject device shares identical indications for use, materials, and design (except for size distribution and minor design modifications that "do not change the intended use or fundamental scientific technology") with the predicates.
• Non-Clinical Performance Data: To support equivalence, the following tests were conducted:
  • Stem Fatigue Test
  • Neck Fatigue Test
  • Range of Motion
  • Bacterial Endotoxin Testing (met USP limits)
• Clinical Performance Data: "None provided as a basis for substantial equivalence." This is common for minor modifications or size extensions of already cleared devices, as new human clinical trials are typically not required if substantial equivalence can be demonstrated through non-clinical means.

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