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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, cemented is for cemented use only.

The "United" Conformity stem, cemented is a triple tapered, polished, collarless stem. It is available in various sizes with standard and high offset types to accommodate various hip surgical requirements. Conformity stem, cemented is manufactured from Co-Cr-Mo alloy which conform to ASTM F799-11 (Raw material: ASTM F1537-11/ISO 5832-12:2007). It is intended to be fixed only with the use of PMMA bone cement and should be used with "United" Cement restrictor.
For total hip arthroplasty, Conformity stem, cemented can be used with "United"acetabular liner, cup and femoral head. For bipolar hip replacement, Conformity stem, cemented can be used with "United" bipolar prosthesis.

The provided text is a 510(k) summary for a medical device (Conformity stem, cemented) and does not describe a study involving an AI/algorithm. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data (mechanical properties, FEM analysis, ROM simulation, bacterial endotoxin testing).

Therefore, I cannot provide information on acceptance criteria and study details related to an AI/algorithm according to your request. The document explicitly states "Clinical Performance Data/Information: None provided as a basis for substantial equivalence."

If this was a misunderstanding and you were looking for the acceptance criteria and performance of the hip stem itself, and not an AI or algorithm, please let me know.

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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 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 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 fractures 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.

This device manufactured from CoCrMo alloy (ASTM F1537) is an extension of cleared "UNITED" U2 Acetabular Cup and Femoral Head (K022520) and "UNITED" U2 Hip System (K111546). The material, design, safety and effectiveness of this subject are identical to the previously cleared femoral heads except for its offset. The previously cleared femoral head offsets for the U2 Hip System are -3, +0, +5, and +10 mm. This submission adds +7.5 and +2.5 mm offset heads for 28, 32 and 36 mm diameter sizes. This device is intended to be used with the previously cleared U2 Acetabular Cup Liner (K050262), U2 XPE Liner (K111546), U2 bipolar implant (K101670), Revision Stem (K062978), HA/Ti Plasma Spray Stem (K003237), Ti Porous Coated Stem (K003237), UTF Stem (K110245), Press-fit Stem (K111546) and Cemented Stem (K111546) in corresponding size. The differences of femoral head offset do not affect the intended use of the device or alter the fundamental scientific technology of the device.

The provided text describes a Special 510(k) submission for "Femoral Heads, +2.5 and +7.5 mm Offset," which are extensions of previously cleared femoral head prostheses. This submission focuses on the addition of new offset sizes.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify a distinct "test set" in the sense of a clinical or imaging dataset with a specific sample size. The evaluation for this device appears to be based on mechanical testing and design assurance processes, not human clinical data or imaging studies that would typically involve a "test set" of patients or scans.

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

Not applicable. The evaluation is based on mechanical testing and engineering principles, not expert interpretation of clinical data or images.

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

Not applicable. There is no mention of a test set requiring adjudication in the context of this device's evaluation.

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 device is a mechanical implant (femoral head) and does not involve AI or human readers for diagnostic interpretation.

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

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

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

The "ground truth" for this device's acceptance stems from established engineering standards and regulatory guidance documents related to the safety and mechanical performance of hip implant components. Specifically, it relies on:

• Design Assurance Process Results: Demonstrating that the new offset configurations maintain the safety and effectiveness established for the predicate devices.
• Compliance with Guidance Documents: Adherence to "Class II Special Controls Guidance Document- Hip Joint Metal Polymer Constrained Cemented or Uncemented Prosthesis" and "Guidance Document for Testing Non-Articulating, 'Mechanically Locked', Modular Implant Components."
• Mechanical Testing Results: "Femoral Head Disassembly loads for the stems" were explicitly mentioned as being completed as part of the design assurance process to show safety and effectiveness.

8. The sample size for the training set:

Not applicable. This device is a mechanical implant and does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. As there is no training set for this mechanical device, the concept of establishing ground truth for it does not apply.

Ask a specific question about this device

This device is indicated for use in total hip arthroplasty for the following conditions: painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis; correction of functional deformity; treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques; revision procedures where other treatment or devices have failed arthroplasty or other procedure.

"UNITED" 36 mm Ceramic Femoral Head – Delta is an additional size extension to the previously cleared "UNITED" Ceramic Femoral Head (K103497). The materials, design, safety and effectiveness of this subject are identical to the previously cleared Ceramic Femoral Head - Delta Components (available in sizes 28 mm and 32 mm), except for its larger diameter (available in sizes 36 mm). 36 mm Ceramic Femoral Head - Delta manufactured from zirconia-toughened alumina ceramic is available in -3, +1, +5 and +9 mm of neck length. This device is intended to articulate against XPE cup liners (K111546) and can be used in conjunction with U2 Acetabular Cups and U2 Hip Stem made of titanium. U2 Acetabular Cups include U2 HA/Ti Plasma Spray Cup (K050262). U2 Ti Plasma Spray Cup (K050262) and U2 Ti Porous Cup (K111546), while U2 Hip Stem include HA/Ti Plasma Spray Stem (K003237), Ti Porous Coated Stem (K003237), Ti Plasma Spray Revision Stem (K062978), Ti Press-fit Stem (K111546) and UTF Stem (K110245). The size extension does not affect the intended use of the device or alter the fundamental scientific technology of the device.

This document describes the acceptance criteria and the study conducted for the "36 mm Ceramic Femoral Head, Delta" device (K112463).

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly detail specific quantitative acceptance criteria or a performance table for the "36 mm Ceramic Femoral Head, Delta" device in terms of clinical outcomes or specific thresholds for mechanical tests. Instead, it relies on demonstrating substantial equivalence to predicate devices through various tests.

The performance data section states: "This 510(k) was prepared in accordance with 'Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems'. Burst test, fatigue test, burst test for post-fatigue, rotational resistance test and pull-off test. completed as part of the design assurance process demonstrated that this device is safe and effective and is substantially equivalent to the predicate device."

This implies that the acceptance criteria for each of these tests were met by comparing the results to those of the predicate devices or to established industry standards outlined in the referenced guidance document. Without the specific guidance document or detailed test reports, the precise numerical acceptance criteria and the exact reported performance cannot be extracted from the provided text.

However, based on the text, the following can be inferred:

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

The text does not specify the exact sample sizes used for each of the "burst test, fatigue test, burst test for post-fatigue, rotational resistance test and pull-off test." The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective, beyond being "completed as part of the design assurance process." Given the nature of these tests for an orthopedic implant, they would typically be laboratory-based mechanical tests performed on newly manufactured devices.

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

This information is not applicable and not provided in the document. The study described is a mechanical performance study, not one requiring expert human interpretation for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document. The study described is a mechanical performance study, not one requiring adjudication by human experts.

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 in the document. The device is a physical orthopedic implant, not an AI or imaging diagnostic tool that would involve human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable and not provided in the document. The device is a physical orthopedic implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the mechanical performance tests (burst, fatigue, rotational resistance, pull-off) would be the objective, quantitative measurements derived from the tests themselves, as compared against established engineering standards and performance of legally marketed predicate devices. It is based on objective physical properties and not on expert consensus, pathology, or outcomes data in the context of this specific 510(k) submission for mechanical properties.

8. The Sample Size for the Training Set

This information is not applicable and not provided in the document. The described study is a mechanical performance evaluation of an orthopedic implant, not a machine learning 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 in the document, as there is no training set mentioned.

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:

• 1. Non-inflammatory degenerative joint disease such as osteoathritis, 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 are unmanageable using other techniques.
     This device is a single use implant and intended for cementless use only.

The U2 Hip Stem, Ti plasma spray is composed of a metallic femoral stem, which is designed to articulate with commercially available U1 and U2 acetabular components and They are manufactured from titanium alloy (ASTM F620). The stems femoral heads. are designed to provide secure fit and fixation in revision hip arthroplasty for anteroposterior bone loss, calcar area defects, metaphyseal bone loss situation. The U2 Hip Stem have a 130° neck angle and Morse taper to receive modular femoral heads. The U2 Hip Stem are available in with collar and collarless types. Each type is available in two lengths, 180mm and 230mm, and 7 diameters: 11mm, 12mm, 13mm, 14mm, 15mm, 16.5mm, 18mm. Distally, the stem is cylindrical with a polished bullet shape tip. The 180mm U2 Hip Stem is available as a straight stem, the 230mm femoral stem has an anterior bow for left and right specific applications. The U2 Hip Stem are fully coated with CP Ti (ASTM F1580). The coating is sprayed with CP Ti powder in thickness 500 um +/-100 um using 200~350 um powder to establish a rough surface for press-fit fixation. This device is a single use implant and intended for cementless use only.

This 510(k) summary (K062978) for the U2 Hip Stem, Ti Plasma Spray, does not contain specific acceptance criteria or details of a study proving the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity, as would be expected for an AI/ML powered device.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices based on materials, design, and indications for use. For medical implants like this hip stem, the "acceptance criteria" primarily relate to demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through characterization of its mechanical properties, biocompatibility, and manufacturing processes, rather than performance metrics measured against a ground truth.

Therefore, many of the requested categories related to AI/ML device studies (like sample size for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of traditional medical device submission.

Here's a breakdown of the information that is available or implied in the provided text:

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

• Acceptance Criteria (Implied for Substantial Equivalence): The primary "acceptance criteria" for a 510(k) submission for this type of device is demonstrating substantial equivalence to predicates. This means showing that the U2 Hip Stem is as safe and effective as the predicate devices, the Reach® Hip Stem, Ti plasma spray (K000760) and United U2 HA/Ti Plasma Spray (K003237). This is typically achieved by demonstrating comparable performance in areas like:

  • Material composition (ASTM F620 titanium alloy, CP Ti coating per ASTM F1580).
  • Design features (130° neck angle, Morse taper, cylindrical distal stem, collar/collarless options, lengths, diameters, anterior bow for 230mm stem).
  • Intended Use/Indications (same clinical conditions as predicates).
  • Mechanical properties, fatigue strength, and wear characteristics (though not detailed in this summary, these would be evaluated in the full submission).
  • Biocompatibility of materials.
  • Manufacturing processes (implicitly assessed for consistency and quality).

• Reported Device Performance: The summary states: "Features comparable to predicate devices, United U2 HA/Ti Plasma Spray (K003237), Reach® Hip Stem, Ti Plasma Spray (K000760), include same materials, design and indications." This is the core "performance" claim for substantial equivalence. No specific quantitative performance metrics (e.g., in vivo survival rates, specific biomechanical test results) are provided in this summary document beyond the physical characteristics.

Regarding items 2-7 (which are primarily relevant for AI/ML device studies):

These items are not applicable to this 510(k) submission for a mechanical implant. This document is a summary for a traditional medical device, not an AI/ML software device or diagnostic tool. Therefore, there's no discussion of test sets, training sets, ground truth derived from experts or pathology, or multi-reader studies.

However, to address them directly for completeness:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
* N/A. This device is a mechanical implant, not an AI/ML diagnostic tool requiring a test set of data. Substantial equivalence is typically proven through bench testing, material characterization, and comparisons to predicate device designs and indications.

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)
* N/A. No expert ground truth establishment for a diagnostic test set.

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

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
* N/A.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
* N/A. The "ground truth" for this device type would be established standards for implant design, material science, and biocompatibility, as well as clinical experience with similar predicate devices.

8. The sample size for the training set
* N/A. This is not an AI/ML device.

9. How the ground truth for the training set was established
* N/A. This is not an AI/ML device.

Ask a specific question about this device

This device is indicated in partial 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 procedure 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 U1 Hip system - Bipolar is designated as a hemiarthroplasty component and is 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 U1 Hip system - Bipolar has 23 sizes (40-62 mm in 1 mm increments) of option with a hemispherical design, easy snap-in and take out mechanism. The metallic outer shell is produced from casting Co-Cr-Mo alloy (ASTM F75). The plastic liner with a 26 mm inner diameter is machined from extruded UHMWPE bars (ISO 5834/1). The U1 26 mm femoral head (K994078) has four different neck lengths (+0, +3, +6, +9 mm), which can meet the various needs of patient. The inner femoral head will be pressed into the polyethylene liner firstly, and then the polyethylene liner with inner head will be pressed into the outer shell using a bipolar head assembly device in the operating room.

The provided document (K050269) is a 510(k) summary for a medical device (U1 Hip system - Bipolar) and does not contain detailed information about a clinical study with acceptance criteria, sample sizes, expert ground truth, or MRMC studies.

Instead, the document states in the "Performance" section: "A review of the mechanical test data indicated that the locking strength of this Bipolar system is strong enough to prevent locking mechanism failure in clinical use." This suggests that the device's performance was evaluated through mechanical testing rather than a clinical study involving human subjects or AI algorithms.

Therefore, I cannot provide the requested information from the given text as it only describes the device, its intended use, and a general statement about mechanical test data, not a study that fits the criteria you've outlined.

Summary of unavailable information from the provided text:

• Acceptance Criteria and Reported Device Performance: No specific acceptance criteria or quantitative performance metrics from a clinical study are provided. The statement about "locking strength" is qualitative.
• Sample Size for Test Set and Data Provenance: No clinical test set data or provenance is mentioned.
• Number of Experts and Qualifications: Not applicable as no expert-derived ground truth for a test set is discussed.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: No such study is mentioned.
• Standalone Performance Study (Algorithm Only): Not applicable, as this is a physical medical device, not an AI algorithm.
• Type of Ground Truth Used: Not applicable, as no ground truth for a clinical study is discussed.
• Sample Size for Training Set & How Ground Truth Was Established: Not applicable, as no training set for an AI algorithm is relevant here.

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.

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