Search Results

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, traumatic arthritis, rheumatoid 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 including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement or total hip replacement.
5. Certain cases of ankylosis.
   Conformity stem is for cementless use only.

The subject device is an extension line of 510(K) cleared device Conformity stem, cementless (K183312, K242249), which introduces four new variations: (1) Conformity stem, #0; (2) Conformity stem, collared, #0; (3) Conformity stem, coxa vara, 125° STD, collared, #0; and (4) Conformity stem, short neck, collared #0. The indications, design rationales, materials, manufacturing process, and sterilization method of the subject devices are identical to the 510(k) cleared Conformity Stem, cementless (K183312, K242249).
Conformity Stem can collocate with “United” metallic femoral heads (K994078, K022520, K111546, K122504, K152439, K162957, K221675) or ceramic femoral heads (K103497, K112463, K122185).

• Conformity stem, #0
  Conformity stem, #0 is an extension in terms of sizes to 510 (k) cleared device Conformity stem, #1-11 (K183312). The material, coating thickness, neck angle (135°), and neck length (35.5mm) design are identical to 510 (k) cleared device Conformity Stem, #1, #11 (K183312)The only differences in the items are the offset specifications and stem length.
• Conformity stem, collared, #0
• Conformity stem, collared, #0 is an extension in terms of sizes to 510 (k) cleared device Conformity stem, collared, #1-11 (K183312). The material, coating thickness, neck angle (135°), and neck length (35.5mm) design are identical to 510 (k) cleared device Conformity stem, collared, #1, #11 (K183312).The only differences in the items are the offset specifications and stem length.
• Conformity Stem, coxa vara, 125° STD, collared, #0
• Conformity Stem, coxa vara, 125° STD, collared, #0 is an extension in terms of sizes to 510 (k) cleared device Conformity stem, coxa vara 125° STD, collared, #1-7 (K242249). The material, coating thickness, neck angle (125°), and neck length (32.5mm) design are identical to 510 (k) cleared device Conformity stem, 125° STD, collared, #1, #7 (K242249). The only differences in the items are the offset specifications and stem length.
• Conformity Stem, short neck, collared #0
• Conformity Stem, short neck, collared #0 is an extension in terms of sizes to 510 (k) cleared device Conformity Stem, short neck, collared, #1-7 (K183312 and K242249). The material, coating thickness, neck angle (135°), and neck length (28.5mm) design are identical to 510 (k) cleared device Conformity Stem, short neck, collared, #1, #7 (K183312 and K242249). The only differences in the items are the offset specifications and stem length.

The provided text is a 510(k) summary for a medical device (hip stem extension line). It details the device's identity, intended use, and comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria, especially not in the context of an AI/ML-driven device.

The document primarily focuses on demonstrating substantial equivalence to existing legally marketed devices based on:

1. Identical Indications for Use: The new device has the same indications as the predicate devices.
2. Similar Technological Characteristics: The material, principle of operation, regulation number, product code, risk class, intended users, fixation method, surface coating, locking mechanism, and sterilization method are the same as the predicate device.
3. Non-Clinical Performance Data: The submission includes tests like Range of Motion, Neck Fatigue Assessment, Stem Fatigue Test, Characterization of HA Plasma Spray Coating, and Usability Evaluation. These are standard engineering and material tests for orthopedic implants, not AI/ML performance metrics.

Therefore, I cannot extract the requested information regarding:

• A table of acceptance criteria and reported device performance (for AI/ML).
• Sample size and data provenance for a test set (for AI/ML).
• Number and qualifications of experts for ground truth (for AI/ML).
• Adjudication method (for AI/ML).
• MRMC comparative effectiveness study or human reader improvement with AI.
• Standalone algorithm performance.
• Type of ground truth (expert consensus, pathology, outcomes data, etc.) for AI/ML validation.
• Sample size for the training set (for AI/ML).
• How ground truth for the training set was established (for AI/ML).

The document is about a physical orthopedic implant and its substantial equivalence based on mechanical and material testing, not an AI/ML diagnostic or assistive device.

Ask a specific question about this device

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, traumatic arthritis, rheumatoid 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 including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement or total hip replacement.
5. Certain cases of ankylosis.
   Conformity stem is for cementless use only.

The "United" Conformity Stem cementless type (K183312) is designed 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-6Al-4V alloy, which conforms 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 "United" Conformity Stem cementless is available in various sizes with collarless and collared types to accommodate various hip surgical requirements.
For the subject device, it's an extension line of the 510(K) cleared device Conformity Stem cementless type (K183312), which introduces two new variations: (1) Conformity stem, coxa vara, 125° STD, collared, #1-7; and (2) Conformity stem, short neck, #4-7. The indications, design rationales, materials, major manufacturing process, and sterilization method of the subject devices are identical to the 510(k) cleared Conformity Stem, cementless (K183312).
Conformity Stem can collocate with "United" metallic femoral heads (K994078, K022520, K111546, K122504, K152439, K162957, K221675) or ceramic femoral heads (K103497, K112463, K122185).

• Conformity stem, coxa vara, 125° STD, collared
  Conformity stem, coxa vara, 125° STD, collared is a new coxa vara type variation of 510(k) cleared Conformity stem, coxa vara (1110-52XX, K183312). The same as this 510(k) cleared device, it's also made of Ti-6Al-4V alloy (ASTM F136), and the distal part is coated with hydroxyapatite(HA) (ASTM F1185). In addition, the subject device is also a collared stem with a 125° neck angle. The only difference is the offset design. The subject device is standard offset, while the 510(k) cleared coxa vara collared stem (110-52XX) is high offset
• Conformity Stem, short neck, #4-7
  Conformity stem, short neck, #4-7 is an extension in terms of sizes to 510 (k) cleared device Conformity stem, short neck, #1-3 (K183312). The design, material, coating thickness, geometrical characteristics, neck angle (135°), and neck length (28.5mm) design are identical to 510 (k) cleared device Conformity Stem, short neck, #1-3 (K183312). The only different is the stem length sizes.

This is an FDA 510(k) clearance letter for a medical device called "Conformity Stem Extension Line." This document does not describe acceptance criteria for an AI/ML device or a study proving that an AI/ML device meets those criteria. Instead, it describes mechanical analyses performed on a physical orthopedic implant.

Therefore, I cannot extract the requested information regarding acceptance criteria and study details for an AI/ML device from this document. The document pertains to a hip joint prosthesis, which is a physical implant, not a software device.

Ask a specific question about this device

This device is intended for use in combination with UNITED Femoral System for cemented or cementless hip replacement. This device may be used for the following conditions:

• Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, 1. 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.
• Treatment of nonunion femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

U2 Bipolar Implant is intraoperatively assembled to any appropriately size UNITED femoral stem with compatible head size. This device is offered in 38-56 mm outer diameters and with 22mm, 26mm and 28mm inner diameter. It is comprised of an outer shell (ASTM F75-12/ ISO 5832-4:2014 casting Co-Cr-Mo allov, raw materials ASTM F1537-11/ISO 5832-12:2007) into a permanently assembled bearing insert (ASTM F648-14/ISO 5834-1:2005 and ISO 5834-2:2011). The minimum thickness of the polyethylene at the load bearing area is 5 mm. The assembled prosthesis provides for primary articulation at the femoral head/inner polyethylene bearing interface and secondary articulation at the outer shell/acetabulum interface. The internal aspect of the shell is designed to lock the polyethylene liner. The outer metal surface of the bipolar hip prosthesis is highly polished for articulation with the patient's acetabulum.

Femoral head for size 22mm is designed for use with U2 Bipolar Implant. It is made of Co-Cr-Mo alloy (ASTM F1537-11). The material and process method of 22 mm femoral head are identical to the previous cleared "United" femoral head (K994078).

The provided document describes a 510(k) premarket notification for a medical device, the "U2 Bipolar Implant and 22mm Femoral Head." This particular type of document from the FDA is a regulatory submission for medical devices that are substantially equivalent to legally marketed predicate devices, and it generally does not include detailed clinical study reports or acceptance criteria/performance results in the same format as a novel device approval.

Based on the content, here's an analysis of what can and cannot be answered regarding acceptance criteria and device study:

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

The document does not provide a table of acceptance criteria with corresponding device performance values. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo acceptance criteria and then proving the device meets them through clinical or extensive non-clinical studies for novel products.

The "Performance Data" section lists non-clinical tests performed:

• a. Locking Mechanism of U2 Bipolar Implant
• b. Range of Motion of U2 Bipolar Implant
• c. Disassembly Force for Femoral Head and Stem

However, specific acceptance criteria for these tests (e.g., minimum disassembly force in Newtons, minimum range of motion in degrees) and the numerical results of these tests are not provided in this document extract. The document simply states that these tests were "conducted to evaluate the safety and effectiveness of the subjected device."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The document mentions non-clinical performance tests but does not detail the sample sizes used for these mechanical tests or the provenance of any data beyond indicating "Taiwan" as the submitter's location.

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 information is not applicable/provided. Since the document refers to non-clinical (mechanical) tests and no clinical data, there is no mention of experts establishing a ground truth as would be relevant for diagnostic imaging or similar devices.

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

This information is not applicable/provided. Adjudication methods are typically associated with human-read clinical studies, which are not detailed here.

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

An MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic AI devices, which is not the nature of this hip implant.

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

This information is not applicable/provided. This device is a passive hip implant, not an algorithm.

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

For the non-clinical tests, the "ground truth" would be the engineering specifications and performance expectations derived from predicate devices and relevant ISO/ASTM standards. However, the specific "type of ground truth" (e.g., a specific standard section referencing a required force or range) is not explicitly stated in this document. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this submission, as no clinical studies are presented.

8. The sample size for the training set

This information is not applicable/provided. This device is a mechanical implant, not an AI/algorithm-based device that would require training data.

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

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

Summary of what is known from the document regarding acceptance criteria and study:

• Device Type: U2 Bipolar Implant and 22mm Femoral Head (hip joint femoral prosthesis).
• Submission Type: 510(k) Premarket Notification based on substantial equivalence to predicate devices.
• Study Focus: Primarily non-clinical performance tests.
• Non-clinical Tests Conducted:
  • Locking Mechanism of U2 Bipolar Implant
  • Range of Motion of U2 Bipolar Implant
  • Disassembly Force for Femoral Head and Stem
• Clinical Performance Data: "None provided as a basis for substantial equivalence."
• Acceptance Criteria & Performance Values: Not explicitly detailed in the document. The statement "the performance evaluation for stopper ring of subject device was also conducted" implies successful evaluation without providing specific results or criteria.
• Sample Sizes / Provenance / Ground Truth for Experts: Not provided or not applicable given the nature of the device and submission.

Ask a specific question about this device

• 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.

Ask a specific question about this device

This device is indicated for use in total hip replacement or bipolar hip replacement . undergoing primary and revision surgery for the following conditions: non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia; inflammatory degenerative joint disease such as rheumatoid arthritis; correction of functional deformity; treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; revision procedures where other treatments or devices have failed.

This device is designed for cementless use.

This subject device is a modification and an additional size extension to the previously cleared "UNITED" UTF Stem (K110245). The materials, safety and effectiveness of this subject device are identical to "UNITED" UTF Stem (K110245). Compared with the UTF Stem (K110245), the distal width of UTF Stem-reduced is reduced to provide more selection for clinical demand, and the thread diameter of impact hole of UTF Stem-reduced is enlarged to increase the mechanical strength of stem holder which is locked with impact hole.

As the same as UTF Stem (K110245), UTF Stem-reduced, forged from a Ti-6A1-4V alloy (ASTM F136), is a modular, wedge-shaped stem with 12/14 neck taper and 130° neck angle. The proximal part of each femoral stem is plasma coated with CP Ti powder (ASTM F1580) in thickness 500±127μm. UTF Stem-reduced is available with standard and high offset options, and each,type is available in sizes #111. The specifications of UTF Stem-reduced in size #16 and #9 are identical with UTF Stem (K110245) in size #7.5, 9, 10, 11, 12, 13, 16.5, respectively, while size #7, 8, 10 and 11 are new items which is between size # 13 and #22 in UTF Stem (K110245). These modifications will not affect its safety and effectiveness.

For total hip replacement, UTF Stem-reduced can be used in conjunction with UNITED Femoral Head (K994078, K022520, K111546 and K122504), Ceramic Femoral Head (K103497, K112463), U2 Acetabular Cup Liner (K050262), XPE Cup Liner (K111546), U2 HA/Ti Plasma Spray Cup (K050262, K12177), U2 Ti Plasma Spray Cup (K050262, K121777) and U2 Ti Porous Coated Cup (K111546). As using with U2 Acetabular Cup Liner (K050262), UTF Stem-reduced can be used with 26 mm and 28 mm metal Femoral Head (K994078, K022520, K122504) and 28 mm Ceramic Femoral Head (K103497). As using with XPE Cup Liner (K111546), UTF Stem can be used with 28 mm, 32 mm and 36 mm metal Femoral Head (K022520, K111546, K122504) and 28 i mm, 32 mm and 36 mm Ceramic Femoral Head (K103497, K112463).

For bipolar hip replacement, UTF Stem-reduced also can be used in conjunction with 26 mm, 28 mm, 32mm and 36mm metal Femoral Head (K994078, K022520, K111546, K122504), 28 mm, 32 mm and 36 mm Ceramic Femoral Head (K103497, K112463) and Bipolar implants (K101670). UNITED Femoral Head and Bipolar Cap are made of Co-Cr-Mo alloy, while Ceramic Femoral Head is manufactured from alumina. Acetabular Cup Liner and Bipolar Cap Liner are made of UHMWPE, while U2 Acetabular Cup shells are manufactured from forged Titanium alloy.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Study Information

This submission is for a medical device (UTF Stem, reduced) and does not involve an AI/ML-based diagnostic or prognostic device, therefore many of the typical questions related to such studies (sample size for test/training sets, ground truth establishment, MRMC studies) are not applicable. The provided document is a 510(k) summary for a modified orthopedic implant. The "study" described is primarily non-clinical engineering analysis and refers to previous testing of a predicate device.

1. Sample size used for the test set and the data provenance: Not applicable. No specific "test set" in the context of image-based or data-driven AI diagnostics is mentioned. The non-clinical testing involved mechanical testing of the predicate device and engineering analysis of the modifications to the subject device.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth in the context of expert review for diagnostic accuracy is mentioned.
3. Adjudication method for the test set: Not applicable.
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: No MRMC study was done, as this is not an AI/ML-based device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML-based device.
6. The type of ground truth used: For the non-clinical testing of the predicate device, the "ground truth" was defined by international standards (ISO 7206-4 and ISO 7206-6) for mechanical performance criteria. For the modified coating, it was conformance to FDA Guidance.
7. The sample size for the training set: Not applicable. No training set for an AI/ML model is mentioned.
8. How the ground truth for the training set was established: Not applicable.

Summary of the "Study" and Basis for Acceptance

The submission is for a modification and size extension to a previously cleared hip stem ("UNITED" UTF Stem, K110245). The core argument for acceptance is substantial equivalence to the predicate device.

• Non-Clinical Testing of Predicate Device: The predicate device (UTF Stem K110245) had its stem fatigue test completed according to ISO 7206-4 and its neck fatigue test according to ISO 7206-6. These tests established the performance benchmarks for the original design.
• Engineering Analysis for the Subject Device (UTF Stem, reduced): For the new "UTF Stem, reduced" device, no additional non-clinical mechanical testing was performed on the stem itself. Instead, the manufacturer relied on Finite Element Method (FEM) analysis. This analysis concluded that the modifications (reduced distal width and enlarged thread diameter of the impact hole) did not decrease the stem fatigue strength or neck fatigue strength compared to the predicate device.
• Materials Testing: For the modified coating, chemical analysis, microstructural characterization, and mechanical strength were evaluated. The results were found to conform to the requirements of the FDA Guidance, "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements."
• Clinical Testing: No clinical testing was required or performed for this submission, further indicating the reliance on substantial equivalence and non-clinical data.
• Conclusion: Based on the engineering analysis of the design modification and the materials testing, the manufacturer determined that the "UTF Stem, reduced" is substantially equivalent to legally marketed predicates, meaning it is considered "as safe, as effective, and performs at least as safely and effectively."

Ask a specific question about this device

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 for use in total hip arthroplasty or bipolar arthroplasty undergoing primary and revision surgery for the following conditions:

• Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia
• Inflammatory degenerative joint disease such as rheumatoid arthritis
• Correction of functional deformity
• Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
• Revision procedures where other treatments or devices have failed

UTF Stem is designed for cementless use.

UTF Stem is a modular, wedge-shaped stem with 12/14 neck taper, which is made from forging Ti-6A1-4V alloy conforming to ASTM F 620 and the proximal part of each femoral stem is coated with CP Ti plasma spray. The net-shape of stem was forged by the titanium bar (ASTM F136). Circumferential titanium plasma coating sprayed with CP Ti powder (ASTM F1580) provides biological fixation. This device is collarless to allow for self-seating of the implant between the lateral and medial cortices of the femoral canal. UTF Stem is available with standard offset and high offset options to restore hip biomechanics. Each type of offset is available in 10 sizes ranging.

For total hip replacement, UTF Stem can be used in conjunction with UNITED Femoral Head (K994078, K022520 and K111546), U2 Acetabular Cup Liner (K050262), XPE Cup Liner (K111546), U2 HA/Ti Plasma Spray Cup (K050262), U2 Ti Plasma Spray Cup (K050262) and U2 Ti Porous Coated Cup (K111546). As using with the U2 Acetabular Cup Liner (K050262), UTF Stem can be used with 26 mm and 28 mm Femoral Head (K994078 and K022520) and 28 mm ceramic Femoral Head (K103479). As using with XPE Cup Liner (K111546), UTF Stem can be used with 28 mm, 32 mm and 36 mm metal Femoral Head (K022520, K111546), and 28 mm and 32 mm Ceramic Femoral Head (K103479). Only U2 Ti Porous Coated Cup (K111546) and XPE Cup Liner (K111546) can be used in conjunction with the 32 mm and 36 mm Femoral Head (K111546, K103479). For bipolar hip replacement, UTF Stem also can be used in conjunction with 26 mm. 28 mm. 32mm and 36mm Femoral Head (K994078, K022520, K111546) and Bipolar implants (K050269, K101670). UNITED Femoral Head and Binolar Cap are made of Co-Cr-Mo alloy, while Ceramic Femoral Head is manufactured from alumina. Acetabular Cup Liner and Bipolar Cap Liner are made of UHMWPE, while U2 Acetabular Cup shells are manufactured from forged Titanium alloy.

The provided text describes a 510(k) summary for the "UTF Stem" total hip prosthesis. The acceptance criteria and supporting studies are limited to bench testing to demonstrate substantial equivalence to predicate devices. It does not contain information about clinical studies with human participants, expert review processes, or multi-reader multi-case studies.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the 510(k) was prepared in accordance with several guidance documents, including "Class II Special Controls Guidance Document-Hip Joint Metal Polymer Constrained Cemented or Uncemented Prosthesis" and "Guidance for Non-clinical Information for Femoral Stem Prostheses." This implies that the tests performed adhered to the acceptance criteria outlined in these guidance documents, even if the specific numerical thresholds are not explicitly listed in this summary. The successful clearance by the FDA (K110245) indicates that the device was deemed to meet these criteria.

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

• Sample Size: Not specified. The document only mentions that the listed tests "have been performed." For bench testing, the sample size would typically refer to the number of physical samples of the device components tested for each specific test.
• Data Provenance: Not applicable in the context of clinical data. For bench testing, the data would originate from laboratory experiments conducted by the manufacturer or a contracted lab. The manufacturer is United Orthopedic Corporation, located in Hsinchu, Taiwan.

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

• Not applicable. This summary only describes non-clinical, bench testing. There is no indication of a "ground truth" established by human experts for these mechanical or material property tests. The "ground truth" for bench tests is typically defined by engineering specifications, material standards (e.g., ASTM), and regulatory guidance documents.

4. Adjudication Method for the Test Set

• Not applicable. This summary pertains to non-clinical bench testing, where adjudication by multiple experts is not typically a component of determining test outcomes.

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

• No. This document focuses solely on the substantial equivalence through bench testing (mechanical and material properties) of a hip prosthesis. It does not involve human readers or image interpretation, thus no MRMC study was conducted.

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

• Not applicable. This device is a physical medical implant, not a software algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

• Engineering Specifications and Standardized Test Methods: The "ground truth" for the bench tests would be the established performance criteria and thresholds defined in relevant ASTM standards (e.g., ASTM F 620, ASTM F136, ASTM F1580), FDA guidance documents (e.g., "Guidance for Non-clinical Information for Femoral Stem Prostheses"), and the manufacturer's internal design specifications for a hip prosthesis.

8. The Sample Size for the Training Set

• Not applicable. This report describes the performance of a physical device, not an AI or machine learning model that would require a training set.

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

• Not applicable. As above, there is no training set for a physical medical device.

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:

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 factures 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.

The U2 Hip System for hip arthroplasty is a metal/polymer/metal semi-constrained prosthesis with femoral components and acetabular components. The femoral components are composed of a ball mechanical locked with a stem by means of a Morse taper, while the acetabular components are composed of an highly crosslinked ultra - high - molecular - weight - polyethylene articulating bearing surface fixed in a metal shell. Components of this premarket notification include the following components:

• Ti Porous Coated Cup
• XPE Cup Liner
• 32 mm and 36 mm Femoral Head
• U2 Hip Stem, Press-fit
• U2 Hip Stem, Cemented

The titanium bar (ASTM F136) was forged into a net-shape of acetabular cup and then the forged part was machined into the final shape of Ti Porous Coated Cup. The outer surface is porous coated with three layers of CP Ti beads (ASTM F1580). XPE Cup Liner is manufactured from highly crosslinked UHMWPE which conform to ASTM F2565 and the UHMWPE raw material is in accordance with ASTM F648 and ISO 5834. The first series of XPE Cup Liner with the sizes of 44 to 80 mm has an inner diameter of 28 mm. The second series with the sizes of 50 to 80 mm have an inner diameter of 32 mm. The third series with the sizes from 54 to 80 mm have an inner diameter of 36 mm. The 32 and 36 mm Femoral Head is manufactured from CoCrMo alloy (ASTM F1537) with neck length of -3, +0, +5, and +10 mm. U2 Press-fit Stem is manufactured from titanium alloy (ASTM F620) which is intended for cementless fixation within the prepared femoral canals of patients requiring hip arthroplasty. U2 Cemented Hip Stem manufactured from forging CoCrMo alloy (ASTM F799) is intended for cement fixation. Moreover, this device is available to use with an accessory, called "Cement Restrictor, Full PE" made of Ultra-High Molecular Weight Polyethylene (ASTM F648).

The Ti Porous Coated Cup will be used with 510k cleared cup liner of the U2 Acetabular Component (K050262) and currently submission XPE Cup Liner. As using with the existing cup liner (K050262), the Ti Porous Coated Cup may be used with 26 mm and 28 mm Femoral Head (K994078 and K022520) and 28 mm Ceramic Femoral Head (K103479). As using with currently submission XPE Cup Liner, this component may be used with currently submission 32 mm and 36mm Femoral Head, the 28 mm Femoral Head (K022520) and 28 mm and 32 mm Ceramic Femoral Head (K103479). Besides, XPE Cup Liner may also be used with existing U2 Acetabular Cup (K050262). The 32 mm and 36 mm Femoral Head may also be used with U2 Bipolar Implant (K101670), Revision Stem (K062978) and current submission Cemented Stem and Press-fit Stem.

The Press-fit Stem and Cemented Stem will be used with currently submission 32mm and 36 mm metal Femoral Head and may be used with 26 mm and 28 mm metal Femoral Head (K994078 and K022520). The Press-fit Stem which made from Ti alloy can also be used with Ceramic Femoral Head (K103479).

The provided text describes the U2 Hip System, a semi-constrained hip prosthesis. It details the device components, materials, and indications for use. The document focuses on demonstrating substantial equivalence to predicate devices through comparisons of design, operational principles, material composition, and extensive bench performance tests. There is no information about acceptance criteria or a study proving the device meets acceptance criteria in the sense of clinical performance or diagnostic accuracy. Instead, the "performance test - bench" section outlines mechanical tests conducted to ensure the device's safety and effectiveness regarding its physical properties and mechanical integrity.

Here's an analysis based on the provided text, addressing the user's questions where applicable, and noting where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as pass/fail thresholds for clinical performance or diagnostic accuracy. Instead, it describes mechanical tests performed to demonstrate the device's ability to withstand expected in vivo loading. The "reported device performance" is that these tests were performed and a "review of the mechanical data indicates that the U2 Hip System is capable of withstanding expected in vivo loading without failure." No specific numerical results of these tests and their comparison against predefined limits are provided in this summary.

Here's a summary of the tests performed and the general conclusion:

The document states: "A review of these tests has demonstrated that there are no new issues related to the safety and effectiveness of the subject devices."

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

Not applicable. The study described is a series of bench performance tests on the device's components, not a clinical trial or a study involving human subjects or data. Therefore, there is no "test set" in the context of patient data.

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

Not applicable. This is a medical device (hip prosthesis), and the "study" involves mechanical testing, not interpretation of data by experts for ground truth establishment.

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

Not applicable. This is a medical device (hip prosthesis) and the "study" involves mechanical testing.

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 document pertains to a medical device (hip prosthesis), not an AI algorithm or a diagnostic tool that would involve human readers.

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

Not applicable. This document pertains to a medical device (hip prosthesis), not an algorithm.

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

Not applicable in the conventional sense of diagnostic accuracy studies. For mechanical tests, the "ground truth" is defined by the objective physical properties and performance characteristics as measured against established ASTM and ISO standards for medical implants. The tests themselves are designed to evaluate whether the components meet these engineering standards for safety and effectiveness.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning algorithm.

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

Not applicable. There is no "training set" as this is not an AI/machine learning algorithm.

Additional Information from the document:

• Clinical Data: "Clinical data was not needed to support the safety and effectiveness of the subject devices." This implies that the substantial equivalence argument was entirely based on non-clinical (bench) testing and comparison to predicate devices.
• Regulatory Basis: The 510(k) was prepared in accordance with several FDA guidance documents for hip joint prostheses and orthopedic implants, reinforcing that the testing conducted (as detailed in the "Performance Test - Bench" section) is the accepted method for demonstrating safety and effectiveness for this type of 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.

Ask a specific question about this device