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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, 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.

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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, 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.

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The device is used for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
2. Revision of pervious unsuccessful femoral head replacement, cup arthroplasty or other procedure.
3. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
4. Correction of function deformity.
5. Treatment of nonunion femoral neck and trochanteric fracture of the proximal femur with head involvement that is unmanageable using other techniques.
   The device is intended for cementless use.

This device is an extension in terms of additional size to the previously cleared U-Motion II Acetabular System (K122185) and U-Motion II PS+ Cup (K132455). U-Motion II acetabular component includes U-Motion II Cup and U-Motion II XPE Cup Liner. The indications, materials, design, safety and effectiveness of U-Motion II Cup and Cup Liner are identical to the cleared U-Motion II Acetabular System (K122185) and U-Motion II PS* Cup (K132455) except the dimension. The subject U-Motion II Cups are available in size Ø 50 mm and Ø 46 mm O.D. and the subject U-Motion II Cup Liners are available in 32 mm and 36 mm I.D. The 32 mm and 36 mm inserts fit the acetabular shells with 46 mm O.D. and 50 mm O.D., respectively.

I am sorry, but the provided text does not contain the information required to answer your request. The text describes a 510(k) premarket notification for a medical device (U-Motion II Acetabular System- Additional Sizes), focusing on its substantial equivalence to previously cleared predicate devices.

The document discusses:

• Device name and regulation
• Indications for use
• Device description, including materials and design
• Comparison to predicate devices

However, it does not contain any information regarding acceptance criteria, study methodologies (like sample sizes, data provenance, expert usage, adjudication methods, MRMC studies, standalone performance), or ground truth establishment related to a study proving the device meets acceptance criteria. It only states, "The mechanical properties of this device have been evaluated, and the analysis results shown that this subjected device is not the worst case within all sizes of U-Motion II Acetabular System. These adding sizes would not affect the safety and effectiveness." This sentence indicates that some evaluation was done, but does not provide the specific details requested in your prompt.

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• 1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia.
• Inflammatory degenerative joint disease such as rheumatoid arthritis. 2.
• 3. Correction of function deformity.
• 4. Revision procedures where other treatments or devices have failed.
• 5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that is unmanageable using other techniques.

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

The U2 Ti Porous Coated Matrix Stem is single use component intended for cementless fixation within the prepared femoral canals of patients requiring hip arthroplasty. U2 Ti Porous Coated Matrix Stem, made from a Ti-6Al-4V alloy conforming to ASTM F136-13/ISO 5832-3:1996, is a modular stem with 12/14 neck taper and 130° neck angle. The proximal part of each femoral stem is coated with porous coating in thickness 600±100 um using -45+60 mesh of CP Ti powder (ASTM F1580-12). The bulleted geometry stem tip of U2 Ti Porous Coated Matrix Stem helps reduce distal point loading while creating a smooth transition zone for load transfer. This stem system is available in thirteen sizes. U2 Ti Porous Coated Matrix Stem can be used with U1, U2 Acetabular components (K994078, K050262, K12177, K111546), U-Motion II Acetabular System components (K122185, K132455) and UNITED Femoral Head (K994078, K022520, K122504, K103497, K111546, K112463, K122185) for total hip replacement. For hip hemi-arthroplasty, U2 Ti Porous Coated Matrix Stem can be used in conjunction with Bipolar products (K101670).

The provided text describes a medical device, the U2 Hip Stem, Ti Porous Coated, Matrix, and its 510(k) summary, but it does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically understood for AI/algorithm-based devices. This document is for a physical orthopedic implant.

Therefore, I cannot fulfill the request as it pertains to AI device acceptance criteria and studies. The document describes:

1. Device Type: A hip stem (orthopedic implant).
2. Regulatory Pathway: 510(k) premarket notification, indicating substantial equivalence to a predicate device.
3. Non-clinical Performance Data: Mentions stem fatigue, neck fatigue, and mechanical properties of the porous coating surface. These tests comply with FDA guidance for femoral stem prostheses.
4. Clinical Performance Data: Explicitly states "None provided as a basis for substantial equivalence."

Key points missing (and why they are missing based on the document):

• Acceptance Criteria Table: Not applicable as this is a physical implant, not an AI/algorithm with performance metrics like sensitivity, specificity, etc.
• Sample Size for Test Set, Data Provenance, Experts for Ground Truth, Adjudication, MRMC Study, Standalone Performance, Ground Truth Type, Training Set Sample Size, Ground Truth for Training Set: All these points are relevant to AI/algorithm performance studies and are not found in this document because it concerns a physical medical device (hip stem). The "studies" mentioned are mechanical tests, not clinical evaluations or algorithm performance assessments.

If you have a document describing an AI/algorithm-based medical device, I would be happy to analyze it according to your requested format.

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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.

U-Motion II PS Cup is an extension of cleared "UNITED" U-Motion II Acetabular System (K122185). The indications, major design features, materials, major manufacture processing and methods, size distribution of this subject are identical to the cleared U-Motion II Acetabular System (K122185). This device is manufactured from titanium alloy forging (ASTM F620) which are forged by titanium alloy bars (ASTM F136). The outer surface of U-Motion II PS+ Cup is coated with CP Ti power (ASTM F1580), and the coating layer is thicker than the cleared U-Motion II PS Cup (K122185). U-Motion II PS* Cup includes cluster-holed, no-hole and multi-hole series, and there are nineteen sizes of acetabular shell available, ranging from 44 through 80 mm outer diameter in 2 mm increments.

The provided text is a 510(k) Summary for the "U-Motion II PS+ Cup" acetabular cup, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the context of a clinical trial or AI model validation.

Therefore, many of the requested elements (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, etc.) are not applicable in this regulatory submission for a orthopedic implant.

Here's an analysis based on the available information:

Description of Acceptance Criteria and Proving Device Meets Them

The "acceptance criteria" in this context are for demonstrating substantial equivalence to a legally marketed predicate device, as required for 510(k) clearance by the FDA. The study proving the device meets these criteria is the comparison presented in the 510(k) summary, specifically focusing on physical and mechanical properties.

The core "acceptance criteria" are that the device shares the same intended use, materials, basic design features, and performs at least as safely and effectively as the predicate device, or any differences do not raise new questions of safety and effectiveness.

The document states:
"The mechanical properties of the modified surface have been evaluated to conform to FDA guidance: 'Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis; Guidance for Industry and FDA' and 'Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement.' The analysis results demonstrate that the coating layer thickness increase would not affect the safety and effectiveness."

This indicates that the acceptance criteria for the device involved adherence to specific FDA guidance documents for mechanical property testing of orthopedic implants with modified metallic surfaces. The "study" proving this was the mechanical property evaluation of the modified surface.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) for an orthopedic implant extension, specific numerical performance metrics like sensitivity, specificity, accuracy (which would be common for AI/diagnostic devices) are not presented in this summary. Instead, the "performance" is about meeting safety and effectiveness standards through material and mechanical testing.

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

• Sample size used for the test set: Not applicable in this context. The "test set" here refers to physical components undergoing mechanical testing, not patient data or images. The specific number of physical samples tested is not disclosed in the summary.
• Data provenance: Not explicitly stated for the mechanical testing. This would typically be generated by the manufacturer's R&D or an accredited testing lab.

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)

• Number of experts: Not applicable. Ground truth in this context refers to the results of mechanical and material property tests (e.g., tensile strength, fatigue resistance), which are objectively measured, not subject to expert consensus in the same way as diagnostic image interpretation.
• Qualifications of experts: N/A.

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

• Adjudication method: Not applicable. This concept pertains to resolving discrepancies in expert interpretations, which is not relevant for physical product 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

• MRMC study: No, this is not an AI/diagnostic device. This is a medical implant (acetabular cup).

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

• Standalone performance: Not applicable. This is not an AI algorithm.

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

• Type of ground truth: The "ground truth" for this device revolves around objective engineering and material science measurements, such as:
  • Material composition analysis (e.g., ASTM F620, ASTM F136, ASTM F1580 standards).
  • Dimensional accuracy checks.
  • Mechanical strength tests (e.g., fatigue, static strength), as per the specified FDA guidance documents.
  • Verification of coating thickness and adhesion.

8. The sample size for the training set

• Sample size for the training set: Not applicable. This is not an AI/machine learning device.

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

• How ground truth was established: Not applicable. This is not an AI/machine learning device.

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