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The Maxx Libertas Bipolar Head is intended for use in combination with a Maxx Libertas Hip System femoral stem for uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:

• Femoral neck and trochanteric fractures of the proximal femur;
• Osteonecrosis of the femoral head;
• Revision procedures where other devices or treatments for these indications have failed.

The Maxx Libertas Bipolar Head consists of three factory-assembled parts: a cobalt chromium outer shell, a UHMWPE liner, and a UHMWPE retention ring. The outer shell has a highly polished spherical outer surface for articulating with the acetabular joint socket. The liner has an hemispherical inner surface for articulating with the spherical head component of the Libertas femoral stem (28 mm). The retention ring provides a locking function to resist dislocation of the femoral head from the bipolar head.

The provided FDA 510(k) clearance letter and summary for the Maxx Libertas Bipolar Hip Head (K243634) describe the device and its intended use, but it does not contain information regarding statistically significant acceptance criteria derived from a clinical or standalone study comparing the device's performance against specific metrics.

Instead, the clearance is based on demonstrating substantial equivalence to a predicate device (BioPro Bipolar Head, K100761) primarily through non-clinical mechanical testing and engineering analysis. This type of submission relies on showing that the new device is as safe and effective as a legally marketed device, often by demonstrating similar design, materials, and performance in simulated conditions.

Therefore, many of the specific details requested in your prompt (e.g., sample size for test set, expert qualifications, MRMC study, ground truth type) are typically not included in a 510(k) summary that relies solely on bench testing and
engineering analysis for substantial equivalence.

Here's an analysis of the information that is available and what is not based on the provided document:

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

• Range of Motion tests were performed.
• Static push-out tests were performed.
• Static Lever-out tests were performed.
  Engineering Analysis:
• Impingement scenarios analysis was performed.

Overall Conclusion: The device performed "identical to the predicate device," supporting substantial equivalence. |

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

• Sample Size for Test Set: Not applicable/Not provided. The "test set" in this context refers to physical test articles used for mechanical testing, not a patient cohort or imaging dataset. The number of physical samples tested is not specified in the summary.
• Data Provenance: Not applicable/Not provided in the summary. Mechanical testing data does not have country of origin in the same way clinical data would.

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)

• Not applicable. For mechanical and engineering testing, "ground truth" is established by standard engineering principles, test methods (e.g., ASTM or ISO standards, though not explicitly cited here), and simulation results, not by human experts interpreting clinical data.

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

• Not applicable. This concept applies to human interpretation of clinical data in studies, not to device 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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/software devices where human-in-the-loop performance is evaluated. The Maxx Libertas Bipolar Hip Head is a physical orthopedic implant.

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

• No, a standalone performance evaluation in the context of an "algorithm only" or AI device was not done. The "standalone" performance here refers to the mechanical and engineering performance of the physical device.

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

• The "ground truth" for demonstrating substantial equivalence for this device was established based on mechanical test results and engineering analysis comparing the subject device's performance to that of the predicate device under simulated conditions. There is no expert consensus, pathology, or outcomes data mentioned in this submission summary.

8. The sample size for the training set

• Not applicable. This term refers to data used to train AI models. This device is a physical orthopedic implant, not an AI/software device that requires a training set.

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

• Not applicable, as there is no training set for this type of device.

Summary of what the study did demonstrate:

The provided document indicates that the Maxx Libertas Bipolar Hip Head gained 510(k) clearance primarily by demonstrating substantial equivalence to a predicate device (BioPro Bipolar Head, K100761). This was achieved through:

• Mechanical Testing: Including Range of Motion, Static push-out, and Static Lever-out tests.
• Engineering Analysis: Specifically for impingement scenarios.
• Technological Comparison: The subject device was deemed "identical to the Predicate Device in design, material, chemical composition, principle of operation."

The conclusion was that the device "performed identical to the predicate device" based on these non-clinical tests, thus supporting its substantial equivalence for the stated Indications for Use.

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Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for:

• Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis
• Inflammatory joint disease including rheumatoid arthritis
• Correction of functional deformity including congenital hip dysplasia & fracture non-union or mal-union
• Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture
• Failed previous hip surgery including internal fixation or joint fusion, hemiarthroplasty, surface replacement, or total hip replacement
• Dislocation risks (when used with SignaSure Dual Mobility System)

Signature Orthopaedics' Longboard Revision Stem is intended for individuals undergoing revision surgery of the hip only.

Signature Orthopaedics' Origin, Origin TT, Aria, Remedy, Origin-NS, Pegasus, Spartan, World, Everglade and Longboard Hip femoral stems, SignaSure Cementless Cups, Logical and World Acetabular Cups are intended for cementless fixation only.

The Longboard Revision Stem is a femoral stem and a partially threaded distal locking screw intended for single use and cementless fixation for revision hip arthroplasties. The components are manufactured from titanium alloy as per ISO 5832-3 and ASTM F136 and the stem has a titanium alloy grit blast along the body. The Longboard Revision Stem is a symmetrical with a neck angle of 135°. The stem body is tapered and finned, while the distal tip is finless to allow for initial version adjustments. The stem neck features a 12/14 taper which allows for compatibility with Signature Orthopaedics' range of previously cleared femoral head components.

This FDA 510(k) Clearance Letter for the Longboard Revision Hip Stem describes a medical device (an orthopedic implant), not a software or AI/ML-based device. Therefore, the questions regarding acceptance criteria and study design for performance evaluation of algorithms and AI/ML systems (e.g., sensitivity, specificity, MRMC studies, ground truth establishment by experts) are not applicable to this document.

The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing for mechanical properties and material characteristics, as is standard for orthopedic implants.

Here's an analysis of the provided information relevant to the device's acceptance criteria and the study that proves it meets them, framed within the context of a physical medical device:

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria

For physical medical devices like the Longboard Revision Hip Stem, acceptance criteria primarily revolve around:

1. Safety and Effectiveness: Ensuring the device is safe for its intended use and performs as expected.
2. Biocompatibility: Materials used must be compatible with the human body.
3. Mechanical Performance: The device must withstand anticipated physiological loads and stresses without failure for its expected lifespan.
4. Conformity to Standards: Compliance with established industry and regulatory standards.
5. Substantial Equivalence: Demonstrating that the device is as safe and effective as a legally marketed predicate device.

The study described to prove the device meets these criteria is the non-clinical performance testing and engineering evaluations.

1. Table of Acceptance Criteria and the Reported Device Performance

The document doesn't provide a precise "table" of numerical acceptance criteria in the format typically seen for AI/ML performance (e.g., "Sensitivity >= X%"). Instead, acceptance is inferred from the successful completion of specified engineering tests and adherence to industry standards, followed by a conclusion of substantial equivalence.

• ISO 21535 (Hip Joint Replacement Implants)
• ASTM F2996 (FEA for Hip Femoral Stems)
• ISO 7206-4 (Endurance of Stemmed Femoral Components)
• ISO 7206-6 (Endurance of Neck Region)
• ASTM F543 (Metallic Medical Bone Screws) |
  | Substantial Equivalence: The device is as safe and effective as existing legally marketed predicate devices. | "The Longboard Revision Hip Stem have the same intended use and same indications for use as the predicate devices. The subject devices use the same operating principle, incorporate the same basic design, and are manufactured using the same materials as the predicate devices. Any differences do not raise new questions of safety and effectiveness as established with performance testing. The subject devices are at least as safe and effective as the legally marketed predicate devices." |

Information Not Applicable/Provided for a Physical Device:

The following points are primarily relevant to software, AI/ML, or diagnostic devices, and therefore are not applicable to this 510(k) for a physical orthopedic implant:

2. Sample size used for the test set and the data provenance: Not applicable. Testing is primarily mechanical/physical on device samples, not on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical implant is its physical behavior under load, measured by engineering methods, not expert consensus on images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is for diagnostic interpretation, not an implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm here.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable in the context of image interpretation. Ground truth for this device is mechanical integrity, material properties, and functionality under specified conditions, verified by laboratory testing.
8. The sample size for the training set: Not applicable as there is no training set for a mechanical device.
9. How the ground truth for the training set was established: Not applicable.

In summary: The clearance of the Longboard Revision Hip Stem relies on non-clinical, laboratory-based mechanical and materials testing of physical device samples against established industry standards and comparison to predicate devices, to demonstrate its safety and effectiveness for its intended use, rather than on clinical data or AI/ML performance metrics.

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Mfinity femoral stems are indicated in patients requiring hip arthroplasty.

Total or partial hip arthroplasty is indicated in the following cases:

• Severely painful and/or disabled joint as a result of osteoarthritis, post-traumatic arthritis, inflammatory arthritis or hip dysplasia.
• Avascular necrosis of the femoral head.
• Acute fracture of the femoral head.
• Acute fracture of the proximal femur, suitable to be treated by means of hip arthroplasty.
• Non-union of proximal femur fracture, suitable to be treated by means of hip arthroplasty.
• Primary pathology involving the femoral head but with a non-deformed acetabulum.
• Failure of previous hip surgery:
  • Conservative hip surgery.
  • Internal fixation.
  • Arthrodesis.
  • Partial or total hip arthroplasty.
  • Hip resurfacing replacement.

The Mfinity Femoral System includes implantable devices provided individually packed, sterile and single-use intended for cementless use in total or partial hip arthroplasty to replace the native femoral neck for primary or revision surgery. The product range is composed of three different versions (Mfinity collarless, Mfinity collared and Mfinity L) available in standard and lateral offset.

The Mfinity femoral stem can be combined with the CoCr ball head (K072857, K080885 and K103721), Endo Head (K111145), the MectaCer BIOLOX® forte (K073337), MectaCer BIOLOX® Delta Femoral Heads (K112115) or MectaCer BIOLOX® Option Heads (K131518).

The subject devices are made of titanium alloy according to ISO 5832-11 and coated with Titanium plasma spray according to ASTM F1580 and Hydroxyapatite according with ASTM F1185.

The provided text is an FDA 510(k) clearance letter for the Mfinity Femoral System, which is a hip prosthesis, not a diagnostic AI device. Therefore, the information requested regarding acceptance criteria and studies that prove a device meets those criteria, specifically concerning AI performance metrics, expert adjudication, training set, and test set details, is not applicable to this document.

The document discusses the substantial equivalence of the Mfinity Femoral System to predicate devices based on non-clinical performance data (fatigue tests, ROM evaluation, surface analyses, biocompatibility, shelf-life, pyrogenicity) and states that no clinical studies were conducted.

The acceptance criteria for this type of medical device (hip prosthesis) would typically involve demonstrating mechanical strength, durability, biocompatibility, and sterilization effectiveness based on recognized standards (e.g., ISO, ASTM, European Pharmacopoeia, USP). The "reported device performance" would consist of the results of these non-clinical tests meeting the specified limits of those standards.

Below is a general interpretation of what "acceptance criteria" and "reported device performance" would entail for a hip prosthesis based on the provided document, acknowledging that specific numerical details of these criteria and results are not explicitly stated in this letter but would be in the full 510(k) submission.

Based on the provided FDA 510(k) Clearance Letter for the Mfinity Femoral System:

This document describes the clearance of a hip prosthesis, not an AI-powered diagnostic device. Therefore, the typical elements of acceptance criteria and study designs relevant to AI (such as sensitivity, specificity, AUC, expert consensus, training/test set sizes, etc.) are not applicable to this submission.

The "acceptance criteria" for this device would generally refer to meeting established mechanical, material, and biological performance standards for medical implants. The "study that proves the device meets the acceptance criteria" refers to the non-clinical performance testing conducted.

Here's an attempt to populate the requested table and answer the questions based on the information available, while highlighting the irrelevance of AI-specific questions:

1. Table of Acceptance Criteria and the Reported Device Performance

• Pull-off strength of femoral head
• Range of Motion (ISO 21535) | - Mfinity Fatigue tests performed according to ISO 7206-4 and ISO 7206-6 (Results are assumed to have met specified limits)
• Pull-Off Test On CoCr Femoral Head performed (Results are assumed to have met specified limits)
• Evaluation of ROM according to ISO 21535 performed (Results are assumed to have met specified limits) |
  | Material Performance | - Coating characteristics (cross-section, SEM, XRD) | - Cross sectioned area evaluation of double coated implant surfaces performed
• Scanning Electron Microscopy pictures of double coated implant surfaces taken
• XRD analyses comparing HA coating on Mfinity stem and planar samples performed (Results are assumed to demonstrate acceptable coating properties) |
  | Biocompatibility | - Material safety
• Cytotoxicity, sensitization, irritation, genotoxicity, chronic toxicity, etc. | - Biocompatibility assessment performed (Results are assumed to demonstrate compliance with standards) |
  | Sterilization & Endotoxin| - Bacterial endotoxin levels (European Pharmacopoeia §2.6.14 / USP )
• Pyrogenicity (USP ) | - Bacterial endotoxin test (LAL test) performed
• Pyrogen test performed (Results are assumed to meet requirements, though note indicates not labeled as non-pyrogenic or pyrogen free) |
  | Shelf-Life | - Maintain integrity and performance over specified shelf-life | - Shelf-life evaluation performed (Results are assumed to demonstrate acceptable shelf-life) |

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

• Sample Size for Test Set: Not specified in the FDA letter. For non-clinical tests (like fatigue or material analysis), sample sizes would be determined by the specific ISO/ASTM standards referenced, but these are not diagnostic "test sets" in the AI context.
• Data Provenance: The data comes from the "Non-Clinical Studies" and "Performance Testing" conducted by Medacta International S.A. No country of origin is explicitly stated for the testing labs or data generation, but the company is based in Switzerland. The studies are by nature prospective in that they are conducted specifically to test the device's performance against standards.

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 hip prosthesis, not an AI diagnostic device. There is no concept of "ground truth" established by experts in the context of interpreting images or medical conditions for this device. The "ground truth" for the performance tests would be the established scientific and engineering principles and the limits defined by the relevant ISO/ASTM standards.

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

• Not Applicable. As this is not an AI diagnostic device, no adjudication method was used. Performance is assessed directly against objective engineering and material standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This is a hip prosthesis, not an AI-assisted diagnostic tool. No MRMC study was performed, and there is no AI assistance involved. The letter explicitly states: "No clinical studies were conducted."

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

• Not Applicable. This is not an algorithm or AI device. The device (a physical implant) is evaluated standalone based on its inherent properties and performance against physical and material standards.

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

• The "ground truth" for the non-clinical performance tests is based on established engineering and material science standards and specifications (e.g., ISO 7206, ISO 21535, ASTM F1580, ASTM F1185, European Pharmacopoeia, USP). The device's performance is compared against the requirements and acceptance limits set forth in these standards.

8. The sample size for the training set

• Not Applicable. This device did not involve machine learning or a "training set."

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

• Not Applicable. This device did not involve machine learning or a "training set."

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Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for:

• Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis
• Inflammatory joint disease including rheumatoid arthritis
• Correction of functional deformity including congenital hip dysplasia
• Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture
• Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement

Signature Orthopaedics' Origin, Origin TT, Aria, Remedy, Origin-NS, Pegasus, Spartan, World and Everglade Hip femoral stems, SignaSure Cementless Cups, Logical and World Acetabular Cups are intended for cementless fixation only.

Signature Orthopaedics' Evolve, Cemented TSI (both CoCr and HNSS variants), and Origin Cemented femoral stems and SignaSure Cemented Cups are intended for cemented fixation only.

Signature Orthopaedics' SignaSure Logical/World Metal Insert is indicated for use with a cementless Signature Orthopaedics' Logical/World Acetabular Cup to provide dual mobility articulation.

Signature Orthopaedics' constrained liner components are indicated particularly for patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.

Signature Orthopaedics' Evolve UniPolar Head and BiPolar Head are intended for hemi-hip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head and BiPolar Head are indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as:

• Acute femoral head or neck fracture
• Fracture dislocation of the hip
• Avascular necrosis of the femoral head
• Non-union of femoral neck fractures
• Certain high subcapital and femoral neck fractures in the elderly
• Degenerative arthritis involving only the femoral head

Signature Orthopaedics' Origin™ Cemented Hip Stems are manufactured from nitrogen stainless steel per ASTM F1568 and ISO 5832-9. The subject stem is straight and tapered with a lateral chamfer. The Cemented Origin™ stem is polished and intended for cemented use in total hip arthroplasty. It features a 12/14 taper which allows for compatibility with Signature Orthopaedics' range of previously cleared femoral head components including the Signature CoCr Femoral Heads (K121297 and K163081), Signature Ceramic Femoral Heads (K190704), Signature BiPolar Head (K133370 and K163081) and Evolve UniPolar Head (K143184). Compatible acetabular cups and liners including the Logical Cup (G-Series K121297, PX-Series K121297 and C-Series K153131) and the Logical Liners (Neutral and 10º Hooded, Lateralised K121297), Logical Liners (20º Hooded, Lateralised 20º Hooded K153131), Logical Constrained Liners (K153131) and Logical Liners Vit-E (Neutral and 10º Hooded, Lateralised, 20º Hooded, Lateralised 20º Hooded, High Wall, 10º Face Changing (K241690).

Based on the provided FDA 510(k) Clearance Letter for the Origin™ Cemented Hip Stem, there is no information present regarding acceptance criteria or a study proving that the device meets specific acceptance criteria in the context of an AI/human reader performance study.

This document is a 510(k) clearance for a physical medical device (a hip stem), not a software or AI-enabled device that would typically involve acceptance criteria related to accuracy, sensitivity, specificity, or human reader performance. The "Performance Testing" section refers to non-clinical mechanical and fatigue testing of the physical hip stem, not a clinical or human-in-the-loop study as described in your request.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, sample sizes for test sets, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth establishment for AI/human reader studies.

If you have a document related to an AI/software device, please provide that, and I would be happy to analyze it against your criteria.

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1. Non-inflammatory degenerative joint disease Including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
5. Revision of previously failed total hip arthroplasty.

This device is a single use implant and intended for cementless use only.

Resolve Modular Revision Hip Stem is a modular stem optimized for femoral primary or revision surgery. It consists of three main components:
(1) Resolve Proximal Component (two types: With Hole or No Hole, each available with HA/Ti plasma spray or Ti plasma spray coating)
(2) Resolve Distal Stem (four types: Taper Stem, Clothespin Stem, Clothespin With Hole Stem, and Interlocking Stems. Taper Stem is uncoated; others are available with HA/Ti plasma spray or Ti plasma spray coating. Clothespin With Hole Stem and Interlocking stem provide holes for additional Distal Interlocking Screw fixation.)
(3) Resolve Distal Interlocking Screw (used with Resolve Clothespin With Hole Stem and Interlocking stem)

Resolve Modular Revision Hip Stem can be used with "United" metallic femoral heads (K994078, K022520, K111546, K122504, K152439, K162957, K221675) or ceramic femoral heads (K103497, K112463, K122185).

All components are manufactured from Ti-6Al-4V alloy (ASTM F136). The coatings (HA/Ti plasma spray and Ti plasma spray) comply with ASTM F1580 and ASTM F1185, ISO 13779-6. Proximal components have standard and high offset designs.

Based on the provided FDA 510(k) Clearance Letter for the "Resolve Modular Revision Hip Stem," it's crucial to understand that this document pertains to a physical medical device (an orthopedic implant), not a software-based medical device or AI/ML algorithm.

Therefore, the concepts of "acceptance criteria for an AI/ML algorithm," "test set," "ground truth establishment," "expert adjudication," "MRMC studies," and "standalone performance" do not apply to the information contained within this 510(k) filing.

The 510(k) process for a physical device like this hip stem primarily focuses on demonstrating substantial equivalence to existing legally marketed predicate devices through:

• Indications for Use Comparison: Showing the device is intended for the same medical purposes.
• Technological Comparison: Demonstrating similar fundamental scientific principles, materials, design, and operating conditions.
• Non-Clinical (Bench) Testing: Conducting a series of engineering and materials tests to ensure the device meets specified mechanical and material performance standards, and that it is as safe and effective as the predicate devices.
• No Clinical Studies (unless specifically required): The letter explicitly states "No clinical studies were required or provided," which is common for devices demonstrating substantial equivalence through bench testing.

There is no "AI/ML algorithm" or "software performance" to describe acceptance criteria or study results for in this context.

Instead, I can extract and present the relevant information about the acceptance of this physical medical device based on the given 510(k) letter.

Acceptance Criteria and Study for the Resolve Modular Revision Hip Stem (Physical Device)

The "acceptance criteria" for a physical device in a 510(k) submission are not typically presented as a table of accuracy metrics. Instead, they are demonstrated by meeting various engineering and material standards, and by showing that the device performs similarly (or better) than the predicate devices in specified non-clinical tests. The "study" refers to the non-clinical (bench) testing performed.

1. Table of "Acceptance Criteria" (represented by tests aligned with regulatory standards) and "Reported Device Performance" (implied compliance or successful test outcomes):

Explanation of "Reported Device Performance": The document states: "Based on the design rationale of the Subject device, the following tests were conducted to evaluate the safety and effectiveness of the subject device, and the test results indicated that this device is safe and effective." This implies that the device successfully met the requirements and specifications of each listed test and standard, thus demonstrating its safety and effectiveness. Specific numerical performance values are not typically included in the summary letter itself but would be detailed in the full submission.

2. Sample Size and Data Provenance:

• Sample Size: Not explicitly stated for each test (e.g., number of stems tested for fatigue). These are typically engineering bench tests on a representative sample of device components or full devices.
• Data Provenance: The tests are non-clinical (bench tests), meaning they were conducted in a laboratory setting, not with human patient data. The manufacturer, United Orthopedic Corporation, is based in Taiwan.

3. Number of Experts and Qualifications for Ground Truth:

• This concept is not applicable as this is a physical device clearance based on non-clinical bench testing, not an AI/ML algorithm requiring expert review for ground truth establishment.

4. Adjudication Method:

• Not applicable for a physical device and non-clinical bench testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Not applicable. This is a clearance for a physical orthopedic implant. The letter explicitly states: "No clinical studies were required or provided." MRMC studies are typically performed for imaging-based AI/ML devices to assess human reader performance with and without AI assistance.

6. Standalone Performance (Algorithm Only):

• Not applicable as there is no algorithm. The performance documented is the standalone mechanical and material performance of the physical implant itself through a series of bench tests.

7. Type of Ground Truth Used:

• For the physical device, the "ground truth" for acceptance is based on established engineering standards (e.g., ISO, ASTM) and regulatory guidance (FDA guidance documents) for mechanical, material, and biological compatibility properties of orthopedic implants. Compliance with these predetermined, objective standards serves as the "ground truth" for safe and effective performance.

8. Sample Size for Training Set:

• Not applicable. This is not a "training set" in the context of AI/ML. The device's design and manufacturing processes are developed based on extensive engineering principles, materials science, and prior knowledge from predicate devices.

9. How Ground Truth for Training Set was Established:

• Not applicable. As there is no AI/ML training set, the concept of establishing ground truth for it does not apply. The "ground truth" for the device's design and material selection would be established through decades of orthopedic research, biomechanical principles, and clinical experience with similar implants.

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Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for:

• · Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis
• · Inflammatory joint disease including rheumatoid arthritis
• · Correction of functional deformity including congenital hip dysplasia
• · Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture
• Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement

Signature Orthopaedics' Origin TT, Aria, Remedy, Origin-NS, Pegasus, Spartan, World and Everglade Hip femoral stems, SignaSure Cementless Cups, Logical and World Acetabular Cups are intended for cementless fixation only.

Signature Orthopaedics' Evolve, Cemented TSI (both CoCr and HNSS variants), Origin Cemented femoral stems and SignaSure Cemented Cups are intended for cemented fixation only.

Signature Orthopaedics' SignaSure Logical/World Metal Insert is indicated for use with a cementless Signature Orthopaedics' Logical/World Acetabular Cup to provide dual mobility articulation.

Signature Orthopaedics' constrained liner components are indicated particularly for patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.

Signature Orthopaedics' Evolve UniPolar Head and BiPolar Head are intended for hemi- hip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head are indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as:

• · Acute femoral head or neck fracture
• · Fracture dislocation of the hip
• · Avascular necrosis of the femoral head
• · Non-union of femoral neck fractures
• · Certain high subcapital and femoral neck fractures in the elderly
• · Degenerative arthritis involving only the femoral head

The Signature Orthopaedics Origin™ TT Stem is intended for single use and cementless fixation. It is manufactured from titanium alloy as per ISO 5832-3 and has a proximal plasma spray coating of titanium as per ASTM F1580 and hydroxyapatite as per ISO 13779-2. It features a 12/14 taper and is compatible for use with Signature CoCr Femoral Heads (K121297 and K163081), Ceramic Femoral Heads (K190704), Logical™ PX, G and C Series Acetabular Cups (K121297 and K153131), Logical™ Liners (K121297, K153131 and K241690), Logical™ Constrained Liners (K153131), BiPolar Heads (K133370 and K163081) and Evolve™ UniPolar Heads (K143184).

The provided text describes the regulatory review for a medical device called the "Origin™ TT Stem," which is a femoral hip prosthesis. However, the document does not contain any information regarding acceptance criteria, study methodologies for device performance, sample sizes, expert involvement, ground truth establishment, or multi-reader multi-case studies.

The document primarily focuses on:

• Regulatory classification and product codes for the device.
• Indications for Use of the hip replacement system, including various components beyond just the Origin™ TT Stem.
• Comparison to predicate devices to establish substantial equivalence.
• Non-clinical performance testing (Range of Motion, Stem and Neck Fatigue FEA, Stem and Neck Fatigue Testing) conducted according to established ISO and ASTM standards to demonstrate the strength and safety of the device.

Therefore, I cannot provide the requested table or answer the specific questions about the study that proves the device meets acceptance criteria, as this information is not present in the provided text.

The document states:

• "Non-clinical testing and engineering evaluations were conducted to verify that the performance of the Signature Orthopaedics Origin™ TT Stem is adequate for anticipated in-vivo use."
• "The results of non-clinical testing show that the strength of the Signature Orthopaedics Origin™ TT Stem is sufficient for their intended use and substantially equivalent to the legally marketed predicate device."

This indicates that internal testing was performed, but the details of the "acceptance criteria" and the specific data from these tests are not provided in the 510(k) summary. The document focuses on demonstrating that the device meets existing standards (ISO, ASTM) and is substantially equivalent to predicate devices, rather than presenting a clinical study with detailed performance metrics against specific acceptance thresholds.

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Indications for Restoration Modular Hip System

• · Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis:
• · Rheumatoid arthritis;
• · Correction of functional deformity;
• · Revision procedures where other treatments or devices have failed; and,
  · Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
  · The RESTORATION Modular Hip System is intended for primary and revision total hip arthroplasty as well as in the presence of severe proximal bone loss. These femoral stems are designed to be proximal femur.

Indications for Accolade C, Accolade HFx, SYSTEM 12 CROSSFIRE, ACCOLADE DISTAL SPACER, CITATION TMZF, PCA Duration Insert, PCA Femoral Head

• · Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• · Rheumatoid arthritis;
• · Correction of functional deformity;
• · Revision procedures where other treatments or devices have failed; and,
  · Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques

Indications for Accolade II Stems
The indications for use of the total hip replacement prostheses include:

• · noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• rheumatoid arthritis;
• · correction of functional deformity;
• · revision procedures where other treatments or devices have failed; and.
  · nonunions, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
  Additional indication specific to use of ACCOLADE II Femoral Stems with compatible Howmedica Osteonics Constrained Liners
  · When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intraoperative instability.
  ACCOLADE II Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.

Indications for OMNIFIT SERIES Acetbular Inserts, Omnifit Crossfire 10 Deg Inserts, Crossfire Inserts, Omnifit Crossfire Inserts, Trident Crossfire Inserts, Trident X3 Inserts, Trident X3 Eccentric Inserts
· Painful, disabling joint disease of the hip from: degenerative arthritis, theumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis.
· Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
· Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
· Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

Indications for ALL POLY CONSTRAINED INSERT, TRIDENT 0 DEG CONSTRAINED INSERT, TRIDENT CONSTRAINED INSERT
A Constrained Acetabular Insert is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.

Indications for UHR Bipolar

• · Femoral head/neck fractures or non-unions.
• · Aseptic necrosis of the femoral head.
  · Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.
  Other Considerations:
  · Pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
  · Salvage of failed total hip arthroplasty

Indications for Artisan Bone Plug
These bone plugs are intended to be placed in the femoral canal prior to the introduction of bone cemented hip procedure.
The plug is placed distally to the femoral stem to help allow cement pressurization and to help prevent cement migration further down the femoral canal.

Indications for C-Taper Alumina Ceramic Heads, V40 Taper Alumina Ceramic V40™ Femoral Head
• Painful, disabling joint disease of the hip from: degenerative arthritis, theumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis.
· Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
· Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
• Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum

Indications for BIOLOX Delta Ceramic Heads, C-Taper to Universal Taper Adapter Sleeve, Universal V40™ Taper Adapter Sleeve
For Use as a Total Hip Replacement:
· Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatic arthritis or late stage avascular necrosis.
• Revision of previous cup arthroplasty or other procedures
· Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
· Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies in the acetabulum.
For Use as a Bipolar Hip Replacement

• · Femoral head/neck fractures or non-unions.
  · Aseptic necrosis of the femoral head.
  • Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion.
  · Pathological considerations or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
  · Salvage of failed total hip arthroplasty

Indications for ADM/MDM X3 Inserts, MDM Acetabular Inserts, MDM Acetabular Liners
The indications for use for total hip arthroplasty include:

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
2. Rheumatoid arthritis;
3. Correction of functional 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.
6. Dislocation risks
   MDM Liners are intended for cementless use only.

The devices included in this submission are femoral heads, acetabular inserts, distal spacers, and bone plugs, used in hip arthroplasty procedures. All devices have been previously deemed substantially equivalent in prior premarket submissions and are commercially available.

This document, K243784, is a 510(k) premarket notification from Stryker Orthopaedics for a "Hip Devices Labeling Update." It states that the purpose of the submission is to add a contraindication to the labeling of existing Stryker Orthopaedics Hip Devices.

Based on the provided document, the device in question is a physical medical device (hip implants and components) and the 510(k) submission is for a labeling update, specifically adding a contraindication. This is not an AI/ML-enabled medical device. Therefore, the questions regarding acceptance criteria and studies proving the device meets those criteria, particularly those related to AI/ML device performance (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies, standalone algorithm performance, ground truth establishment), are not applicable to this submission.

The document explicitly states under "Non-Clinical Testing" and "Clinical Testing":

• "Non-Clinical testing was not required as a basis for substantial equivalence."
• "Clinical testing was not required as a basis for substantial equivalence."

This indicates that no performance studies (clinical or non-clinical in the context of device performance metrics) were conducted or needed to be submitted for this specific 510(k) approval, as the change is solely a labeling update concerning a contraindication, and the device itself (the physical hip implant) has previously been deemed substantially equivalent.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria and performance studies for an AI/ML device, as this context does not apply to the provided document.

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Hip Spacer Molds with stainless-steel reinforcement stems, centralizers and Hip Head Inserts are indicated for use to mold a temporary hemi-hip spacer for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary hemi-hip spacer is molded using Cemex Genta LV, and inserted into femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and debridement. The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection). The temporary hemi-hip spacer made from Hip Spacer Molds is not intended for use more than 180 days, at which time it must be explanted, and permanent devices implanted, or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). Due to the inherent mechanical limitations of the temporary hemi-hip spacer material (Cemex Genta LV) the temporary hemi-hip spacers is only indicated for patients who will consistently use traditional mobility assist devices (e.g., crutches, walkers) throughout the implant period.

Femoral Knee Spacer Molds and Tibial Knee Spacer Molds are indicated for use to mold a temporary total knee replacement (TKR) for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using Cemex Genta LV and inserted into the joint space following removal of the existing total knee replacement implants and debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). The temporary total knee spacer made from the Femoral Knee Spacer Molds and Tibial Knee Spacer Molds is not intended for use more than 180 days, at which time it must be explanted, and permanent devices implanted, or another appropriate treatment performed (e.g., resection arthroplasty fusion, etc.). Due to the inherent mechanical limitations of the temporary total knee spacer material (Cemex Genta LV), the temporary total knee spacer is only indicated for patients who will consistently use traditional mobility devices (e.q., crutches, walkers) throughout the implant period.

Shoulder Spacer Molds with stainless-steel reinforcement stems, centralizers and Shoulder Head Inserts are indicated for use to mold a temporary hemi-shoulder spacer for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary hemi-shoulder spacer is molded using Cemex Genta LV, and inserted into femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and debridement. The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection). The temporary hemi-shoulder spacer made from Shoulder Spacer Molds is not intended for use more than 180 days, at which time it must be explanted, and permanent devices implanted, or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). Due to the inherent mechanical limitations of hemi-shoulder prothesis material (Cemex Genta LV) the temporary hemi-shoulder prothesis is only indicated for patients who will consistently follow activity limitations throughout the implant period.

The Hip Spacer Molds are sterile, single use molds used for forming of interim prothesis from bone cement. These interim prothesis are intended as temporary hemi-hip spacers in a two-stage septic hip joint endoprosthesis. The Hip Spacer Molds are available as modular system, which is combinable to obtain different sized spacers.

The Femoral and Tibial Knee Spacer Molds are sterile, single use molds used for forming of interim prothesis from bone cement. These interim prothesis are intended as temporary knee spacers in a two-stage septic knee joint endoprosthesis. The Knee Spacer Molds are available as modular system, which is combinable to obtain different sized spacers.

The Shoulder Spacer Molds are sterile, sinqle use molds used for forming of interim prothesis from bone cement. These interim prothesis are intended as temporary hemishoulder spacers in a two-stage septic glenohumeral joint endoprosthesis. The Shoulder Spacer Molds are available as modular system, which is combinable to obtain different sized spacers.

This FDA 510(k) clearance letter pertains to medical device molds (Hip, Knee, Shoulder Spacer Molds) used to create temporary orthopedic spacers. The submission does not describe an AI/ML powered device and therefore, the information requested about acceptance criteria and studies proving the device meets the criteria in the context of AI/ML is not available in the provided text.

The document discusses performance data related to the physical characteristics of the molds and the resulting spacers, but not in the context of an AI/ML algorithm's performance. Therefore, I cannot provide information on:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Sample size and data provenance for an AI/ML test set.
• Number and qualifications of experts for AI/ML ground truth.
• Adjudication method for an AI/ML test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study for AI assistance.
• Standalone AI algorithm performance.
• Type of ground truth used for AI/ML.
• Sample size and ground truth establishment for an AI/ML training set.

The performance data mentioned in the document relates to:

• Sterilization and Shelf Life: Validation according to ISO 11135, shelf life of 2 years.
• Biocompatibility: Categorized per ISO 10993-1, with tests performed including Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Intracutaneous reactivity (ISO 10993-23), Pyrogenicity (ISO 10993-11), and Acute systemic toxicity (ISO 10993-11).
• Mechanical Performance Testing:
  • Endurance properties of stemmed femoral hip components according to ISO 7206-4 and ISO 7206-6.
  • Wear of total knee-joint prosthesis according to ISO 14243-1.
  • Endurance properties of tibial trays according to ASTM F1800.
  • Endurance properties of shoulder spacer stem and neck region based on ISO 7206-4 and ISO 7206-6.
  • Antibiotic (gentamicin) elution testing.

These tests are designed to demonstrate the physical and biological safety and effectiveness of the medical device molds and the spacers they produce, showing substantial equivalence to predicate devices, rather than evaluating the performance of an AI/ML algorithm.

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The MUTARS® Proximal Femur Replacement System is a modular hip replacement system offering various components that can be combined to replace the hip joint and address major bone defects with various options depending upon the size and location of the defects of each patient.

The MUTARS® Proximal Femur System is intended for cemented use in total hip arthroplasty or hemiarthroplasty for the following indications:

· Proximal femur replacement in oncology cases where radical resection and replacement of bone is required.

· Limb salvage procedures including surgical intervention for severe trauma, failed previous prosthesis, and/or oncology indications, where radical resection and replacement of the bone is required.

Use of this prosthesis is generally only indicated in skeletally mature patients.

The purpose of this Traditional 510(k) is to expand the MUTARS® Cemented Femoral Stems and MUTARS® Proximal Femur Replacement System with a line extension to the existing stems. The new stems are available with longer lengths (160 and 200mm).

This is a 510(k) premarket notification for a medical device, specifically the MUTARS® femoral stem cemented 160 mm and 200 mm. Such notifications focus on demonstrating "substantial equivalence" to a legally marketed predicate device rather than establishing new acceptance criteria and proving performance against them in the same way one might for a novel device or software.

In this context, the "acceptance criteria" for the new device are implicitly that it performs comparably or acceptably to the predicate device, as demonstrated through adherence to relevant standards and performance testing.

Here's a breakdown of the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

"- Distal Stem Fatigue Testing (ISO 7206-4)"

"All performance testing conducted for the MUTARS® femoral stem cemented 160 mm and 200 mm met the predetermined acceptance criteria or were otherwise considered acceptable." |
| Biocompatibility: Materials should be biocompatible and not elicit adverse biological responses. | While not explicitly detailed in the provided snippets, a 510(k) submission for an implantable device would typically include or reference biocompatibility testing to relevant ISO standards (e.g., ISO 10993 series). The statement "All necessary testing has been performed" implies this was addressed. |
| Material Properties: The materials used in the device should meet specified mechanical and chemical properties. | Not explicitly detailed in the provided snippets, but implied by the "All necessary testing" statement and comparison to the predicate device. |
| Design Equivalence/Similarity: The design features should be comparable to the predicate device for the intended use. | "The MUTARS® femoral stem cemented 160 mm and 200 mm subject to this submission possess the same intended use and technological characteristics as the predicate device system components." |
| Dimensional Specifications: The device dimensions (e.g., length) should meet manufacturing specifications and be within the expected range for the intended application (extension to 160mm and 200mm lengths). | The submission is for a "line extension to the existing stems" with "new stems... available with longer lengths (160 and 200mm)." This implies the dimensional specifications for these new lengths are defined and were adhered to. The testing of "worst-case" further supports this. |
| Manufacturing Quality: The device should be manufactured under a Quality System (QS) Regulation (21 CFR Part 820). | The FDA letter explicitly states, "Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820)..." and references design controls, nonconforming product, and corrective/preventive action. This is a regulatory requirement for acceptance of the device into the market. |

The crucial phrase indicating acceptance criteria were met is: "All performance testing conducted... met the predetermined acceptance criteria or were otherwise considered acceptable."

Regarding the study that proves the device meets the acceptance criteria:

The document describes performance testing conducted on the device.

• Type of Study: This was a bench testing study, specifically focused on Distal Stem Fatigue Testing (ISO 7206-4). This standard is designed to assess the endurance of femoral components of hip prostheses under simulated physiological loading conditions.
• Proof of Meeting Criteria: The conclusion states that "All performance testing conducted for the MUTARS® femoral stem cemented 160 mm and 200 mm met the predetermined acceptance criteria or were otherwise considered acceptable." This directly confirms the device performed as required by the established standard and internal criteria.

The remaining sections are not applicable to the provided document, as this is a mechanical medical device (femoral stem for hip replacement) and not an AI/software device. Therefore, questions related to sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details are not relevant to this 510(k) submission for a physical implant.

Specifically:

2. Sample size used for the test set and the data provenance: Not applicable. For mechanical testing like fatigue, the sample size is determined by the testing standard (e.g., ISO 7206-4) and statistical requirements for demonstrating meeting performance thresholds. The data provenance is from the specific test laboratory where the bench tests were conducted.
3. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth in this context refers to engineering specifications and performance standards, not diagnostic interpretations by experts.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done... effect size: Not applicable as this is not an AI/software imaging device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used: For mechanical devices, the "ground truth" is defined by established engineering principles, material science, and international performance standards (like ISO 7206-4).
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

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Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, atthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

Total hip systems may be indicated for use (i) without bone cement, or (ii) for use with or without bone cement. Refer to the product labeling and literature for specific applications.

The Anthology Hip System, CPCS Cemented Hip System, and Synergy Hip System are for primary surgeries only.

The TANDEM Unipolar and Bipolar Hip System is indicated for use in patients not suitable for total hip arthroplasty, with a non-functional femoral head due to femoral neck fracture.

Acetabular Hip Components are individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of degenerative joint disease or any of its composite diagnoses of osteoarthritis, avascular necrosis, and traumatic arthritis.

Hip components are also indicated for inflammatory degenerative joint disease including theumatoid arthritis, congenital dysplasia. femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques, and fracture-dislocations of the hip.

The Constrained Liners are indicated for primary or revision patients at hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease or intraoperative instability and for whom all other options to constrained acetabular components have been considered.

The purpose of this Traditional 510(k) is the following:

• 1. To add the MR safety information to the product labels and update the MR information within the package insert for the Smith & Nephew Hip Systems included within the scope of this 510(k), and
• 2. To address several iterative legacy design changes made to the subject hip system components.

This document is a 510(k) premarket notification for hip system components and does not describe an AI medical device. Therefore, I cannot provide information on acceptance criteria or studies related to AI algorithms.

The document primarily focuses on demonstrating substantial equivalence of the described hip system components to previously cleared predicate devices. The "Performance Data" section specifically mentions Magnetic Resonance Imaging (MRI) compatibility testing and "additional testing [...] to assess the modifications made to the subject Smith & Nephew Hip Systems devices against their predicates." This indicates performance data related to physical device properties, not AI performance.

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