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NEXUS® Hip stems are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

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 functional deformity; and,
4. revision procedures where other treatments or devices have failed

Titanium plasma spray and HA coatings applied to implant surfaces are intended for uncemented arthroplasty.

The MicroPort NEXUS® Hip Stem is manufactured from titanium alloy (Ti6Al4V per ASTM F620) and includes titanium plasma sprayed coating conforming to ASTM F1580 and a hydroxyapatite (HA) coating conforming to ASTM F1185. The proximal body of the hip stem has a dual titanium and HA plasma spray coating while the distal portion of the hip stem has HA coating only. The NEXUS Hip Stem features collared and collarless options and sizes 0 through 12 with standard and high offsets. The NEXUS Hip Stem is provided sterile and is a single use device. The subject NEXUS Stems are compatible with previously cleared MicroPort femoral head and shell/liner components.

This document is a 510(k) clearance letter for the NEXUS® Hip Stem, a medical device. It does not contain information about an AI/ML medical device, clinical study performance data, or details about the establishment of ground truth by experts. The relevant sections for describing device performance are focused on non-clinical (mechanical) testing of the hip stem itself.

Therefore, I cannot fulfill your request for information related to acceptance criteria, study details, expert involvement, and ground truth establishment in the context of an AI/ML device. The provided FDA clearance letter is for a physical medical implant, not an AI software.

The sections you've asked about (acceptance criteria, sample size, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are typically found in clinical performance studies for AI/ML-driven medical devices, especially those involving image analysis or diagnostic support. This document is instead a regulatory clearance for a traditional orthopedic implant, where "performance" relates to mechanical and material characteristics and "testing" involves physical simulations or analyses, not analysis of clinical data by AI.

To illustrate what you would expect to find if this were an AI/ML device, and why it's not present here:

An AI/ML device would typically have acceptance criteria related to its diagnostic or predictive performance metrics (e.g., sensitivity, specificity, AUC, FROC curves) on a test set. The study proving these criteria would describe:

• A table of acceptance criteria and reported device performance: This would list target thresholds (e.g., "Sensitivity >= 90%") and the actual observed performance (e.g., "Sensitivity = 92.5%").
• Sample size and data provenance: Details on how many cases (e.g., images, patient records) were in the test set, where they came from (e.g., multi-center, specific countries), and if they were collected retrospectively or prospectively.
• Experts for ground truth: The number and qualifications of clinicians (e.g., board-certified radiologists with X years of experience, specializing in Y disease) who reviewed the test cases to establish the definitive diagnosis or finding.
• Adjudication method for ground truth: How disagreements among experts were resolved (e.g., 2-out-of-3 majority vote, third independent expert review, consensus meeting).
• MRMC comparative effectiveness study: If the AI was intended to assist human readers, there would be a study comparing human reader performance with AI assistance vs. without AI assistance. The effect size (e.g., improvement in AUC or reading time) would be reported.
• Standalone performance: The algorithm's performance by itself without human intervention.
• Type of ground truth: Whether it was expert consensus, biopsy-proven pathology, long-term patient outcomes, or a combination.
• Training set size and ground truth establishment: Similar details for the data used to train the AI model.

Since none of this information is available in the provided text, I cannot create the table or answer the specific questions posed using the given input. The input is purely for a physical implant, not an AI product.

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MicroPort total hip systems are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia:

• 2. inflammatory degenerative joint disease such as rheumatoid arthritis;
• 3. correction of functional deformity; and,
• 4. revision procedures where other treatments or devices have failed.

The modular Ceramic Femoral Head is composed of alumina matrix composite, manufactured as per ISO 6474-2. It has a 12/14 taper which is identical to the taper on MicroPort Orthopedics' range of femoral heads. The device articulates with an acetabular liner and is compatible for use across any of MicroPort Orthopedics' total hip component range.

This document is a 510(k) premarket notification summary for a medical device, specifically a "Ceramic Femoral Head." This type of document is used to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria and human-in-the-loop studies.

Therefore, the information requested in your prompt regarding acceptance criteria for an AI/device, human reader studies, and ground truth establishment for such studies, is not applicable to this specific document.

The document primarily focuses on non-clinical (mechanical) testing to demonstrate that the new Ceramic Femoral Head, manufactured from a different material (Permallon Tru by CoorsTek), performs equivalently or better than the predicate device.

Here's a breakdown of what is available in the document, related to the general concept of "acceptance criteria" for the device's mechanical performance:

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

The document general states: "Non-clinical (mechanical) testing results met the applicable acceptance criteria; therefore, acceptable mechanical performance is expected of the Ceramic Femoral Head manufactured by CoorsTek."

While a table of specific numerical acceptance criteria and their corresponding reported performance values is not explicitly presented, the document lists the types of tests performed:

• Axial compression test
• Fatigue test
• Post-fatigue ultimate compression strength test
• Static pull off test
• Static torsion test
• MR Safety Evaluation (per ASTM F2182-19, FDA Guidance, ASTM F2052-21, ASTM F2119-07)

The "acceptance criteria" for these tests would inherently be standard specifications or thresholds defined within the referenced ASTM standards and FDA guidance for orthopedic implants, ensuring the device's mechanical integrity and MR compatibility. The "reported device performance" is summarized as having "met the applicable acceptance criteria."

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

• Test Set (Mechanical Testing): The specific sample sizes for each mechanical test are not mentioned in this summary document. These would typically be specified in the full test reports, but are not required for the 510(k) summary. Given these are mechanical tests on physical devices, the "provenance" is the manufacturing process of the Ceramic Femoral Head by CoorsTek.
• Data Provenance: The data comes from engineering evaluations performed by the manufacturer, MicroPort Orthopedics, Inc. These are laboratory-based mechanical tests, not human data.

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

• Not applicable. This document describes mechanical testing of a physical medical device, not an AI or diagnostic device that requires expert human interpretation for "ground truth." The "ground truth" here is the physical performance measured against established engineering standards.

4. Adjudication method for the test set:

• Not applicable. There is no "adjudication" in the context of mechanical testing. The results are objective measurements from laboratory equipment.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

• No. This is not an MRMC study. MRMC studies compare human reader performance with and without AI assistance, which is irrelevant to verifying the mechanical properties of a ceramic femoral head.

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

• Not applicable. This is not an algorithm, but a physical implant.

7. The type of ground truth used:

• For mechanical testing, the "ground truth" is defined by established engineering standards and material properties (e.g., ISO 6474-2, ASTM F2182-19, ASTM F2052-21, ASTM F2119-07). The device's performance is measured against the requirements of these standards and compared to the predicate device's established performance under these standards.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not an AI or machine learning device.

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

• Not applicable. See point 8.

In summary, this 510(k) notification focuses on demonstrating substantial equivalence of a physical medical implant through established non-clinical mechanical testing, not through AI performance evaluation or human clinical studies.

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The DYNASTY® Dual Mobility Inserts and Liners, when used with compatible acetabular shells and femoral heads, are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients. In revision arthroplasties, all devices associated with the wear couple must be removed and replaced.

Indications for Use:

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 functional deformity; and;

4. revision procedures where other treatments or devices have failed;

5. dislocation risks;

6. treatment of non-union, femoral neck fractures of the proximal femur with head involvement which are unmanageable by other techniques

Dual Mobility Inserts and Liners are single use implants intended for uncemented arthroplasty.

The Dual Mobility (DM) Inserts and Liners are designed for use with compatible DYNASTY® acetabular shells, MicroPort Orthopedics non-skirted femoral heads and PROFEMUR® femoral stems, to create a system with two articulating interfaces in the acetabular joint space of the hip.

The E-CLASS® DUAL MOBILITY INSERTS are manufactured from Vitamin E cross linked polyethylene conforming to ASTM F2695 and are available with an inner diameter of 28 mm and outer diameters from 38 mm to 56 mm in 2 mm increments. The E-Class® DM Inserts are compatible with and provide a primary articulating surface for all 28 mm, non-skirted femoral heads.

DM CoCr Liners are manufactured from cobalt chrome (CoCr) alloy conforming to ASTM F1537 (Type 1) and are available with inner diameters from 38 mm in 2 mm increments. The DM CoCr Liners are designed to mate with all DYNASTY® acetabular shells via a taper locking mechanism and provide the secondary articulating surface for the E-Class® DM Inserts.

This document is a 510(k) Premarket Notification from MicroPort Orthopedics, Inc. to the FDA regarding their E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS. The document focuses on demonstrating substantial equivalence to a predicate device through mechanical testing.

Here's the breakdown of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The document describes mechanical testing to demonstrate substantial equivalence, rather than a clinical study evaluating human-in-the-loop performance of an AI device. Therefore, the "acceptance criteria" discussed are for the mechanical properties of the orthopedic implants, not for an AI algorithm's diagnostic performance.

Tabla de criterios de aceptación y rendimiento informado del dispositivo:

Study Information (Mechanical Testing)

This document describes a premarket notification for an orthopedic implant, not an AI/software device. Therefore, the questions related to AI device performance evaluation (e.g., sample size for test/training set, expert ground truth, MRMC study, standalone performance) are not directly applicable to the type of study described.

However, based on the provided text, we can infer some details about the mechanical testing study:

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

   • The sample size for each mechanical test is not explicitly stated (e.g., "n="). Instead, it mentions "MicroPort has evaluated the subject E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS and data demonstrates substantial equivalence..." This implies multiple samples were tested for each specified mechanical test to comply with the relevant ASTM/ISO standards.
   • Data Provenance: The testing was "performed for the subject E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS" by MicroPort. The location is implied to be within MicroPort's testing facilities, likely in the US (Arlington, Tennessee, is mentioned as their address). It is inherently a prospective execution of validated test methods on newly manufactured devices.

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

   • Not applicable in the context of mechanical testing. "Ground truth" here refers to the precise measurements and evaluations against established engineering standards (ASTM, ISO). The "expertise" involved would be mechanical engineers and technicians conducting the tests and interpreting the results according to the specified standards.

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

   • Not applicable. Mechanical testing involves objective measurements rather than subjective expert consensus. Results are compared directly to numerical acceptance criteria defined by the standards.

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:

   • Not applicable. This is not an AI device or a human-in-the-loop study.

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

   • Not applicable. This is not an AI algorithm. The performance evaluation is inherently "standalone" in the sense that it's testing the physical properties of the device itself, not an algorithm's output.

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

   • The "ground truth" for mechanical testing is defined by the acceptance criteria specified in the referenced ASTM and ISO international standards. These standards provide the validated methodologies and performance thresholds for assessing the safety and efficacy of orthopedic implants.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning study requiring a training set.

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

   • Not applicable, as there is no training set for mechanical testing.

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The EVOLUTION® BIOFOAM® Tibial, EVOLUTION® Revision Tibial, and EVOLUTION® Revision CCK Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

1. Non-inflammatory degenerative joint disease: including osteoarthritis, or avascular necrosis;

2. Inflammatory degenerative joint disease, including rheumatoid arthritis;

3. Correction of functional deformity;

4. Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.

The EVOLUTION® BIOFOAM® Tibial System implants are for cementless use only.

The EVOLUTION® Revision Tibial and EVOLUTION® Revision CCK Systems are for cemented use only.

A labeling change is taking place to include MR Conditional language and symbols to the implant components of the predicate device systems identified above. The changes only apply to the device labeling; therefore, the subject devices are identical to the predicate devices.

The non-clinical testing provided establishes the conditional safety and compatibility of the passive implants in a magnetic resonance (MR) environment. The subject devices include the following components and basic design features:

• . Metal femoral components manufactured from cobalt chrome alloy
• . Femoral revision accessories, including augments, manufactured from titanium alloy
• . CCK tibial inserts manufactured from UHMWPE with locking screws and posts manufactured from titanium alloy
• . Tibial bases manufactured from titanium alloy available in porous and non-porous versions
• Tibial revision accessories, including keels, augments, stem extensions, and adapters, . manufactured from titanium alloy.
• . Patellae manufactured from UHMWPE and cobalt chrome alloy

The provided text is a 510(k) Summary for a medical device (EVOLUTION® Knee Systems – MR Labeling) and outlines nonclinical testing conducted to establish the device's conditional safety and compatibility in a magnetic resonance (MR) environment. It does not describe a study involving device performance against acceptance criteria in the usual sense of diagnostic accuracy or clinical outcomes, but rather safety and compatibility within an MR environment.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical or diagnostic performance are not applicable to this document. I will focus on what is provided regarding the MR safety testing.

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

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

The document does not explicitly state numerical acceptance criteria in a table format for MR safety. Instead, it refers to industry standards that define safe limits. The reported "performance" is that the device met these standards and showed no safety issues.

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

The document states, "The tests evaluated the worst case components and constructs for RF heating, field interactions, and image artifacts." It refers to "passive implants" but does not specify the exact number of components or constructs tested.

• Test set sample size: Not explicitly stated as a numerical count of individual devices, but "worst case components and constructs" were tested.
• Data provenance: Nonclinical testing performed according to U.S. FDA guidance and international standards (NEMA, ASTM). The location of the testing laboratory is not specified (e.g., country of origin).

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

This question is not applicable. The testing was nonclinical (MR safety testing), not involving human diagnostic interpretation or ground truth establishment by medical experts.

4. Adjudication method for the test set

This question is not applicable, as it was nonclinical testing, not involving human readers or interpretation requiring adjudication.

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

There was no MRMC comparative effectiveness study described, as this document concerns the MR safety labeling of knee implant systems, not an AI-assisted diagnostic device.

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

This question is not applicable. The device is a knee implant system, not an algorithm.

7. The type of ground truth used

For an MR safety study, "ground truth" typically refers to the physical properties of the materials and their behavior in an MR field as measured by calibrated equipment following established standards. It's not expert consensus, pathology, or outcomes data in the clinical diagnostic sense. The ground truth is the quantitative measurements against the physical laws and established safety thresholds described by the ASTM and NEMA standards.

8. The sample size for the training set

This question is not applicable. This is not a machine learning or AI device that requires a training set.

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

This question is not applicable as there was no training set.

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PROCOTYL® PRIME hip system is intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

Indications for Use

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankyloses, protrusion acetabuli. and painful hip dysplasia:

2. inflammatory degenerative joint disease such as rheumatoid arthritis;

3. correction of functional deformity; and,

4. revision procedures where other treatments or devices have failed.

Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty.

The PROCOTYL® PRIME E-CLASS™ XLPE Liner is an additional liner option for MicroPort Orthopedics' PROCOTYL® PRIME Acetabular Cup System (K170444). The design features are summarized below:

• Manufactured from E-CLASS™ vitamin E blended highly crosslinked ultra high . molecular weight polyethylene (VEXLPE) conforming to ASTM F2695-12
• Available in Standard, Lipped, or Face-Changing Lateralized Configurations .
• Inner Diameter sizes 22mm to 44mm o

The provided text describes a 510(k) premarket notification for a medical device, the PROCOTYL® PRIME E-CLASS™ XLPE Liner. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through extensive clinical trials with specific acceptance criteria as might be seen for a novel device. Therefore, the response will focus on the non-clinical testing performed to establish this substantial equivalence.

1. Table of acceptance criteria and the reported device performance

Since this is a 510(k) submission, the "acceptance criteria" are generally implied to be meeting the performance of existing, legally marketed predicate devices and established standards (ASTM, ISO). The "reported device performance" refers to the results of the non-clinical tests that demonstrate this equivalence.

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

The document does not specify the exact sample sizes (e.g., number of test specimens) for each non-clinical test. It generally states that "testing was performed" or "underwent testing." The data provenance is internal to MicroPort Orthopedics, Inc. and is generated through their non-clinical testing. This is typically prospective in nature for these types of bench and animal studies. No country of origin of the data is explicitly mentioned beyond the company's location in Arlington, Tennessee.

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

This information is not applicable to a non-clinical 510(k) submission focused on demonstrating substantial equivalence through bench and animal testing. "Ground truth" established by experts is typically relevant for clinical studies, particularly those involving diagnostic accuracy or human interpretation.

4. Adjudication method for the test set

This information is not applicable to the non-clinical testing described. Adjudication methods (like 2+1, 3+1) are used in clinical studies to resolve discrepancies in expert interpretations or assessments.

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 MRMC comparative effectiveness study was done. The document explicitly states: "Clinical data was not provided for the subject devices." This implies that no human reader studies (with or without AI assistance) were conducted as part of this submission. The device is a physical implant, not an AI-assisted diagnostic tool.

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

No standalone algorithm performance study was done. The device is a physical implant, not an algorithm.

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

Given that "Clinical data was not provided," there is no "ground truth" in the sense of clinical outcomes or expert diagnoses from human patients. The "ground truth" for the non-clinical tests would be the established scientific principles, engineering standards (e.g., ASTM F2695-12 for the material), and performance characteristics of predicate devices against which the new liner's properties are compared.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is a physical medical device, not an AI algorithm requiring a training dataset.

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

This information is not applicable, as there is no "training set."

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The ADVANCE® BIOFOAM® and EVOLUTION® BIOFOAM® tibial bases are indicated for use in knee athroplasty in skeletally mature patients with the following conditions:

1. Non-inflammatory degenerative joint disease: including osteoarthritis, or avascular necrosis;
2. Inflammatory degenerative joint disease, including rheumatoid arthritis;
3. Correction of functional deformity;
4. Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
   The ADVANCE® BIOFOAM® Tibial System and EVOLUTION® BIOFOAM® Tibial System implants are for cementless use only.

The DYNASTY® BIOFOAM® Acetabular Shell is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankyloses, protrusion acetabuli, and painful hip dysplasia;
2. Inflammatory degenerative joint disease such as rheumatoid arthritis;
3. Correction of functional deformity;
4. Revision procedures where other treatments or devices have failed.
   The DYNASTY® BIOFOAM® Acetabular Shell is for uncemented use only.

A process change is taking place to introduce BIOFOAM® Additive Manufacturing (BIOFOAM® AM) as an alternative to the currently manufactured BIOFOAM® material used as a porous coating. BIOFOAM® AM will be used as a porous coating for MicroPort Orthopedics' tibial bases and acetabular shells with the current BIOFOAM® material as a porous coating. The BIOFOAM® AM is a porous material manufactured from the same raw material as the predicate, Commercially Pure Titanium conforming to ASTM F67, The surface treatment of BIOFOAM® AM is identical to the predicate and helps to provide initial fixation. The structure and porosity of BIOFOAM® AM is designed to encourage bone apposition.

The provided documentation is a 510(k) Summary for a medical device and does not contain the detailed data or study design typically found in a clinical study report or a validation study for an AI/ML powered device. This document describes the "BIOFOAM® Additive Manufacturing (BIOFOAM® AM)" as an alternative porous coating material for existing orthopedic implants, not an AI/ML device.

Therefore, many of the requested sections about AI/ML device performance, sample sizes for test/training sets, expert adjudication, MRMC studies, and standalone performance metrics are not applicable to the information provided in this document. The document focuses on demonstrating substantial equivalence of a new manufacturing process for a material to existing predicate devices, primarily through non-clinical testing.

However, I can extract the relevant information regarding the acceptance criteria (or performance metrics) used for the material and the study that proves it meets those criteria based on the provided text:

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

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

• Sample Size: Not specified in the provided summary.
• Data Provenance: Not applicable as this is a non-clinical material testing study, not a study involving human data.

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. Ground truth for material performance is established through recognized ASTM standards and engineering measurements, not expert consensus in a medical diagnostic context.

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

• Not applicable. This is a non-clinical material testing study.

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 non-clinical material testing study, not an AI/ML device.

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

• Not applicable. This is a non-clinical material testing study, not an AI/ML device.

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

• The "ground truth" for this device's performance is based on established engineering and material science standards (e.g., ASTM F1044, ASTM F1147, ASTM F1160, ASTM F1854) and comparisons to the performance of the predicate device materials. FDA Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces also served as a benchmark.

8. The sample size for the training set:

• Not applicable. This is a new material/manufacturing process, not an AI/ML model that requires training data.

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

• Not applicable.

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The EVOLUTION® Revision Tibial System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

1. Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis
2. Inflammatory degenerative joint disease, including rheumatoid arthritis;
3. Correction of functional deformity
4. Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.

The EVOLUTION® Medial-Pivot Total Knee System Nonporous implants are for cemented use only.

The EVOLUTION® Revision Tibial System is being introduced to supplement MicroPort Orthopedics' knee product lines to provide revision surgery options with a cemented tibial base. The design features are summarized below:

• Manufactured from titanium alloy conforming to ASTM F620/F136 (forged/wrought) .
• Available in 8 standard sizes, left and right ●
• . Available in 3 plus sizes, left and right
• Tibial base has holes for augment attachment screws
• System includes tibial base, modular keels, block augments, stem adapters (offset & extension), stem extensions (cemented & canal-filling cementless) and stem caps (metallic and poly)

The provided text is a 510(k) Summary for a medical device called the "EVOLUTION® Revision Tibial System." This document is a regulatory submission to the FDA and primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study proving device performance in the way one might expect for a novel AI/software medical device.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts for ground truth, MRMC study, sample size for training set, how training set ground truth was established) are not applicable or provided in this document as it pertains to a mechanical orthopedic implant, not an AI/software device that would involve such testing.

Here's a breakdown of the available information:

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

2. Sample sized 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 testing described is non-clinical (laboratory/mechanical testing of the implant itself) and does not involve human sample sizes or data provenance in the context of clinical trials or AI model evaluation.

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. The ground truth for mechanical device performance is established by engineering standards (e.g., ASTM F1800, ASTM F2009) and the physical properties of the materials and design, not by expert human interpretation in a medical imaging context.

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

Not applicable. Adjudication methods are relevant for human-interpreted medical data, not for mechanical device 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 is not an AI-assisted device.

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

Not applicable. This is not an algorithm-only device.

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

The "ground truth" for the non-clinical testing is based on established engineering standards and specifications (e.g., ASTM standards for fatigue and static evaluation), and the physical test results compared against those standards or the predicate device's established performance.

8. The sample size for the training set

Not applicable. This is a physical orthopedic implant, not a software/AI device that requires a training set.

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

Not applicable. There is no training set for this type of device.

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MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

1. noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
2. inflammatory degenerative joint disease including rheumatoid arthritis;
3. correction of functional deformity;
4. revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.

ADVANCE® 913 Medial Pivot Tibial Base and Insert Components (not licensed for sale in Canada) are for use with bone cement.

Porous-Coated Total Knee Replacement Components are for use without bone cement.

The EVOLUTION® Total Knee System is for cemented use only.

The subject devices for this submission are all the predicate devices listed above, which consists of implant components used in knee arthroplasty. The only changes to the subject devices are updates to their labeling. Specifically, the package inserts and package labels are being updated to include MR Conditional language and symbols. The subjects are identical to the predicates in all aspects except for the labeling updates. Testing is provided in this Traditional 510(k) that establishes the conditional safety and compatibility of the passive implants in a magnetic resonance (MR) environment. The basic design features are the following:

• Metal Femoral component manufactured from cobalt chrome alloy ●
• Femoral components available in porous and non porous versions
• Tibial inserts manufactured from UHMWPE
• Tibial bases manufactured from cobalt chrome alloy or titanium alloy ●
• Tibial bases available in porous and non porous versions ●
• All-poly patellae manufactured from UHMWPE
• Metal portion of metal backed patellae manufactured from titanium allov .

The provided text describes a 510(k) premarket notification for "MPO Total Knee Systems MR Labeling." This submission is solely for updating the labeling of existing total knee systems to include "MR Conditional" language and symbols, indicating their safety and compatibility in a magnetic resonance (MR) environment under specific conditions.

Therefore, the "device" in this context is not a new medical device whose performance is being evaluated in a clinical setting against acceptance criteria for diagnostic accuracy or treatment efficacy. Instead, the "device" is the existing knee implant system, and the study is focused on its MR compatibility, not its clinical performance or diagnostic capabilities.

Given this, the questions about acceptance criteria for device performance, sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable in their usual sense for a typical AI/diagnostic device submission.

However, I can extract information related to the MR compatibility testing:

1. Table of Acceptance Criteria and Reported Device Performance (for MR Compatibility)

Since the standard format of diagnostic accuracy or treatment efficacy performance is not relevant here, the acceptance criteria are related to meeting specific MR safety standards. The document doesn't explicitly list a "table" of acceptance criteria but states that testing was conducted according to specific ASTM standards. The "performance" is that the devices met these standards to be deemed "MR Conditional."

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

• Sample Size: The document mentions "the worst case components and constructs" were evaluated for RF Heating, field interactions, and image artifacts. It does not provide a specific numerical sample size (e.g., number of individual implants tested). This is typical for bench testing where representative "worst-case" configurations are chosen rather than a large statistical sample of every single variation.
• Data Provenance: The testing was non-clinical (bench testing) and performed to recognized ASTM standards and FDA guidance. The "country of origin of the data" is not explicitly stated, but it would have been conducted by the manufacturer or a contracted lab to meet US FDA requirements. It is a prospective test in the sense that it was specifically conducted for this submission.

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

• Not Applicable. For MR compatibility bench testing, "ground truth" in the clinical diagnostic sense established by human experts is not relevant. The "ground truth" is determined by the physical measurements and observations made according to the defined test methods of the ASTM standards.

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

• Not Applicable. Adjudication methods are for interpretation of clinical data or images, not for physical bench testing results. The results are objective measurements against specified thresholds in the 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:

• No. This is not an AI or diagnostic device. This is a knee implant system seeking MR conditional labeling. An MRMC study is not relevant.

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

• No. This is not an algorithm or AI device.

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

• Not Applicable. The "ground truth" for MR compatibility testing is the objective physical measurements and observations obtained by following validated test methods (e.g., temperature changes, deflection angles, artifact size) as defined by the ASTM standards.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not Applicable. As there is no training set.

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The EVOLUTION® BIOFOAM® Tibial System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

1. Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis;
2. Inflammatory degenerative joint disease, including rheumatoid arthritis;
3. Correction of functional deformity;
4. Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
   The EVOLUTION® BIOFOAM® Tibial System is for use without bone cement.

The ADVANCE® BIOFOAM® Tibial System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

1. Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis;
2. Inflammatory degenerative joint disease, including rheumatoid arthritis;
3. Correction of functional deformity;
4. Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
   The ADVANCE® BIOFOAM® Tibial System is for use without bone cement and is intended for use with EVOLUTION® and ADVANCE® modular keels.

The EVOLUTION® BIOFOAM® Tibial System is a line extension of the EVOLUTION® MP Total Knee System product line. The device is an asymmetrical tibial base with a BIOFOAM® coating on the distal surface. The design features are summarized below:
. Manufactured from titanium alloy conforming to ASTM F620/F136 (forged/wrought)
. Available in 11 sizes, left and right
Tibial base is available with and without holes for bone screws ●
. System includes 3 options of modular keels consisting of a two fin bullet-tip, a four fin bullet-tip and a four fin stem-accepting keel
Compatible with 510(k) cleared EVOLUTION® Tibial Inserts, ADVANCE® . Keels and ADVANTIM® Stems

The keel compatibility for the ADVANCE® BIOFOAM® Tibia is being expanded to include all keels subject to this 510(k). The subject design and indications remain identical according to K063128.

The provided text is a 510(k) Summary of Safety and Effectiveness for the EVOLUTION® BIOFOAM® Tibial System and ADVANCE® BIOFOAM® Tibial System. This document focuses on demonstrating substantial equivalence to existing predicate devices, not on providing the results of a primary study proving a device meets specific acceptance criteria in a clinical context.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria. Specifically, it states:

• Clinical Testing: "Clinical data was not provided for the subject devices."
• Acceptance Criteria/Performance: The document discusses non-clinical testing for fatigue strength against a predicate device, but this is not presented as "acceptance criteria" with reported "device performance" in the clinical sense you've outlined.

The non-clinical testing section (D) does mention.

• Nonclinical Testing: "The subject EVOLUTION® BIOFOAM® Tibial System was evaluated for fatigue strength per ASTM F1800 and 3-point stem fatigue. Results concluded that the subject tibial base is expected to perform as well or better than the predicate device in fatigue loading."

While this indicates some engineering performance evaluation, it does not fulfill the requirements of your prompt for clinical acceptance criteria and related study details.

To answer your prompt directly based on the provided text:

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

   • Not available. The document states "Clinical data was not provided for the subject devices." Non-clinical testing for fatigue strength was performed, concluding "the subject tibial base is expected to perform as well or better than the predicate device in fatigue loading," but specific acceptance criteria and detailed performance metrics are not given for this non-clinical test.

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

   • Not available. No clinical test set information is provided. For the non-clinical fatigue testing, the sample size is not mentioned, and given it's a mechanical test, country of origin or retrospective/prospective status is not applicable in the human data sense.

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. No clinical test set was used, therefore no experts were used to establish clinical ground truth.

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

   • Not applicable. No clinical test set was used.

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

   • Not applicable. This device is a knee implant, not an AI diagnostic tool. No MRMC study was performed.

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

   • Not applicable. Not an algorithm/AI device.

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

   • Not applicable for clinical ground truth. For the non-clinical fatigue testing, the "ground truth" would be engineering standards (ASTM F1800) and mechanical measurements.

8. The sample size for the training set

   • Not applicable. This device is a physical implant, not an AI model requiring a training set.

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

   • Not applicable. Not an AI model.

In summary, the provided document is a regulatory submission demonstrating substantial equivalence for a physical medical device (knee implant), not an AI/diagnostic device. Consequently, it does not contain the information you requested about clinical acceptance criteria and associated studies.

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The PROFEMUR® Preserve Sizes 1-3 Hip Stems are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions;

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
2. inflammatory degenerative joint disease such as rheumatoid arthritis;
3. correction of functional deformity; and,
   4, revision procedures where other treatments or devices have failed
   The PROFEMUR® Preserve Sizes 1-3 Hip Stems are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of uncemented total hip arthroplasty.

The purpose of this submission is to provide additional sizing options for the predicate PROFEMUR® Preserve Hip Stems (K112080) by adding a line extension. The PROFEMUR® Preserve Sizes 1-3 Hip Stems are modular stems manufactured from a forged titanium alloy (ASTM F620) and designed for use in uncemented total hip arthroplasty. The PROFEMUR® Preserve Sizes 1-3 Hip Stems are available in three configurations and are coated with titanium plasma spray conforming to ASTM F1580.

The provided document is a 510(k) Pre-market Notification for the PROFEMUR® Preserve Sizes 1-3 Hip Stems. It details the device's substantial equivalence to a predicate device and includes information on nonclinical testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

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

The document does not specify the exact sample sizes (number of devices tested) for the nonclinical tests (proximal fatigue, distal fatigue, range of motion). The studies were nonclinical (laboratory-based mechanical testing), not human clinical studies, so provenance in terms of country of origin or retrospective/prospective is not applicable.

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 question is not applicable to this submission. The "ground truth" for the nonclinical testing of a hip stem involves established engineering and materials science standards (ISO, ASTM). The "experts" in this context would be the engineers and technicians performing the tests and comparing results against the specified standards. Their qualifications are inherent in their ability to conduct these specific standardized tests. No medical experts (like radiologists) were involved in establishing "ground truth" for this type of device.

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

This question is not applicable to the nonclinical engineering tests performed. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where subjective interpretation or classification by multiple experts is required for establishing ground truth, especially in image analysis or disease diagnosis. For mechanical testing, the results are objective measurements against defined pass/fail criteria in the 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:

No MRMC comparative effectiveness study was done. This type of study is relevant for devices involving human interpretation of data, often with AI assistance (e.g., AI for radiology). The PROFEMUR® Preserve Sizes 1-3 Hip Stems are a mechanical implant, and the testing described is nonclinical mechanical testing, not a study of human reader performance.

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

No standalone (algorithm only) performance study was done. This type of study is relevant for AI/software devices. The device is a physical hip stem, and its performance is evaluated through mechanical bench testing, not algorithmic performance.

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

The "ground truth" for the nonclinical testing of the PROFEMUR® Preserve Sizes 1-3 Hip Stems was established by recognized international and national standards for orthopedic implants. Specifically:

• ISO 7206-4 for proximal fatigue.
• ASTM F2068 for distal fatigue.
• ISO 21535 for range of motion.

These standards define the test methodologies and acceptance criteria (e.g., number of cycles survived at a certain load without failure) against which the device's performance is measured.

8. The sample size for the training set:

This question is not applicable. There was no "training set" as this device is a mechanical implant subjected to nonclinical testing, not a machine learning or AI algorithm that requires training data.

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

This question is not applicable as there was no training set.

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