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Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
Collagen disorders, and/or avascular necrosis of the femoral condyle.
Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
Moderate valgus, varus, or flexion deformities.
The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
This device is intended for cemented use only.

Device Description

The Zimmer® Persona™ Personalized Knee System is a semi-constrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial and patellar bones. The Persona Knee System utilizes a modular design between the tibial plates and articular surfaces.

AI/ML Overview

This document describes the non-clinical performance testing for the Zimmer® Persona™ Personalized Knee System, a semi-constrained modular knee prosthesis. Since this is a medical device (knee implant) rather than an AI/software device, many of the requested fields (multi-reader multi-case study, ground truth establishment, training set details) are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for each test are implicitly demonstrating "sufficient" or "adequate" strength/wear/constraint, or being "comparable" to predicate devices. The "Test Results" column describes how the device performance met these implicit criteria.

Property or Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
Fatigue Test of the Persona Tibia Keel and Stem Extension	Sufficient fatigue strength to survive expected worst-case loading conditions.	Demonstrated that the Persona tibia keel and stem extension taper junction provide sufficient fatigue strength to survive expected worst-case loading conditions.
Cantilever Fatigue Test of the Persona Cemented Tibia	Adequate fatigue strength in the cantilever loading condition.	Demonstrated adequate fatigue strength in the cantilever loading condition.
Wear Testing of Persona CR Conventional Articular Surfaces Under Load and Motion Curves From the ISO 14243 Standard	Sufficient wear characteristics to survive expected in-vivo loading conditions.	Demonstrated that the wear characteristics of the Persona CR articular surfaces, when articulated against the Persona CR femoral component, are sufficient to survive expected in-vivo loading conditions.
Wear Testing of Persona PS Conventional UHMWPE Articular Surfaces Under Load and Motion Curves from the ISO 14243 Standard	Sufficient wear characteristics to survive expected in-vivo loading conditions.	Demonstrated that the wear characteristics of the Persona PS articular surfaces, when articulated against the Persona PS femoral component, are sufficient to survive expected in-vivo loading conditions.
Wear Testing of Persona UC Conventional UHMWPE Articular Surfaces Under Displacement Control with Load and Motion Curves from the ISO 14243-1 Standard	Sufficient wear characteristics to survive expected in-vivo loading conditions.	Demonstrated that the wear characteristics of the Persona UC articular surfaces, when articulated against the Persona CR femoral component, are sufficient to survive expected in-vivo loading conditions.
Spine Fatigue Evaluation of the Persona PS Conventional UHMWPE Articular Surfaces	Sufficient strength to survive expected in-vivo stress/strain loading conditions.	Demonstrated that the spine of the Persona PS articular surfaces has sufficient strength to survive expected in-vivo stress/strain loading conditions.
Tibiofemoral Constraint Evaluation of the Persona Conventional UHMWPE Articular Surface	Constraint values comparable to similar NexGen articular surfaces to provide adequate constraint through needed tibiofemoral flexion angles.	Demonstrated that constraint values for the Persona articular surfaces are comparable to data from similar NexGen articular surfaces. Therefore, the Persona articular surfaces provide adequate constraint through the needed tibiofemoral flexion angles.
Lateral Constraint Evaluation of the Persona Conventional All-Poly Patellar Component on the Persona CR and PS Femoral Components	Lateral subluxation force comparable to control testing on NexGen predicate devices.	Demonstrated that the lateral subluxation force of the Persona conventional all-poly patellar component on the Persona CR and PS femoral implants at tibiofemoral flexion angles 0° to 90° was comparable to control testing on NexGen predicate devices.
Tibiofemoral Contact Area and Contact Pressure Evaluation of the Persona CR/UC/PS Conventional Articular Surfaces	Contact area and contact pressure comparable to previous testing on similar NexGen articular surfaces.	Demonstrated that the contact area and contact pressure of the Persona articular surfaces are comparable to data from previous testing on similar NexGen articular surfaces.
Contact Area and Contact Stress Evaluation of the Persona Conventional All-Poly Patellar Component on the Persona Primary CR and PS Femoral Components	Contact areas similar between CR and PS femoral components for all flexion angles.	Demonstrated that, for all flexion angles, the contact areas were similar between the CR and PS femoral components.
Anterior Liftoff Testing of the Persona Articular Surfaces	Sufficient locking mechanism strength to survive potential worst-case anterior liftoff loading conditions during deep flexion.	Demonstrated sufficient locking mechanism strength to survive potential worst-case anterior liftoff loading conditions during deep flexion.
Posterior Liftoff Fatigue Strength of the Persona Articular Surfaces	Sufficient locking mechanism strength to survive potential worst-case shear loading conditions.	Demonstrated sufficient locking mechanism strength to survive potential worst-case shear loading conditions.
Assembly Testing of the Persona Tibia Locking Mechanism	Successful assembly of the modular articular surfaces at normal and maximum interference conditions.	Demonstrated successful assembly of the modular articular surfaces at normal and maximum interference conditions.
Static Shear Strength of the Persona Tibia Locking Mechanism	Adequate resistance of the modular articular surfaces to disassembly.	Demonstrated adequate resistance of the modular articular surfaces to disassembly.

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

The document does not explicitly state the sample sizes for each mechanical test. These "tests" are non-clinical (laboratory-based mechanical and wear simulations) rather than using patient data. Therefore, the concept of "data provenance" (country of origin, retrospective/prospective) is not applicable here as these are not studies involving human subjects or patient data.

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

Not applicable. This is a medical device, not an AI/software device that requires expert ground truth for its performance evaluation. The "ground truth" for these tests is based on established engineering principles, industry standards (e.g., ISO 14243), and comparison to predicate devices, not expert human interpretation.

4. Adjudication Method for the Test Set

Not applicable. As described above, this is non-clinical mechanical testing, not a clinical study requiring human 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

Not applicable. This is a physical medical device (knee implant), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and the concept of "human readers improving with AI assistance" are not relevant.

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

Not applicable. As this is not an AI/software device, the concept of a "standalone algorithm" is not relevant. The device itself (the knee implant) is the "standalone" item being tested in these non-clinical performance studies.

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:

Industry Standards: For instance, wear testing was conducted "Under Load and Motion Curves From the ISO 14243 Standard."
Established Engineering Principles: Tests like fatigue, static shear strength, and contact mechanics rely on well-known engineering material and biomechanical principles.
Predicate Device Performance: Many tests established comparability to existing, legally marketed predicate devices (e.g., NexGen articular surfaces, NexGen predicate devices). The performance of these predicate devices, which have a history of safe and effective use, serves as a benchmark or "ground truth" for acceptable performance.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device (knee implant), not a machine learning or AI algorithm. There is no concept of a "training set" for the device itself.

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

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

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K Number

K110950

Device Name

CONSENSUS KNEE SYSTEM

Manufacturer

CONSENSUS ORTHOPEDICS, INC.

Date Cleared

2011-06-27

(84 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K073286,K070214,K932837,K954818,K962215,K001456,K983004,K102927

Intended Use

The CONSENSUS® KNEE SYSTEM Primary Knee is designed as a system and is not intended for substitution of components from other systems.

A. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis.
B. Failed osteotomy or unicompartmental replacements.
C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
D. The porous coated (CoCr beads with Titanium) components may be used with or without cement.

Device Description

The Consensus Total Knee System (CKS) is a primary fixed-bearing total knee system that has been on the market since the mid-1990's.

The CKS has been designed to replicate the natural anatomy of the knee in order to restore knee function. It has been developed to preserve and utilize healthy ligamentous structures. For cases where the soft tissues are not functional, the PCL substituting tibial inserts or the posterior stabilized system are available for increased stability.

The CKS incorporates femoral, tibial, and patellar components and all associated instrumentation needed for implantation. The CKS can be used for total knee replacement with posterior cruciate ligament (PCL) retaining or substituting.

The femoral components are provided in left and right side versions and are designed to replicate natural kinematic motion between the femur, tibia and patella. The Consensus femoral component is designed to provide uniform contact zones in the coronal plane throughout the range of motion when the knee is properly aligned. The femoral component is also designed with a large distal radius to optimize contact areas and reduce contact stress. The trochlear groove in the femur is designed to allow the load from the patella to be evenly distributed on the femur with adequate lateral constraint.

The CKS metallic components are available in non-porous and porous coated variants for cemented use and in a porous coated (CoCr beads with Titanium) version for uncemented use.

AI/ML Overview

This document describes the non-clinical performance data for the Consensus® Knee System Line Extensions. The data focuses on material properties and mechanical performance rather than AI or human reader studies.

Here's the breakdown of the requested information based on the provided text, with an emphasis on addressing the relevant sections and noting where information is not applicable:

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

Specification	Acceptance Criteria	Verification Results
Porous Coating: CoCr beads with Ti coating
Microstructure of the modified surface	N/A (Detailed parameters are reported, no specific acceptance criteria)	Bead to Bead Neck Diameter 0.33 mm
Pore Size 0.432 mm
Volume % Porosity 37%
Coating Thickness 0.889 mm
Corrosion of the modified surface	Equal to or improved corrosion resistance when compared with CoCr beads using ASTM F746 & G61	Critical Potential Breakdown Potential
CoCr Beads 1290 mV 1200 mV
Ti Coated CoCr Beads 1315 mV 1200 mV
Static tensile strength	The static tensile strength will exceed 20 MPa.	Static Tensile Strength of 58.32 MPa
Static shear strength	The static shear strength will exceed 20 MPa.	Static Shear Strength of 58.32 MPa
Shear fatigue strength	The shear fatigue strength will exceed 10 million cycles.	10 million cycles achieved with a strength of 13.78 MPa
Rotating beam fatigue strength	The rotating beam fatigue strength will exceed 10 million cycles.	10 million cycles achieved with a strength of 206.7 MPa
Excessive abrasion	N/A (Results are reported, no specific acceptance criteria defined)	200N load: Avg. mass loss 0.006 g; Avg. thickness loss 6%
1500N load: Avg. Mass loss 0.179 g; Avg. thickness loss 23%
RLP Femoral Components
Articulating surface of the RLP components	Similar contact area and surface stress distributions.	RLP had the same contact area as the original CKS. The PS RLP matches the articulating surface of the RLP.
Size 0 Tibial Base Plate and Insert
Size 0 tibial baseplate/insert assembly push-in/push-out force	Similar push-in/push-out loads when compared with existing baseplate/insert combinations.	Minimum push-out load was 428 lbs with failure mode being deformation of anterior snap recess in poly insert; Similar to other insert/baseplate combinations. Components can be easily inserted by hand.
Thicker Tibial Insert
Insert thickness per FDA Guidance Jan. 16, 2003	Insert thickness must be >6mm.	Insert thickness was greater than 6mm.
Porous Coated Metal Backed Patella
Articulating surface of the porous coated metal backed patella	Identical articulating surface.	Articulating surface of the porous coated metal backed patella is identical to existing patella.
Mating geometry between the UHMWPE and metal back of the porous coated metal backed patella	Identical mating geometry.	The mating geometry of the porous coated metal backed patella is identical to the existing metal backed patella.

The remaining information requested is largely not applicable (N/A) to this specific type of device and study. The provided document describes a 510(k) submission for line extensions of a knee prosthetic system, focusing on non-clinical performance data related to material properties, mechanical strength, and design conformity. It does not involve any AI, diagnostic imaging, or human reader performance studies.

Here's an explanation for each point:

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: The document does not specify a "sample size" in the context of clinical trials or data sets for an AI model. For mechanical testing, the number of samples tested for each specification is not explicitly stated, although it's implied that multiple samples were tested to achieve "Avg. mass loss," etc.
Data Provenance: N/A. This is non-clinical mechanical and material testing, not data collected from human subjects or from a specific geographical origin. It's likely laboratory testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

N/A. This study does not involve expert evaluation for establishing ground truth as it's not a diagnostic or AI-based device. The "ground truth" here refers to the physical properties and performance metrics measured in a lab setting according to established standards.

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

N/A. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes, which is not the case here.

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

N/A. This is not an AI-assisted diagnostic or interpretation device.

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

N/A. This device does not involve any algorithm or AI requiring standalone performance evaluation.

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

The "ground truth" for this device's performance is based on objective engineering and material science standards and measurements. This includes:
- ASTM standards (e.g., F746 & G61 for corrosion).
- Pre-defined mechanical thresholds (e.g., static tensile strength > 20 MPa, fatigue strength > 10 million cycles).
- Physical design specifications (e.g., "Identical articulating surface," "Insert thickness must be >6mm").

8. The sample size for the training set

N/A. There is no AI or machine learning model, so no training set is applicable.

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

N/A. As there is no training set, this question is not applicable.

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K Number

K102927

Device Name

CONSENSUS KNEE SYSTEM

Manufacturer

Consensus Orthopedics, Inc

Date Cleared

2011-01-26

(114 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K051229,K030623,K033489,K073286,K070214,K001456,K983004

Intended Use

The CONSENSUS® KNEE SYSTEM Primary Knee is designed as a system and is not intended for substitution of components from other systems.

A. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis.
B. Failed osteotomy or unicompartmental replacements.
C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
D. The porous coated (CoCr beads with Titanium) femoral and tibial components may be used with or without cement.

Device Description

The Consensus Total Knee System (CKS) is a primary fixed-bearing total knee system that has been on the market since 1990's.

AI/ML Overview

Here's an analysis of the provided text, focusing on acceptance criteria and the study proving device performance:

Acceptance Criteria and Device Performance for Consensus® Knee System (K102927)

This submission (K102927) is primarily to expand the indications for the already cleared Consensus® Knee System (CKS) porous-coated components to allow for uncemented use. The non-clinical performance data provided specifically addresses the porous coating's mechanical and chemical properties, demonstrating its suitability for this expanded use.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document includes a clear table outlining the specifications, acceptance criteria, and verification results for the modified surface (porous CoCr bead with Ti coating).

Specification	Acceptance Criteria	Verification Results
Microstructure of the modified surface	N/A	Bead to Bead Neck Diameter: 0.33 mm
		Pore Size: 0.432 mm
		Volume % Porosity: 37%
		Coating Thickness: 0.889 mm
Corrosion of the modified surface (shall be equal or less than that measured in a legally marketed device)	Equal to or improved corrosion resistance when compared with CoCr beads using ASTM F746 & G61	Critical Potential (CoCr Beads): 1290 mV; Breakdown Potential: 1200 mV
		Critical Potential (Ti Coated CoCr Beads): 1315 mV; Breakdown Potential: 1200 mV
Modified surface shall exhibit adequate static tensile strength	The static tensile strength will exceed 20 MPa.	Static Tensile Strength: 58.32 MPa
Modified surface shall exhibit adequate static shear strength	The static shear strength will exceed 20 MPa.	Static Shear Strength: 58.32 MPa
Modified surface shall exhibit adequate shear fatigue strength	The shear fatigue strength will exceed 10 million cycles.	10 million cycles achieved with a strength of 13.78 MPa
Modified surface shall exhibit adequate rotating beam fatigue strength	The rotating beam fatigue strength will exceed 10 million cycles.	10 million cycles achieved with a strength of 206.7 MPa
Modified surface shall not exhibit excessive abrasion	N/A	200N load: Avg. mass loss 0.006 g, Avg. thickness loss 6%
		1500N load: Avg. Mass loss 0.179 g, Avg. thickness loss 23%

Note: For microstructure and abrasion, the "Acceptance Criteria" are listed as "N/A" in the table, indicating these are descriptive measurements rather than pass/fail thresholds in this summary. However, the reported values are provided as verification results. For corrosion, the results for both CoCr beads and Ti Coated CoCr Beads demonstrate a comparable or improved resistance against the breakdown potential.

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

The document describes non-clinical performance data which typically involves laboratory testing of materials and components, not clinical data from patients. Therefore, terms like "test set" in the context of patient data, "country of origin of the data," or "retrospective/prospective" studies are not applicable here.

The sample sizes for the mechanical and corrosion tests are not explicitly stated in this summary. It's common in such submissions for the detailed test reports (which would include sample sizes, testing methodologies, and raw data) to be referenced but not fully reproduced in the 510(k) summary. These tests are performed on material coupons or device components in a laboratory setting.

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

This question is not applicable to this submission. The "test set" here refers to material samples or device components tested in a lab. The "ground truth" is established by direct physical and chemical measurements (e.g., measuring dimensions, applying forces, assessing corrosion) using standardized test methods (like ASTM standards mentioned). Therefore, human expert consensus on image interpretation or clinical outcomes is not relevant for this type of non-clinical data.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human experts when establishing ground truth, typically in clinical studies or image review. Since this involves non-clinical laboratory testing, there is no human adjudication process of this nature.

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

No MRMC study was done. This type of study assesses how human readers' diagnostic performance changes with and without AI assistance, which is irrelevant for a submission concerning the material properties and expanded uncemented use of a knee implant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No standalone algorithm performance study was done. This typically refers to the performance of an AI algorithm on its own. The Consensus® Knee System is a medical device (a knee implant), not an AI algorithm.

7. Type of Ground Truth Used

The ground truth used for this non-clinical performance data is direct physical and chemical measurement against predefined specifications and ASTM standards. This includes:

Physical dimensions and morphology (e.g., bead neck diameter, pore size, coating thickness).
Electrochemical properties (e.g., critical potential, breakdown potential for corrosion resistance).
Mechanical properties (e.g., static tensile strength, static shear strength, shear fatigue strength, rotating beam fatigue strength, mass and thickness loss from abrasion).

8. Sample Size for the Training Set

This question is not applicable. There is no AI model or algorithm being trained within the scope of this 510(k) submission. The data presented are for validating the material properties of the porous coating.

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

This question is not applicable, as there is no training set mentioned or implied in the context of this device submission.

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