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510(k) Data Aggregation
(260 days)
Consensus Knee System with TiNbN
The indications for use are:
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 non-porous (uncoated, coated with CoCr beads without Titanium, and uncoated with a TiNbN overcoat) components may only be used with cement
E. The porous coated (CoCr beads with Titanium) components may be used with or without cement
The femoral implants are provided in left and right-side versions and designed to replicate the natural anatomy of the femur. They are available in a single variant only - CR, with sizes ranging from 1 to 6. The femoral implants have a R.P design, which offers surgeon an option for patients where a more minimal anatomic design is preferred. The femoral implants are manufactured using cast CoCrMo alloy (ASTM F75). A monolayer of TiNbN coating (thickness: 3 to 7 microns) is applied to the femoral implants.
The tibial baseplates are provided in left and right-side versions and designed to replicate the natural anatomy of the tibial baseplates are available in three variants – holed, pegged, and pegless, with sizes ranging from 0 to 6. The tibial baseplates are manufactured using cast CoCMo alloy (ASTM F75). A monolayer of TiNbN coating (thickness: 3 to 7 microns) is applied to the entire surface of the tibial baseplates.
The provided text describes the regulatory clearance for the "Consensus Knee System with TiNbN" and discusses its substantial equivalence to predicate devices, primarily focusing on the addition of a TiNbN coating. However, this document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria related to AI/software performance.
The text is a 510(k) summary for a medical device (knee prosthesis), which focuses on demonstrating substantial equivalence to existing devices. The "tests" mentioned are non-clinical, primarily material and mechanical tests (biocompatibility, wear performance, fatigue, range of motion) conducted for the physical implant and its new coating, not for any AI or software component.
Therefore, I cannot provide the requested information, as the input document does not contain details about:
- Acceptance criteria for AI/software performance.
- A study validating AI/software performance.
- Sample sizes for test sets (in the context of AI/software).
- Expert involvement in establishing ground truth for AI/software.
- Adjudication methods for AI/software test sets.
- MRMC studies.
- Standalone AI algorithm performance.
- Types of ground truth for AI/software.
- Training set sample sizes or ground truth establishment for an AI/software component.
The document is about a physical medical device (a knee implant), not an AI/software device.
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(65 days)
Consensus Knee System Modular Tibial Baseplate
The CONSENSUS® KNEE SYSTEM Primary Knee is designed as a system and is not intended for substitution of components from other systems.
The indications for use are:
- 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 non-porous (uncoated and coated with CoCr beads without Titanium) components may only be used with cement.
- E. The porous coated (CoCr beads with Titanium) components may be used with or without cement.
The Consensus Knee System (CKS) modular tibial baseplate is a non-porous (uncoated), anatomic, fixed-bearing design made from cast CoCrMo (ASTM F75). Its boss-and-fin type keel employs a modular 12/14 female taper for assembly with Consensus Revision Knee System (RKS) stems or the RKS taper plug. The CKS modular baseplate is offered in pegged, pegless, and holed configurations. Holed configurations are supplied with preassembled cement dams manufactured from UHMWPE (ASTM F648). All configurations are supplied with a distal plug intended for assembly in the operating room when stems are not desired. Distal plugs are manufactured from UHMWPE (ASTM F648). Other components compatible with the CKS modular baseplate include all CKS tibial inserts, femoral components, and patella components; all RKS femoral components; and the 6.5mm cancellous bone screw used with CKS holed baseplates.
This document is a 510(k) premarket notification for the "Consensus Knee System Modular Tibial Baseplate." It demonstrates the device's substantial equivalence to previously marketed devices rather than providing a study demonstrating the device meets a set of acceptance criteria in the typical sense of a clinical trial for an AI/CAD product.
Therefore, the requested information elements related to AI/CAD system performance (e.g., sample size for test set, experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this regulatory submission.
However, I can extract the closest analogous information regarding the evaluation of this medical device.
1. A table of Acceptance Criteria and the Reported Device Performance:
The document describes non-clinical performance data (bench testing) to verify the device's safety and effectiveness. The "acceptance criteria" are implied by the standards used for testing (ASTM F1800-12) and the stated objective to ensure no failure or involuntary dislocation.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Baseplate Tray Region: No failure under fatigue when fully supported by its lateral compartment (per ASTM F1800-12). | Tested per ASTM F1800-12 to ensure the tray would not fail under fatigue when fully supported by its lateral compartment. (Specific results like load cycles or maximum load are not provided in this summary, but the general statement implies successful testing.) |
| Keel and Taper Connection: No failure under fatigue when fully supported by an intramedullary stem (per ASTM F1800-12). | Tested per ASTM F1800-12 to verify that the keel would not fail under fatigue when fully supported by an intramedullary stem. (Specific results not provided, but implies successful testing.) |
| Distal Plug Dislocation: Resists involuntary dislocation from the keel. | Tested to ensure it would resist involuntary dislocation from the keel. (Implies successful resistance.) |
| Distal Plug Insertion/Extraction: Manual insertion and extraction possible in the operating room using available instrumentation. | Tested to ensure it could be manually inserted and extracted in the operating room using available instrumentation. (Implies successful functionality.) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: Not specified in terms of clinical cases or patient data, as this is bench testing. For bench testing, "sample size" would refer to the number of device components tested, which is not detailed in this summary.
- Data Provenance: Non-clinical bench testing. The country of origin of testing is not specified, but the device is manufactured by a US-based company (Consensus Orthopedics, Inc., El Dorado Hills, California).
- Retrospective/Prospective: Not applicable. This is non-clinical bench 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):
Not applicable. Ground truth in this context refers to the physical properties and performance of the device component itself, evaluated through engineering tests, not interpretation by medical experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. This refers to the adjudication of clinical outcomes or diagnostic interpretations, not bench testing results.
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 conventional medical device, not an AI/CAD system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a conventional medical device, not an AI/CAD system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's evaluation is derived from engineering specifications and the established performance standards of ASTM F1800-12 for fatigue testing, as well as functional testing for the distal plug's retention and operability.
8. The sample size for the training set:
Not applicable. This is a conventional medical device, not an AI/CAD system.
9. How the ground truth for the training set was established:
Not applicable. This is a conventional medical device, not an AI/CAD system.
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(84 days)
CONSENSUS KNEE SYSTEM
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.
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.
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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(114 days)
CONSENSUS KNEE SYSTEM
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.
The Consensus Total Knee System (CKS) is a primary fixed-bearing total knee system that has been on the market since 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.
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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(90 days)
CONSENSUS KNEE SYSTEM
The Consensus® Knee System and the CoCr/Ti porous or CoCr nonporous tibial baseblate is design for use as a system, and is not intended for substitution with components of other systems. This device is intended for cemented use only. The indications for use are:
- Primary intervention of rheumatoid arthritis, osteoarthritis, post traumatic arthritis or degenerative arthritis.
- Failed osteotomy or unicompartmental replacements.
- Replacement of unsatisfactory cemented or press fit knee components, if sufficient bone stock exists.
Tibial Baseplate, Cast, CorCr/Ti Porous and CoCr Non-Porous
I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance. The document is an FDA 510(k) clearance letter for a tibial baseplate, indicating that the device is substantially equivalent to previously marketed devices. It outlines the indications and contraindications for use, but does not include any performance metrics, study designs, or data related to acceptance criteria.
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