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510(k) Data Aggregation
(22 days)
The Freedom® Total Knee System is indicated for the following:
- Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
- Correction of functional deformities.
- Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, or prior patellectomy.
- Moderate valgus, varus, or flexion trauma.
- Knee fractures untreatable by other methods.
- Revision surgery where sufficient bone stock and soft tissue integrity are present (For PCK Components and Primary PCK Components only).
The Freedom® Total Knee System – Titanium Tibial Base Plate is intended for cemented and single use only.
The Freedom® Total Knee System is comprised of a femoral component, all-poly tibial component, patellar component, tibial base plate and tibial articular surface. The Freedom® Total Knee System's Femoral Component is offered as different versions such as stemmed PCK design, primary PCK, cruciate retaining, posterior stabilizing. The Freedom® Total Knee System's Tibial Base Plate is offered with stemmed design and without stemmed design. The Freedom® Total Knee System was originally cleared under the 510(k) number K082019. Later on, several modifications were made and were cleared under 510(k)s K091280, K192148, K090411, K182574, K131481, K111785 and K200912 respectively.
The primary purpose of this special 510(k) Device Modification to the Freedom® Metal Backed Tibial Component (K090411) is to notify the FDA of the change in materials used to manufacture the tibial base plate from CoCrMo to Wrought Titanium-6Aluminium-4Vanadium ELI Alloy (Ti6Al4V ELI, ASTM F136-13) as an alternative material option for the tibial base plate.
The Titanium Tibial Base Plate is fabricated from Titanium alloy Ti-6Al-4V ELI, compliant with ASTM F136 and is intended for cemented application to replace the articulating surface of the proximal tibia in a measured resection technique.
The Titanium Tibial Base Plates are available in 8 different sizes (1 to 8) based on Anterior/Posterior (A/P) and Medial/Lateral (M/L) dimensions.
This 510(k) clearance letter pertains to a Class II medical device, specifically the Freedom® Total Knee System - Titanium Tibial Base Plate (K251717). The submission is a special 510(k) Device Modification, indicating that the changes made to the device are well-defined and do not significantly alter the indications for use or raise new questions of safety and effectiveness.
The core change is the material of construction for the tibial base plate, shifting from CoCrMo to Wrought Titanium-6Aluminium-4Vanadium ELI Alloy (Ti-6Al-4V ELI). The design, geometry, surfaces, and locking features remain identical to the previously cleared predicate device (K090411).
Therefore, the acceptance criteria and the study proving the device meets these criteria primarily focus on mechanical performance and biocompatibility related to this material change, rather than extensive clinical efficacy studies or comparative effectiveness studies involving human readers, as would be typical for AI/software devices.
Acceptance Criteria and Reported Device Performance
Given the nature of this submission (a material change for an orthopedic implant with identical design), the acceptance criteria are not explicitly numerical thresholds like sensitivity/specificity, but rather involve demonstrating mechanical equivalence to the predicate device and biocompatibility of the new material.
Here's a table summarizing the implicit acceptance criteria based on standard regulatory requirements for such a device modification, and how the document indicates they were met:
| Acceptance Criteria Category | Specific Criteria (Implicit from Submission Type) | Reported Device Performance (as per 510(k) Summary) |
|---|---|---|
| Mechanical Performance | The Titanium Tibial Base Plate must demonstrate equivalent or superior mechanical integrity and fatigue resistance compared to the predicate device to ensure durability and prevent failure under intended physiological loads. | Met. "The design, geometry, surface features, locking features and dimensional attributes of the Titanium Tibial Base Plate are identical to those of the previously cleared Freedom® Metal Backed Tibial Base Plate (K090411)." |
| "Hence, to evaluate the device function and performance for its intended use, the Freedom® Titanium Tibial Base Plate was subjected to the following mechanical tests:Tibial Tray Fatigue Testing per ASTM F1800Range of Motion & Modular disassembly testing was leveraged from the reference device (K090411) as the subject device uses an identical tibial insert locking mechanism." | ||
| Material Biocompatibility | The new material (Ti-6Al-4V ELI) must be biocompatible and not elicit adverse biological responses (e.g., toxicity, sensitization, irritation) when implanted in the human body. | Met. "Biocompatibility testing is not required for the subject Titanium Tibial Base Plate device, because the material, Ti-6Al-4V ELI Titanium Alloy is compliant with ASTM F136, is a well-established material with a long history of safe use in orthopedic implants." |
| "This material has been used extensively for many years without any major biocompatibility related safety concerns." | ||
| "Additionally, the material has been used in multiple components of Maxx Orthopedics' previously cleared Freedom® Total Knee System…" | ||
| "It also complies with the biocompatibility requirements outlined in 'Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA'". | ||
| "Furthermore, Ti-6Al-4V ELI Titanium Alloy (ASTM F136) has also been used in similar tibial base plate components from other legally marketed devices, intended for same anatomical location and patient contact type, as demonstrated in K220737." | ||
| "A risk-based assessment, following the principles outlined in FDA's 2023 Biocompatibility guidance (Use of ISO 10993-1), confirms that the material change does not introduce new types of patient contact, contact duration, or clinical use conditions that would require additional biocompatibility testing." | ||
| Equivalence in Design/Function | The device design must be substantially equivalent to the predicate, with any minor differences not raising new safety or effectiveness concerns. | Met. "The design, geometry, surface features, locking features and dimensional attributes of the Titanium Tibial Base Plate are identical to those of the previously cleared Freedom® Metal Backed Tibial Base Plate (K090411)." |
| "There are no significant technological differences between the subject and predicate device. The subject device uses a similar design and dimensions, geometry and sizing, and achieves its intended use in an identical manner as the primary predicate and both devices are manufactured using similar subtractive manufacturing techniques." | ||
| Sterilization Method (Minor Change) | If the sterilization method changes, its effectiveness must be validated. | Addressed. "Minor differences in subject device are that it uses different materials of constructions and sterilization method that are addressed via performance testing and similarity to the secondary predicate devices (K241597)." While not explicitly detailed, the mention implies this was covered. |
Study Details (Relevant to Orthopedic Implants, Not AI)
The provided text describes a submission for an orthopedic implant and does not involve an AI/software component, nor does it detail a clinical study with human patients for AI performance evaluation. Therefore, many of the requested points regarding sample sizes for test/training sets, expert readers, ground truth for AI, MRMC studies, etc., are not applicable to this type of device clearance and are consequently not found in the document.
However, based on the information provided, here's what can be inferred/stated:
-
Sample size used for the test set and data provenance:
- Test Set: Not applicable in the context of clinical AI performance data. For mechanical testing (ASTM F1800), standard test methods specify the number of samples required (e.g., minimum of 6 samples for fatigue per ASTM F1800-97), but the exact number used in this specific submission is not reported in the summary.
- Data Provenance: Not applicable for AI performance data. For material and design, the device is manufactured by Maxx Orthopedics Inc. (Norristown, PA, USA) and Meril Healthcare Pvt. Ltd. (Vapi, Gujarat, India).
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Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- Not applicable as this is a mechanical and material modification, not an AI diagnostic device requiring expert interpretation of images for ground truth.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable for the type of device/study described.
-
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 type of study (MRMC, AI assistance) is not relevant or performed for this device. The submission is for a physical orthopedic implant with a material change.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as there is no algorithm or AI component in this device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the mechanical testing, the "ground truth" would be the engineering specifications and performance of the predicate device, alongside adherence to international standards (e.g., ASTM F1800).
- For biocompatibility, the "ground truth" is established long-term clinical use data, compliance with ASTM F136 (Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI Alloy for Surgical Implant Applications), and prior FDA clearances of devices using this material.
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The sample size for the training set:
- Not applicable (no AI training set).
-
How the ground truth for the training set was established:
- Not applicable (no AI training set).
In summary, the FDA clearance for K251717 as a special 510(k) is based on demonstrating that the new Titanium Tibial Base Plate is mechanically equivalent to its predicate and that the new material is biocompatible and has a well-established history of safe use in similar orthopedic applications. The regulatory review focuses on engineering performance criteria and material biocompatibility rather than clinical performance data from patient studies or AI algorithm validation.
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(255 days)
The Freedom® Total Knee System is indicated for the following:
• Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Correction of functional deformities.
• Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, or prior patellectomy.
• Moderate valgus, varus, or flexion trauma.
• Knee fractures untreatable by other methods.
• Revision surgery where sufficient bone stock and soft tissue integrity are present (For PCK Components and Primary PCK Components only).
The Freedom® Porous Tibial Base Plate and Cementless Femoral Components are indicated for Cemented or Uncemented use. All other components are indicated for cemented use only.
The Freedom® Porous Tibial Base Plate is a line extension of the Freedom® Total Knee System comprising of tibial base plate components for cemented or uncemented use in total knee arthroplasty. Freedom® Porous Tibial Base Plates are intended for use with existing, compatible Freedom® femoral and tibial liner components. Freedom® Porous Tibial Base Plates are additively manufactured from Ti-6Al-4V ELI Grade 23 and include a porous lattice structure on the distal face. Freedom® Porous Tibial Base Plates are available in eight asymmetric design offerings (Sizes 1 – 8, Left / Right configurations), based on anterior / posterior (A/P) and medial / lateral (M/L) dimensions.
The provided document is a 510(k) premarket notification for a medical device, specifically the Freedom® Total Knee System - Porous Tibial Base Plate. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a de novo clinical study with strict acceptance criteria and performance analysis. Therefore, the information requested about acceptance criteria and a study proving the device meets them, typically found in a clinical trial report or a performance study for novel devices or software, is not directly applicable in the same way.
However, I can extract the information related to the non-clinical performance testing conducted to support the substantial equivalence claim. This testing serves as the "study" demonstrating that the device performs as intended and is similar to the predicate.
Here's an interpretation 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" for each test in the way a clinical trial might. Instead, the "acceptance" is implicitly defined by demonstrating that the subject device's performance is substantially equivalent to established performance standards or the predicate/reference devices. The "reported device performance" is summarized as the satisfactory completion of these tests.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Tibial Tray Fatigue: Device must withstand fatigue loading per ASTM F1800. | All necessary testing performed. (Implies satisfactory performance meeting the standard). |
| Residual Particle Characterization: Device must meet acceptable levels of residual particles per ASTM F1877, comparable to literature. | Results were shown to be substantially equivalent to values presented in the literature for the reference device (K030623). |
| Porous Surface Characterization: Porous structure must meet specifications for various characteristics per ASTM F1854, F1160, F1044, F1978, F1147. | All necessary testing performed. (Implies satisfactory performance meeting the standards). |
| Sterilization: Device must achieve a sterility assurance level (SAL) of 10^-6 per ISO 11137-2. | Sterilization per ISO 11137-2. (Implies successful sterilization to the required SAL). |
| Endotoxin: Device must meet acceptable endotoxin levels per AAMI ST72. | Endotoxin per AAMI ST72. (Implies acceptable endotoxin levels). |
| Biocompatibility: Device materials must be biocompatible per ISO 10993-1, ISO 10993-5. | Biocompatibility per ISO 10993-1, ISO 10993-5. (Implies successful demonstration of biocompatibility). |
| Modular Disassembly: If applicable, modular components must meet disassembly force requirements (leveraged from reference device). | Modular disassembly testing was leveraged from the reference device (K090411) as the subject device uses an identical tibial insert locking mechanism. (Implies that the design similarity ensures equivalent performance without new testing). |
2. Sample sized used for the test set and the data provenance
- Sample Size: The document does not specify the exact number of implants or test coupons used for each non-clinical test (e.g., how many tibial trays were fatigue tested). It mentions that "All testing was performed on worst case implants or test coupons as dictated by the relevant performance standards."
- Data Provenance: The tests are non-clinical (laboratory/mechanical testing), not human clinical data. Thus, terms like "country of origin" or "retrospective/prospective" are not applicable. The data originates from laboratory testing conducted by or for the manufacturer (Maxx Orthopedics, Inc.).
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. The "test set" here refers to physical specimens (implants/coupons) for non-clinical testing, not patient data requiring expert interpretation or ground truth establishment. The "ground truth" for these tests is defined by the technical specifications and requirements of the referenced ASTM and ISO standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the tests are non-clinical, mechanical, and material evaluations performed against established standards, not clinical data requiring adjudication by experts.
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
This is not applicable. The device is a physical knee implant, not an AI software or diagnostic tool used by human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical knee implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance tests, the "ground truth" is defined by the technical specifications and requirements outlined in the referenced ASTM and ISO standards. For example, the acceptable number of cycles for fatigue testing is defined by ASTM F1800. For residual particles, the "ground truth" is the acceptable range established in the literature for the reference device, as evaluated against ASTM F1877.
8. The sample size for the training set
This is not applicable. The device is a physical knee implant. There is no "training set" in the context of machine learning or AI. The manufacturing process is validated, and the device's design is based on engineering principles and existing predicate designs, not a data-driven training set.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated above.
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(70 days)
The Opulent TiNbN Coated Knee is indicated for the following:
· Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, traumatic arthritis, and polyarthritis.
· Correction of functional deformities.
- · Post-traumatic loss of knee join contour, particularly when there is patellofemoral erosion, dysfunction, and/or prior patellectomy.
- Moderate valgus, varus, or flexion trauma.
- · Knee fractures untreatable by other methods.
- · Revision surgery where sufficient bone and soft tissue integrity are present.
The Opulent TiNbN Coated Knee is intended for cemented use only. This device is for single use only.
The Opulent TiNbN Coated Knee comprises of a Femoral Component and Tibial Component as described below,
- Femoral Knee Component CR and PS (Left and Right) ●
- Tibial Component (Tibial Base Plate) ●
Each of these components is described below. These components are compatible with previously cleared components of the Destiknee Total Knee System (e.g., patellae, tibial inserts).
I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets acceptance criteria. The document is an FDA 510(k) clearance letter and a 510(k) summary for a knee prosthesis called "Opulent TiNbN Coated Knee."
This type of document primarily focuses on demonstrating substantial equivalence to a predicate device, as opposed to a detailed clinical study demonstrating meeting specific performance acceptance criteria for a novel device. While it mentions non-clinical performance data and mechanical tests, it doesn't provide specific acceptance criteria values or the detailed results of a study designed to prove the device meets those criteria in the context of the questions you've asked (e.g., sample size for test/training sets, expert ground truth establishment, MRMC studies, effect sizes, standalone performance).
The information provided includes:
- Device Name: Opulent TiNbN Coated Knee
- Regulation Number: 21 CFR 888.3560 (Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis)
- Regulatory Class: Class II
- Product Code: JWH
- Predicate Device: Freedom® - TiNbN Coated Knee (K200912) from Maxx Orthopedics Inc., USA, and Destiknee Total Knee System (K160771 and K172936) from Meril Healthcare Pvt. Ltd.
- Device Description: Comprises Femoral and Tibial Components, made of Cobalt-Chromium-Molybdenum (Co-Cr-Mo) coated with Titanium Niobium Nitride (TiNbN).
- Indications for Use: Severe knee joint pain, loss of mobility, disability due to various arthritis types, correction of functional deformities, post-traumatic loss of knee joint contour, moderate valgus/varus/flexion trauma, knee fractures untreatable by other methods, and revision surgery. Intended for cemented use only, single use.
- Comparison of Technological Characteristics: Stated to be substantially equivalent to the predicate device with same indications, design, materials, packaging, surgical implantation technique, intended use, TiNbN coating, and sterilization method.
- Non-clinical Performance Data: Mentions mechanical tests performed on TiNbN coating (Wear Resistance, Coating Chemical Composition, Coating Thickness, Coating Hardness, Coating Adhesion Strength, Roughness, Metal Ion Analysis) and leveraged mechanical tests from predicate devices (Tibial-Femoral Contact Area Stress and Surface Stress Testing, Tibial-Femoral Constraint Testing, Range of motion analysis, Patello-Femoral Lateral Subluxation, Patello-Femoral Contact Area Stress and Surface Stress Testing, Tibial Tray Locking Mechanisms Testing, Finite Element Analysis of Tibial Tray, Tibial base plate component fatigue testing, Tibial Post Fatigue Strength).
Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, ground truth, expert review, MRMC studies, or training data for a typical AI/software device evaluation, as this document pertains to a mechanical knee implant and a substantial equivalence review for a 510(k) clearance.
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(147 days)
The Freedom® Total Knee Cruciate Retaining (CR) Femoral Component consists of a cobalt-chromium molybdenum (CoCrMo) femoral component designed to be used with the Freedom® Total Knee System, and the Freedom® Total Knee Metal Backed Tibial Components. The Freedom Total Knee System is indicated for the following:
- Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
- Correction of functional deformities,
- Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, and/or prior patellectomy.
- Moderate valgus, varus, or flexion trauma.
- Knee fractures untreatable by other methods
The Freedom® Total Knee Cruciate Retaining (CR) Femoral Component is intended for cemented use only. This device is for single use only.
The Maxx Orthopedics' Freedom® CR Femoral Component is compatible with the Maxx Orthopedics Freedom® Total Knee System subject of K082019 and the Metal Backed Tibial Component subject of K090411. The Maxx Orthopedics' Freedom® Total Knee System subject of K082019 is comprised of a femoral component, tibial component and patella component.
The proposed Freedom® CR Femoral Component consist of a cobalt-chromium molybdenum (CoCrMo) component that is designed to be used with the Freedom® Total Knee System described in K082019 and the Freedom Metal Backed Tibial Component subject of K090411. The Maxx Orthopedics' Freedom® Total Knee System subject of K082019 is comprised of a femoral component (posterior stabilizing), an all-poly tibial component, and a patellar component. The Freedom Metal Backed Tibial Component subject of K090411 consists of a metal backed tibial component and polyethylene insert. The proposed CR Femoral Component will provide the surgeon with an alternative femoral component in the event that the surgeon prefers to use a CR component rather than the PS component with the Freedom® Total Knee System. In addition, a second metal backed tibial component was cleared for use with the Freedom Total Knee System under K090411. The proposed CR Femoral Component and a (UHMWPE) insert will be used in place of the PS Femoral component with the Freedom® Total Knee System.
The CR Femoral Component of the Freedom® Total Knee System CR is designed to replace the articulating surface of the distal femur. The cruciate retaining femoral component is utilized when total knee replacement is indicated, and accommodates the posterior cruciate ligament if it is present.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) summary for a medical device (Freedom® Total Knee Cruciate Retaining (CR) Femoral Component) and focuses on describing the device, its intended use, and its substantial equivalence to predicate devices, along with some general information about performance testing.
Specifically, the document states:
- "Mechanical and functional testing described in K082019, K090411 and in Section 8 demonstrates that the Freedom® CR Femoral Component are mechanically and functionally similar to the parent Freedom UHMWPE Tibial Component and other legally marketed knee systems."
- "Evaluations were performed to determine the material and mechanical characteristics of the Maxx Orthopedics' Freedom® CR Femoral Component and the Freedom® Total Knee System according to the Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Fernorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA."
- "The verification and validation testing have been performed which demonstrate that the CR Femoral Component functions as intended and is safe and effective for its intended use."
However, it does not provide:
- A table of specific acceptance criteria.
- Reported device performance against those criteria.
- Details about sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for software/AI components. This is likely because the device is a physical knee implant, not a software or AI-driven diagnostic/treatment tool.
Therefore, I cannot provide the requested table and information.
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