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The Klassic® Knee System is intended for prosthetic replacement with the use of bone cement of the following:

• · Patient conditions of non-inflammatory degenerative joint disease (NIDID): avascular necrosis and osteoarthritis
• Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis
• · Patients with failed previous surgery where pain, deformity, or dysfunction persists
• · Correctable varus-valgus deformity and moderate flexion contracture
• · Revision of a previously failed knee arthroplasty
• · Patients who require a total knee replacement

The Klassic® Knee System is a cemented total knee joint replacement system comprised of modular components with varying sizes available for each component. The purpose of this Special 510(k) is to add All-Poly Tibias, CR/Congruent and All-Poly Tibias, Ultra-PS® to the Klassic Knee System. These components are manufactured with ultrahigh molecular weight polyethylene (UHMWPE). The CR/Congruent and Ultra-PS® A11-Poly Tibias are available in sizes to match various patient anatomies.

This document is an FDA 510(k) premarket notification for a medical device, the Klassic® Knee System. This type of document is a regulatory submission to demonstrate that a device is substantially equivalent to a legally marketed predicate device, not typically a study report designed to "prove" a device meets specific acceptance criteria in the way a clinical trial or performance study would. It focuses on engineering analyses and comparisons to predicate devices for safety and effectiveness.

Therefore, the requested information elements related to clinical studies, ground truth establishment, expert review, sample sizes for test and training sets, and MRMC studies are largely not applicable or not present in this type of regulatory filing. The "acceptance criteria" here refer to the engineering performance criteria used to demonstrate substantial equivalence, not clinical performance metrics.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not applicable for a clinical test set. The submission refers to "Engineering analyses" for mechanical performance. These analyses would typically involve simulated testing (e.g., finite element analysis, structural testing) rather than a clinical "test set" of patients.
• Data Provenance: The analyses are based on engineering principles and relevant standards for orthopedic implants, likely conducted by the manufacturer or a contract lab. Specific countries of origin are not mentioned, but the submission is to the U.S. FDA. The data is pre-market verification.

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

• Not applicable. This document describes engineering verification testing, not a clinical study requiring expert ground truth establishment for a diagnostic output.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for interpretation of results by multiple readers. This document outlines engineering test results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done including effect size of improvement with AI vs without AI assistance

• Not applicable. This device is a total knee replacement system, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance is irrelevant here.

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

• Not applicable. This is a physical medical device (knee implant), not an algorithm or software. "Standalone performance" in this context would refer to the mechanical performance of the implant itself, which is what the engineering analyses assess.

7. The Type of Ground Truth Used

• Engineering Standards and Predicate Device Performance: The "ground truth" for this type of submission is typically established by recognized engineering standards (e.g., ISO, ASTM for orthopedic implants) and the established performance and safety profile of the legally marketed predicate devices. The new device's engineering performance is compared against these benchmarks to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

• Not applicable. This document does not describe the development of an algorithm or AI model that would require a "training set."

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

• Not applicable. As there is no training set for an algorithm, this question is not relevant.

In summary: This FDA 510(k) summary focuses on demonstrating that a modified knee implant system is substantially equivalent to existing predicate devices through engineering analyses and material compliance, rather than presenting a clinical study with detailed patient data, expert reviews, or AI performance metrics.

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This device is indicated for patients with severe knee pain and disability due to:

• 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.

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.

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.

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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Spacer-K is indicated for use as a temporary total knee replacement (TKR) for skeletally mature patients undergoing a two-stage procedure due to a septic process. Spacer-K is only indicated for an implantation period of 180 days or less. Because of the inherent mechanical limitations of the device material (gentamicin/polymethylmethacrylate), Spacer-K is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period.

The Spacer-K is a temporary device that mimics a "total knee prosthesis". The twocomponent unconstrained design incorporates a femoral and a tibial component. The device is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) bone cement. The device is supplied sterile to an assurance level (SAL) of 10-6

The provided text does not contain information about acceptance criteria or a study proving the device meets them. Instead, it is a 510(k) premarket notification for a medical device (Tecres Spacer-K, a temporary knee prosthesis).

The document mainly focuses on:

• Administrative Information: Applicant/Consultant, Manufacturer, Date, Contact Person.
• Classification Information: Classification name, product code, CFR section, device class, classification panel, trade/proprietary names.
• Substantial Equivalence: Comparison to a legally marketed predicate device ("Natural Knee" - K936159).
• Device Description: Two-component unconstrained design (femoral and tibial), made of gentamicin/PMMA bone cement, supplied sterile.
• Indications for Use: Temporary total knee replacement (TKR) for skeletally mature patients undergoing a two-stage procedure due to a septic process, for an implantation period of 180 days or less, with consistent use of mobility assist devices due to mechanical limitations.
• Contraindications: A comprehensive list of conditions under which the device should not be used.
• FDA Clearance Letter: Confirmation of substantial equivalence and permission to market.

Therefore, I cannot provide a table of acceptance criteria and device performance, nor details about a study evaluating these criteria, as this information is not present in the provided text.

The document is a regulatory submission for premarket clearance, which typically establishes substantial equivalence to a predicate device rather than presenting detailed performance studies against specific acceptance criteria.

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The general indications associated with the use of Patellofemoral Joint Prosthesis in patellofemoral arthroplasty include:

• 1. Patients with osteoarthritis in the distal femur and patella.
• Patients with a history of patellar dislocation or patellar 2. fracture.
• 3. Those patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release, etc.) where pain, deformity or dysfunction persists.

The design of the Patellofemoral Joint Prosthesis closely replicates the anatomic features of the patellar groove on a femur. In addition, the design of the highly polished concave gliding anterior surface of the Patellofemoral Joint Prosthesis is identical to the proximal anterior surface of the articulating geometry of the Natural Knee II System's femoral component which has been determined substantially equivalent by the FDA via 510(k) K936159. The highly polished concave gliding surface of the Patellofemoral Joint Prosthesis complements the design of the articulating geometry of the IOI's patella components for optimal patellar tracking.

The posterior surface of the Patellofemoral Joint Prosthesis employs two fixation pegs for enhanced stability of the prosthesis when cemented into the femur. In addition, the posterior surface of the Patellofemoral Joint Prosthesis employs a grit blasted roughened surface to facilitate interdigitation with bone cement. The roughness of the grit blasted surface ranges from 175 - 225 uinch.

The Patellofemoral Joint Prosthesis is an asymmetrically designed component and, therefore, is available in both left and right configurations.

This document is a 510(k) premarket notification for a medical device submitted in 1996. It outlines the device's characteristics and compares them to predicate devices to establish substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) notice explicitly states that the device's safety and effectiveness are established through substantial equivalence to predicate devices, rather than through specific performance metrics and acceptance criteria from a clinical study. The "performance" here refers to the device's features and materials matching or being similar to those of previously approved devices.

Study Proving Acceptance Criteria:

The study proving the device meets the "acceptance criteria" (i.e., substantial equivalence) is the 510(k) Premarket Notification itself, which acts as a regulatory submission. It does not describe a clinical performance study with specific acceptance criteria that were met with statistical significance. Instead, it argues that the device is "substantially equivalent" to legally marketed predicate devices based on design, materials, and intended use.

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

This document does not describe a clinical test set with human subjects. The "test" is a comparison of the device's specifications and design features against those of predicate devices. There is no sample size of patients or data provenance in the context of a clinical study.

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

Not applicable. The "ground truth" for this 510(k) submission is the pre-existing regulatory approval and market presence of the predicate devices. There were no experts used to establish ground truth for a clinical test set in this context.

4. Adjudication Method for the Test Set:

Not applicable. There was no clinical test set requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This submission focuses on engineering and design comparisons for substantial equivalence, not clinical effectiveness studies comparing human readers or AI.

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

Not applicable. This is a physical medical device (prosthesis), not an algorithm or AI system.

7. The Type of Ground Truth Used:

The "ground truth" used in this context is the existence and regulatory approval of the predicate devices. The argument for the new device's safety and effectiveness is based on its similarity to these already-approved devices, assuming their safety and effectiveness are established. There is no pathology, expert consensus (in the context of clinical outcomes), or outcomes data presented for the new device itself to establish ground truth.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device requiring a training set. The "training" for this device's development would be engineering design principles and knowledge of existing prostheses.

9. How the Ground Truth for the Training Set was Established:

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

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