Search Results

The Klassic® Knee System is intended for prosthetic replacement of the following:

• · Patient conditions of non-inflammatory degenerative joint disease (NID); 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 indicated for cemented use only, except for the Klassic Femur, with Cobalt 3D®, the Klassic Tibial Baseplate with Ti-Coat®, and the Universal™ Cones with Ti-Coat® which are also indicated for cementless use.

The Klassic® Tibial Baseplate, Revision (Ti6Al4V) is being introduced as a line extension for use with the Klassic® Knee System during total knee arthroplasty.

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a medical device (Klassic Knee System - Revision Tibial Baseplate) and a summary of the device, its indications for use, and a discussion of non-clinical testing.

However, it does not include any details on:

1. Acceptance criteria and reported device performance in a table format.
2. Sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details for any clinical or performance studies.
3. Training set sample size or ground truth establishment for a machine learning model.

The document discusses non-clinical testing (e.g., fatigue analysis, modular interface fatigue testing, fretting corrosion analysis, MRI safety testing) and states that "Testing and engineering analyses showed that the subject components met the pre-determined acceptance criteria identified in the Design Control Activities." However, it does not specify what those acceptance criteria were or the precise performance metrics and their achieved values.

Therefore, I cannot fulfill your request based on the provided text.

Ask a specific question about this device

The Klassic Knee System is intended for prosthetic replacement in treatment of the following:

· Patient conditions of non-inflammatory degenerative joint disease (NIDJD): 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 indicated for cemented use only, except for the Klassic Femur with Cobalt 3D™, and the Klassic Tibial Baseplate with Ti-Coat®, which are indicated for cementless use.

The purpose of this 510(k) is to add Klassic® Knee CR/Congruent Tibial Inserts and Ultra-PS® Tibial Inserts, which are fabricated with E^X Poly, to the Klassic® Knee System. E^X Poly is a crosslinked UHMWPE containing alpha-tocopherol. The subject Klassic® Knee CR/Congruent and Ultra-PS® Tibial Inserts are available in various sizes and thicknesses to match patient anatomy.

The provided text is a 510(k) summary for the Klassic Knee System, focusing on the addition of new tibial inserts. It outlines the device description, indications for use, and a comparison to predicate devices, but it does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of AI/ML or diagnostic performance.

The document primarily describes the regulatory submission for a physical medical device (knee implants) and its substantial equivalence to previously cleared devices based on bench testing and engineering analyses for wear, stability, stress, range of motion, and modular disassembly. It does not mention any AI/ML components, digital image analysis, or diagnostic performance evaluation studies that would typically involve acceptance criteria for metrics like sensitivity, specificity, or AUC, or require a test set with ground truth established by experts.

Therefore, I cannot extract the requested information (1-9) from the provided text. The document is about a mechanical orthopedic implant, not a diagnostic AI/ML device.

Ask a specific question about this device

The Klassic® Knee System is intended for prosthetic replacement of the following:

• · Patient conditions of non-inflammatory degenerative joint disease (NID): 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 indicated for cemented use only, except for the Klassic Femur, Porous, and the Klassic Tibial Baseplate, Porous, which are indicated for cementless use.

The Klassic® Femur with Aurum®, is being introduced as a line extension for use with the Klassic® Knee System for cemented implantation during total knee arthroplasty. The Klassic® Femur with Aurum® is manufactured from Titanium alloy (Ti6Al4V per ASTM F136) with a titanium nitride surface.

The provided text is a 510(k) Premarket Notification for a Knee Joint Prosthesis (Klassic® Knee System). It details the device's indications for use, its classification, and a comparison to predicate devices, particularly focusing on a new line extension, the Klassic® Femur with Aurum®.

This document does not contain any information regarding AI/ML device performance testing, clinical studies with human readers, or ground truth establishment relevant to AI/ML systems. The "acceptance criteria" discussed are likely related to the mechanical and biocompatibility performance of the knee implant, not an AI/ML algorithm's diagnostic accuracy.

Therefore, I cannot provide an answer based on the prompt's request for AI/ML device performance without the presence of such information in the provided text.

The closest relevant sections in the provided text are:

• Non-Clinical Bench Testing and Engineering analyses: These were performed to evaluate the physical properties of the Klassic® Femur with Aurum® (e.g., strength of coating, fatigue, wear, stability, contact stress, range of motion, patella-femoral resistance). This refers to the mechanical integrity and function of the physical implant, not an AI algorithm.
• LAL testing requirements for orthopedic implants: This refers to Limulus Amebocyte Lysate testing for bacterial endotoxins, a biocompatibility test, not an AI algorithm's performance.

To answer your request, the input text would need to describe a study evaluating an AI/ML algorithm's performance, including details such as:

• Acceptance criteria for algorithm metrics (e.g., sensitivity, specificity, AUC).
• Test set characteristics (sample size, data provenance, image types).
• Ground truth establishment (number and qualifications of experts, adjudication methods).
• Human reader studies (MRMC design, effect sizes of AI assistance).
• Standalone algorithm performance.
• Training set details (sample size, ground truth methodology).

Ask a specific question about this device

The Klassic® Knee System is intended for prosthetic replacement 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 indicated for cemented use only, except for the Klassic® Femur with Cobalt 3D®, and the Klassic® Tibial Baseplate with Ti-Coat® which are indicated for cementless use.

The purpose of this Special 510(k) is to add the Klassic® Tibial Inserts, PS-Max®, an additional posterior stabilizing design option, to the Klassic® Knee System (K112906). The Klassic® Tibial Inserts, PS-Max® are available in various sizes and thicknesses to match patient anatomy and provide surgical options.

This submission describes the Klassic® Knee System Tibial Inserts, PS-Max®, a medical device intended for prosthetic replacement in knee arthroplasty. The submission is a Special 510(k), meaning it aims to add a new design option to an already cleared Klassic® Knee System (K112906). The primary goal is to demonstrate substantial equivalence to a predicate device, the Klassic® Tibial Inserts, PS-Post™ (K183596).

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

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the subject device met pre-determined acceptance criteria for various verification activities. However, it does not explicitly list the quantitative acceptance criteria or the specific reported device performance values in a table format within the provided text. It generally states that the device "met the pre-determined acceptance criteria" and that "the results of analysis and testing indicate that the subject tibial inserts are substantially equivalent to the predicate components."

The types of tests performed indicate the areas for which performance criteria would have been established:

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

The document does not provide details on the sample size used for the test set or the data provenance. It only mentions "Bench testing and engineering analysis were performed." This implies laboratory-based testing rather than clinical data from human subjects.

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

Not applicable. The study appears to be engineering and bench testing, not involving human expert assessment of a test set for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. The study focused on bench testing, which doesn't typically involve adjudication in the clinical sense.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document describes bench testing and engineering analysis, not a clinical MRMC study.

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

This question is not directly applicable as the device is a physical knee implant component, not a software algorithm. The "standalone" performance here refers to the physical properties of the insert as tested in a lab, separate from human implantation. The bench tests performed are essentially the "standalone" evaluation of the device's physical and mechanical characteristics.

7. The Type of Ground Truth Used

The "ground truth" for this type of device (physical implant) is established by engineering specifications, industry standards (e.g., LAL requirements), and comparative performance with a legally marketed predicate device. The tests performed (stability, contact stress, range of motion, wear, strength, fatigue, modular disassembly) are designed to assess these physical and mechanical properties against pre-defined engineering targets and the performance of the predicate.

8. The Sample Size for the Training Set

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

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

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

Ask a specific question about this device

The Klassic® Knee System is intended for prosthetic replacement of the following:

• Patient conditions of non-inflammatory degenerative joint disease (NIDJD): 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 indicated for cemented use only, except for the Klassic Femur, Porous, and the Klassic Tibial Baseplate, Porous, which are indicated for cementless use.

The Klassic® Knee System employs prostheses designed to help surgeons restore knee joint biomechanics intra-operatively. The purpose of this 510(k) is to add the posterior stabilizing Klassic® Knee Femur, PS-Post; Klassic Femoral Pegs; and the Klassic® Tibial Insert, PS-Post with Standard Poly; and the Klassic® Tibial Insert, PS-Post with E-Link® Poly; to the Klassic Knee System. The subject femoral and tibial components are available in various sizes and thicknesses to match patient anatomy.

The document provided is a 510(k) premarket notification letter from the FDA to Total Joint Orthopedics, Inc. regarding their Klassic Knee System. It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general controls and regulations. While it mentions that "All results met the predetermined acceptance criteria," it does not provide the specific acceptance criteria or the detailed study results that prove the device meets these criteria.

Therefore, I cannot extract the requested information from this document.

Missing Information:

• Detailed Acceptance Criteria: The document states that "All results met the predetermined acceptance criteria," but it does not list what those criteria are.
• Specific Device Performance Data: While it mentions types of engineering analysis and testing (e.g., Modular Peg Strength Analysis, Knee Simulator Wear, Tibial Insert Post Fatigue), it does not provide the reported performance values that resulted from these tests.
• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set Information): None of this detailed study information is present in the provided FDA letter. This type of information would typically be found in the 510(k) submission summary or a more detailed technical report, not in the FDA's clearance letter itself.

Ask a specific question about this device

The Klassic Knee System is intended for prosthetic replacement in treatment 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 indicated for cemented use only, except for the Klassic Femur with Cobalt 3D™, and the Klassic Tibial Baseplate with Ti-Coat®. which are indicated for cementless use.

The purpose of this 510(k) is to add size 5, 10mm Sombrero Patella components in Standard Poly and E-Link Poly to be used in conjunction with the Klassic® Knee System during total knee replacement. The components are manufactured from ultrahigh molecular weight polyethylene or Vitamin E blended ultrahigh molecular weight polyethylene with a 40mm diameter and 10mm thickness.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, focusing on the product submitted in K190280:

The document (K190280) describes a 510(k) submission for new sizes of patella components (size 5, 10mm Sombrero Patella in Standard Poly and E-Link Poly) to be added to the existing Klassic® Knee System. The primary method of demonstrating substantial equivalence is through engineering analyses and comparison to predicate devices that are already cleared.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not describe a clinical study with a "test set" in the traditional sense of patient data. Instead, it relies on engineering analyses and comparison to predicate devices. Therefore:

• Sample Size for Test Set: Not applicable as it's not a clinical study with patient data. The "test set" would be the specific physical components (size 5, 10mm Sombrero Patellae) that were subjected to the engineering analyses. The number tested is not specified but would typically be one or more samples per analysis to ensure consistency.
• Data Provenance: Not applicable as it's engineering analysis, not patient data from a specific country or collected retrospectively/prospectively. The analyses are performed on the device itself.

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

• Number of Experts: Not applicable. For engineering analyses, "ground truth" is established through engineering principles, material science, and regulatory standards, not by expert consensus on clinical images or outcomes.
• Qualifications of Experts: The analyses would be performed by qualified engineers or technicians with expertise in biomaterials, biomechanics, and medical device testing, but this is not a ground truth establishment by clinical experts.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no ambiguous patient data requiring adjudication. The results of the engineering analyses are typically objective measurements and calculations compared against established criteria or predicate device performance.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This is a medical device for knee replacement components, not an AI/imaging device.

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

• Standalone Performance Study: No, this is not an AI/algorithm-driven device. It's a physical orthopedic implant.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: The "ground truth" in this context refers to the established performance characteristics and safety profile of the predicate devices (size 1-4 Sombrero Patellae, K150105 & K180159), as well as established engineering and material science principles and regulatory standards for orthopedic implants. The new device components are deemed substantially equivalent if they meet these established engineering performance benchmarks or demonstrate comparable performance to the predicates.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not a machine learning or AI device that requires a "training set."

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

• Ground Truth for Training Set: Not applicable.

Ask a specific question about this device

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.

Ask a specific question about this device

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

• Patient conditions of non-inflammatory degenerative joint disease (NIDJD): 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 expand the size offerings of the Klassic® Knee System to include a Size 7 femoral component. These components are manufactured from Cobalt-Chromium Alloy.

This document is a 510(k) premarket notification for the Klassic® Knee System. It is primarily concerned with establishing substantial equivalence of an expanded size offering (Size 7 femoral component) to a previously cleared version of the same device. Therefore, it does not contain the detailed clinical study information typically provided for novel devices or AI/software-as-a-medical-device (SaMD) clearances.

Based on the provided text, here's what can be extracted and what information is not present:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document references "pre-determined acceptance criteria for the verification activities" but does not explicitly list what those criteria were (e.g., specific stress limits, acceptable range of motion, wear rates, etc.) or the detailed quantitative results for each.

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

• Not Applicable. This document describes a modification to a medical device (a knee implant) primarily based on engineering analyses rather than clinical study data involving patients. No "test set" of patient data is mentioned. The assessment is based on comparing the new size to existing sizes through engineering principles.

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

• Not Applicable. As above, no patient-based clinical "test set" requiring expert ground truth establishment is described. The evaluation is based on engineering analyses.

4. Adjudication Method for the Test Set:

• Not Applicable. No human adjudication of a clinical test set is relevant to this type of device modification submission.

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

• No. This document does not describe an MRMC study. Such studies are typically for evaluating diagnostic imaging or AI-assisted diagnostic tools, not for a physical implant modification directly.

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

• Not Applicable. This device is a physical knee implant, not an algorithm or software.

7. The Type of Ground Truth Used:

• Engineering principles and predicate device data. The "ground truth" for demonstrating substantial equivalence of the new femoral component size is rooted in established engineering analysis methods, material properties, and the performance characteristics of the previously cleared predicate Klassic® Knee System components.

8. The Sample Size for the Training Set:

• Not Applicable. This document does not describe a machine learning algorithm or an AI model, and therefore, there is no "training set" in this context.

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

• Not Applicable. See point 8.

In summary: This document is focused on demonstrating the substantial equivalence of a new size of a previously cleared knee implant through engineering analyses and comparison to a predicate device, rather than through a clinical study with patient data or an evaluation of an AI algorithm's performance. Therefore, many of the requested data points related to clinical efficacy, expert review, and AI model evaluation are not applicable or present in this specific regulatory submission.

Ask a specific question about this device

The Klassic™ Knee System is intended for prosthetic replacement with the use of bone cement in treatment 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 18mm Ultra-PS and 18mm CR/Congruent tibial inserts to the Klassic™ Knee System. These components are manufactured from ultrahigh molecular weight polyethylene and each is available in 6 sizes.

This 510(k) pertains to adding new tibial inserts (18mm Ultra-PS and 18mm CR/Congruent) to an existing Klassic™ Knee System. The document focuses on demonstrating that these new components are substantially equivalent to the previously cleared components and meet the required performance criteria. Therefore, the information provided isn't a typical study demonstrating a device's clinical performance, but rather an engineering evaluation for new component additions.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "The information summarized in the Design Control Activities Summary demonstrates that the 18mm Ultra-PS and 18mm CR/Congruent tibial insert met the pre-determined acceptance criteria for the verification activities." However, the specific acceptance criteria and detailed performance results are not provided in this summary document. The summary only generally states that engineering analyses were performed to evaluate "resistance to modular disassembly and stability characteristics."

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

The document describes "engineering analyses" performed on the new tibial inserts. This implies a laboratory-based, in-vitro testing scenario, not a study involving human subjects or real-world clinical data.

• Sample Size for Test Set: Not explicitly stated as a numerical value for "samples". It refers to "the 18mm Ultra-PS and 18mm CR/Congruent tibial inserts" and "the previously cleared tibial inserts." This suggests that the analyses were performed on representative physical components or their digital models.
• Data Provenance: Not applicable in the context of clinical data. The analyses are engineering-based, likely performed in a controlled laboratory environment by the manufacturer or a contracted lab. The document does not specify a country of origin for the data beyond the manufacturer's location in Salt Lake City, UT, USA.
• Retrospective or Prospective: Not applicable as this is an engineering analysis, not a clinical study.

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

• Number of Experts: Not applicable. Ground truth in this context would be defined by engineering specifications, material properties, and biomechanical principles, not expert clinical consensus.
• Qualifications of Experts: Not applicable. The analyses are based on engineering principles.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This is an engineering verification, not a clinical study requiring adjudication of observations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No. This is not a clinical imaging or diagnostic device requiring an MRMC study. It's an orthopedic implant.
• Effect Size: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: Not applicable. This device is a physical orthopedic implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

• Type of Ground Truth: Engineering specifications, material science principles, biomechanical testing standards, and previously established performance benchmarks for the predicate devices. The "ground truth" is defined by the physical and mechanical properties required for a safe and effective knee implant component.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. There is no mention of machine learning or an "algorithm" being trained in this 510(k). The evaluation is based on engineering analyses of physical components.

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

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set mentioned in this context.

Ask a specific question about this device

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

• · Patient conditions of non-inflammatory degenerative joint disease (NIDJD): 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 Sombrero Patella component will be used in conjunction with the Klassic Knee System during total knee replacement. The component is manufactured from ultrahigh molecular weight polyethylene in four diameters and two thicknesses.

This is a 510(k) premarket notification for a medical device called the "Klassic Knee System," specifically discussing the Sombrero Patella component. 510(k) submissions don't typically include a study of device performance against acceptance criteria in the way a clinical trial or AI/software validation would. Instead, they focus on demonstrating substantial equivalence to a legally marketed predicate device.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth for test/training sets) are not applicable to the information provided in this 510(k) summary.

However, I can extract the information relevant to the preclinical testing and the determination of substantial equivalence.

Here's a breakdown of the available information in the requested format, with an emphasis on what is and isn't applicable for a 510(k) submission of this type:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable in the traditional sense of a clinical or performance study. This is a 510(k) submission relying on preclinical engineering analyses and comparison to predicate devices, not a test set of patient data.
• The "test set" here would refer to the designs and materials of the Sombrero Patella and the predicate devices being physically and/or computationally analyzed. The document doesn't specify a numerical "sample size" for these analyses.
• Data Provenance: The analyses were performed internally by the manufacturer (TJO - Total Joint Orthopedics). This is preclinical, in-house engineering data.

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

• Not Applicable. The "ground truth" for a 510(k) of this nature is substantial equivalence to a predicate device based on material, design, and performance characteristics (evaluated through engineering analyses, not expert consensus on patient outcomes). The experts involved would be the engineers and regulatory professionals conducting the analyses and preparing the submission. No external panel of clinical experts is described for determining a "ground truth" for a test set.

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

• Not Applicable. Adjudication methods are typically used in clinical trials or studies with human readers/raters where a consensus or tie-breaking mechanism is needed. This submission focuses on engineering analysis.

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 mechanical knee implant, not an AI/software device. MRMC studies are completely irrelevant in this context.

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

• Not Applicable. This is a mechanical knee implant, not an algorithm or software. Standalone performance as described is irrelevant.

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

• The "ground truth" for this 510(k) is the established safety and effectiveness profile of the predicate devices (Klassic Knee Domed Patella (K112906) and Zimmer Natural Knee All Polyethylene Patella (K934695)). The new device is considered "substantially equivalent" if it meets similar performance characteristics as demonstrated by engineering analyses. There is no mention of pathology or clinical outcomes data for this specific submission for the Sombrero Patella.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of a 510(k) mechanical device submission. This concept applies to machine learning algorithms.

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

• Not Applicable. As there is no training set, this question is not relevant.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" or justification for the Klassic Knee System's Sombrero Patella component meeting acceptance criteria is primarily a demonstration of substantial equivalence to two legally marketed predicate devices: the Klassic Knee Domed Patella (K112906) and the Zimmer Natural Knee All Polyethylene Patella (K934695).

This demonstration was achieved through preclinical engineering analyses. These analyses directly compared the Sombrero Patella to the previously cleared TJO Domed Patella in terms of:

• Contact stress
• Mechanical strength

The submission also asserts substantial equivalence based on similarities in:

• Intended use
• Material (ultrahigh molecular weight polyethylene)
• Geometry
• Method of fixation

The conclusion drawn from these analyses and comparisons (which are summarized in a "Design Control Activities Summary" not provided in full) was that "the Sombrero Patella met the pre-determined acceptance criteria for the verification activities" and is "substantially equivalent to the predicate devices." The FDA's review of this submission resulted in a determination of substantial equivalence, allowing the device to be marketed.

Ask a specific question about this device