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The Balanced Knee® System High Flex PS is intended for use in cemented total knee arthroplasty procedures.

Total knee arthroplasty is indicated for the following conditions:

1. Loss of knee joint configuration and joint function.
2. Osteoarthritis of the knee joint.
3. Rheumatoid arthritis of the knee joint.
4. Post-traumatic arthritis of the knee joint.
5. Valgus, varus, or flexion deformities of the knee joint.
6. Revision procedures where other treatments or devices have failed.

The Balanced Knee System High Flex PS (High Flex PS) is designed to accommodate increased range of motion up to 150° of flexion. The High Flex PS includes a highly polished Co-Cr-Mo PS femoral component and a compression molded UHMWPE PS tibial insert component. The High Flex PS femoral and insert components may be used in conjunction with the Balanced Knee System (BKS) standard and modular tibial trays, tibial augments, stems, and patellae to complete the semi-constrained modular knee prosthesis.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Balanced Knee System High Flex PS, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

This document describes a 510(k) premarket notification for a medical device (a knee replacement prosthesis). The "Performance Data" section primarily focuses on mechanical testing results rather than clinical study data from a "test set" of patients.

• Test Set Sample Size: Not applicable in the context of clinical patient data. The sample sizes for the mechanical tests (e.g., number of components tested for fatigue) are not specified in the provided summary.
• Data Provenance: Not applicable for patient data. The "Performance Data" describes laboratory mechanical testing of the device components.

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

Not applicable. As described above, this document refers to mechanical testing for device performance, not clinical studies requiring expert-established ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable. This is not a clinical study involving human readers or expert consensus for adjudication.

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

No. This document does not mention or describe a multi-reader multi-case (MRMC) comparative effectiveness study. It focuses on the mechanical equivalence of a knee prosthesis to predicate devices.

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 prosthesis), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to established engineering and biomechanical principles, and the performance characteristics of predicate devices. The device's performance is compared against:

• Mechanical benchmarks: Sufficient strength for in-vivo loading for fatigue tests.
• Predicate device characteristics: Similarity in range of motion, constraint, and contact areas to the Balanced Knee System (BKS) and LPS-Flex predicate devices.

8. The Sample Size for the Training Set

Not applicable. This document pertains to a physical medical device and its mechanical testing, not a machine learning model requiring a training set.

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

Not applicable. As this is not a machine learning context, there is no "ground truth for the training set." The performance
evaluation relies on mechanical testing against defined standards and comparison with predicate device characteristics.

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The Balanced Knee System Revision Offset Tibia is indicated for use in total knee arthroplasty procedures, for cemented use only.

Total knee arthroplasty is indicated for the following conditions:

1. Loss of joint configuration and joint function.
2. Osteoarthritis of the knee joint.
3. Rheumatoid arthritis of the knee joint.
4. Post-traumatic arthritis of the knee joint.
5. Valgus, varus, or flexion deformities.
6. Revision procedures where other treatments or devices have failed.

The proposed Balanced Knee System Revision Offset Tibia is a modular system intended for primary and revision knee surgery. It consists of an offset tibial tray, adapter, screw, and stem. All components are machined from titanium alloy (Ti-6Al-4V ELI).

The provided text is a 510(k) summary for a medical device (Balanced Knee System Revision Offset Tibia) and it details the regulatory process and claims of substantial equivalence. However, it does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the way described in the request.

The document discusses:

• Mechanical testing: "Mechanical testing shows that the Balanced Knee System Revision Offset Tibia can withstand anticipated in vivo loading and cycling."
• Tests for substantial equivalence: "The Tests for substantial equivalence include Tibial Tray fatigue and progressive static load mechanical tests, as well as assembly and disassembly tests."

These statements indicate that some form of testing was performed, likely to demonstrate the mechanical integrity and durability of the device in comparison to predicate devices. However, the document does not provide quantitative acceptance criteria or the reported device performance against such criteria. It also lacks details on:

• Sample size used for the test set or data provenance.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone performance study.
• Type of ground truth used.
• Sample size for the training set (as this is a mechanical device, not an AI/algorithm-based one).
• How ground truth for the training set was established.

Therefore, I cannot populate the requested table and information as the provided text does not contain these specific details. The 510(k) process for this type of device relies on demonstrating substantial equivalence to existing legally marketed devices, primarily through engineering principles, material compatibility, and mechanical performance testing, rather than clinical efficacy studies with expert consensus or AI performance metrics.

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The Ortho Development Balanced Knee® System is indicated for patients suffering from severe knee pain and disability. Specific indications include femoral, tibial and patellar replacement due to:

1. Loss of joint configuration and joint function.
2. Osteoarthritis of the knee joint.
3. Rheumatoid arthritis of the knee joint.
4. Post-traumatic arthritis of the knee joint.
5. Valgus, varus, or flexion deformities.
6. Revision procedures where other treatments or devices have failed.

The Balanced Knee® System is indicated in the salvage of previously failed surgical attempts where femoral bone loss does not require the use of augments or stem extensions and where collateral ligaments may be relied upon for medial/lateral (M/L) stability.

The Balanced Knee System Ultracongruent Tibial Insert may be used in conjunction with the Balanced Knee System CR femorals, standard and modular tibial trays, tibial augments, stems, and patellae. The Ultracongruent Tibial Insert has an anterior lip and tighter anterior curvature to stabilize the knee in the anterior direction and are snap fitted into the tibial trays and locked in place by mating features, the circumferential rim of the tray, and tabs on the anterior and posterior sides. The Ultraconqruent Tibial Insert is available in seven sizes to fit the majority of patients encountered. The sizes match each size of the Balanced Knee System tibial trays cleared under Premarket Notifications K994370, K020383, and K031201. The insert is symmetric, not left/right specific. It is supplied in thicknesses of 7, 8, 9, 10, 11, 12, 13. 14. 16. 18. and 20mm.

Materials: The device is manufactured from Compression Molded Ultra High Molecular Weight Polyethylene (UHMWPE, ASTM F-648).

Function: The system functions to provide restoration of function as a replacement for diseased and arthritic knees.

The provided text does not contain specific acceptance criteria or detailed study results that would allow for the construction of a table with reported device performance or a comprehensive description of a study as requested. The document is a 510(k) summary for a medical device (Balanced Knee System® Ultracongruent Tibial Insert) and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed performance study with acceptance criteria.

The key information regarding performance testing is as follows:

• Performance Testing: "The Food and Drug Administration have established no performance standards applicable to the Ultracongruent Tibial Insert, however biomechanical testing and analysis of the device was performed with results included as part of the submission. Clinical data and conclusion were not needed for this device."
• Basis for substantial equivalency: "Testing met all acceptance criteria and verifies that the performance of the Ultracongruent Tibial Insert is substantially equivalent in design, function, material and intended use to the predicate devices."

Based on the available information, I can only provide a limited response:

Acceptance Criteria and Study Details for K090705: Balanced Knee System® Ultracongruent Tibial Insert

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state specific numerical acceptance criteria or detail the reported device performance. It only states that "Testing met all acceptance criteria." Therefore, a table detailing these cannot be created from the provided text. The submission relied on biomechanical testing and analysis to demonstrate substantial equivalence, rather than specific performance standards established by the FDA for this device type.

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

The document mentions "biomechanical testing and analysis," but does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the submission states that "Clinical data and conclusion were not needed for this device." This implies that the evaluation for substantial equivalence did not rely on human expert interpretation of clinical outcomes or images to establish a 'ground truth' in the way a diagnostic AI device would. The evaluation focused on engineering and material characteristics.

4. Adjudication Method

This information is not applicable for the same reasons as point 3.

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

An MRMC comparative effectiveness study was not conducted as this is a knee implant device, not a diagnostic imaging or AI-assisted interpretation device that would involve human readers.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study of an algorithm was not conducted as this is a physical medical device (knee implant), not a software algorithm.

7. Type of Ground Truth Used

The "ground truth" for the biomechanical testing would have been based on established engineering and material science principles and physical measurements/simulations of the device's performance against defined parameters (e.g., strength, durability, wear resistance) compared to predicate devices. It was not clinical, pathological, or outcomes data in the traditional sense for a diagnostic device.

8. Sample Size for the Training Set

This is not applicable as there is no mention of an algorithm or machine learning model that would require a training set.

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

This is not applicable as there is no mention of an algorithm or machine learning model.

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The Ortho Development Balanced Knee™ Tibial Tray Pegged is indicated for patients suffering from severe knee pain and disability. Specific indications include femoral, tibial and patellar replacement due to degenerative bone disease such as rheumatoid arthritis or osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyles, pseudo-gout, or complications from a previous prosthesis. This device is intended for cemented use only.

The Balanced Knee™ Tibial Tray Pegged is intended for single use in primary total knee replacement only. Indications include:

• Loss of joint configuration and joint function; .
• Osteoarthritis of the knee joint; .
• Rheumatoid arthritis of the knee joint; .
• Post-traumatic arthritis of the knee joint; ♥
• Moderate valgus, varus, or flexion deformities.

The Ortho Development Balanced Knee™ Tibial Tray Pegged serves as an additional option to the tibial tray configurations currently offered in the Ortho Development Balanced Knee™ System, K994370, which include the tibial tray nonporous and the tibial tray porous.

The devices are manufactured from forged Ti-6AI-4V ELI alloy and coated with CP Materials: Titanium per ASTM standards.

The Tibial Tray Pegged functions to provide restoration of function as a replacement for Function: diseased and arthritic knees as part of the Ortho Development Balanced Knee™ System.

The provided document is a 510(k) premarket notification for a medical device (Ortho Development Balanced Knee™ Tibial Tray Pegged). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a new, comprehensive study to establish specific performance acceptance criteria from scratch.

Therefore, the document does not contain the kind of direct clinical study data, acceptance criteria, or performance evaluation that would typically be found for novel device approvals or AI/software-as-a-medical-device (SaMD) clearances.

However, I can extract information related to the device's characteristics and how its equivalence was "proven" for its specific regulatory pathway.

Here's a breakdown based on the information provided, outlining what is and isn't available:

Description of Acceptance Criteria and the Study that "Proves" Device Meets Them

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) submission, "acceptance criteria" are primarily related to demonstrating substantial equivalence to a predicate device across various technological characteristics. Performance is assessed through comparison to the predicate, rather than against independent, pre-defined metrics.

Regarding aspects typically relevant to AI/SaMD studies:

2. Sample size used for the test set and the data provenance:

• This document describes a medical device (implant) and not an AI or software product. Therefore, there is no "test set" of data or data provenance in the context of an algorithm or model evaluation. The "test" is a regulatory comparison to a predicate device.

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

• Not applicable. There is no "ground truth" establishment in this context, as it's a hardware device comparison.

4. Adjudication method for the test set:

• Not applicable.

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, as this is not an AI/software product.

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 product.

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

• Not applicable. The "ground truth" for this submission is the safety and effectiveness of the legally marketed predicate device, to which the new device is compared for substantial equivalence.

8. The sample size for the training set:

• Not applicable. This is not an AI/software product.

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

• Not applicable. This is not an AI/software product.

Summary for this specific document:

The Ortho Development Balanced Knee™ Tibial Tray Pegged met its "acceptance criteria" by demonstrating substantial equivalence to an already legally marketed predicate device (the Balanced Knee™ System). This "study" was primarily a comparison of technological characteristics (design, materials, manufacturing, biocompatibility, pyrogenicity, sterility, and intended use) between the new device and the predicate. No clinical studies or AI algorithm evaluations were performed or deemed necessary for this specific 510(k) pathway, as explicitly stated: "Clinical data and conclusion were not needed for this device."

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The Ortho Development Balanced Knee™ System is indicated for patients suffering from severe knee pain and disability. Specific indications include femoral, tibial and patellar replacement due to degenerative bone disease such as rheumatoid arthritis or osteoarthritis. primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyles, pseudo-gout, or complications from a previous prosthesis. This device is intended for cemented use only.

The Balanced Knee™ System is intended for single use in primary total knee replacement only. Indications include:

• Loss of joint configuration and joint function: ●
• Osteoarthritis of the knee joint;
• Rheumatoid arthritis of the knee joint; .
• Post-traumatic arthritis of the knee joint; .
• . Moderate valgus, varus, or flexion deformities.

The Ortho Development Balanced Knee™ System is a semi-constrained total knee replacement system, consisting of femoral, tibial and patellar components.

• The devices are manufactured from CoCr alloy (cast or Wrought), Ti-6Al-4V alloy Materials: and Ultra High Molecular Weight Polyethylene (UHMWPE) per ASTM standards,
• The system functions to provide restoration of function as a replacement for Function: diseased and arthritic knees.

This document is a 510(k) premarket notification for the Ortho Development Balanced Knee™ System. It focuses on establishing substantial equivalence to previously marketed devices rather than presenting a de novo study with acceptance criteria and test results. Therefore, much of the requested information about device performance against acceptance criteria and study details is not present in this document.

Here's an analysis of the provided text in relation to your questions:

1. Table of acceptance criteria and the reported device performance:

This document does not report specific acceptance criteria or quantitative device performance metrics. The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use, technological characteristics, and performs as safely and effectively as the predicate. It does not typically involve setting novel performance acceptance criteria or conducting de novo clinical studies to prove these. Instead, it relies on comparison to existing devices.

2. Sample size used for the test set and the data provenance:

Not applicable. This document does not describe a "test set" in the context of performance testing with human subjects or a dataset for AI. It's a regulatory submission for a medical device.

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

Not applicable. This document does not pertain to establishing ground truth for a test set, as no such test set (in the AI/clinical study sense) is described.

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

Not applicable. No test set or adjudication method is described.

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 document describes a knee replacement system, not an AI or imaging diagnostic device that would typically undergo MRMC studies.

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

Not applicable. This is a physical medical device, not an algorithm.

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

Not applicable. No ground truth is established in this document, as it is a regulatory submission for substantial equivalence.

8. The sample size for the training set:

Not applicable. This document does not describe an AI device or a training set for an algorithm.

9. How the ground truth for the training set was established:
Not applicable. As above, no training set is described.

Summary of Relevant Information from the Document:

• Device Type: Ortho Development Balanced Knee™ System (semi-constrained total knee replacement system).
• Purpose of Submission: 510(k) premarket notification to demonstrate substantial equivalence to legally marketed predicate devices.
• Predicate Devices: Performance Total Knee System (Kirschner), NexGen Total Knee System (Zimmer), PCA Modular Total Knee System (Howmedica), Natural Knee System (Intermedics), AGC Modular Total Knee System (Biomet), Foundation Total Knee System (Encore).
• Basis of Equivalence: The document states, "There are no significant differences between the Ortho Development Balanced Knee™ System and the systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use." This comparison of design, function, materials, and intended use is the "testing" or "proof" presented in a 510(k) submission, rather than de novo performance metrics.
• Intended Use/Indications: For patients suffering from severe knee pain and disability, including various forms of arthritis and complications from previous prostheses. Intended for cemented use only and for single use in primary total knee replacement.
• Materials: CoCr alloy (cast or Wrought), Ti-6Al-4V alloy, and Ultra High Molecular Weight Polyethylene (UHMWPE) per ASTM standards.

In conclusion, this document is a regulatory submission focused on demonstrating substantial equivalence, not a study reporting specific performance data against a set of acceptance criteria. Therefore, most of your questions, which are geared towards performance studies and AI evaluation, do not directly apply to the content provided.

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