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The Unity Total Knee System is intended for use in total knee arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged knee joint articulation where there is sufficient sound bone to seat and support the components.

The General total knee arthroplasty indications include:

· Painful, disabling joint disease of the resulting from: degenerative arthritis, theumatoid arthritis or post-traumatic arthritis

· Post-traumatic loss of knee joint configuration and function

• · Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function
• · Revision of previous unsuccessful knee replacement or other soft tissue stability is adequate
• · Fracture of the distal femur and/or proximal tibia that cannot be standard fracture management techniques
• · The posterior stabilized variant is also indicated for PCL instability requiring implant bearing surface with
• increased anterior-posterior constraint and absent or non-functioning posterior cruciate ligament

The Unity Total Knee System is intended for cemented use, single use only.

The Unity Total Knee System is a fixed bearing total knee replacement system that consists of a cobalt chromium alloy (CoCr) femoral component, a UHMWPE (Ultra-High-Molecular-Weight-Polyethylene) or ECiMa (Vitamin E enriched advanced polyethylene) tibial tray with a titanium alloy keel extension and all-polyethylene (UHMWPE) patellar component for use in primary and revision total knee arthroplasty. The Unity Total Knee System femoral component is provided in two variants, cruciate retaining (CR) and posterior stabilised (PS).

• The CR femoral component is intended for use in conjunction with the CR tibial insert or Medial Constrained (MC) tibial insert where the posterior cruciate ligament (PCL) is functional or in conjunction with a Condylar Stabilised (CS) tibial insert or MC tibial insert where the PCL is present but is lax or non-functioning or when the PCL is absent.
• The PS femoral component is intended for use in conjunction with the PS tibial insert where the posterior cruciate ligament is non-functioning or absent, resulting in joint instability, or in conjunction with the constrained posterior-stabilized (PS-C) tibial insert where is instability of the lateral collateral ligament and/or medial collateral ligament (LCL/MCL).

The Unity Total Knee System patellar component is optional and for use with either the CR or PS femoral variants and is intended for use where replacement of the articular surface of the patella is required. The system also provides titanium alloy augments including femoral augments, tibial augments, stem extensions and offset adapters.

The Unity Total Knee System is intended for use in total knee arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the joint articulation where there is evidence of sufficient sound bone to seat and support the components.

The Unity Total Knee system was originally cleared in K113060. This submission is for the inclusion of an additional range of Unity Knee MC Tibial Inserts. The additional range of tibial inserts has the same intended purpose as those cleared in the original 510(k) submission (K113060).

The provided document is a 510(k) Premarket Notification from the FDA for the "Unity Total Knee System." It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than on a clinical study proving device meets specific acceptance criteria in the way a de novo or PMA submission might.

However, it does outline the non-clinical tests performed to support substantial equivalence. While it doesn't present acceptance criteria and reported performance in a table with specific thresholds, it implies that the device met the requirements of the standards and analyses conducted.

Here's an attempt to structure the information based on your request, understanding that the scope of this document is a 510(k) and not a detailed clinical study report:

1. Table of Implied Acceptance Criteria and Reported Device Performance

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

This document does not specify sample sizes for mechanical testing. For example, for "Constraint determination," it doesn't state how many implants were tested.

• Sample Size (Test Set): Not explicitly stated for each test, but implied to be sufficient for the non-clinical tests mentioned.
• Data Provenance: Not explicitly stated (e.g., country of origin), but the tests are non-clinical (laboratory-based) and not human subject data. Retrospective/Prospective is not applicable to these types of non-clinical tests.

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 these non-clinical tests is established by the accepted scientific and engineering principles codified in the referenced ASTM and ISO standards, and by established scientific methods, not by expert consensus on clinical cases.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical data interpretation or image annotation, not for mechanical or material testing of devices. The "judgment" for these tests comes from adherence to the test standard and engineering analysis.

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

No. This document does not describe an MRMC comparative effectiveness study. The submission is for a 510(k) clearance based on substantial equivalence, which often relies on non-clinical performance and comparison to predicate devices rather than direct human clinical trials for effectiveness in the same way a new drug or novel device might require.

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

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

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is based on:

• Standardized Test Methods: Adherence to established ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards (e.g., ASTM F1223-20, ISO 21536:2023, ASTM F2723-21). These standards define procedures and acceptable performance metrics.
• Engineering Principles and Benchmarking: Comparison to known performance characteristics of the legally marketed predicate devices, as well as established material properties.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI model or software algorithm that would require a training set.

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

Not applicable for the reasons mentioned in point 8.

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General total knee arthroplasty indications include:

• Painful, disabling joint disease of the knee resulting from: degenerative arthritis ● or post-traumatic arthritis
• Post-traumatic loss of knee joint configuration and function .
• Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function
• Revision of previous unsuccessful knee replacement or other procedure, where soft tissue stability is ● adequate
• . Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture management techniques
• The posterior stabilized variant is also indicated for PCL instability requiring implant bearing surface . geometries with increased anterior-posterior constraint and absent or non-functioning posterior cruciate ligament

The Unity Knee™ is intended for cemented use, single use only.

The Unity Knee™ is a fixed bearing total knee replacement system that consists of a Cobalt Chromium Allov (CoCr) femoral component, a UHMWPE polyethylene tibial insert, a Cobalt Chromium Alloy (CoCr) tibial tray with a Titanium Alloy keel extension and all-polyethylene patellar component for use in primary and revision total knee arthroplasty. The Unity Knee™ femoral component is provided in two variants, cruciate retaining (CR) and posterior stabilized (PS).

• . The Unity Knee™ CR femoral component is intended for use in conjunction with the CR tibial insert where the posterior cruciate ligament (PCL) is functional or in conjunction with a Unity Knee™ CS tibial insert only where the PCL is present but is lax or non-functioning or when the PCL is absent.
• The Unity Knee™ PS femoral component and tibial insert variant is indicated for use where the posterior cruciate ligament is non-functioning or absent, resulting in joint instability.

The Unity Knee™ patellar component is optional for use with either the CR or PS variant and is indicated for use where replacement of the articular surface of the patella is required. The system also provides Titanium Alloy augment components including femoral augments, tibial augments and stem extensions.

The Unity Knee™ is intended for use in total knee arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged knee joint articulation where there is evidence of sufficient sound bone to seat and support the components.

The Unity Total Knee system was originally cleared in K113060. This submission is for the inclusion of an additional range of Unity Knee™ CS Tibial Inserts. The additional range of Tibial Insert has the same intended purpose as those cleared in the original 510(k) submission (K113060).

The provided text is a 510(k) Premarket Notification from the FDA for a medical device, the "Unity Total Knee System." It outlines the device's indications for use, its description, and its claim of substantial equivalence to predicate devices. Crucially, the document explicitly states that "Clinical testing was not necessary to determine substantial equivalence between the additional components of the Unity Knee™ CS tibial insert and the predicate devices."

Therefore, I cannot extract information regarding acceptance criteria or a study that proves the device meets those criteria, as no clinical study was performed or required for this 510(k) submission. The document focuses on demonstrating substantial equivalence through non-clinical testing and comparison to existing, legally marketed devices.

However, I can extract the information regarding the non-clinical testing performed:

1. Table of Acceptance Criteria (for Non-Clinical Testing) and Reported Device Performance:

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

• Sample Size: Not specified for the non-clinical tests. These are typically material and mechanical tests performed on a defined number of device components, not human subjects or patient data.
• Data Provenance: The tests are performed in a laboratory setting per specified ASTM standards. The document does not specify the country of origin of the lab or if the data is retrospective or prospective, as it pertains to engineering and material testing, not clinical data.

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

• This is not applicable as no clinical test set or ground truth established by experts was used. The substantial equivalence claim is based on non-clinical engineering testing.

4. Adjudication method for the test set:

• Not applicable as no clinical test set requiring human adjudication was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not necessary to determine substantial equivalence..."

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

• Not applicable. The device is a physical knee implant system, not a software algorithm.

7. The type of ground truth used:

• For the non-clinical testing, the "ground truth" is established by the specified ASTM standards and the performance of the predicate device (Stryker Triathlon® CS and Corin Unity Total Knee System CR tibial insert). The device's performance is compared against these engineering and material benchmarks to claim substantial equivalence.

8. The sample size for the training set:

• Not applicable. This is not a machine learning model, so there is no training set.

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

• Not applicable.

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The Unity™ Total Knee System is intended for use in total knee arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged knee joint articulation where there is evidence of sufficient sound bone to seat and support the components.
General total knee arthroplasty indications include:
• Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis
• Post-traumatic loss of knee joint configuration and function
• Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function
• Revision of previous unsuccessful knee replacement or other procedure, where soft tissue stability is adequate
• Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture management techniques
• The posterior stabilized variant is also indicated for PCL instability requiring implant bearing surface geometries with increased anterior-posterior constraint and absent or non-functioning posterior cruciate ligament
The Unity™ Total Knee System is indicated for cemented use, single use only.

The Unity Knee™ is a fixed bearing total knee replacement system that consists of a cobalt chromium alloy (CoCr) femoral component, a UHMWPE polyethylene tibial insert, a cobalt chromium Alloy (CoCr) tibial tray with a titanium alloy keel extension and all-polyethylene patellar component for use in primary total knee arthroplasty. The Unity Knee™ is provided in two variants, cruciate retaining (CR) and posterior stabilized (PS). The Unity Knee™ CR is intended for use in instances where the posterior cruciate ligament (PCL) is functional. The Unity Knee™ PS variant is utilized when a total knee replacement is indicated, and the posterior cruciate ligament is non-functioning or absent, resulting in joint instability. The Unity Knee™ patellar component is optional and is used in situations where replacement of the articular surface of the patella is required. The system also provides titanium alloy augments including femoral augments tibial augments and stem extensions.

I am sorry, but based on the text provided, I cannot fulfill your request. The document is a 510(k) premarket notification for a medical device (Unity Total Knee System) and does not contain any information about acceptance criteria, device performance, sample sizes for test or training sets, ground truth establishment methods, expert qualifications, adjudication methods, or MRMC comparative effectiveness studies related to an AI/ML device.

The document specifically states under "13. Clinical Testing": "Clinical testing was not necessary to determine substantial equivalence between the Unity™ Total Knee System augment and the predicate devices." This indicates that the device's substantial equivalence was established through non-clinical testing and comparison to predicates, not through performance metrics derived from a study involving human readers or an AI algorithm.

Therefore, I cannot extract the information required to populate the tables and answer your questions about the device's acceptance criteria and the study proving it meets them.

Ask a specific question about this device

The Unity Total Knee System is intended for use in total knee arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged knee joint articulation where there is evidence of sufficient sound bone to seat and support the components.

General total knee arthroplasty indications include:

• Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis
• Post-traumatic loss of knee joint configuration and function
• Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function
• Revision of previous unsuccessful knee replacement or other procedure, where soft tissue stability is adequate
• Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture management techniques
• The posterior stabilized variant is also indicated for PCL instability requiring implant bearing surface geometries with increased anterior-posterior constraint and absent or non-functioning posterior cruciate ligament

The Unity Total Knee System is indicated for cemented, single use only.

The Corin Unity Knee System is a fixed bearing total knee replacement system that consists of a femoral component, tibial insert, tibial tray and all-polyethylene patellar component for use in primary total knee arthroplasty. The Unity Knee System is provided in two variants, cruciate retaining (CR) and posterior stabilized (PS). The Unity CR Total Knee System is intended to accommodate the posterior cruciate ligament (PCL) if it is present. The Unity posterior stabilized variant is utilized when total knee replacement is indicated, and the posterior cruciate ligament is non-functioning or absent, resulting in joint instability. The Unity system patellar component is optional and is used in situations where replacement of the articular surface of the patella is required. The system also provides augments including femoral wedges, tibial wedges, a short keel extension and stem extensions.

The Unity Total Knee system was originally cleared in K113060. This submission is for the size of stem extension size to the range, a size 30mm in two available diameters 10mm and 14mm. Like the originally cleared stem extensions the 30mm has the same identical modular taper connection.

This document is a 510(k) summary for the Unity Total Knee System. It details the device's technical specifications and how it relates to predicate devices, but it does not contain information about the acceptance criteria or a study proving the device meets said criteria in the context of device performance metrics such as sensitivity, specificity, or accuracy.

The provided text describes a submission for an orthopedic implant (a knee replacement system), not a diagnostic or AI-driven medical device that would have performance metrics like those typically associated with acceptance criteria in the input request.

Therefore, I cannot extract the requested information from this document. The document primarily focuses on:

• Device Name: Unity Total Knee System
• Regulation Number: 21 CFR 888.3560
• Regulatory Class: Class II
• Product Code: JWH
• Indications for Use: Detailed for total knee arthroplasty in skeletally mature patients to increase mobility and reduce pain by replacing the damaged knee joint.
• Device Description: Discusses the components (femoral, tibial insert, tibial tray, patellar component), variants (cruciate retaining and posterior stabilized), and augments (femoral/tibial wedges, stem extensions).
• Substantial Equivalence: Claims equivalence to the predicate Corin Unity Total Knee System (K113060) based on identical intended use, indications, materials, and similar design for the new stem extension size.
• Non-Clinical Testing: Mentions fatigue endurance and fretting properties testing, concluding that the device is expected to be safe and effective.
• Clinical Testing: Explicitly states that clinical testing was not necessary to determine substantial equivalence.

In summary, the document does not contain the information required to answer your specific questions related to acceptance criteria and performance study details for an AI/diagnostic device.

Ask a specific question about this device