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The Columbus Revision Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplasties or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture.

The Columbus Revision Knee System is designed to for use with bone cement.

The cemented Columbus Revision Knee System is a fixed prosthesis system that is available with one femoral design, the Posterior Stabilizing (PS) which offers stabilization it the ligament (PCL) is absent, weakened, or sacrificed during implantation. The system is manufactured from CoCrMo with the exception of the tibial "gliding surfaces" which are manufactured from UHMWPE. The complete system (femoral and tibial) makes up of numerous component available in various sizes. All components are sterile and for single use only.

This document is a 510(k) summary for the Columbus REVISION Knee System, a medical device. It does not contain information about acceptance criteria or a study proving that the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to previously cleared devices.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text.

The "PERFORMANCE DATA" section (page 1, section 2) mentions:

• "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements' were done where applicable."
• "In addition, testing per the 'Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-Constrained Total Knee Prostheses', and 'Class II Special Controls Guidance Document for Knee Joint Patellofemorotibial & . Femorotibial Metal/Polyer Porous-Coated Uncemented Prostheses: Guidance for Industry and FDA.'"

These statements indicate that specific guidance documents were followed for performance testing, but they do not provide the detailed acceptance criteria or the results of the studies themselves. To get that information, one would need to refer to the full 510(k) submission, which is not included in this extract.

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The Columbus (CR) Total Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplasties or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture. The Columbus Knee is designed for use with bone cement.

The Columbus MIOS CR/PS tibial tray is a sterile, single-use device that is intended to be used with the previously cleared femoral component, insert, patella, and attachned to mechanism of the Columbus (CR) Total Knee System or with the femoral component and insert of the Columbus (PS) Total Knee System.

The Columbus Total Knee System MIOS CR/PS Tibial Tray is a medical device. The provided text refers to a 510(k) Premarket Notification to the FDA, which focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study with human subjects.

Therefore, many of the requested details about acceptance criteria, detailed study design, sample sizes, expert ground truth, and MRMC studies are not applicable or explicitly stated in this type of regulatory submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not directly available. For 510(k) submissions for orthopedic implants, the "acceptance criteria" are typically demonstrating that the new device has similar technological characteristics and performs at least as safely and effectively as a legally marketed predicate device. This is primarily done through mechanical testing to ensure the device meets established industry standards or recognized guidance documents.

• "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements"
• "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement"
• "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements"
• "Guidance Document for Testing Non-articulating, "Mechanically Locked" Modular Implant Components"
• "Data Requirements for Ultrahigh Molecular Weight Polyethylene (UHMPE) Used in Orthopedic Devices"

(The text states "All required testing... were done where applicable" and lists these specific guidance documents. This implies that the device met the criteria outlined in these documents, as it received clearance.) |
| Material Compatibility: Use materials commonly used in medical devices and similar to predicate. | Materials Used: Base material for the Aesculap Implant Systems device is the same as predicate devices. PMMA Nano-Bond surface pretreatment uses materials commonly used on other medical devices. |
| Dimensional & Design Similarity: Similar shapes and sizes to predicate devices. | Similar Characteristics: "The MIOS CR/PS tibial tray is offered in similar shapes and sizes as the predicate devices." |

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

Not applicable in the context of a 510(k) submission for this type of device based on the provided text. The "test set" here refers to mechanical testing of the device itself (e.g., fatigue, wear, strength), not a clinical study on human subjects. Sample sizes for such engineering tests are specified within the listed guidance documents, but not explicitly detailed in this summary. Data provenance would be from laboratory testing conducted by the manufacturer or a contracted lab. There's no mention of country of origin for such mechanical test data.

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

Not applicable. For mechanical testing, the "ground truth" is defined by the engineering specifications and performance standards outlined in the guidance documents. Expert consensus in a clinical sense is not used for this type of testing.

4. Adjudication Method for the Test Set

Not applicable. Mechanical tests have pass/fail criteria based on objective measurements against engineering standards, not through adjudication by human experts.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an orthopedic implant, not an AI-powered diagnostic tool requiring MRMC studies for human reader performance.

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

Not applicable. This device is an orthopedic implant, not an algorithm.

7. The Type of Ground Truth Used

For mechanical testing, the "ground truth" is the established engineering standard or performance requirement outlined in the various FDA guidance documents and recognized consensus standards (e.g., ISO, ASTM) that are referenced. It relies on objective, repeatable measurements.

8. The Sample Size for the Training Set

Not applicable. This device does not use a "training set" in the machine learning sense. The "development" or "design" process for an implant involves engineering principles, material science, and prior knowledge from predicate devices.

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

Not applicable. As there is no "training set" for an algorithm, there's no ground truth established in this context. The design of the implant is based on established biomechanical principles, material properties, and the performance history of predicate devices.

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The Columbus (CR) Total Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplasties or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture.

The Columbus Knee (CR) is designed for use with bone cement.

The cemented Columbus (CR)Total Knee System additions include a CRA/PSA tibial tray and hemispacers, commonly known as wedges. The CRA/PSA tibial tray and wedges can be used with the existing femoral component, insert, patella and attachment mechanism of the Columbus (CR) Total Knee System cleared via K022672 or with the femoral component and insert of the Columbus (PS) Total Knee System cleared via K030367. The CRA/PSA tibial tray and wedges are manufactured from CoCrMo.

The provided document is a 510(k) summary for the Columbus (CR) Total Knee System. This type of regulatory submission is for medical devices that are substantially equivalent to a predicate device already on the market. It does not contain information about clinical studies with acceptance criteria or performance metrics in the way you've described for an AI/software device.

Instead, the document focuses on:

• Substantial Equivalence: Comparing the new device (Columbus (CR) Total Knee System additions) to existing legally marketed devices (predicates) based on technological characteristics (materials, shapes, sizes).
• Performance Data: This section refers to non-clinical testing, specifically mechanical and materials testing, to ensure that the device meets established standards for orthopedic implants. It does not involve patient data, expert interpretations, or AI algorithm performance.

Therefore, I cannot extract the information required by your request (acceptance criteria, device performance table, sample size, ground truth, experts, adjudication, MRMC, standalone) because this type of information is not relevant to a 510(k) submission for a mechanical orthopedic implant.

The document states:
"All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements' were done where applicable. In addition, testing per the

• 'Guidance Document for Testing Orthopedic Implants with Modified Metallic . Surfaces Apposing Bone or Bone Cement',
• 'Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on . Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements'
• 'Guidance Document for Testing Non-articulating, "Mechanically Locked" Modular . Implant Components', and
• 'Data Requirements for Ultrahigh Molecular Weight Polyethylene (UHMPE) Used . in Orthopedic Devices' was completed where applicable."

This indicates that the performance data involved fulfilling specific mechanical and material testing standards outlined in FDA guidance documents for orthopedic implants, not clinical studies with human readers or AI algorithms.

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