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The VEGA 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.

Posterior Stabilized (PS) components are also for absent or non-functioning posterior cruciate ligament and severe anteroposterior instability of the knee ioint.

The VEGA Knee System is designed for use with bone cement.

The VEGA Knee System is a semi-constrained cemented prosthesis with a Posterior Stabilization (PS) design. The femoral component, tibial plateau and extension stem are manufactured from Cobalt Chromium Molybdenum alloy (CoCrMo) with a Zirconium nitride (ZrN) coating. The tibial "gliding surfaces" (inserts) and patella are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE) and the tibial plug is made of PEEK. The system is made up of numerous components available in various sizes. The VEGA Knee System is compatible with Aesculap Columbus cruciate retaining/posterior stabilizing tibial plateau and augments (CRA/PSA). All components are sterile and for single use only.

Here's an analysis of the provided FDA 510(k) summary for the VEGA Knee System, focusing on the acceptance criteria and the study that proves the device meets those criteria:

Acceptance Criteria and Device Performance for VEGA Knee System (K140452)

1. Table of Acceptance Criteria and Reported Device Performance

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

This submission (K140452) is for a line extension, specifically the addition of optional compatible Aesculap Columbus CRA/PSA tibial plateau and augments to the existing VEGA Knee System.

• Sample Size for Test Set: Not applicable in the traditional sense of a clinical or in-vitro study with a specific number of units. The assessment was a geometrical worse-case comparison, which would involve analyzing the designs and dimensions of the components rather than testing a "sample size" of physical devices.
• Data Provenance: The data is based on the design specifications and geometrical properties of the existing VEGA Knee System (cleared under K101281 and K121879) and the Columbus CRA/PSA components (previously cleared in 510(K) K053390, K071220 and K120955). This is considered retrospective in the sense that it relies on previously designed and cleared components rather than newly generated test data from a prospective study. The country of origin is not explicitly stated for the designs, but the company is US-based.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. Given the nature of the "geometrical worse-case comparison," these would likely be engineering experts with expertise in orthopedic implant design, tolerancing, and biomechanics.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The "study" was a geometrical comparison, not a clinical trial requiring adjudication of patient outcomes or expert consensus on clinical findings.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret results, which is not applicable to an orthopedic implant line extension.

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

• Standalone Performance Study: No, a standalone algorithm performance study was not done. This type of study is relevant for AI/ML algorithms, which is not applicable to this physical implant device.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this submission is based on engineering design principles, dimensional compatibility, and risk analysis methodologies. The "truth" is whether the combined components fit together without creating new risks or compromising the function of the knee system. This is an engineering/design-based ground truth.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This submission does not involve an AI/ML algorithm that requires a training set. The "fundamental scientific technology and materials" for the VEGA system are established.

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this device. The underlying design principles and performance of the predicate devices (VEGA and Columbus components) were established through their respective 510(k) clearances, which would have involved various mechanical testing, biocompatibility, and design verification activities.

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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 corrective valgus or varus deformity and moderate flexion contracture.

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

The cemented Columbus REVISION Knee System is a semi-constrained cemented prosthesis system. The system offers femoral and tibial augments as well as stems to provide options for use during reconstructive surgery, particularly revision cases. The system is manufactured from CoCrMo with the exception of the tibial "gliding surfaces" which are manufactured from UHMWPE and the tibial mask which is made of PEEK. The system is made up of numerous components available in various sizes. All components are sterile and for single use only. All components manufactured from CoCrMo are also available with a ZrN (Zirconium nitride) coating which has been cleared in Aesculap Columbus AS Knee submission (K071220) and described in cleared Columbus Revision submission (K083772).

The provided text describes a 510(k) premarket notification for a medical device, the Columbus REVISION Knee System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy or safety through clinical trials with defined acceptance criteria for device performance as would be seen in a PMA or De Novo submission.

Therefore, much of the requested information regarding acceptance criteria, specific studies proving performance against those criteria, sample sizes, expert ground truth, MRMC studies, and standalone algorithm performance, is not applicable or not present in this type of regulatory document.

However, I can extract information related to the performance data provided in the 510(k) submission.

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

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: The document does not specify the number of samples (individual devices or components) used for the endurance testing.
• Data Provenance: The study was "Customized endurance testing based on ASTM F 2722-08," implying it was a laboratory-based, prospective engineering test. There is no information on country of origin of data in the context of clinical studies as this was a bench test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This was a mechanical endurance test, not a clinical study requiring expert interpretation or ground truth establishment in that typical sense. The "ground truth" here is the performance of the predicate device under the same test conditions.

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

• Not applicable. This was a mechanical endurance test, not a clinical study involving human assessment and adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is a knee implant, not an AI or diagnostic imaging device. No MRMC study was performed.

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

• Not applicable. This device is a knee implant; it does not involve algorithms or AI. The endurance testing evaluated the device's mechanical integrity on its own.

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

• For the endurance test, the "ground truth" or reference point was the performance of the legally marketed Columbus REVISION Knee System (the predicate device) under the same customized ASTM F 2722-08 test conditions. The goal was to show "similarity" rather than an absolute performance benchmark.

8. The sample size for the training set

• Not applicable. This device is a medical implant, not an AI algorithm requiring a training set.

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

• Not applicable. This device is a medical implant, not an AI algorithm.

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