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• Osteoarthritis, rheumatoid arthritis or traumatic arthritis 1.
• Failure of a previously failed joint replacement procedure 2.
• Correction of varus, valgus or post-traumatic deformity 3.
• Correction or revision of unsuccessful osteotomy or arthrodesis 4 .
  The device is intended for use with bone cement (USA)

The AGC V2 Revision Knee System is an extension of Biomet's knee families. Specifically, the devices are similar to the AGC Primary Knee cleared through 510(k) K833921, the AGC Revision (posterior stabilized) Knee cleared through 510(k) K912245 and Maxim Knee System cleared through K915132. The device consists of a femoral component with modular stems that articulates with a one-piece tibial component. The AGC V2 system employs Biomet's standard all polyethylene patella button.
Unique features of the AGC V2 System included the femoral stem angle being built into the stem itself rather than the boss of the femoral component like other systems. The device expands Biomet's existing AGC product line by providing a device with more constraint than current components and additional augments for the femoral component.
The AGC V2 tibial component provides a one-piece molded component with a high post posterior stabilized option. Pegs on the bottom of the tray provide stability for the augmentations.

This document focuses on the substantial equivalence of the AGC V2 Revision Knee System to previously cleared devices, rather than presenting a study with specific acceptance criteria and performance data. The FDA 510(k) approval process for devices like this typically relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than on new clinical performance studies with predefined acceptance criteria.

Therefore, many of the requested elements for a detailed study description are not available in the provided text.

Based on the provided text, here's what can be inferred:

1. Table of acceptance criteria and reported device performance:

This information is not provided in the document. The document primarily focuses on establishing "substantial equivalence" to predicate devices, not on presenting specific performance metrics against defined acceptance criteria.

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

This information is not provided. The document does not describe a "test set" in the context of a performance study.

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

This information is not provided. The concept of "ground truth" established by experts for a test set is not applicable to this type of submission.

4. Adjudication method for the test set:

This information is not provided.

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:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is a knee implant, not an AI-assisted diagnostic tool.

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

No, a standalone algorithm-only performance study was not done. This device is a physical knee implant.

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

The concept of "ground truth" as it relates to evaluating an algorithm's performance is not applicable here. Instead, the "truth" for this regulatory submission is the established safety and effectiveness of the predicate devices to which the AGC V2 Revision Knee System is compared.

8. The sample size for the training set:

This information is not provided. There is no mention of a "training set" in the context of a machine learning model.

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

This information is not applicable as there is no training set for a machine learning model.

Summary regarding acceptance criteria and studies:

The provided K984054 document is a 510(k) premarket notification for a medical device (AGC V2 Revision Knee System). The core of a 510(k) submission is to demonstrate substantial equivalence to a device already legally marketed in the U.S. (a predicate device). This process typically involves:

• Comparison of technological characteristics: Showing that the new device has similar design, materials, and operational principles to the predicate.
• Discussion of intended use: Confirming the new device's indications for use are the same as or comparable to the predicate.
• Performance data (often non-clinical): This might include bench testing, mechanical testing, or material characterization to show that the device performs as intended and is as safe and effective as the predicate. In this case, the document states, "In function and overall design, Biomet's AGC V2 Revision Knee System is equivalent to almost all knee components on the market."

The document lists several Biomet knee systems as comparators (predicate devices):

• AGC 2000 Total Knee Prosthesis (K833921)
• AGC Revision Knee Prosthesis (K912245)
• MCK (Maxim) Knee System (K915132)

The "study" in this context is the comparison to these predicate devices to establish substantial equivalence. Specific quantitative acceptance criteria for clinical performance are generally not a requirement for this type of 510(k) pathway, as the safety and effectiveness are established by reference to the predicate.

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Total knee replacement is indicated for patients suffering from severe knee pain and disability. Specific indications include ternoral, titbial and patellar replacement in a wide size range of patients who require implantation due to degenerative bone disease such as rheumatoid arthritis or osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle, pseudo-gout or complications from a falled prosthesis.

The Kirschner Knee Modified encompasses the Kirschner Performance Total Knee System, Kirschner TC-IV Total Condylar Knee System and Kirschner HybridFit Total Knee.

Kirschner Performance Total Knee System features an anatomically designed cast cobalt chromium femoral component whose geometry allows for maximum range of motion and size interchangeability. It comes with a non-porous coated proximal supracondylar flange and two non-porous coated fixation pegs to minimize stress shielding and permit compression between the porous coated surface and bone. Five sizes in left/right anatomic configurations are available to better match the patient's anatomy. The modular titanium tibial component has four screw holes and comes with either a cruciate or round Available is an all polv tibial component. There are femoral and tibial stem. augmentations to fill cavitary defects.

Kirschner TC-IV Total Condylar Knee Svstem features a cobalt chromium femoral component with a "waffled" non-porous coated proximal flange and two non-porous fixation peas. The one-piece cobalt chromium tibled component has a posterior recess allowing for the retention of the posterior cruciate ligament.

The UHMWPE patellar component for both the Performance and TC-IV knee systems come in porous-coated metal-backed or all UHMWPE options.

The HybridFit cobalt chrome tibial tray accepts the TC-IV or Performance bearing inserts and can be used with either the Performance or the TC-IV femoral component.

These knee devices are intended for use with bone cement.

The major changes are in material and method of the porous coating and in the manufacturing process of the Ultra High Molecular Weight Polyethylene.

Porous coated Kirschner Knees Modified features plasma spray coating of titanium alloy powder. The integrity of this coating has been proven in the performance of many Biomet joint prosthesis previously reviewed by the FDA. There have been no reported incidents of coating failure.

The polyethylene components are of ArCom UHMWPE, Biomet's improved polyethylene components.

This document describes a medical device, the Kirschner® Knee Modified, which is a total knee replacement system. It details the device's components, indications for use, and potential risks, as well as asserting its substantial equivalence to other legally marketed devices.

However, the provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria in the way an AI/ML medical device would. The information is typical of a 510(k) submission for a traditional, non-software medical device.

Therefore, I cannot fulfill your request for the specific points related to acceptance criteria, device performance tables, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, or ground truth establishment, as this information is not present in the provided text.

The closest relevant statements are:

• "The integrity of this coating has been proven in the performance of many Biomet joint prosthesis previously reviewed by the FDA. There have been no reported incidents of coating failure." This refers to previous FDA reviews and lack of reported incidents, but not a specific, controlled study with defined acceptance criteria and performance metrics for this specific modified device.
• The comparison to other "substantially equivalent" devices (Maxim Total Knee System, AGC 2000 Total Knee Prosthesis) is a regulatory pathway, not a performance study against acceptance criteria.

In summary, the provided text does not contain the information necessary to describe acceptance criteria and a study proving device performance as requested.

Ask a specific question about this device