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For Tibial baseplate, CMA, #0
This device is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in sketetally mature patients with severe knee pain and disability due to rheumatoid arthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral joint surfaction or prior patellectorny, moderate valgus, varus, or flexion contraction. This device may also be indicated in the salvage or previously failed surgical attempts or for knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. This device system is designed for cemented use only.

For Tibial insert, #0
The device is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in sketally mature patients with severe knee pain and disability due to rheumatoid arthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. This device is a single use implant and intended for cemented use only.

The U2 Total Knee System consists of Femoral components, patella components, Tibial baseplate components and Tibial inserts components which are designed to be used together to achieve total replacement of the knee joint. This system includes Cruciate Retained (CR) type, Ultracongruent (UC) type, and Posterior Stabilized (PS) type.

The U2 Total Knee System, Tibial baseplate, CMA, #0 (Subject device) is a size extension of the cleared "UNITED" U2 Total Knee System, Tibial baseplate, CMA, #1 to #7 (K131864). The materials, indications, sterilization of this subject are identical to the cleared "UNITED" U2 Total Knee System, Tibial baseplate, CMA, #1 to #7 (K131864).

The U2 Total Knee System, Tibial insert, #0 (Subject device) is a size extension of the cleared "UNITED" U2 Total Knee System, Tibial insert, #1 to #7 (K051640, K103733, K131864, K132752, K150829 and K161705). The materials, indications, sterilization of this subject are identical to the cleared "UNITED" U2 Total Knee System, Tibial insert, #1 to #7 (K051640, K103733, K131864, K132752, K150829 and K161705). The Subject Tibial insert, CR, #0 and Tibial insert, PS, #0 have a more concave sagittal plane design while comparing to the marketed predicate devices

Surgical procedures with the use of the Subject device shall be performed with the support of orthopedic instrumentation, to facilitate their proper insertion and removal from the patient. All the surgical instruments have been cleared as part of the predicate devices.

This is a medical device clearance, not an AI/ML device. Therefore, the questions regarding AI/ML device evaluations (sample size, experts, adjudication, MRMC, standalone performance, ground truth establishment for training set, etc.) are not applicable.

The document describes the acceptance criteria and study for a Tibial baseplate and Tibial insert, which are components of a knee replacement system. This is a traditional medical device, not an AI/ML powered device. Therefore, the concepts related to AI/ML device performance such as ground truth, expert adjudication, train/test sets, effect size of AI assistance, etc., are not relevant to this document.

However, I can extract the information provided regarding the device's performance analysis and acceptance criteria, based on the non-clinical tests conducted.

Here's the summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The document does not explicitly list 'acceptance criteria' with numerical targets and then 'reported device performance' side-by-side in a table format. Instead, it states that "the following non-clinical tests were conducted to evaluate the safety and effectiveness of the subjected device, and the test results indicated that this device is safe and effective." This implies that the device met the internal acceptance criteria for each test.

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

The document does not specify the sample sizes (number of devices tested) for the non-clinical tests. It also does not provide information about data provenance as these are laboratory-based mechanical tests, not clinical data sets.

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 is a mechanical device, not an AI/ML device requiring expert ground truth for image interpretation or diagnosis.

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

Not applicable. This is a mechanical device. Adjudication methods are relevant for subjective interpretations, typically in clinical studies or AI/ML ground truth establishment.

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 is a mechanical device, not an AI/ML device.

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

Not applicable. This is a mechanical device, not an AI/ML device.

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

Not applicable. For mechanical devices, "ground truth" is typically defined by engineering specifications, material properties, and mechanical test standards (e.g., ISO or ASTM standards) that define acceptable performance limits. The document states that the "non-clinical tests were conducted to evaluate the safety and effectiveness," implying adherence to established engineering and material science principles, but specific ground truth definition is not explicitly detailed in this summary.

8. The sample size for the training set

Not applicable. This is a mechanical device, not an AI/ML device that requires a training set.

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

Not applicable. This is a mechanical device, not an AI/ML device.

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• Primary intervention of rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, A. collagen disorders, and/or avascular necrosis of the femoral condyle.
• Post-traumatic loss of joint configuration (particularly when there is patellofemoral erosion, B. dysfunction, or prior patellectomy).
• Failed osteotomy or unicompartmental replacements. C.
• Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone D. stock exists.
• The salvage of previously failed surgical attempts if the knee can be satisfactorily balanced E. and stabilized at the time of surgery.
• Moderate valgus, varus, or flexion deformities. F.

All MRKS femoral components and tibial baseplates are intended for cemented use only: All MRKS stems are intended uncemented use.

The MILESTONE Revision Knee System (MRKS) is a semi-constrained, cemented knee prosthesis designed for either primary or revision total knee arthroplasty. The MRKS contains left and right configurations of a femoral component and a fixed-bearing tibial component, in addition to accessory components including stems, augments, screws, pegs, a taper plug, and a baseplate plug. The femoral component and tibial baseplate employ modularity for stem and augment attachment.

The MRKS femoral component is manufactured from cast cobalt chrome alloy. It is offered in six sizes (1-6) and is designed to articulate with the MRKS ultracongruent tibial insert and the MILESTONE Knee System (MKS) all poly patellar component (K112285). The MRKS femoral component is not designed to articulate with the MKS posterior stabilizing (PS) tibial insert (K112285) or any condylar constrained tibial components. The MRKS box profile is thicker than the MKS femoral component to accommodate increased bone loss.

The MRKS tibial component consists of two parts to be assembled at the time of surgery: a tibial baseplate and an ultracongruent (PCL substituting) tibial insert. The baseplate is manufactured from cast cobalt chrome alloy and is designed with an identical locking mechanism as the MKS tibial baseplate (K112285). The baseplate is offered in seven sizes (0-6) and is designed to accommodate the MRKS ultracongruent insert when used with the MRKS femoral component or the MKS PS tibial insert (K112285) when used with the MKS PS femoral component (Ki 12285). The MRKS tibial baseplate is thicker than the MKS baseplate to accommodate increased bone loss. The MRKS insert is manufactured from ultra-high molecular weight polyethylene (UHMWPE) and is designed with an identical locking mechanism, thickness, and size range as the MKS PS insert.

The MRKS accessory components are manufactured from Titanium alloy. The stems are available in three lengths (80, 110, and 150mm) and seven diameters (10-22mm). They employ a male 12/14 Morse taper for attachment to the CRKS femoral component or tibial baseplate. The taper plug is available in one size and is intended for use when a stem is not desired. The taper plug employs an identical male taper as the stem. The augments are available in left and right configurations, and are offered in a range of sizes to accommodate all sizes of the MRKS femoral components and tibial baseplates. Femoral augments are split into distal and posterior segments, each available in 5mm thicknesses. Tibial augments are available in 5mm and 10mm thicknesses. The pegs are offered in three sizes (short, medium, and long). Screws are offered in two sizes (short and long). The baseplate plug is offered in one size. The pegs and screws are designed for mechanically attaching the augments to their respective implants. Pegs also aid in stabilizing the implant post-operatively and are designed to fill the distal augments holes of the femoral component and augment holes of the tibial baseplate when augments are not desired. The baseplate plug is designed to fill the baseplate augment holes when pegs and augments are not desired.

This document is a 510(k) summary for a medical device called the "MILESTONE Revision Knee System (MRKS)", a revision knee prosthesis. It details the device description, indications for use, and a claim of substantial equivalence to predicate devices. Crucially, the provided text does NOT contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically found for AI/ML-driven medical devices.

Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, which is the regulatory pathway taken for this type of medical implant.

Therefore, I cannot populate the requested table and answer the study-related questions as those details are not present in the provided text. The document states:

"Because the MRKS components employ identical geometry and material characteristics as those employed by their respective predicate CRKS and CKS components, non-clinical bench testing and analyses were provided for these predicate components to validate the safety and effectiveness of the MRKS. No further testing on MRKS components was necessary."

This indicates that instead of new performance studies with specific acceptance criteria, the device relies on the established safety and effectiveness of its predicate devices through the substantial equivalence pathway.

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