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The CPM Medical Consultants Tibial Revision Knee System is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthrius, osteoarthritis, primary and secondary traumatic arthritis, 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. The device is intended for use in patients who require augmentation and/or stem extensions due to inadequate bone stock and/or require constrained stabilization for tibiofemoral joint due to soft tissue in-balance. The tibial augments are to be attached to their respective components with a fixation screw or screws.

The CPM Medical Consultants Tibial Revision Knee System 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. The CPM Medical Consultants Tibial Revision Knee System is designed for cemented use only.

The CPM Medical Consultants Tibial Revision Knee System is to be used in conjunction with the Progressive Orthopaedic Company Total Knee System cleared via K142649 & K150783.

The CPM Medical Consultants Tibial Revision Knee System is an extended design of The Modal Manufacturing Total Knee System (K142649/K150783). It is a cobalt-chromium-molybdenum (Co-Cr-Mo) metallic baseplate with a variety of components including tibial augments, stems, and offset adapters that provide more choice for surgeon treatment of their patients. The CPM Medical Consultants posterior stabilized plus inserts is a line extension to the previously cleared Modal Manufacturing posterior stabilized tibial insert (K142649). The CPM Medical Consultants Tibial Revision Knee System is to be used in conjunction with the previously cleared Modal Manufacturing Total Knee System (K142649/K150783) which is a fixed bearing implant available in posterior-stabilized (PS) and cruciate-retaining (CR) configurations. It is a patellofemorotibial, polymer/metal/polymer, semi-constrained, cemented knee prosthesis that consists of a femoral component, tibial insert, tibial tray and patellar component. The PS version has tibial inserts with posts and femoral components with cams that interact with the posts to help stabilize the knee after the posterior cruciate ligament is removed. The CR version of the Progressive Orthopaedic Total Knee System has tibial inserts and femoral components without posts or cams, allowing the posterior cruciate ligament to be "retained" and provide stability to the knee joint. The femoral component articulates with the tibial insert component. The underside of the tibial insert component is flat and "snaps" into the tibial baseplate component. The design and sizing of the femoral components correspond to the natural femoral anatomy, enhancing stress distribution and restoring original femoral dimensions and normal rotation, and flexion. Each femoral component has the same intercondylar distance and radius of curvature. Each tibial insert component is complimentarily shaped to conform to the femoral components. This allows any size femoral component to be matched with any size tibial component. The dome shape of each UHMWPE patellar component provides excellent contact with the femoral component and evenly distributes stresses. The dome shape of each patellar component also simplifies implantation by eliminating the need for rotation.

This document is a 510(k) summary for a medical device called the "CPM Medical Consultants Tibial Revision Knee System". It's a submission to the FDA to demonstrate that the new device is "substantially equivalent" to legally marketed predicate devices, meaning it's safe and effective for its intended use. Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly state "acceptance criteria" in a quantitative manner (e.g., minimum fatigue cycles, maximum stress values) for comparison. Instead, it refers to the performance of the predicate device as demonstrating substantial equivalence for the subject device. The reported device performance is that the testing confirms the components exhibit "appropriate mechanical characteristics" and are "substantially equivalent" to the predicate devices.

2. Sample size 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 sample sizes for the performance tests conducted on the predicate devices. It states "Extensive preclinical testing was performed on the predicate devices per K142649 and K150783."

Data provenance (country of origin, retrospective/prospective) is not mentioned. Given that this is a 510(k) summary for a revision knee system, the testing is typically bench testing, not clinical trials with human subjects.

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)

This information is not applicable to this type of submission. The performance testing described is mechanical bench testing, not an evaluation that requires expert medical opinion to establish "ground truth."

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

Not applicable. The tests are physical and mechanical, not subject to human adjudication as would be the case in an image-based diagnostic study.

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 not a study involving human readers or AI assistance. It's a submission for a mechanical implant.

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

Not applicable. This is not an algorithm or AI device.

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

Not applicable. The "ground truth" for mechanical performance in this context would be the established engineering standards and specifications for orthopedic implants, which the predicate device demonstrated compliance with.

8. The sample size for the training set

Not applicable. This is not an AI/ML device where a "training set" would be used.

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

Not applicable.

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The Precision Casting Solutions Total Knee System is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, 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.

The Precision Casting Solutions Total Knee System 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. The Precision Casting Solutions Total Knee System is designed for cemented use only.

The Precision Casting Solutions Total Knee System is a fixed bearing implant available in posterior-stabilized (PS) and cruciate-retaining (CR) configurations. It is a patellofemorotibial, polymer/metal/polymer, semiconstrained, cemented knee prosthesis that consists of a femoral component, tibial tray and patellar component. The PS version has tibial inserts with posts and femoral components with cams that interact with the posts to help stabilize the knee after the posterior cruciate ligament is removed. The CR version of the Precision Casting Solutions Total Knee System has tibial inserts and femoral components without posts or cams, allowing the posterior cruciate ligament to be "retained" and provide stability to the knee joint. The femoral component articulates with the tibial insert component. The underside of the tibial insert component is flat and "snaps" into the tibial baseplate component. The design and sizing of the femoral components correspond to the natural femoral anatomy, enhancing stress distribution and restoring original femoral dimensions and normal rotation and flexion. Each femoral component has the same intercondylar distance and radius of curvature. Each tibial insert component is complimentarily shaped to conform to the femoral components. This allows any size femoral component to be matched with any size tibial component. The dome shape of each UHMWPE patellar component provides excellent contact with the femoral component and evenly distributes stresses. The dome shape of each patellar component also simplifies implantation by eliminating the need for rotational orientation.

The provided text describes a medical device, the "Precision Casting Solutions Total Knee System," and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML algorithm or software as a medical device (SaMD).

The document is a 510(k) summary for a physical medical implant (a knee replacement system), which follows a different regulatory pathway and testing methodology than an AI/ML system. The performance testing mentioned (fatigue, strength, contact area, range of motion) are mechanical tests relevant to a physical orthopedic implant.

Therefore, I cannot provide the requested information for an AI/ML device based on the given text. The text does not mention:

1. A table of acceptance criteria and reported device performance
2. Sample size used for the test set or data provenance
3. Number of experts and qualifications to establish ground truth
4. Adjudication method
5. Multi-reader multi-case (MRMC) comparative effectiveness study
6. Standalone (algorithm-only) performance
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
8. Sample size for the training set
9. How ground truth for the training set was established

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The Progressive Orthopaedic Total Knee System is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, postraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities.

The Progressive Orthopaedic Total Knee System 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. The Progressive Orthopaedic Total Knee System is designed for cemented use only.

The present 510k submission is for a cruciate retaining (CR) version of the Progressive Orthopaedic Total Knee System and a line extension of HC PS tibial inserts. The main predicate device (K142649) is a posterior stabilized (PS) version of the Progressive Orthopaedic Total Knee System. All implant components are the same between the two versions, except for the tibial inserts and the femoral components. The posterior stabilized version has tibial inserts with posts and femoral components with cams that interact with the posts to help stabilize the knee after the posterior cruciate ligament is removed. The cruciate retaining version of the Progressive Orthopaedic Total Knee System has tibial inserts and femoral components without posts or cams, allowing the posterior cruciate ligament to be "retained" and provide stability to the knee joint.

The Progressive Orthopaedic Total Knee System is a Patellofemorotibia, polymer / metal / polymer, semi-constrained, cemented knee prosthesis, consisting of a femoral component, tibial insert, tibial tray and patellar component. The femoral component articulates with the tibial insert component. The underside of the tibial insert component is flat and "snaps" into the tibial baseplate component. Each femoral component has the same intercondylar distance and radius of curvature. Each tibial insert component is complimentarily shaped to conform to the femoral components. This allows a range of sizes of the femoral component to be matched with up to one size up/down of the tibial component. The dome shape of each UHMWPE patellar component provides excellent contact with the femoral component and evenly distributes stresses. The dome and sombrero shape of each UHMWPE patellar component provides contact with the femoral component.

This FDA 510(k) K150783 document is for a medical device called the "Progressive Orthopaedic Total Knee System", specifically a cruiciate retaining (CR) version. It is a knee replacement system. The document does not describe an AI/ML device or an algorithm. As such, the information requested in your prompt (e.g., acceptance criteria for an AI model, sample sizes for test and training sets, number of experts for ground truth, MRMC studies, etc.) is not applicable to this document.

The document focuses on demonstrating that the new CR version of the knee system is substantially equivalent to a previously cleared posterior stabilized (PS) version and another predicate device. This is done through a comparison of technological characteristics and performance testing of mechanical aspects of the device.

Here's the information gleaned from the document that is somewhat related to your request, but adapted to the context of a physical medical device (a knee prosthesis):

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

Explanation: The "acceptance criteria" here are not explicitly stated as numerical thresholds in the document. Instead, the document demonstrates "substantial equivalence" to a predicate device. The performance tests were conducted to show that the CR version performs similarly to the predicate device in terms of these mechanical properties, implying that the performance of the CR version is "acceptable" if it is equivalent to a device already on the market.

2. Sample size used for the test set and the data provenance:
Due to this being a mechanical device and not an AI/ML model, there is no "test set" in the sense of medical images or patient data. The "tests" performed are mechanical engineering tests on the device components. The sample sizes for these specific mechanical tests are not provided in this summary document. The "data provenance" is derived from in-vitro mechanical testing of the physical device components.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth as typically defined for AI/ML validation (e.g., expert consensus on medical images) does not apply to the mechanical testing of a knee prosthesis. Device performance is measured through objective physical tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This refers to consensus among human readers for medical image analysis, which is not relevant here.

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 for AI/ML systems and their impact on human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This document pertains to a physical medical device, not an algorithm.

7. The type of ground truth used:
For the mechanical performance tests, the "ground truth" would be the objective measurements obtained from the mechanical testing, demonstrating the physical properties (e.g., contact area, shear strength) of the device components. The implicit "ground truth" for showing substantial equivalence is the established performance of the predicate devices.

8. The sample size for the training set:
Not applicable. This document is not about AI/ML.

9. How the ground truth for the training set was established:
Not applicable. This document is not about AI/ML.

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