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510(k) Data Aggregation
(267 days)
The NextStep Arthropedix 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, 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.
The NextStep Arthropedix 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 NextStep Arthropedix Total Knee System is designed for cemented use only.
The subject device submission includes a combination of devices based on previously cleared devices (K142649 and K150783) and devices with new designs. This submission will include several identical devices reviewed in K142649 and K150783, new devices not yet reviewed by FDA, and new cleaning, packaging, and sterilization validations for all implants. The subject device submission includes 2 system options for total knee replacement:
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Option 1 – Posterior Stabilized (PS), Cruciate Retaining (CR), and Ultra Congruent Cruciate Retaining (UC-CR) patellofemorotibial total knee replacement system that is based on the Progressive Orthopedic Total Knee System cleared in K142694 and K150783
- Includes additional femoral component sizes, additional vitamin E UHMWPE material option for the symmetrical tibial inserts, and manufacturing patellar components from vitamin E UHMWPE only.
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Option 2 – Medial Pivot Total Knee System, including cruciate retaining (MP-CR) and cruciate substituting (MP-CS) tibiofemoral articulation
The provided FDA 510(k) clearance letter describes a medical device, the NextStep Arthropedix Total Knee System, but it is not a software device or an AI/ML device.
The document primarily focuses on the mechanical and material properties of a knee implant system, comparing it to predicate devices. There is no mention of "acceptance criteria" related to an algorithm's performance, nor is there a "study" involving data sets, expert ground truth, or statistical measures like sensitivity, specificity, or AUC, which are typical for AI/ML device evaluations.
Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/ML device from this document. The concepts of "test set," "data provenance," "number of experts," "adjudication method," "MRMC study," "standalone performance," "ground truth type," and "training set" are not applicable to the information provided in this 510(k) summary for a physical knee implant.
The "Non-Clinical and/or Clinical Tests Summary" section lists mechanical tests performed for the physical device, such as fatigue performance, interlock mechanism strength, and wear testing. These are physical tests, not evaluations of an AI algorithm's computational performance.
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(161 days)
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.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Implicit: Device components possess appropriate mechanical characteristics for tibial revision knee joint replacement. | "All components of the CPM Medical Consultants Tibial Revision Knee System exhibit the appropriate mechanical characteristics for tibial revision knee joint replacement." |
| Implicit: The subject device is substantially equivalent to the predicate devices in terms of mechanical performance. | "The results confirm that... [the subject device components] 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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(90 days)
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:
- A table of acceptance criteria and reported device performance
- Sample size used for the test set or data provenance
- Number of experts and qualifications to establish ground truth
- Adjudication method
- Multi-reader multi-case (MRMC) comparative effectiveness study
- Standalone (algorithm-only) performance
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Sample size for the training set
- How ground truth for the training set was established
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