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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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The Apex Knee System Tibial Baseplate Augment is intended for use with the Apex Knee System as a primary or revision total knee replacement. This knee replacement system is intended for cemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate:

• . Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• Rheumatoid arthritis;
• Correction of functional deformity: .
• Revision procedures where other treatments or devices have failed. .

The Augments are used as optional spacers and are cemented below the Tibial Tray using PMMA bone cement.

The Tibial Baseplate Augment is available in the following Sizes:
• Size 1 x 8mm
• Size 2 x 8mm
• Size 3 x 8mm
• Size 4 x 8mm
• Size 5 x 8mm

This document describes the 510(k) submission for the OMNI life science Apex Knee System Tibial Baseplate Augment. It is a premarket notification to demonstrate substantial equivalence to previously marketed devices, not a study proving device safety and effectiveness through clinical trials with specific acceptance criteria as might be expected for an AI/clinical diagnostic device. Therefore, much of the requested information regarding AI device evaluation is not applicable here.

Here's a breakdown of the available information:

1. Table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria in terms of performance metrics (sensitivity, specificity, accuracy, etc.) because this is a mechanical medical device (a knee implant component). Instead, the acceptance criteria are related to mechanical and material properties and a demonstration of substantial equivalence to predicate devices.

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

This information is not applicable. The device is a mechanical implant, and its evaluation does not involve "test sets" or "data provenance" in the way an AI diagnostic device would. The "performance testing" and "bench testing" mentioned are likely mechanical tests performed in a lab setting, not on patient data.

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 is not applicable. Ground truth for mechanical device performance is established through engineering specifications, material properties, and physical testing, performed by engineers and technicians, not clinical experts establishing diagnostic ground truth from patient data.

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

This is not applicable. Adjudication methods are used for resolving disagreements in expert opinions, typically in diagnostic or clinical trial settings. Mechanical testing results are objective measurements.

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

This is not applicable. An MRMC study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks. This device is an implant, not an AI diagnostic tool.

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

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

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

The "ground truth" for this device's acceptance is based on engineering specifications, material standards, and the results of the bench testing demonstrating mechanical integrity, fit, and function as being equivalent to legally marketed predicate devices. This is a regulatory pathway (510(k)) focused on demonstrating substantial equivalence, rather than proving clinical efficacy through extensive outcomes data, which would typically be required for a PMA application.

8. The sample size for the training set

This is not applicable. There is no AI model or "training set" involved in the development or evaluation of this mechanical device.

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

This is not applicable, as there is no training set for an AI model.

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The tibial spacer is a primary component intended for cemented use only in total knee arthroplasty in skeletally mature individuals for treatment of the following:

• Patient conditions of Noninflammatory Degenerative Joint Disease (NIDJD); e.g., avascular . necrosis, osteoarthritis and Inflammatory Joint Disease (IJD); e.g., rheumatoid arthritis;
• Correctable valgus-varus deformity and moderate flexion contracture.
• . Those patients with failed previous surgery where pain, deformity, or dysfunction persists.

These Tibial Spacers are optional components designed to mate with the previously-cleared Natural-Knee II Cemented Modular Tibial Baseplate. Like the Tibial Baseplate, the Tibial Spacers are manufactured from cobalt chrome alloy. The tibial spacers are available in seven sizes (00 through 5) and in two thickness levels. They are available in both medial and lateral and both left and right configurations to match the radial contour of the baseplates.

The provided text is a 510(k) summary for a medical device called "Tibial Spacer for the Natural-Knee® II Cemented Modular Tibial Baseplate." It describes the device, its intended use, and states that it is substantially equivalent to a predicate device.

However, the document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria through clinical data, statistical analysis, or expert review related to AI/ML or diagnostic performance. The basis of substantial equivalence is stated as "Performance testing, design comparisons, and functional analyses conducted on Tibial Spacers for the Natural-Knee® II Cemented Modular Tibial Baseplate demonstrate that the Tibial Spacer is substantially equivalent to the predicate device."

Therefore, based only on the provided text, I cannot fill out the requested table or answer the specific questions related to acceptance criteria, diagnostic performance studies, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance, as these concepts are not mentioned in the context of this 510(k) submission.

This document is for a traditional medical device (a knee implant component) and not an AI/ML-driven diagnostic or image analysis tool, which is typically where the "acceptance criteria" and "study proving criteria met" for performance metrics like sensitivity, specificity, or AUC would be detailed. The "performance testing" mentioned likely refers to mechanical and biocompatibility testing common for implantable devices, not diagnostic accuracy.

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Ask a specific question about this device

The indications for use of this tibial insert are noninflammatory degenerative joint disease including osteoarthritis or traumatic arthritis, avascular necrosis of the femoral condyle, post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus or flexion deformities, rheumatoid arthritis, treatment of fractures that are unmanageable using other techniques.

This component is available in seven sizes to fit into, and articulate with, the existing Foundation Baseplates and Femoral Components. This device is used in conjunction with the Foundation® Tibial Baseplates and Femurs. This insert is intended to provide more congruency between the insert and femur than is available with the primary insert. However, it will provide similar, or slightly more, congruency than the Foundation® Posterior Stabilized Knee. Anterior/posterior stability is greater than the primary insert because of the increased height of the anterior and posterior lips. Rotational stability is similar to the primary insert.

This document, K963028, describes a medical device called a "Tibial Insert." It is a summary of safety and effectiveness information for a 510(k) submission to the FDA.

The provided text does not contain any information related to acceptance criteria or studies that prove the device meets acceptance criteria in the context of AI/ML performance evaluation.

Therefore, I cannot fulfill your request for the tables and information outlined.

The document describes a mechanical implant (a tibial insert for knee replacement surgery) and discusses its design, indications for use, and comparison to predicate devices, but it contains no data on:

• Device performance metrics (e.g., accuracy, sensitivity, specificity for an AI model)
• Sample sizes for test or training sets
• Ground truth establishment
• Expert involvement or adjudication methods
• Comparative effectiveness studies with human readers
• Standalone algorithm performance

It appears the request is based on an assumption that the provided document is describing an AI/ML device, which it is not.

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The AXIOM™ Total Knee System is indicated for use in total knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:

1. noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
2. inflammatory degenerative joint disease including rheumatoid arthritis;
3. correction of functional deformity:
4. revision procedures where other treatments or devices have failed; and
5. treatment of fractures that are unmanageable using other techniques.

The Tibial Tray Plug is intended to be used with all the tibial bases that are available in the AXIOM™ Total Knee System. The purpose of the Tibial Tray Plug is to provide a filler for the screw holes to prevent extrusion of bone cement through the holes when the metal base is implanted without screw fixation. The Tibial Tray Plug will be machined from ultra high molecular weight polyethylene (UHMWPE) conforming to ASTM F 648. The one-piece design will be offered in two alternative slot styles, 4-slotted and 3-slotted.

The Tibial Tray Plug will be offered sterile in a pack of four for insertion into one or more of the four screw holes of the tibial base by the surgeon intraoperatively. The Tibial Tray Plug will also be available preassembled into the tibial tray. Tibial Tray Plugs are placed into the screw holes from the underside of the metal tibial base and snap fit snugly into place. If desired, the Tibial Tray Plug can be removed by using an instrument such as a hemostat to push the plug from the top of the base back through the screw hole.

This document is a 510(k) summary for a medical device called the "Tibial Tray Plug." It provides a description of the device, its indications for use, and a comparison to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of device performance metrics like sensitivity, specificity, or accuracy, which are typically found in studies for diagnostic or AI-powered devices.

The document focuses on:

• Device Description: Material (UHMWPE), design (one-piece, 4-slotted and 3-slotted), and how it snaps into the tibial base.
• Intended Use: As a filler for screw holes in total knee arthroplasty to prevent cement extrusion.
• Indications: For use in the AXIOM™ Total Knee System for various knee conditions.
• Comparison to Predicate Devices: Similarities in material, design, availability, and intended use. The only noted difference is the sterilization method (ethylene oxide for the new device vs. gamma radiation for predicates), both achieving a sterility assurance level of 10⁻⁶.

Therefore, I cannot provide the requested table and study details as they are not present in the provided text.

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