Search Results

General Total Knee Arthroplasty (TKR) Indications:
• Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis.
· Post-traumatic loss of knee joint configuration and function.
· Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
· Revision of previous unsuccessful knee replacement or other procedure.

• Fracture of the distal femur and/or proximal tibia that cannot be standard fracture -management techniques.
  The Triathlon® Tritanium® Total Knee System components are indicated for both uncemented use. The Triathlon® Total Knee System beaded with Peri-Apatite components are intended for uncemented use only.
  The Triathlon® All Polyethylene tibial components are indicated for cemented use only.
  Additional Indications for Posterior Stabilized (PS) and Total Stabilizer (TS) Components:
• · Ligamentous instability requiring implant bearing surface geometries with increased constraint.
• · Absent or non-functioning posterior cruciate ligament.
  · Severe anteroposterior instability of the knee joint.
  Additional Indications for Total Stabilizer (TS) Components:
  · Severe instability of the knee secondary to compromised collateral ligament integrity or function.
  Indications for Bone Augments:
  · Painful, disabling joint disease of the knee secondary to: degenerative arthritis, rheumatic arthritis, complicated by the presence of bone loss.
  · Salvage of previous unsuccessful total knee replacement or other surgical procedure, accompanied by bone loss.
  Additional Indications for Cone Augments:
• · Severe degeneration or trauma requiring extensive resection and replacement
• · Femoral and Tibial bone voids
• Metaphyseal reconstruction
  The Triathlon TS Cone Augment components are intended for cemented or cementless use.

Triathlon Pro Posterior Stabilized Femoral Components Indications for Use:
General Total Knee Arthroplasty (TKR) Indications:
· Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis.

• · Post-traumatic loss of knee joint configuration and function.
  · Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
  · Revision of previous unsuccessful knee replacement or other procedure.
  · Fracture of the distal femur and/or proximal tibia that cannot be standard fracture -management techniques. Additional Indications for Posterior Stabilized (PS) components:
• · Ligamentous instability requiring implant bearing surface geometries with increased constraint.
• · Absent or non-functioning posterior cruciate ligament.
• · Severe anteroposterior instability of the knee joint.
  The Triathlon® Pro PS Femoral Components are intended for cemented use only.

Triathlon Tritanium Tibial Baseplate Indications for Use:
General Total Knee Arthroplasty (TKR) Indications:
· Painful, disabling joint disease of the knee resulting from: non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis

• · Post-traumatic loss of knee joint configuration and function
• · Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability
• · Revision of previous unsuccessful knee replacement or other procedure
• · Fracture of the distal femur and/or proximal tibia that cannot be standard fracture management techniques
  Additional General Total Knee Arthroplasty (TKR) Indications specific to the PS implant:
• · Ligamentous instability requiring implant bearing surface geometries with increased constraint
• Absent or non-functioning posterior cruciate ligament
• · Severe anteroposterior instability of the knee joint
  The Triathlon Tritanium Tibial Baseplates are indicated for both cemented and uncemented use.

Triathlon Low Profile Tibial Tray Indications for Use:
The Triathlon Low Profile Tibial Tray is intended to be used with commercially available Triathlon® femoral components and associated patellar components, and tibial bearing inserts in primary cemented total knee arthroplasty. The indications for the Triathlon® Low Profile Tibial Tray are outlined below:
Indications for Use:
· Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis.
· Post-traumatic loss of knee joint configuration and function.
· Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.

Triathlon Metal Backed Patella Indications for Use:

• · Noninflammatory degenerative joint disease including osteoarthritis or avascular necrosis;
• Rheumatoid arthritis;
• · Correction of functional deformity;
• · Revision procedures where other treatments or devices have failed;
• · Post traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy; and,
• · Irreparable fracture of the knee.
  These products are intended to achieve fixation without the use of bone cement.

Triathlon Partial Knee System Indications for Use:
Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis
· Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee prosthesis
· As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis
· Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the femoral condyle/tibial plateau.
These components are intended for implantation with bone cement.

Avon Patello-femoral Joint Prosthesis Indications for Use:
The Avon Patello-femoral Joint Prosthesis is intended to be used in cemented patellofemoral arthroplasty in patients with degenerative arthritis in the distal femur and patients with a history of patellar dislocation or patella fracture, or patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity, or dysfunction persists. These components are single use only and are intended for implantation with bone cement.

Restoris Multi-Compartmental Knee System Indications for Use:
Restoris MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO, the Robotic Arm Interactive Orthopedic System, in individuals with osteoarthritis of the tibiofemoral and/or patellofemoral articular surfaces.
The specific knee replacement configurations include:

• Medial unicondylar
• Lateral unicondylar
• Patellofemoral
• · Medial bi-compartmental (medial unicondylar and patellofemoral)
  Restoris Multi Compartmental Knee is for single use only and is intended for implantation with bone cement.

All of the subject devices have been found substantially equivalent in previous 510(k)s. All the subject devices have been cleared for MR conditional labeling in previous 510(k)s. The purpose of this submission is to modify the MR conditional information in the instructions for use to update the parameters in which a patient who has the device can be safely scanned, per testing conducted accordance to updated FDA guidance. There have been no changes made to the devices requiring 510(k) clearance - only the MR conditional information in the instruction for use is being modified.
An additional contraindication is being added to the components of the Triathlon Total Knee System. This contraindication regarding material sensitivity to implant materials is being added.

This document is a 510(k) premarket notification for knee arthroplasty devices, specifically for the Triathlon Knee System and related components. It is important to note that this document does NOT describe a study evaluating the performance of a device driven by an AI algorithm or software.

Instead, this submission is for physical medical devices (knee implants) and their associated labeling. The core purpose of this 510(k) submission is to modify the MR conditional information in the instructions for use for these existing, previously cleared devices due to updated FDA guidance on MR safety testing. The document explicitly states:

• "There have been no changes made to the devices requiring 510(k) clearance - only the MR conditional information in the instruction for use is being modified." (Page 16)
• "There have been no changes requiring 510(k) clearance to the technological characteristics of the Stryker Knee systems as a result of the revision to the labeling." (Page 19)
• "Clinical testing was not required as a basis for substantial equivalence." (Page 20)

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI-driven device's performance (e.g., accuracy, sensitivity, specificity, human-in-the-loop studies) cannot be extracted from this document, as it pertains to entirely different types of evaluation (mechanical performance, biocompatibility, and in this specific case, MR safety of physical implants, not AI algorithm performance).

To explicitly answer your questions based on the provided document, even if they don't fully apply to the nature of this submission:

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

   • Acceptance Criteria (Implicit for this submission): The new MR safety testing results must demonstrate that the device is safe for use in an MR environment under the updated parameters to justify the labeling changes, and that the device remains substantially equivalent to its predicates.
   • Reported Device Performance: The document states: "New testing was performed to comprehensively assess the RF-related heating effects induced by the subject devices when implanted into bone, following the FDA guidance document, "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," dated May 20, 2021." (Page 19). While the specific quantitative results of this testing are not provided in this summary document, the FDA's clearance (the letter at the beginning) implies the acceptance criteria for MR safety were met.

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

   • This document describes non-clinical (laboratory) testing for MR safety. It does not involve "test sets" in the sense of patient data for AI evaluation. The "sample size" would refer to the number of physical implants tested for MR compatibility. This specific number is not provided in the summary.
   • Data Provenance: N/A for clinical data; the testing was performed per FDA guidance, implying controlled laboratory conditions.

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

   • N/A. This is not a study requiring expert readers or ground truth establishment in the context of AI performance. The "ground truth" for MR safety is established by quantitative measurements in a laboratory setting based on physics principles and regulatory standards.

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

   • N/A. Not a clinical study requiring human adjudication.

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. This document does not pertain to AI or human reader performance.

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

   • No. This document does not describe an algorithm.

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

   • N/A for artificial intelligence context. The ground truth for this submission relates to physical properties and safety in an MR environment, established through standardized physical testing and engineering measurements.

8. The sample size for the training set:

   • N/A. There is no training set mentioned or implied for an AI algorithm in this submission.

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

   • N/A. There is no training set mentioned or implied.

In summary, this 510(k) notification is for knee replacement components and deals with updating their MR conditional labeling based on physical testing, not with the performance evaluation of an AI-powered device.

Ask a specific question about this device

The Avon Patello-femoral Joint Prosthesis is intended to be used in cemented patellofemoral arthroplasty in patients with degenerative arthritis in the distal femur and patella, patients with a history of patellar dislocation or patella fracture, or patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists.

These components are single use only and are intended for implantation with bone cement.

This submission covers the Avon femoral and patellar components of the Avon Patello-femoral Joint Prosthesis. The femoral components are manufactured from Cobalt Chrome (CoCr) and the patellar components are manufactured from Ultra-high Molecular Weight Polyethylene (UHMWPE) materials.

The purpose of this submission is to add Magnetic Resonance (MR) Conditional labeling to the labeling of the Avon femoral and patellar components of the Avon Patello-femoral Joint Prosthesis. Additionally, minor labeling and packaging updates, as detailed in the respective sections, are also included in this submission.

The provided text is a 510(k) Summary for a medical device (Avon Patello-femoral Joint Prosthesis) seeking clearance for minor labeling and packaging updates, specifically to add Magnetic Resonance (MR) Conditional labeling. This submission does not describe a study to prove the device meets acceptance criteria related to its clinical effectiveness or performance in a patient.

Instead, it describes non-clinical testing to demonstrate that the device is "MR Conditional" as per relevant ASTM standards. Therefore, many of the requested categories are not applicable to the information provided.

Here's the breakdown of what can be extracted:

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

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

This information is not provided. The testing was non-clinical (laboratory testing of the device components), not involving human subjects or 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)

Not applicable. The ground truth for the MR Conditional testing is established by the ASTM standards themselves, which define methodologies and criteria for measurement. No human experts were involved in establishing "ground truth" for this non-clinical testing.

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

Not applicable. This was non-clinical, objective testing against predefined engineering standards.

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 document is not about AI or diagnostic imaging interpretation. It is for a joint prosthesis and its MR compatibility.

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

Not applicable. This document is not about an algorithm, but a physical medical device.

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

The "ground truth" for the non-clinical testing was defined by adherence to published ASTM standards for MR compatibility. These are objective engineering and physics standards.

8. The sample size for the training set

Not applicable. This was non-clinical testing, not a machine learning study.

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

Not applicable. This was non-clinical testing, not a machine learning study.

Ask a specific question about this device

The Avon® Patello-femoral Joint Prosthesis is intended to be used in cemented patellofemoral arthroplasty in patients with degenerative arthritis in the distal femur and patella, patients with a history of patellar dislocation or patella fracture, or patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists.

These components are single use only and arc intended for implantation with bone cement.

The Avon® Patello-femoral Joint (PFJ) Prosthesis was cleared for marketing in K010100. K020841 and K041160. The current system consists of cobalt-chromium femoral components available in four sizes (extra small, small, medium, and large), and all-polyethylene components available in various sizes (small, medium. and large) and styles. This 510(k) submission is a line extension to the Avon "Patello-femoral Joint Prosthesis to add additional styles of patellar components to the system and update the labeling.

The provided text describes a 510(k) Premarket Notification for the Avon® PFJ Prosthesis, focusing on its substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance metrics in the format requested.

The document is a summary of safety and effectiveness, and subsequently, the FDA's letter of substantial equivalence. This type of submission relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, largely through comparison of design, materials, indications, and operational principles, often supported by bench testing where relevant. It does not typically involve clinical studies with human subjects that would generate acceptance criteria and performance data in the context of sensitivity, specificity, or similar metrics for diagnostic devices.

Therefore, many of the requested categories concerning acceptance criteria and study details cannot be directly answered from the provided text.

Based on the provided information, here's what can be extracted and what cannot:

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

The document does not specify quantitative acceptance criteria or reported device performance in terms of clinical outcomes or diagnostic accuracy per se. The "performance" assessment is based on the claim of substantial equivalence to a predicate device.

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

Not applicable. The document describes a 510(k) submission for a medical device (prosthesis), which typically relies on bench testing and comparison to a predicate device, rather than patient-based test sets with a specific sample size. The "testing" mentioned refers to compatibility testing, not a clinical trial or performance study 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)

Not applicable. There is no mention of a ground truth established by experts as this is not a diagnostic device or a study involving human-in-the-loop assessment of images or clinical findings.

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

Not applicable. No test set or expert adjudication is described in the context of this device submission.

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 device is a prosthesis, not an AI-powered diagnostic tool, so an MRMC study is not relevant here.

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

Not applicable. This is a physical implantable device, not an algorithm.

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

Not applicable in the sense of a clinical or diagnostic study. The "ground truth" for this submission is the established safety and effectiveness of the predicate device, and the demonstrating that the new device meets the same standards through design, material, and functional equivalence, often supported by bench testing.

8. The sample size for the training set

Not applicable. No training set is mentioned as this is not a machine learning or AI device.

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

Not applicable.

Ask a specific question about this device

Ask a specific question about this device