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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.

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The Triathlon® Tritanium Tibial Baseplates are designed to be implanted with or without bone cement in primary or revision Total Knee Arthroplasty procedures.

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), theumatoid 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 stabilized by standard fracture management techniques

Additional Indications for Posterior Stabilizing (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® Tibial Baseplates are indicated for both cemented and uncemented use.

The Triathlon Tritanium Tibial Baseplate is an extension of the Triathlon® Total Knee System product line for use in primary or revision Total Knee Arthroplasty. It is a sterile, single patient use, tibial baseplate and will be offered in the same size range as the current Triathlon® cementless baseplates (Sizes 1-8). This porous-coated baseplate is for use in both cemented and cementless applications. The Triathlon® Tritanium Tibial Baseplates are packaged with a sterile, single patient use, disposable Impactor Pad in-The Impaction Pad is to be used during the tibial baseplate impaction step only, and is to situ. be discarded once the impaction has been completed. The Impaction Pad is not for implantation.

The Triathlon® Tritanium Tibial Baseplate is compatible for use with the Triathlon® PS, CS and CR Tibial Inserts (NoVac or X3 polyethylene), Triathlon® PS and CR Femoral components (cemented & cementless), Triathlon Symmetric Patellar components (NoVac or X3 polyethylene) (cemented), Triathlon Asymmetric Patellar components (NoVac or X3 polyethylene) (cemented), Triathlon® Metal Backed Asymmetric Patellar with PA (cementless), Duracon® Symmetric & Asymmetric Patellar components (cemented), and Duracon® Inset Patella component (cemented) . These implants may also be used with ShapeMatch Cutting Guides.

The provided text describes a medical device, the Triathlon® Tritanium® Tibial Baseplates, and its FDA 510(k) summary for substantial equivalence. However, it does not contain information about a study that establishes acceptance criteria for AI/ML device performance or a study proving the device meets such criteria.

The document is for a traditional medical device (a knee implant), not an AI/ML diagnostic or therapeutic tool. Therefore, the questions related to AI/ML device performance, sample sizes for test/training sets, experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable to this submission.

The "Non-Clinical Testing" section describes mechanical and wear testing for the orthopedic implant, which are the relevant performance evaluations for this type of device.

Here's a breakdown of the information that is present and a clear indication of what is not applicable based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the context of AI/ML device performance. The device is a physical knee implant. Its "performance" is assessed through non-clinical mechanical and wear testing against established standards, not through metrics like sensitivity, specificity, or AUC against a ground truth.

The non-clinical tests performed were to determine "substantial equivalence" and included:

• Mechanical properties of materials: ASTM F1580, ASTM F67, ASTM F136, ASTM F1147, ASTM F1044, ASTM F1160.
• Device fatigue strength: ASTM F1800, ASTM F2083.
• Wear evaluation of conventional polyethylene inserts: ASTM F2025, ISO 14243-3.
• Adherence to FDA Guidance Document: 'Guidance document for testing orthopaedic implants with modified metallic surfaces apposing bone or bone cement,' dated April 28, 1994.

The document states that these tests were performed to determine "substantial equivalence" to predicate devices, implying that the results met the established criteria within these standards to demonstrate equivalent material properties, strength, and wear characteristics. Specific numerical acceptance criteria or reported performance data for each test are not detailed in this summary document.

2. Sample size used for the test set and the data provenance

Not applicable for AI/ML performance. The "test set" in this context refers to the physical samples of the implant and its materials subjected to mechanical and wear testing. The sample sizes for these engineering tests are typically specified within the referenced ASTM and ISO standards, but are not provided in this summary. Data provenance (e.g., country of origin, retrospective/prospective) is not relevant for physical product testing.

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

Not applicable for AI/ML performance. "Ground truth" for an orthopedic implant's mechanical properties is established by objective engineering measurements against physical standards, not by expert consensus on data interpretation.

4. Adjudication method for the test set

Not applicable for AI/ML performance.

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 is not an AI/ML device. No MRMC study was performed.

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

No. This is not an AI/ML device.

7. The type of ground truth used

Not applicable for AI/ML performance. The "ground truth" for this device's performance is compliance with established engineering standards for material properties, fatigue strength, and wear, demonstrated through physical laboratory testing.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set.

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

Not applicable. This is not an AI/ML device, so there is no training set or associated ground truth.

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