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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.

The Triathlon® Tritanium® Total Knee System components are indicated for both uncemented use.

The Triathlon® Total Knee System beaded with Per-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, rheumatoid arthritis, or post-traumatic 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 Augments are intended for cemented or cementless use.

The additional components being added to the Triathlon Total Knee System are:

• Size 0 Cruciate Retaining Femoral Component (cemented use) .
• o Size 0 Primary Cemented Tibial Baseplate
• Size 0 Tritanium Tibial Baseplate for cemented/cementless use ●
• Size 0 CR, CS, and PS Tibial Inserts in X3 ETO and N2Vac ●
• New PS Femoral Component with modified intercondylar PS box (cemented use) ●
• o New PSR (Posterior Stabilizing Rotation ) tibial insert in sizes 0-8 in X3 ETO

Additionally, engineering analyses and finite element analyses were presented to document the range of motion available with the Triathlon Total Knee System.

This document is a 510(k) summary, which is a premarket notification to the FDA to demonstrate that a device is at least as safe and effective as a legally marketed predicate device. It is not a clinical study report that would typically include detailed acceptance criteria and performance data for an AI/ML device.

Therefore, the provided text does not contain the information needed to describe acceptance criteria and a study proving a device meets them, especially for an AI-based medical device. The document concerns modifications to an existing total knee system (implants), not an AI/ML device.

The questions you've asked are highly relevant for the regulatory approval of AI/ML medical devices. If this document were for an AI/ML device, here's how I would break down why the requested information is missing:

Reasoning for Missing Information (Applicable if this were an AI/ML device submission):

The provided text is a 510(k) summary for a "Triathlon Total Knee System - Additional Components." This is a premarket notification for an orthopedic implant (knee replacement components), not an AI/ML (Artificial Intelligence/Machine Learning) device.

The questions posed are specifically for describing the regulatory submission and study design for an AI/ML medical device, which often requires:

• Demonstrating performance metrics (e.g., sensitivity, specificity, AUC) against established acceptance criteria.
• Detailing the ground truth establishment process (expert consensus, pathology, etc.).
• Describing the size and provenance of training and test datasets.
• Explaining human-in-the-loop studies (multi-reader multi-case studies).

Since the device under review is a physical medical implant (knee components), these types of studies and acceptance criteria are not applicable. The sponsor instead provides:

• Engineering analyses and finite element analyses: To document range of motion.
• Non-clinical testing: Fatigue testing, static shear testing, contact area/stress analysis, range of constraint, sterilization validation, and MR Conditional status.
• Bacterial endotoxin testing.

The document explicitly states: "Clinical Testing: Clinical testing was not required as a basis for substantial equivalence." This further confirms that the type of performance evaluation relevant to AI/ML devices was not conducted or required for this orthopedic implant.

In summary, none of the requested information regarding acceptance criteria, study design for AI/ML device performance, sample sizes for training/test sets, ground truth establishment, or human expert involvement is present in this 510(k) summary because it pertains to a mechanical orthopedic implant, not an AI/ML software device.

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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 and 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, rheumatoid arthritis, or post-traumatic 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 Augments are intended for cemented or cementless use.

The subject Triathlon Intermediate Tibial Inserts will be available in the following configurations:

• Cruciate Retaining (CR) intermediate thicknesses of inserts (10mm, 12m, 14mm) will . be added to the previously cleared size range of 9mm, 13mm, 16mm and 19mm
• Cruciate Substituting (CS) intermediate thicknesses of inserts (10mm, 12mm and ● 14mm) will be added to the previously cleared size range of 9mm, 11mm, 13mm, 16mm, 19mm, 22mm and 25mm
• Posterior Stabilizing (PS) intermediate thicknesses of inserts (10mm. 12mm and . 14mm) will be added to the previously cleared size range of 9mm, 11mm, 13mm, 16mm, 19mm, 22mm and 25mm

The design of these inserts are identical to the predicate devices in terms of condylar geometry. post dimensions (in PS design) and locking wire feature. The inserts will be available in X3 ETO, and N2Vac styles.

Additionally. MR Conditional labeling is being added for the subject intermediate thickness inserts as well as those X3 ETO tibial inserts and patellar components previously cleared in premarket notification K172634.

This document is a 510(k) premarket notification from the FDA for the Triathlon Total Knee System. It is a regulatory approval and not a detailed study report with acceptance criteria and performance metrics typically seen in AI/ML device submissions. Therefore, many of the requested fields cannot be filled.

However, I can extract the information related to the non-clinical testing performed to demonstrate substantial equivalence, which serves as a form of acceptance criteria and evidence of performance for this type of medical device.

Acceptance Criteria and Study for Triathlon Total Knee System (K173849)

This submission is for a Traditional 510(k) for an orthopedic implant (knee replacement system), not an AI/ML diagnostic device. As such, the concept of "acceptance criteria" and "device performance" relies on demonstrating substantial equivalence to already legally marketed devices through material characterization, mechanical testing, and biocompatibility, rather than evaluating diagnostic accuracy or clinical outcomes as would be done for AI/ML.

The "study" here refers to the non-clinical testing conducted to support the substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, "acceptance criteria" are generally compliance with recognized standards and demonstration that new designs do not create a "new worst case" compared to predicate devices. "Reported device performance" is the manufacturer's conclusion that these criteria are met.

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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 stabilized by standard fracture -management techniques.

The Triathlon® Tritanium® Total Knee System components are indicated for both uncemented and cemented use.

The Triathlon® Total Knee System beaded and 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, . rheumatoid arthritis, or post-traumatic 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 o

The Triathlon TS Cone Augment components are intended for cemented or cementless use.

Indications for Use for the Triathlon Tritanium Tibial Baseplate are:
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 stabilized by 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 o 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.

Indications for Use for the Triathlon Low Profile Tibial Tray are:
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.

Indications for Use for the Triathlon Metal Backed Patella are:

• . Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis 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.

Indications for Use for the Triathlon PKR System are:

• . 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.

Indications for Use for the Restoris MCK System:
Restoris MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIQ, the Robotic Arm Interactive Orthopedic System, in individuals with osteoarthritis, or post-traumatic arthritis 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.

The devices covered by this submission include femoral components, tibial baseplates, tibial inserts, all-polyethylene tibial components, patellar components, metal backed patellar components, tibial and femoral augments, stems, stem extenders and offset adaptors used in total knee arthroplasty procedures, as well as femoral components, tibial inserts, tibial baseplates, patellofemoral components and patellar components used in partial knee replacements. All devices have been previously determined substantially equivalent in prior 510(k) submissions and are commercially available. The Triathlon/Restoris Knee system components are manufactured from the following materials Cobalt Chromium Alloy, Titanium Alloy, Commercially Pure Titanium, Ultra-High Molecular Weight Polyethylene and Calcium Phosphate.

The purpose of this submission is to modify the labeling of the Triathlon Total Knee System, Triathlon PKR System, and Restoris MCK System to add MR Conditional labeling. Additionally, a revision to the contraindications for the Triathlon PKR System is being made.

This document describes the premarket notification (510(k)) for the Stryker Orthopaedics Triathlon Total Knee System, Triathlon PKR System, and Restoris MCK System. The submission primarily focuses on modifying the labeling to add MR Conditional labeling and revising contraindications for the Triathlon PKR System. Therefore, the "device" in question is the existing knee replacement systems with updated MRI compatibility information.

As such, the provided text DOES NOT describe a study that proves a device meets acceptance criteria related to its functional performance (e.g., accuracy, sensitivity, specificity, or improvement in human reader performance for an AI/CAD device). Instead, it details the non-clinical testing performed to establish the MR compatibility of the knee systems.

Given this, I will tailor the answer to reflect the information available regarding the MR compatibility studies, rather than a clinical performance study often associated with AI/CAD devices.

Here's a breakdown 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 acceptance criteria are implicitly defined by the standards and guidance used for MR compatibility testing. The reported performance is that the devices passed these tests and are therefore deemed "MR Conditional" under specific parameters.

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

The text does not specify the sample size in terms of the number of devices tested for MR compatibility. Typically, for such non-clinical bench testing, a representative sample of device types and sizes would be tested according to the standards. The data provenance is "non-clinical laboratory testing." This is implicitly a prospective study conducted in a controlled lab setting, not involving human or animal data, and thus no country of origin for patients or retrospective/prospective human data is applicable.

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 question is not applicable to the type of testing performed. For MR compatibility, the "ground truth" is established by the physical measurements taken according to standardized test methods (e.g., measuring temperature rise, displacement, torque, or evaluating artifact characteristics against defined limits). This does not involve human expert consensus on diagnostic images.

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

This question is not applicable to the type of testing performed. Adjudication methods are typically used when human interpretation of data (e.g., radiologist reads) is required to establish ground truth or evaluate performance, for example in clinical trials of AI algorithms. For MR compatibility testing, the results are objectively measured per established 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

No such study was performed or described. This type of study is relevant for AI/CAD devices where human reader performance is a key metric. This submission is for knee implants and their MR compatibility, not an AI device.

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

This question is not applicable. The device is a physical knee implant, not an algorithm.

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

The ground truth for MR compatibility testing is based on:

• Physical measurements: Quantifiable measurements of magnetic force, torque, temperature rise, and the extent of image artifacts, as defined by the respective ASTM standards.
• Standardized protocols: Adherence to established test methods that determine safety in the MR environment.

This is a form of objective, physical measurement ground truth, not based on expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This question is not applicable. The device is a physical product (knee implant) and there is no mention of an AI/machine learning component that would require a training set.

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

This question is not applicable as there is no training set mentioned for this product.

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General Total Knee Arthroplasty (TKA) Indications

• 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.
• . Revision of previous unsuccessful uni-knee replacement or other procedure.

Additional Indications for Universal Baseplates and Stem Components:

• Ligamentous instability requiring implant bearing surface geometries with increased constraint. ●
• Absent or non-functioning posterior cruciate ligament. .

Indications for Bone Augments:

• Painful, disabling joint disease of the knee secondary to: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis, complicated by the presence of bone loss.
• Salvage of previous unsuccessful uni-knee replacement or other surgical procedure, accompanied . by bone loss.

The Triathlon® Total Knee System components are intended for cemented use only.

Not Found

The provided text does not contain any information about acceptance criteria or a study proving device performance, as it is an FDA 510(k) clearance letter for the Triathlon® Total Knee System. This letter confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements. It does not include details on clinical studies, performance metrics, ground truth, or expert involvement for AI/device performance evaluation.

Therefore, I cannot provide the requested table and study details based on the given input.

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