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), 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.
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
The Triathlon TS Cone Augments are intended for cemented or cementless use.
The subject Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components are a modified version of the predicate Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components. The device designs are identical to the predicate devices which are available in the posterior stabilized (PS), cruciate retaining (CR), condylar stabilizing (CS) and total stabilizing (TS) designs for the tibial inserts, and the symmetric and asymmetric designs for the patellar components. The subject inserts and patellar components will have a different method of terminal sterilization (ethylene oxide) and will be formed by consolidating Type 1 (GUR1020) resin via conventional methods which meet the specifications of ASTM F648. Like the predicate devices, the subject Triathlon® X3® CR, CS, PS and TS+ tibial inserts will contain a Cobalt Chromium locking wire as per ASTM F90, and the Triathlon TS+ tibial insert will also additionally contain a Cobalt Chromium tibial support pin as per ASTM F1537.
The provided text does not contain information about the acceptance criteria or a study that proves a device meets specific acceptance criteria in the context of an AI/ML medical device. Instead, the document is a 510(k) premarket notification for Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components, which are orthopedic implants (knee joint replacement components).
The document details the substantial equivalence of this device to previously cleared predicate devices based on material, design, intended use, and non-clinical performance testing. It explicitly states: "Clinical Testing: Clinical testing was not required as a basis for substantial equivalence."
Therefore, I cannot provide the requested information, including:
- Table of acceptance criteria and reported device performance: This document does not specify performance metrics or acceptance criteria for an AI/ML driven device.
- Sample size, data provenance: Not applicable as no clinical study for an AI/ML device is discussed.
- Number of experts, qualifications: Not applicable.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study, effect size: Not applicable.
- Standalone performance: Not applicable.
- Type of ground truth: Not applicable.
- Training set sample size: Not applicable.
- Ground truth for training set: Not applicable.
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.