(171 days)
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.
§ 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.