(72 days)
The intended use of the Triathlon™ PS Femoral Component is: it is intended to be used with Triathlon™ PS tibial inserts, Triathlon™ Primary Cemented Tibial Tray, and Triathlon™ and/or Duracon® patellar components in primary or revision cemented total knee arthroplasty. Specific indications:
Indications:
- · Painful, disabling joint disease of the knee resulting from: noninflammatory 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 Indications for Posterior Stabilized Components:
- · Ligamentous instability requiring implant bearing surface geometries with increased constraint.
- · Absent or non-functioning posterior cruciate ligament.
The modified Triathlon™ PS Femoral Component (catalog number 5515) is identical to the previously released Triathlon™ PS Femoral Component in terms of intended use, material, and general design features. The only difference is the removal of material from the superior, posterior portion of the cam. Physical testing was performed to show that the component could withstand load over ten million cycles.
Here's an analysis of the provided 510(k) summary, focusing on acceptance criteria and the supporting study:
The provided document describes a 510(k) premarket notification for a design modification of a knee femoral component. The primary purpose of this submission is to demonstrate substantial equivalence to a previously cleared predicate device, rather than proving a novel device's performance against clinical acceptance criteria.
Key takeaway: This 510(k) submission is for a material removal design change to an existing device (Triathlon™ PS Femoral Component, previously cleared under K031729). The acceptance criteria and "study" described are focused on demonstrating that this minor design change does not negatively impact the device's original performance and that it remains substantially equivalent to the predicate. Therefore, the information provided is not a typical clinical study proving the device meets performance acceptance criteria against a ground truth in the way one might expect for a new diagnostic or prognostic device.
Here's the breakdown based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit from 510(k)) | Reported Device Performance |
|---|---|
| Mechanical Durability: The modified component must withstand physiological loading without failure. | The component "could withstand load over ten million cycles" in physical testing. |
| Material Equivalence: The material of the modified component must be the same as the predicate. | The modified component is "identical to the previously released Triathlon™ PS Femoral Component in terms of intended use, material, and general design features" (with the exception of the removed material). |
| Functional Equivalence: The design modification should not alter the articular surface designs or intended function. | "The articular surface designs of the component (both patello-femoral and tibio-femoral) are unchanged by this modification." |
| Manufacturability: The design change should improve manufacturability. | "This material is being removed to improve manufacturability of the component." This is the primary driver for the change. |
| Intended Use & Indications: The modified device must retain the same intended use and indications as the predicate. | "The intended use of the Triathlon™ PS Femoral Component is identical to that of the predicate." (Specific indications are listed). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the traditional sense for a clinical test set. The "test set" here refers to the physical component that underwent testing. The document refers to "the component" as a singular item rather than a specified quantity.
- Data Provenance: The testing was "Physical testing" performed on the modified component. There's no information about country of origin or whether it's retrospective/prospective clinical data; it's laboratory/bench testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This is not a study involving human interpretation or ground truth established by experts in the context of clinical data. The "ground truth" for mechanical durability is derived from mechanical testing standards and engineering principles.
4. Adjudication Method for the Test Set
- Not applicable. There was no clinical test set requiring 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
- Not applicable. This is not a study involving human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for the assessment of this mechanical device is based on mechanical engineering principles and established testing standards for orthopedic implants, specifically regarding fatigue life and structural integrity under simulated physiological loads. The acceptance criterion is typically defined by these standards (e.g., ISO standards for knee implants, or internal company standards validated against such). The document states the component "could withstand load over ten million cycles," which is a common benchmark for fatigue testing in orthopedic implants.
8. The Sample Size for the Training Set
- Not applicable. This is a physical device, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
- Not applicable.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.