(28 days)
The TRULIANT Femoral Components, Tibial Inserts, and Tibial Trays are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
The TRULIANT Femoral Components, Tibial Inserts, and Tibial Trays are indicated for cemented use only.
Truliant femoral components are for use in resurfacing femoral bone as part of tricompartmental total knee arthroplasty employing modular components from the Optetrak / Optetrak Logic and Truliant device families.
Truliant femoral components represent modifications to Exactech One Logic femoral components cleared per 510(k) K153776. The proposed Truliant femoral components are identical to predicated One Logic femoral components, with the following key exceptions:
- . Tapered anterior chamfer and patella flange to reduce the appearance of implant / bone overhang
- . Patella flange cement pocket has been modified to increase cement / bone contact area
Additional modifications have been made to facilitate manufacturing.
Like other femoral implants in compatible device families, One Logic femoral components are made from CoCr alloy and are designed to articulate on an ultra-high molecular weight polyethylene tibial insert seated in a metal tibial tray.
Truliant femoral components have the same basic features and articulating surface finish as predicate One Logic femoral components while providing surgeons with an option for a femoral implant with a patella flange that has been comparatively streamlined in the medial-lateral aspects. The articulating congruence featured in all Optetrak and Optetrak Logic femoral-tibial condyle contact is maintained for Truliant femoral components. Cruciate-retaining Truliant femoral components also feature the same patella entry / exit point at the distal trochlear groove featured on predicate One Logic femoral components and intended to enhance patella transition.
The proposed devices operate using same fundamental scientific technology, have the same intended use and design features, employ the same materials of construction, are offered in the same product size scopes, and are implanted using a similar surgical technique and the same or similar instrumentation. The only modifications proposed by this submission are dimensional.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Exactech Truliant Femoral Components:
This document is a 510(k) Summary of Safety and Effectiveness for a medical device (knee implant components). Such documents typically demonstrate substantial equivalence to a predicate device rather than presenting a novel device that requires a statistically powered study to prove "acceptance criteria" against clinical endpoints like diagnostic accuracy or efficacy.
Therefore, many of the requested categories (like sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable in the context of this device and submission type. The focus here is on demonstrating that the new device performs as well as or similarly to an existing, legally marketed device through engineering testing.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this 510(k) submission, the "acceptance criteria" are implied by the performance of the predicate device and the new device's ability to maintain similar performance or not introduce new worst-case scenarios.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical performance comparable to predicate device. | Mechanical Patellofemoral Constraint and Contact Pressure Testing: "Results conclude the proposed Truliant devices do not represent a new worst-case for risks associated with patellofemoral contact." This implies that the patellofemoral constraint and contact pressure are within acceptable limits, not exceeding a "worst-case" scenario compared to the predicate. |
| Sterility and pyrogenicity meet regulatory standards. | Pyrogen Testing: "Pyrogen testing was conducted in accordance with USP , USP , and ANSI/AAMI ST72 to ensure the proposed Truliant components meet recommended limits per FDA's Guidance Document Submission and Review of Sterility Information in Premarket (510(k)) Submission for Devices Labeled as Sterile." This indicates compliance with established sterility and pyrogenicity standards. |
| Maintains fundamental scientific technology and design features. | "The proposed devices operate using same fundamental scientific technology, have the same intended use and design features, employ the same materials of construction, are offered in the same product size scopes, and are implanted using a similar surgical technique and the same or similar instrumentation. The only modifications proposed by this submission are dimensional." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document refers to "mechanical patellofemoral constraint and contact pressure testing" and "pyrogen testing" as "engineering studies." These typically involve a limited number of device samples tested to failure or under specific conditions rather than a large human subject test set.
- Data Provenance: Not applicable in the context of human data. These are laboratory-based engineering and biological safety tests performed on device components.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. The "ground truth" for engineering and pyrogenicity tests is established by recognized standards (e.g., ANSI/AAMI, USP) and the physical properties of the materials and design, not by clinician experts reviewing data.
4. Adjudication Method for the Test Set
- Not applicable. There is no human interpretation or subjective assessment that would require an adjudication method. The tests are objective measurements against predefined criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This is a submission for a knee implant component, not a diagnostic AI system or a device that directly interacts with human readers in a diagnostic capacity. Effectiveness is primarily demonstrated through mechanical performance relative to a predicate device.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
- Not applicable. This device is a physical implant, not an algorithm.
7. Type of Ground Truth Used
- Engineering Standards and Specifications: For mechanical testing, the "ground truth" is defined by the engineering design specifications of the device and the performance characteristics of the predicate device.
- Biological Safety Standards: For pyrogen testing, the "ground truth" is defined by the recognized standards (USP , USP , ANSI/AAMI ST72) for acceptable pyrogen levels.
8. The Sample Size for the Training Set
- Not applicable. This is a hardware device, not an algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, no training set is involved.
§ 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.