(21 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.
Proposed Truliant femoral components represent modifications to Truliant femoral components cleared per 510(k) K170240. The proposed Truliant femoral components are identical to cited predicate femoral components except for dimensional modifications representing new additions to the product scope.
Proposed Truliant tibial trays represent modifications to One Logic tibial trays cleared per 510(k) K152170 and rebranded as Truliant per 510(k) K170240. The proposed Truliant trays are identical to cited predicate trays except for dimensional modifications representing new additions to the product scope.
Proposed Truliant tibial inserts represent modifications to One Logic tibial inserts cleared per 510(k) K152170 and rebranded as Truliant per 510(k) K170240. The proposed Truliant inserts are identical to cited predicate inserts except for dimensional modifications representing new additions to the product scope.
The proposed devices operate using the 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.
Based on the provided text, the device in question is the Exactech® Truliant™ Line Extensions, which are knee prosthesis components (Femoral Components, Tibial Inserts, and Tibial Trays). This document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a clinical study to prove the device meets specific acceptance criteria in terms of performance in patients.
Therefore, many of the requested criteria for an AI/device performance study (like MRMC studies, ground truth establishment, training set details, and specific acceptance metrics like AUC, sensitivity, specificity) are not applicable to this type of submission. This document describes a substantial equivalence determination for a medical device based on engineering and mechanical testing, not a study evaluating human-in-the-loop performance or standalone AI algorithm performance.
Here's a breakdown based on the provided text, addressing the points where information is available or explaining why it's not applicable:
1. A table of acceptance criteria and the reported device performance
The document does not detail specific acceptance criteria in numerical terms for clinical performance (e.g., a certain percentage improvement). Instead, it states that the testing "conclude[s] the proposed Truliant devices do not represent a new worst-case for risks associated with patellofemoral contact, insert / tray assembly properties, or biocompatibility." This implies that the acceptance criterion was non-inferiority or equivalency to the predicate devices in these mechanical and biocompatibility aspects.
The reported performance is described qualitatively:
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Patellofemoral constraint (Mechanical) | "Results conclude the proposed Truliant devices do not represent a new worst-case for risks associated with patellofemoral contact..." |
| Patellofemoral contact pressure (Mechanical) | "Results conclude the proposed Truliant devices do not represent a new worst-case for risks associated with patellofemoral contact..." |
| Insert / tray assembly micromotion (Mechanical) | "Results conclude the proposed Truliant devices do not represent a new worst-case for risks associated with... insert / tray assembly properties..." |
| Insert / tray locking strength (Mechanical) | "Results conclude the proposed Truliant devices do not represent a new worst-case for risks associated with... insert / tray assembly properties..." |
| Biocompatibility | "Results conclude the proposed Truliant devices do not represent a new worst-case for risks associated with... biocompatibility." |
| Pyrogenicity / Sterility (USP , , ANSI/AAMI ST72) | "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..." |
2. Sample size used for the test set and the data provenance
- Sample Size: The document refers to "engineering studies" and "mechanical testing." These typically involve a limited number of physical prototypes for testing the stated properties. The specific number of components or test specimens for each mechanical test (e.g., number of inserts, trays, or femurs tested for micromotion or strength) is not specified in this summary.
- Data Provenance: Not applicable in the sense of clinical patient data. The data comes from in vitro mechanical and biocompatibility testing of the device components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study requiring human expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring human expert interpretation or 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 device is a physical knee prosthesis, not an AI imaging analysis tool.
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 AI algorithm. Its performance is evaluated through mechanical and materials testing.
7. The type of ground truth used
For mechanical and biocompatibility testing, the "ground truth" is established by engineering specifications, material science standards, and recognized test methods (e.g., ASTM standards for mechanical properties, ISO standards for biocompatibility, USP for pyrogenicity). The device's performance is compared against these predefined physical and chemical limits or against the performance of predicate devices.
8. The sample size for the training set
Not applicable. There is no concept of a "training set" for this type of device submission.
9. How the ground truth for the training set was established
Not applicable. There is no concept of a "training set" for this type of device submission.
§ 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.