(90 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 posttraumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
All TRULIANT Femoral Components, Tibial Inserts, and Tibial Trays are indicated for cemented use only, except the TRULIANT Porous Tibial Trays, which are indicated for cemented or cementless use.
Exactech Alteon Bone Screws are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Exactech Alteon Bone Screws are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.
The Exactech Alteon Bone Screws are also 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 tibial tray implant and its porous structure is manufactured from Ti-6Al-4V titanium alloy using electron beam melting (EBM) technology. This product line represents a scope extension of the Truliant knee implant system. The previously cleared Alteon Bone Screws are now cleared for use with the TRULIANT Porous Tibial Trays.
This document does not describe a study involving an algorithm or AI. It is a 510(k) summary for a medical device (TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws), which means it focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and performance data from non-clinical (mechanical) testing.
Therefore, many of the requested categories, such as "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of AI performance, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable to this type of submission.
Here's an analysis based on the information provided, focusing on the mechanical performance data:
1. A table of acceptance criteria and the reported device performance
| Test Mode | Standard Used | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Tibial tray fatigue | ASTM F1800-12 | Sufficient for intended use and substantially equivalent to predicates | Results deemed sufficient for intended use and substantially equivalent to legally marketed predicate devices. |
| Shear fatigue of an EBM porous structure | ASTM F1160-14 (2017) | Sufficient for intended use and substantially equivalent to predicates | Results deemed sufficient for intended use and substantially equivalent to legally marketed predicate devices. |
| Static shear of an EBM porous structure | ASTM F1044-05 (2017) | Sufficient for intended use and substantially equivalent to predicates | Results deemed sufficient for intended use and substantially equivalent to legally marketed predicate devices. |
| Static tension of an EBM porous structure | ASTM F1147-95 (2017) | Sufficient for intended use and substantially equivalent to predicates | Results deemed sufficient for intended use and substantially equivalent to legally marketed predicate devices. |
| Static compression of an EBM porous structure | ASTM E9-09 (2018) | Sufficient for intended use and substantially equivalent to predicates | Results deemed sufficient for intended use and substantially equivalent to legally marketed predicate devices. |
| Porous coating characterization | ASTM F1854-15 | Sufficient for intended use and substantially equivalent to predicates | Results deemed sufficient for intended use and substantially equivalent to legally marketed predicate devices. |
| Pyrogenicity testing | Not specified (standard) | Endotoxin limit less than 20 EU/device | Endotoxin limit is less than 20 EU/device |
Note: The document states that "The results of this non-clinical testing show that the strength of the TRULIANT Porous Tibial Tray is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." The specific numerical acceptance criteria (e.g., minimum load or cycles) and quantitative results for the mechanical tests are not provided in this 510(k) summary, but are implicitly met as per the FDA's clearance.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the given text. For mechanical testing, sample sizes are typically determined by the relevant ASTM standards, but the exact numbers are not mentioned here. The data provenance is also not specified, as this is non-clinical lab testing rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the document describes mechanical and pyrogenicity testing, not studies requiring expert review for ground truth in the context of medical image analysis or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the type of testing described. Adjudication methods are relevant for studies involving human interpretation or clinical endpoints, not for standardized mechanical tests.
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
This is not applicable. This document describes the clearance of a physical medical device (tibial tray and bone screws) through non-clinical testing, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This document does not pertain to an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical tests, the "ground truth" would be the physical properties and performance of the device under controlled laboratory conditions as measured against established ASTM standards. For pyrogenicity, it's the measured endotoxin level. This is not "expert consensus", "pathology," or "outcomes data" in the clinical sense.
8. The sample size for the training set
This is not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This is not applicable. There is no "training set" and thus no ground truth to establish for it in this context.
§ 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.