(85 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 Cemented Femoral Components, Tibial Inserts, and Tibial Trays are indicated for cemented use only. The TRULIANT Porous Femoral Components are indicated for cemented or cementless use.
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 porous femoral components represent modifications to Optetrak Logic porous femoral components cleared per 510(k) K140302. The proposed Truliant porous femoral components are identical to other Truliant femoral components but employ a porous structure identical to that used for the cited predicate femoral components and can be implanted as part of an uncemented surgical approach.
Proposed and predicate 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 similar product size scopes, are implanted using similar surgical techniques and the same or similar instrumentation, have equivalent Indications for Use statements, and, size for size, are compatible with the same Optetrak, Optetrak Logic, and Truliant patellar and tibial components.
The provided document is a 510(k) summary for the Exactech Truliant Porous Femoral Components. This type of submission is for medical devices seeking clearance from the FDA by demonstrating substantial equivalence to a legally marketed predicate device. The document does not describe a study assessing the performance of a diagnostic or AI-driven device against acceptance criteria in the way requested in the prompt.
Instead, the "acceptance criteria" here refer to the criteria for demonstrating substantial equivalence to an existing predicate device, primarily through engineering analysis and simulated use activities for a physical orthopedic implant.
Therefore, many of the requested fields about AI-specific performance, reader studies, and ground truth establishment are not applicable to this document. I will answer the relevant parts based on the information provided.
1. A table of acceptance criteria and the reported device performance
Since this is an orthopedic implant and not an AI/diagnostic device, the acceptance criteria are related to mechanical performance, biocompatibility, and maintaining similar characteristics to the predicate device. The document does not provide a quantitative table of acceptance criteria with specific thresholds and device performance values. Instead, it broadly states that "engineering studies referenced in this 510(k) submission demonstrate proposed Truliant porous femoral components are substantially equivalent to cited cleared predicate Optetrak Logic porous femoral components."
The "performance" described is about meeting the requirements for substantial equivalence to the predicate device.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functional Equivalence | - Proposed and predicate 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 similar product size scopes.
- Are implanted using similar surgical techniques and the same or similar instrumentation.
- Have equivalent Indications for Use statements.
- Size for size, are compatible with the same Optetrak, Optetrak Logic, and Truliant patellar and tibial components. |
| Mechanical Performance | - Referenced simulated use activities and engineering analysis of device press-fit (details not provided in this summary). The summary indicates these studies demonstrate substantial equivalence. |
| Biocompatibility/Sterility | - 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. (Implies satisfactory results to meet standards, but no specific values are given in the summary). |
| Clinical Performance (Surgeon feedback) | - Referenced Surgeon expert evaluation (details of methodology or specific findings are not provided in this summary, but it implies positive feedback supporting equivalence). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to "simulated use activities" and "engineering analysis of device press-fit" and "surgeon expert evaluation." It does not provide specific sample sizes for these tests, nor does it specify data provenance (e.g., retrospective/prospective clinical data or country of origin) as this is likely primarily bench testing and expert design review for a 510(k) of an orthopedic implant.
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)
The document mentions "Surgeon expert evaluation." However, it does not specify the number of surgeons, their qualifications, or how their input was used to establish a "ground truth" in the context of typical AI/diagnostic device evaluation. For a physical implant, expert evaluation would likely involve assessing design, surgical technique, and perceived performance against the predicate.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 are typically used in clinical studies with human readers interpreting results (e.g., radiology reads). This information is not applicable to the documentation provided, as it pertains to a physical orthopedic implant and its engineering/simulated use evaluation.
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 MRMC study was done, as this document is not about an AI-assisted device or diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical knee implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For an orthopedic implant seeking 510(k) clearance, the "ground truth" for substantial equivalence is primarily based on:
- Demonstrating equivalent materials, design, indications for use, and technological characteristics to the predicate device.
- Satisfactory results from engineering analyses (e.g., stress, fatigue, press-fit) and simulated use activities to ensure mechanical performance is equivalent or better than the predicate.
- Compliance with relevant standards (e.g., for pyrogenicity).
- Surgeon expert evaluation likely provides qualitative validation of the design and surgical approach.
8. The sample size for the training set
This question is not applicable, as this is an orthopedic implant, not an AI model requiring a training set.
9. How the ground truth for the training set was established
This question is not applicable, as this is an orthopedic implant, not an AI model.
§ 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.