(269 days)
The TRULIANT E-PX Tibial Inserts and Patellas 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 E-PX Patellas are intended for cemented use only.
The TRULIANT Knee System is a system of orthopedic implants intended for total knee replacement. The system includes Femoral components, Tibial Trays, Tibial Inserts, and Patellas. The Tibial Inserts and Patellas used in the TRULIANT Knee system currently are constructed of compression molded UHMWPE and extruded UHMWPE respectively. This submission proposes TRULIANT Tibial Inserts and Patellas made from UHMWPE containing vitamin E. This submission additionally proposes minor geometric change(s) to all Tibial Insert devices as well as additional intermediate TRULIANT CC Tibial Insert size options.
The provided text is a 510(k) summary for the TRULIANT® E-PX Tibial Inserts and Patellas. It describes the device, its intended use, and comparative testing to demonstrate substantial equivalence to predicate devices. However, this document does not contain specific acceptance criteria, reported device performance metrics (numerical results), or information about a clinical study with a test set, ground truth establishers, or adjudication methods.
The document outlines a series of non-clinical tests and engineering analyses that were performed. These tests, listed under "Non-Clinical and/or Clinical Tests Summary & Conclusions" (although it explicitly states "non-clinical testing"), are:
- Material Characterization
- Wear
- Fatigue
- Range of Motion
- Tibial-femoral stability characteristics
- Tibial modular disassembly characteristics
- Biocompatibility
- Bacterial endotoxins
The document concludes that "The differences in raw material and geometry do not change the intended use, safety, or performance requirements of the proposed devices, nor do they adversely affect their safety or effectiveness. This conclusion is based on consideration of the preclinical testing and analysis including material characterization, biocompatibility assessment and testing and mechanical testing and analysis completed to establish substantial equivalence of the proposed devices to the predicate devices."
Therefore, I cannot populate the table or answer most of the questions you've asked because the information is not present in the provided text. The text describes a pre-market notification (510(k)) for a medical device which relies on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical testing and engineering analysis, rather than a clinical study with human patients, a test set, or human expert evaluations in the way you've described.
Here's what I can provide based on the text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. Performance is demonstrated through comparison to predicate devices via non-clinical tests, but specific metrics and their acceptance thresholds are not provided. | Not specified in the document. The document states that the testing "demonstrate[s] that the Exactech TRULIANT Tibial Inserts and Patellas perform as intended and are substantially equivalent to the identified predicate devices," but no numerical performance results are given. |
2. Sample size used for the test set and the data provenance: Not applicable. The document describes non-clinical engineering and material tests, not a clinical study with a "test set" of patients or data provenance in that context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical study with human expert ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical study with adjudication of expert opinions is described.
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 document pertains to a knee implant, not an AI-assisted diagnostic device, so an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This document pertains to a knee implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for demonstrating substantial equivalence for this device is based on the performance of the predicate devices and the outcomes of the non-clinical tests described (material characterization, wear, fatigue, etc.) designed to show comparable safety and effectiveness.
8. The sample size for the training set: Not applicable. No machine learning training set is described.
9. How the ground truth for the training set was established: Not applicable. No machine learning training set is described.
§ 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.