(70 days)
The Optetrak Logic Total Knee System is 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.
In the USA, the OPTETRAK Logic Total Knee System is indicated for cemented use only.
Proposed Optetrak Logic CR Knee System femoral components are modifications to existing femoral components cleared per Optetrak Cruciate Retaining Cemented Total Knee System 510(k) #K932690 and Optetrak Logic Total Knee System 510(k) #K093360.
Proposed Optetrak Logic CR Knee System tibial inserts are modifications to existing tibial inserts cleared per Optetrak Cruciate Retaining Cemented Total Knee System 510(k) #K932690 and Optetrak CR Slope 510(k) #K082022.
The predicate and proposed devices have the same intended use and basic fundamental scientific technology and share the following similarities:
- the same indications for use .
- the same design features .
- . the same materials
- the same shelf life .
- . packaging and sterilization using the same materials and processes
- compatible with the same corresponding Optetrak tibial trays ●
The Optetrak Logic CR Knee System is not being submitted as the result of a recall or any corrective action related to the Optetrak product lines.
The provided document describes the Exactech® Optetrak® Logic® CR Knee System, a cemented total knee prosthesis. The submission is a Special 510(k) and focuses on demonstrating substantial equivalence to previously cleared predicate devices.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative, measurable format with pass/fail thresholds. Instead, the performance evaluations are centered around demonstrating substantial equivalence to existing predicate devices. The "performance data" table describes the activities performed to support this claim.
| Evaluation Area | Activities Performed | Reported Device Performance/Conclusion |
|---|---|---|
| Logic CR insert/femoral component compatibility | Engineering drawing comparison to mating components and equivalent predicates | "Results of engineering studies referenced in this 510(k) submission demonstrate proposed Optetrak Logic CR Knee System devices are substantially equivalent to cited cleared predicate devices." (Implied: compatible with mating components) |
| Logic CR insert/tibial tray compatibility | Engineering drawing comparison to mating components and equivalent predicates | "Results of engineering studies referenced in this 510(k) submission demonstrate proposed Optetrak Logic CR Knee System devices are substantially equivalent to cited cleared predicate devices." (Implied: compatible with mating components) |
| Tibial insert scope addition mechanical properties | Engineering evaluation using Finite Element Analysis to compare contact stresses with predicates | "Results of engineering studies referenced in this 510(k) submission demonstrate proposed Optetrak Logic CR Knee System devices are substantially equivalent to cited cleared predicate devices." (Implied: comparable mechanical properties) |
| Femoral component scope addition equivalency | Engineering drawing comparison to mating components and equivalent predicates | "Results of engineering studies referenced in this 510(k) submission demonstrate proposed Optetrak Logic CR Knee System devices are substantially equivalent to cited cleared predicate devices." (Implied: equivalent design) |
| Femoral component design modification | Engineering evaluation using Finite Element Analysis to compare contact stresses with predicates | "Results of engineering studies referenced in this 510(k) submission demonstrate proposed Optetrak Logic CR Knee System devices are substantially equivalent to cited cleared predicate devices." (Implied: comparable mechanical properties) |
The overall acceptance criterion is based on demonstrating substantial equivalence to the predicate devices. The reported "performance" is that the results of the engineering studies demonstrate substantial equivalence.
2. Sample Size Used for the Test Set and the Data Provenance
The document describes engineering evaluations (drawing comparisons and Finite Element Analysis), not a test set in the traditional sense of human subjects or clinical data. Therefore, there is no sample size for a test set, nor is there information on data provenance (country of origin, retrospective/prospective) as these evaluations are based on design specifications and simulation, not patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
No experts were used to establish ground truth in the context of a test set, as the evaluations were engineering-based rather than involving diagnostic interpretation or clinical outcomes. The "experts" in this context would be the engineers performing the drawing comparisons and finite element analysis, but their qualifications and numbers are not specified.
4. Adjudication Method for the Test Set
Not applicable. There was no test set requiring adjudication in the medical or clinical sense. The comparisons and analyses are engineering-based.
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 knee prosthesis, not an AI-assisted diagnostic tool. Therefore, an MRMC study and AI-related improvement metrics are irrelevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is a physical medical implant, not an algorithm or software.
7. The Type of Ground Truth Used
The "ground truth" in this context is the design specifications and performance characteristics of the predicate devices. The new device's design, compatibility, and mechanical properties were compared against these established predicates to demonstrate equivalence.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not a machine learning model, so there is no training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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.