(60 days)
The Optetrak® HI-FLEX Asymmetric Posterior-Stabilized Cemented Femoral Components (herein referred to as the Optetrak® HI-FLEX PS Femoral Components) and Optetrak® HI-FLEX Posterior-Stabilized Tibial Inscrts (Herein referred to as the HI-FLEX PS Tibial Inserts) are intended to be used with an Optetrak® Tibial Tray to replace the patient's distal fomur and proximal tibia during primary or revision total knee arthroplasty. The Optetrak® HI-FLEX PS Femoral components are intended for use when needed to closely match the geometry of the patient's resected distal femur and allows for more flexion than the standard Optetrak® components.
The Optetrak® HI-FLEX PS Tibial Insert is intended for use with the Optetrak® HI-FLEX PS Femoral components to afford the patient a higher degree of flexion than the standard Optetrak " femoral/tibial insert combination.
The proposed components are intended for use in total knee arthroplasty procedures in which the Posterior Cruciate Ligament (PCL) must be sacrificed.
All proposed femoral components are intended for cemented use only.
The OPTETRAK® Total Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knce replacement due to osteoarthritis, osteonecrosis, theurnatoid 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 device modifications to the femoral components presented in this Special 510(k) represent changes to the Optetrak® Asymmetric (AK), Posterior-Stabilized, Cemented Femoral Components (K032606) and the Optetrak® B-Series Postcrior-Stabilized Femoral Component (K010434). These changes represent a combination of
- The condyle, anterior cam, asymmetric flange and PCL stabilizing box geometries of the Optetrak® AK Femoral components, and
- The Posterior condyle radius and cam geometries of the Optetrak® B-Series Femoral Component
The device modifications to the tibial insert components presented in this Special 510(k) represent changes to the Optetrak® Posterior-Stabilized Tibial Inserts (K011976 and K933610) and changes to the Optetrak® B-scries Tibial Inserts (K010434). These changes represent a combination of:
- The articulating surfaces, mating geometry and anterior spine geometry of the Optetrak® Posterior-Stabilized Tibial Inscrts, and
- The posterior portion of the spine and the posterior scallops of the Optetrak® B-Series Tibial Insert Component
No changes were made to the patellar or tibial tray components of the Optetrak® Total Knec System.
The Exactech Optetrak® Total Knee System Line Extension-Optetrak® HI-FLEX Knee Components is a medical device. The provided text is a 510(k) premarket notification for this device, outlining its safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are not explicitly stated as numerical performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the acceptance criteria are based on demonstrating substantial equivalence to legally marketed predicate devices. The performance data presented focuses on verifying the implant's mechanical adequacy for anticipated in vivo loading.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (functionality, safety, basic technology) | The Optetrak® Hi-FLEX PS Femoral Components and the Optetrak® Hi-FLEX PS Tibial Inserts are concluded to be substantially equivalent to Exactech's predicate Optetrak® AK Femoral and Optetrak® Posterior-Stabilized tibial insert. |
| Adequate Implant Performance for Anticipated In Vivo Loading | Verification and Validation analyses were conducted to verify that the implant performance would be adequate for anticipated in vivo loading. |
| Indications for Use | Identical to predicate device. |
| Contraindications | Identical to predicate device. |
| Materials | (Implied to be same as predicate, as no material changes are mentioned in relation to the new components; the focus is on geometry modifications).* |
Note: While not explicitly stated as "acceptance criteria," these are the aspects evaluated for a 510(k) submission to demonstrate that the new device is as safe and effective as a legally marketed device.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical data or patient outcomes for this 510(k) submission. The performance assessment primarily relies on "Verification and Validation analyses" which are typically engineering tests, mechanical simulations, and material characterizations.
- Sample Size for Test Set: Not applicable as no clinical test set data is described. The "sample" would refer to the components tested in engineering analyses. The specific number of components or iterations for these tests is not provided in the summary.
- Data Provenance: Not applicable for clinical data. For the engineering analyses, the provenance would be internal to Exactech, likely conducted in a laboratory setting. The country of origin of such data is not specified but presumed to be the USA where Exactech is located. The study is a retrospective analysis of the design modifications and their compliance with established engineering and manufacturing standards, as opposed to a prospective clinical trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This 510(k) submission is for a line extension of an orthopedic implant, focusing on mechanical performance and substantial equivalence, not on diagnostic accuracy requiring expert interpretation of results. The "ground truth" for mechanical performance would be established by engineering specifications, material properties, and biomechanical standards, not by expert consensus on clinical images or patient outcomes.
4. Adjudication Method for the Test Set
Not applicable. There is no clinical test set involving human interpretation that would require an adjudication method.
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 implant (hardware), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant to this submission.
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 algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this submission is based on engineering specifications, biomechanical testing standards, material science principles, and comparison to the established performance of predicate devices. The verification and validation analyses would have used these objective measures to confirm the safety and performance of the modified components.
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no "training set" for an AI model, the concept of establishing ground truth for it does not apply.
§ 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.