(21 days)
The OPTETRAK® Total Knee Systems 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. CAUTION: For cemented use only in the USA.
The proposed Optetrak Line Extension (Size 0) femoral components are composed of Cobalt Chromium alloy (ASTM F-75). The proposed Size 0 femoral component is available in the cruciate retaining (CR) and posterior stabilized (PS) styles. The design incorporates the same design features as the predicate Optetrak femoral components on a smaller scale. The existing Optetrak patellar components (#K932690) are fully compatible with the proposed Optetrak Line Extension (Size 0) femoral components. The proposed Line Extension (Size 0 and 1 Delta) tibial inserts are composed of Ultra High Molecular Weight Polyethylene - UHMWPE (ASTM F648). The proposed insert components for the Size 0 are available in the cruciate retaining (CR) and posterior stabilized (PS) styles, similar to those in the existing Optetrak system. The proposed insert components for the Size 1 Delta are available in cruciate retaining (CR), posterior stabilized (PS), and constrained condylar (CC) styles, similar to those in the existing Optetrak system. The predicate and proposed models have the same locking mechanism . for assembly of the polymer insert into the tibial trav. In addition, the CC spine stiffener screw line has been expanded to accommodate the Size 1 Delta CC tibial inserts. This screw acts as a stabilizing force in the spine of the CC tibial insert. The screw varies in length according to tibial insert thickness and is packaged with the appropriate insert. Optetrak Line Extension (Size 0 and 1 Delta) tibial tray components are designed to accept the modular tibial insert (described above). The proposed tibial tray components are composed of Titanium alloy (Ti 6A1 4 V), which is the same as the predicate Optetrak trays. The locking mechanism is identical to that of the predicate Optetrak system. Similarly, the proposed line extension offers a finned stem tray version and a trapezoid stem tray version. Both designs have tibial component options that allow for upsizing and downsizing on the tibia. The proposed Optetrak Line Extension (Size 0 and 1 Delta) tibial augment components are designed to work with their corresponding Size 0 and 1 Delta trapezoid tibial trays. The components are composed of Titanium alloy (Ti 6 Al 4V) conforming to ASTM F136.
The provided document is a 510(k) summary for the Exactech Optetrak Total Knee System Size 0/1 Delta. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics in the way a novel device might.
Therefore, the information you've requested regarding acceptance criteria, specific performance metrics, sample sizes, expert involvement, and ground truth establishment from a new study is not available in this document. The submission relies on "performance data" in the form of "design assurance reviews" to verifiy that the implant performance would be adequate by comparing to predicate devices.
Here's an explanation based on the provided text:
Based on the provided K011976 document for the Exactech Optetrak Total Knee System Size 0/1 Delta:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of explicit acceptance criteria or specific numeric device performance metrics from a new study. Instead, the submission relies on demonstrating substantial equivalence to existing predicate devices.
The "performance data" section states:
"Design assurance reviews were conducted to verify that the implant performance would be adequate for anticipated in vivo loading. These activities did not indicate the need for additional testing beyond that performed for validation of the previously mentioned predicate Optetrak models."
This indicates that the acceptance criteria implicitly align with the performance standards and safety profiles established for the predicate devices. The reported device performance is therefore deemed to be equivalent to these predicate devices.
2. Sample Size Used for the Test Set and Data Provenance:
No explicit test set sample size is mentioned, as no new clinical study with a dedicated test set was conducted for this 510(k) submission. The assessment was based on design assurance reviews relative to predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable, as no new test set requiring expert ground truth establishment was used for this submission.
4. Adjudication Method for the Test Set:
Not applicable, as no new test set was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described in this 510(k) submission. This type of study would typically assess the improvement of human readers with AI assistance, which is outside the scope of this device submission for a knee prosthesis.
6. Standalone (Algorithm Only) Performance Study:
A standalone performance study (i.e., algorithm only without human-in-the-loop performance) was not conducted or described. This term typically applies to AI/software as a medical device (SaMD), not a knee prosthesis.
7. Type of Ground Truth Used:
The "ground truth" for the assessment of this device is implicitly the established safety and effectiveness profile of the predicate devices to which it is compared. The design assurance reviews aimed to confirm that the new device's design, materials, and intended use aligned with these established standards.
8. Sample Size for the Training Set:
Not applicable. As this is a physical medical device (knee prosthesis) and not an AI/ML algorithm, there is no "training set" in the conventional sense of machine learning.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. 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.