(91 days)
The OPTETRAK Comprehensive 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.
In the USA, the OPTETRAK Comprehensive Knee System is indicated for cemented use only.
The proposed Optetrak Logic 17mm & 19mm Thick Inserts are modifications to Optetrak Logic ultra high molecular weight polyethylene (UHMWPE) tibial insert components cleared per 510(k)s K093360. K110547. K111400. K121307, and K123342.
This submission proposes adding 17mm and 19mm tibial insert options to the existing 9mm-15mm range of Optetrak Logic insert thicknesses. The 17mm and 19mm thick inserts will be provided across the current component size range (size 0 through size 6). Like the predicate devices, the proposed inserts are used in total knee arthroplasty (TKA) with metal femoral components and tibial trays. The thicker inserts are proposed for both posterior-stabilized (Logic PS, Logic PSC) and cruciate-retaining (Logic CR. Logic CRC) product options.
The provided text describes a 510(k) submission for Exactech® Optetrak Logic® 17mm & 19mm Thick Inserts, which are modifications to existing tibial inserts for total knee arthroplasty (TKA). The submission focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical performance data.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Evaluation) | Reported Device Performance (Activity) |
|---|---|
| Locking stability | Anterior/posterior liftoff/dissociation testing |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "engineering studies" and "non-clinical performance data" but does not specify sample sizes for the test set or directly refer to a "test set" in the context of clinical data or human subjects. The evaluation is focused on the device's mechanical properties. The data provenance is non-clinical testing performed by the manufacturer,Exactech, Inc.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable as the provided text describes non-clinical engineering testing. There is no mention of human experts establishing ground truth for a clinical test set.
4. Adjudication Method for the Test Set:
This information is not applicable as the assessment is based on non-clinical engineering tests, not on human interpretation or clinical adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission is for a medical device modification, and the provided text focuses on engineering studies, not clinical effectiveness studies involving human readers and interpretations.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:
This information is not applicable. The device is a physical medical implant (tibial insert), not an algorithm or AI system.
7. The Type of Ground Truth Used:
The "ground truth" for the non-clinical performance data is derived from the results of mechanical and physical testing (e.g., anterior/posterior liftoff/dissociation testing) designed to assess the locking stability of the tibial inserts. This is based on established engineering principles and test methods for medical devices.
8. The Sample Size for the Training Set:
This information is not applicable as the device is a physical medical implant and 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:
This information is not applicable as there is no "training set" for this type of medical device submission.
§ 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.