(48 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.
The proposed Optetrak CR Slope 9mm ++ devices are ultra high molecular weight polyethylene tibial inserts intended to enable surgeons to adjust tibial slope, and therefore PCL function, at the end of a procedure without the need for additional bone cuts. The proposed devices are made from the same materials as the predicated devices. There the also compatible with the same femoral, tibial and patellar components as the cleared predicate devices. The only difference between devices is a +6° posterior angle built into the Optetrak CR Slope 9mm ++ tibial inserts.
The provided text describes a Special 510(k) submission for a medical device called the "Exactech® Optetrak® 9mm Cruciate Retaining Tibial Insert Slope ++". This submission is for a modification to an existing, previously cleared device. Therefore, the "study" conducted to prove the device meets acceptance criteria is an engineering evaluation, rather than a clinical study with human subjects, given that the new device is substantially equivalent to a predicate device.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Equivalence: Materials used for the proposed devices are the same as the predicate devices. | The proposed devices are made from the same materials as the predicated devices. |
| Compatibility: The proposed devices are compatible with the same femoral, tibial, and patellar components as the cleared predicate devices. | The proposed devices are compatible with the same femoral, tibial and patellar components as the cleared predicate devices. |
| Mechanical Performance: Performance of the proposed components is adequate for anticipated in vivo use. | Engineering evaluations were conducted to verify that the performance of the proposed components would be adequate for anticipated in vivo use. This resulted in "successful results". |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated as a number of physical units. Since this was an engineering evaluation, the "test set" would likely refer to the specific modifications or new designs evaluated. The document states "Engineering evaluations were conducted."
- Data Provenance: The evaluations were conducted by Exactech, Inc. in Gainesville, Florida, USA. The study design is not a traditional retrospective or prospective clinical study, but rather a design verification (engineering evaluation).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. For this specific device modification (a change in posterior angle for a tibial insert), ground truth would be established through engineering principles, material science, and biomechanical testing, not by expert interpretation of clinical data in the same way an AI diagnostic device would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like "2+1" or "3+1" are typical for clinical studies involving human interpretation (e.g., radiologists, pathologists). The "ground truth" for this device modification was established by engineering evaluations and testing.
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 physical medical device (knee implant component), not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant 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 implant, not an algorithm or AI system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The ground truth for this device modification is based on engineering principles, material science, and biomechanical performance data derived from the engineering evaluations. The substantiation for substantial equivalence relies on demonstrating that the modified device performs adequately and equivalently to the predicate device under anticipated in vivo use conditions.
8. The sample size for the training set
Not applicable. This device is not an AI algorithm that requires a "training set". The document describes a physical medical device.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 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.