(25 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 Systems are indicated for cemented use only, except for the OPTETRAK Logic PS and CR Porous Femoral Components, which are indicated for cemented or cementless use.
Optetrak Advanced Patella implants represent dimensional modifications to "classic" Optetrak patella components. Like the predicate devices, Optetrak Advanced Patella implants are intended for resurfacing the patella during tri-compartmental total knee arthroplasty with other Optetrak and Optetrak Logic components. Optetrak Advanced Patella implants are designed to provide expanded options to help surgeons optimize bone coverage while keeping the same basic features and device compatibility as predicate "classic" Optetrak patella implants.
This document is a 510(k) Pre-Market Notification from the FDA regarding the Exactech Optetrak Advanced Patella device. It is a notification for a medical device, not an AI/ML device, therefore the information requested about acceptance criteria and studies (sample size, data provenance, expert numbers, adjudication, MRMC, standalone, ground truth, training set) is not applicable to this document.
The document discusses the substantial equivalence of the new device to a legally marketed predicate device, primarily based on design and material similarities, and mechanical testing.
Here's what information is available that partially relates to "acceptance criteria" and "study":
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide a formal table of quantitative acceptance criteria as would be expected for an AI/ML model's performance metrics (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" can be inferred as demonstrating that the new device does not introduce a new worst-case scenario compared to the predicate device in terms of mechanical performance.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Patellofemoral contact pressure is not a new worst-case | Reported results show the Optetrak Advanced Patella Devices do not represent a new worst-case (compared to predicate) in patellofemoral contact pressure analysis. |
| Substantial equivalence to predicate device in technological characteristics | The device is an orthopedic implant made from ultra-high molecular weight polyethylene. It features the same spherical articulating geometry, mating device congruence, and bone-apposing fixation features as other Optetrak patella implants. It also has similar product scope, an increased medial-lateral area, and an asymmetric "avocado"-shaped perimeter, intended for cemented fixation. These characteristics are compared to the predicate. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. This is a mechanical device, and the "test set" refers to mechanical testing, not a dataset of patient images or information. The testing conducted is described as "engineering studies."
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. Ground truth, in this context, would involve objective measurements from mechanical testing performed by engineers/technicians, not expert consensus as in AI/ML validation.
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 used for resolving disagreements among human readers or annotators in AI/ML studies. This is not relevant to mechanical 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 device is an orthopedic implant, not an AI system. Therefore, an MRMC study related to AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This refers to AI algorithm performance.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
For the mechanical testing, the "ground truth" would be the direct measurements and physical properties observed during the engineering studies (e.g., contact pressure values). There is no "expert consensus" or "pathology" in this context.
8. The sample size for the training set:
Not applicable. There is no AI model or training set for this medical device submission.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set.
§ 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.