(70 days)
The P.F.C. Modular Total Knee System is indicated for use in a total knee replacement for patients suffering from severe pain and disability due to permanent structural damage in the knee joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, or pseudogout.
This damage may also be the result of trauma or failed prior surgical intervention.
The P.F.C. ® Modular Plus Offset Tibial Tray is indicated for use with polymethylmethacrylate (PMMA) bone cement.
The P.F.C. Modular Plus Offset Tibial Tray is part of a modular system for use in total knee replacement. The subject device is a titanium tibial tray component, which is designed to accept snap-in tibial inserts in a range of thicknesses and a variety of surface topographies.
The P.F.C. Modular Plus Offset Tibial Tray and its parent device, the P.F.C. Modular Plus Tibial Tray (K923807) have the same keel geometry and adjusted cement pockets that accommodate four screw holes for optional wedge attachment.
The P.F.C. Modular Plus Offset Tibial Tray has been designed with a proximal baseplate offset from the central stem to accommodate patients whose anatomic canal is not centered within the tibia.
This document is a 510(k) summary for a medical device (P.F.C.® Modular Plus Offset Tibial Tray), not a study report for an AI/ML powered device. Therefore, most of the requested information regarding acceptance criteria, study design, ground truth, and expert involvement is not applicable.
Here's an assessment based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document describes a submission for a new medical device, the P.F.C.® Modular Plus Offset Tibial Tray, to demonstrate substantial equivalence to an existing, legally marketed device. It does not present a study with specific acceptance criteria and performance metrics in the way one would for a diagnostic or AI-powered device.
Instead, the "acceptance criteria" are implicitly the requirements for substantial equivalence to predicate devices. The "reported device performance" is not quantified with specific metrics but is stated as being "similar in performance" to the predicate devices.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (as stated in the document) |
|---|---|
| Similar in performance to predicate devices | Similar in performance to P.F.C.® Modular Tibial Tray (K884796 and K892394) and P.F.C.® Modular Plus Tibial Tray (K923807), and Zimmer NexGen® LCCK Knee System (K960279). |
| Similar in intended use to predicate devices | Similar in intended use to predicate devices. |
| Similar in materials to predicate devices | Similar in materials to predicate devices. |
| Similar in design to predicate devices | Similar in design to predicate devices. |
| Similar in performance characteristics to predicate devices | Similar in performance characteristics to predicate devices. |
| Similar in packaging to predicate devices | Similar in packaging to predicate devices. |
| Similar in sterilization method to predicate devices | Similar in sterilization method to predicate devices. |
| Conformance with voluntary performance standards | Conformance with ASTM F136 and the FDA "Draft Guidance for the Preparation of Premarket Notifications {510(k)s} for Cemented, Semi-Constrained Total Knee Prostheses." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not applicable and not provided in the document. This is a 510(k) submission for a physical medical device, not a data-driven study of an AI/ML product. The "test set" for substantial equivalence primarily involves comparing specifications, performance characteristics (e.g., mechanical testing), and materials to predicate devices, rather than a clinical dataset in the context of an AI study.
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):
This information is not applicable and not provided. "Ground truth" in the context of expert consensus on data is relevant for AI/ML performance evaluation. For a physical medical device asserting substantial equivalence, the "ground truth" is established through engineering design, material specifications, and performance testing against industry standards, not typically by expert review of a "test set" in the sense of an AI study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable and not provided. Adjudication methods are used in studies involving human interpretation (e.g., radiology reads) to resolve discrepancies and establish a consensus "ground truth." This is not relevant for the type of device and submission described.
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:
This information is not applicable and not provided. This document describes a physical medical implant (a knee replacement component), not an AI-assisted diagnostic tool. Therefore, an MRMC study and
AI-driven improvement are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable and not provided. As explained above, this is not an AI/ML device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
This information is not applicable in the context of AI/ML validation. For this physical medical device, the "ground truth" for its safety and effectiveness is established through:
- Engineering design principles.
- Material testing (e.g., biocompatibility, mechanical strength as per ASTM F136).
- Performance testing (e.g., wear, fatigue characteristics, likely bench testing according to the FDA "Draft Guidance for the Preparation of Premarket Notifications {510(k)s} for Cemented, Semi-Constrained Total Knee Prostheses").
- Comparison to the established performance and safety profiles of legally marketed predicate devices.
8. The sample size for the training set:
This information is not applicable and not provided. There is no "training set" for this type of device.
9. How the ground truth for the training set was established:
This information is not applicable and not provided. There is no "training set" or corresponding "ground truth" in the context of AI/ML for this 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.