(379 days)
The P.F.C.® Σ Uni-compartmental Knee System is indicated for use as a uni-compartmental knee replacement for patients suffering from severe pain and disability due to structural damage caused by advanced femoral-tibial uni-compartmental degenerative arthritis resulting from primary osteoarthritis or trauma. The device is also indicated for use in patients with osteochondritis dissecans of the femoral or tibial condyle. The system is indicated for use only with bone cement.
The P.F.C. ® T Uni-compartmental Knee System is a uni-compartmental knee replacement consisting of a femoral component of cobalt-chromium-molybdenum alloy, and either an allplastic tibial component of ultra-high molecular weight polyethylene, or an alternative modular tibial component comprised of a titanium-6 aluminum-4 vanadium alloy tray with a modular UHMWPE insert.
This document describes a 510(k) summary for the P.F.C.® Σ Uni-compartmental Knee System, a medical device. The summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable or cannot be extracted from the provided text. The provided text outlines performance testing conducted to establish substantial equivalence based on material and mechanical characteristics, not clinical outcomes for a diagnostic or therapeutic effect.
Here's a breakdown based on the provided text, indicating where information is present and where it is not:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in relation to clinical performance or diagnostic accuracy. Instead, it describes "performance testing" to demonstrate substantial equivalence to a predicate device. The "performance" reported is that the modified device is "substantially equivalent" to the predicate device based on these tests.
| Acceptance Criteria Category | Specific Test | Reported Device Performance |
|---|---|---|
| Substantial Equivalence (Overall) | Comparison to P.F.C.® Uni-compartmental Knee System (predicate device) | The modified device, the P.F.C.® Σ Knee system, is substantially equivalent to the predicate device. |
| Material Conformance | Adherence to ASTM standards | Materials used conform to ASTM standards. |
| Surface Characteristics | Surface Finish Analysis | (Details not provided, but implies satisfactory conformance to establish substantial equivalence) |
| Mechanical Stability | Tibial Insert and Tibial Tray Interlock Testing | (Details not provided, but implies satisfactory conformance to establish substantial equivalence) |
| Contact Mechanics | Femoral-Tibial Contact Area Analysis | (Details not provided, but implies satisfactory conformance to establish substantial equivalence) |
| Stress Distribution | Contact Stress Calculation | (Details not provided, but implies satisfactory conformance to establish substantial equivalence) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify sample sizes for the "performance testing" (Surface Finish Analysis, Interlock Testing, Contact Area Analysis, Contact Stress Calculation). These are typically bench or laboratory tests, not clinical studies with patient data.
- Data provenance (country of origin, retrospective/prospective) is not applicable or provided, as these are not human clinical 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)
- This question is not applicable. The "ground truth" for demonstrating substantial equivalence of a knee implant is based on engineering specifications, material properties, and mechanical test results, not expert interpretation of clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable. Adjudication methods are used in clinical studies for interpretation of ambiguous data. Mechanical testing typically relies on predefined test protocols and measurement standards.
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 question is not applicable. This device is a knee implant, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. This device is a knee implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this submission is based on engineering specifications, material standards (ASTM), and comparative mechanical performance against a predicate device. There is no expert consensus, pathology, or outcomes data used as "ground truth" for the substantial equivalence claim.
8. The sample size for the training set
- This question is not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- This question is not applicable. There is no "training set" or corresponding ground truth.
§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.