(70 days)
The P.F.C.® ∑ Cruciate Retaining Knee System is indicated for use only with bone cement (PMMA) for patients suffering from severe pain and disability due to permanent structural damage resulting 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.® ∑ Cruciate Retaining Knee System (Size 1.5) consists of:
- Size 1.5 asymmetrical Femoral component, both porous & non-porous coated:
- Size 1.5 Tibial inserts;
- Size 1.5 All-Polyethylene Tibiae (APT);
- Size 1.5 Tibial trays;
- Size 32mm Oval dome patellae, three and single peg.
The device is a prosthetic device intended to replace the natural knee joint. The device is constructed of UHMWPE. Titanium and Co-Cr-Mo alloy.
The provided text describes a 510(k) submission for a knee prosthesis, not a device that relies on algorithms or AI for its function. Therefore, most of the requested information regarding acceptance criteria for device performance based on studies, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment is not applicable to this physical medical device.
The document lists "Performance Tests" that were conducted, but these are engineering tests of the physical components, not studies of diagnostic or image analysis performance.
Here's a breakdown of what can be extracted based on the provided text, and where the information is not applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Applicable - No specific numerical acceptance criteria for clinical performance are reported in this document for this type of physical device. | Constraint Testing: No specific results or criteria provided |
| Contact Areas between all Interfacing Components: No specific results or criteria provided | |
| Surface Characteristics of Articulating Surfaces: No specific results or criteria provided | |
| Modified Surface Data Form Testing: No specific results or criteria provided | |
| Tibial Insert/Tibial Tray Interlock Testing: No specific results or criteria provided | |
| Lateral Stability of Patellofemoral Joint: No specific results or criteria provided | |
| Fixation Testing of Patella Component (Tensile & Shear): No specific results or criteria provided | |
| Fatigue Strength of the Tibial Component: No specific results or criteria provided |
Explanation: The document lists several "Performance Tests" but does not provide specific acceptance criteria (e.g., "Constraint must be within X degrees") or the numerical results of these tests. For a physical implant, these tests typically demonstrate mechanical integrity and comparability to a predicate device, rather than diagnostic accuracy. The claim is "substantially equivalent" to the predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. The described "Performance Tests" are engineering/mechanical tests on components, not studies involving patient data or test sets in the context of AI/algorithmic performance.
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 the context of expert consensus, is not relevant for the mechanical testing of a knee implant.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are not relevant for mechanical testing of a knee implant.
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. MRMC studies are for technologies involving human interpretation (e.g., radiology AI), not for physical orthopedic implants.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical knee prosthesis, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. Ground truth, in this context, is not relevant for the mechanical testing of a knee implant. The "ground truth" for these tests would be the established engineering specifications and performance of the predicate device.
8. The sample size for the training set
- Not Applicable. There is no training set for a physical implant.
9. How the ground truth for the training set was established
- Not Applicable. There is no training set or ground truth in the AI/algorithmic sense for this device. The "ground truth" for the mechanical characteristics would be established engineering principles and the performance of the predicate device.
§ 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.