(107 days)
The P.F.C. Sigma Knee System (Size 1.5) 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. ® Sigma Knee System (Size 1.5) consists of:
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- Femoral components with an asymmetric trochlear groove;
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- Tibial inserts or All-Polyethylene Tibiae;
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- Femoral augmentation pieces;
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- Tibial Wedges.
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.
- Tibial Wedges.
The provided text is a 510(k) summary for a medical device (P.F.C. Sigma Knee System Size 1.5) and an FDA clearance letter. It describes the device, its intended use, and its substantial equivalence to a predicate device based on performance tests.
However, the document does NOT contain information about acceptance criteria or a study that rigorously proves the device meets specific acceptance criteria in the way described by your request (e.g., in terms of clinical performance, diagnostic accuracy, or human reader improvement with AI). This document focuses on demonstrating substantial equivalence for regulatory clearance, primarily through mechanical performance tests and comparison to a predicate device.
Therefore, I cannot populate the requested table and answer many of the specific questions as the information is not present in the provided text.
Here is what I can extract based on the provided text, and where I must state that the information is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Not explicitly stated as numeric targets in the document) | Reported Device Performance (Summary statement) |
|---|---|
| Mechanical integrity and performance comparable to predicate device | "All testing concluded the device performed as well or better that the predicate device." |
| - Constraint against specified forces | Device underwent "Constraint Testing" |
| - Contact areas/stress under load | Device underwent "Contact Areas/Contact Stress between all Interfacing Components" |
| - Surface characteristics of articulating components | Device underwent "Surface Characteristics of Articulating Surfaces" |
| - Tibial insert/tray interlock holding strength | Device underwent "Tibial Insert/Tibial Tray Interlock Testing" |
| - Patellofemoral joint lateral stability | Device underwent "Lateral Stability of Patellofemoral Joint" |
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: Not specified. The document only mentions "Performance Tests" without detailing the number of units tested.
- Data provenance: Not specified. This would typically relate to clinical trial data, which is not described here.
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: This type of information is relevant for studies involving human interpretation or diagnostic accuracy, which is not the nature of the "Performance Tests" described for this knee prosthesis (which are mechanical tests).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: See point 3.
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
- No, an MRMC comparative effectiveness study was not done. This type of study is for evaluating AI/diagnostic tools and is not relevant to this mechanical device submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is an orthopedic implant, not an algorithm. Therefore, "standalone performance" in the context of AI algorithms does not apply. The device's "standalone" performance is assessed through the mechanical tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable: For mechanical tests, the "ground truth" is typically defined by engineering specifications, material properties, and comparison to the predicate device's established performance or accepted biomechanical standards. The document states that the testing concludes the device performed "as well or better than the predicate device."
8. The sample size for the training set
- Not Applicable: This is not an AI device or a diagnostic device that would require a training set in the context of machine learning.
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.