(42 days)
The Durcaon® Total Knee System components included in this submission are intended for use in total knee arthroplasty to relieve pain and restore knee functions for indications such as:
- Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular necrosis,
- Rheumatoid arthritis,
- Correction of functional deformity,
- Revision procedures where other treatments or devices have failed,
- Post-traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy; and,
- Irreparable fracture of the knee
These products are intended to achieve fixation with and without the use of bone cement.
This submission is a line extension to the Duracon® Total Knee System for a tibial insert. Tibial inserts will be identical in design to the predicate tibial inserts of the Duracon® Total Knee System and manufactured from the same material as the Triathlon® and Scorpio® X3TM Tibial Inserts.
This document pertains to the 510(k) submission for the Duracon® X3™ CS Tibial Insert. The information provided focuses on demonstrating substantial equivalence to predicate devices through engineering analysis, rather than presenting a study with specific acceptance criteria for device performance in a clinical setting.
Therefore, the requested information regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details cannot be fully provided from the given text. The submission relies on an engineering analysis to demonstrate equivalence in strength, implying that if the new device is structurally comparable to existing, approved devices, it should meet an equivalent safety and effectiveness profile.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the provided text, there are no explicit acceptance criteria or reported device performance metrics in the way one would typically find for a clinical study (e.g., sensitivity, specificity, accuracy). The acceptance criterion implicitly seems to be "substantial equivalence" in terms of design, materials, and strength to predicate devices.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Substantial Equivalence in Strength to Predicate Devices (Duracon® Total Knee System, Triathlon® X3™, and Scorpio® X3TM Tibial Inserts) | "The engineering analysis demonstrates that the subject components are substantially equivalent in strength to the predicate components." |
2. Sample size used for the test set and the data provenance:
- Sample size: Not applicable to this type of submission. There is no "test set" of clinical data described. The evaluation is based on engineering analysis of the device itself and comparison to predicate devices.
- Data provenance: Not applicable. The "data" here refers to the engineering analysis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no mention of experts establishing ground truth for a clinical test set. The "ground truth" for the engineering analysis would be the established material properties and mechanical performance standards for such devices, likely evaluated by internal engineers and potentially external consultants if needed.
4. Adjudication method for the test set:
- Not applicable. There is no test set or adjudication process described for clinical performance.
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 is a medical device (tibial insert) submission, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used:
- For the substantial equivalence claim, the "ground truth" is largely based on:
- Engineering analysis results: Demonstrating comparable physical and mechanical properties (specifically strength) to predicate devices.
- Regulatory precedent: The substantial equivalence of the predicate devices themselves to other legally marketed devices.
- This is not a clinical "ground truth" (e.g., pathology, clinical outcomes).
8. The sample size for the training set:
- Not applicable. There is no "training set" in the context of an AI/algorithm. For the engineering analysis, the "data" would be the specifications and testing of the materials and designs.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
Summary of the Study (Engineering Analysis) that Proves the Device Meets the Acceptance Criteria:
The "study" in this context is an engineering analysis. The purpose of this analysis was to demonstrate that the Duracon® X3™ CS Tibial Insert is substantially equivalent to existing predicate devices already on the market (Duracon® Total Knee System, Triathlon® X3™, and Scorpio® X3TM Tibial Inserts).
The specific finding from this analysis is: "The engineering analysis demonstrates that the subject components are substantially equivalent in strength to the predicate components."
This implies that through various engineering calculations, simulations, and/or physical testing (though the specific methods are not detailed in this summary), the new tibial insert was shown to meet the same structural integrity and mechanical performance characteristics as the already approved devices. This equivalence in strength is the primary basis for the FDA's substantial equivalence determination for this particular 510(k) submission.
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.