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510(k) Data Aggregation
(71 days)
OPTETRAK LOGIC CRC TIBIAL INSERT
The OPTETRAK Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. In the USA, the OPTETRAK Comprehensive Knee System is indicated for cemented use only.
The proposed Optetrak Logic CRC Tibial Insert devices represent modifications to existing Optetrak Logic CR Knee System components cleared per 510(k) K111400 and 510(k) K121307. Both proposed and predicate devices are made from the same materials using the same processes and are compatible with the same Optetrak Logic tibial trays and femoral components.. Compared to predicate Logic CR inserts; the proposed Logic CRC inserts are designed to provide additional stability in the absence of a fully functioning PCL.
Here's a breakdown of the acceptance criteria and the study proving the device meets it, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance (vs. predicate Logic CR inserts) |
|---|---|
| Anterior Constraint | Increased 54% |
| Posterior Constraint | Increased 14% |
| Overall Anterior-Posterior Constraint | Increased 34% |
| Medial-Lateral Constraint | Increased 6% |
| Rotational Constraint | Increased 33% |
| Substantial Equivalence | Demonstrated to be substantially equivalent to cleared predicate devices. |
Note: The document only provides comparative performance against predicate devices, indicating the changes introduced by the new design. It doesn't define explicit pass/fail thresholds for each constraint measure as "acceptance criteria" but rather presents the observed increases as the performance that justifies equivalence. The ultimate acceptance criterion is the determination of "substantial equivalence" to the predicate.
Study Details
2. Sample Size and Data Provenance
- Sample Size for Test Set: n=5 (This likely refers to the number of devices tested in the engineering study).
- Data Provenance: Not explicitly stated beyond "engineering studies" and "cadaver lab testing." The engineering studies are likely laboratory tests conducted by the manufacturer. Cadaver lab testing would involve human cadavers.
3. Number and Qualifications of Experts for Ground Truth (Test Set)
- Number of Experts: Not explicitly stated, but referred to as "surgeon experts" (plural).
- Qualifications of Experts: "Surgeon experts." Specific years of experience or specialty (e.g., orthopedic surgeon) are not provided.
4. Adjudication Method (Test Set)
- Adjudication Method: Not specified. The document only states that "Devices were also evaluated by surgeon experts during cadaver lab testing." How their evaluations were combined or reconciled is not detailed.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. The document describes engineering studies and cadaver lab testing, not a comparative effectiveness study involving human readers (e.g., surgeons interpreting images with and without AI).
6. Standalone (Algorithm Only) Performance
- Was a standalone study done? Not applicable. This device is a physical knee implant, not an algorithm or AI system. The "performance" relates to the mechanical properties of the device itself.
7. Type of Ground Truth Used
- Type of Ground Truth:
- Engineering Study: Based on objective measurements according to ASTM F1223-08 to characterize constraint. The "ground truth" here is the measured mechanical output of the device under specific test conditions.
- Cadaver Lab Testing: Expert evaluation by surgeons. This would be based on clinical judgment and experience with the device in a simulated anatomical environment.
8. Sample Size for Training Set
- Sample Size for Training Set: Not applicable. This device is a physical product, not an AI/ML algorithm that requires a training set. The design was likely developed through iterative engineering and simulation, not "training" in the AI sense.
9. How Ground Truth for Training Set was Established
- How Ground Truth was Established: Not applicable, as there is no "training set" in the context of this physical device. The design was likely refined based on engineering principles, biomechanical understanding, and potentially feedback from prior designs or clinical experience.
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