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510(k) Data Aggregation
(268 days)
A. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis.
B. Failed osteotomy or unicompartmental replacements.
C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
D. The non-porous (uncoated and coated with CoCr beads without Titanium) components may only be used with cement.
E. The porous coated (CoCr beads with Titanium) components may be used with or without cement.
F. Stemmed baseplates of the CKS Plus Knee System are intended for cemented use only
The CKS Plus extension to the Consensus Knee System (CKS) is a primary fixed bearing total knee system offering flexibility to restore knee function using either cruciate retaining (CR) or posterior stabilizing (PS) components with the option of tibial cancellous screw, tibial intramedullary (IM) stem fixation, and tibial augments
The provided text describes a 510(k) premarket notification for the "CKS Plus Knee System." It details the device, its indications for use, and claims substantial equivalence to predicate devices. Crucially, as a 510(k) summary for a medical device (a knee prosthesis), the focus is on demonstrating substantial equivalence through comparison to existing devices and bench testing, not on clinical performance studies involving AI or complex statistical analyses of diagnostic accuracy. Therefore, many of the requested elements for an AI/diagnostic device study (like sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, and detailed ground truth establishment) are not applicable to this type of document.
The document primarily discusses non-clinical performance data (bench testing) to verify the safety and effectiveness of the CKS Plus Knee System's components, focusing on mechanical properties and stability rather than diagnostic accuracy or human interpretation.
Here's an attempt to address the request based only on the provided text, highlighting what is (and isn't) present:
A. Table of Acceptance Criteria and Reported Device Performance
The document does not present acceptance criteria in a formal table with reported performance side-by-side, as would be typical for a diagnostic device's clinical study. Instead, it lists the types of bench tests performed and implies that the device "meets" the requirements by stating it passed. The criteria are implicit in the ASTM standards and other specified tests.
| Acceptance Criteria (Implicit from Test Standards/Purpose) | Reported Device Performance (Implied from "Testing Performed") |
|---|---|
| Adequate tray fatigue strength (per ASTM F1800-12) | "the tray would not fail under fatigue when one compartment collapses" |
| Tibiofemoral joint stability (per ASTM F1223-14) | Tested for PS-C insert per ASTM F1223-14 |
| Adequate tibial insert locking mechanism strength | Tested per FDA's Class II Special Controls Guidance to ensure adequate connection strength and ease of insertion |
| No failure in PS Post Fatigue Testing | "PS Post Fatigue Testing, Report" (implies successful completion) |
| No failure in Baseplate Fatigue Testing | "Baseplate Fatigue Testing, Report" (implies successful completion) |
| No failure in Tibial Insert Dislocation Testing | "Tibial Insert Dislocation Testing, Report" (implies successful completion) |
| No failure in VitalitE PS Post Fatigue Testing | "VitalitE PS Post Fatigue Testing, Report" (implies successful completion) |
| No failure in Tray Fatigue (FEA Worst Case) | "Tray Fatigue: FEA Worst Case Scenario, Report" (implies successful completion) |
| No failure in Stem Fatigue (FEA Worst Case) | "Stem Fatigue: FEA Worst Case Scenario, Report" (implies successful completion) |
| Pyrogenicity absence | "Pyrogenicity testing has been performed" (implies successful completion) |
B. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in terms of number of devices or components tested. The document mentions "bench testing" was carried out, but does not provide specific sample quantities for each test.
- Data Provenance: The tests are "bench testing," meaning they are performed in a laboratory setting on components or full devices, not on human subjects. Thus, there is no country of origin for human data, nor is it retrospective or prospective in that context.
C. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Experts: Not applicable. This is not a study requiring expert consensus for ground truth on diagnostic performance. The "ground truth" for mechanical testing is adherence to validated ASTM standards and engineering principles.
D. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This is not an image-based or diagnostic study requiring adjudication of expert interpretations.
E. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size.
- MRMC Study: No, an MRMC study was not done. This device is a knee prosthesis, not an AI or diagnostic tool that relies on human interpretation of cases. Therefore, there is no "effect size of how much human readers improve with AI vs without AI assistance" to report.
F. If a Standalone (algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a physical medical device (knee implant), not an algorithm or AI system.
G. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for the performance claims for this device is based on engineering standards, ASTM specifications, and mechanical testing results. For example, ASTM F1800-12 defines criteria for tray fatigue, and success is determined by meeting those predefined engineering benchmarks.
H. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This document describes the testing of a physical medical device, not the training of an AI algorithm.
I. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set mentioned or implied for an AI algorithm.
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