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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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(299 days)
The PS2 KNEE SYSTEM is designed as a system and is not intended for substitution of components from other systems.
The indications for use are:
- 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 PS2 KNEE SYSTEM is intended for cemented use.
The PS2 Knee System 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 and tibial stem fixation. The uncoated femoral components (CR and PS) and uncoated tibial baseplates (pegged, pegless, and holed) are made from cast CoCr alloy (ASTM F75), and are intended for cemented use only. The tibial inserts (CR and PS) and all-poly patellar components (oval and round) are made from UHMWPE (ASTM F648) or VitalitE (ASTM F2695). The PS2 tibial baseplate employs a modular keel, which is compatible with the previously cleared Consensus Revision Knee System (CRKS) stem and taper plug made from Titanium alloy (ASTM F1472). The PS2 holed baseplate is compatible with the previously cleared Consensus Knee System (CKS) 6.5mm cancellous bone screw made from Titanium alloy (ASTM F136). The PS2 baseplate is supplied with four preassembled cement dams made from UHMWPE and supplied with a distal plug made from UHMWPE intended for assembly in the operating room when stems are not desired.
The provided document describes the PS2 Knee System, a medical device, and its substantial equivalence to legally marketed predicate devices, rather than detailing the acceptance criteria and the study proving it meets those criteria in the context of an AI/ML device.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, ground truth, or MRMC comparative effectiveness studies because this document is for a traditional medical device (knee prosthesis), not an AI/ML device.
The document discusses:
- Indications for Use: What the device is intended for.
- Substantial Equivalence: How the device is similar to previously cleared devices.
- Non-Clinical Performance Data: Bench testing performed on the device's components to ensure safety and effectiveness, following various ASTM standards and FDA guidance for traditional medical devices. This includes topics like fatigue testing, joint stability, contact characteristics, locking mechanisms, and wear testing.
This information is typical for a 510(k) submission for a non-AI/ML device where the primary pathway to market is demonstrating substantial equivalence to a predicate device based on material properties, design, and mechanical performance.
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(65 days)
The CONSENSUS® KNEE SYSTEM Primary Knee is designed as a system and is not intended for substitution of components from other systems.
The indications for use are:
- 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.
The Consensus Knee System (CKS) modular tibial baseplate is a non-porous (uncoated), anatomic, fixed-bearing design made from cast CoCrMo (ASTM F75). Its boss-and-fin type keel employs a modular 12/14 female taper for assembly with Consensus Revision Knee System (RKS) stems or the RKS taper plug. The CKS modular baseplate is offered in pegged, pegless, and holed configurations. Holed configurations are supplied with preassembled cement dams manufactured from UHMWPE (ASTM F648). All configurations are supplied with a distal plug intended for assembly in the operating room when stems are not desired. Distal plugs are manufactured from UHMWPE (ASTM F648). Other components compatible with the CKS modular baseplate include all CKS tibial inserts, femoral components, and patella components; all RKS femoral components; and the 6.5mm cancellous bone screw used with CKS holed baseplates.
This document is a 510(k) premarket notification for the "Consensus Knee System Modular Tibial Baseplate." It demonstrates the device's substantial equivalence to previously marketed devices rather than providing a study demonstrating the device meets a set of acceptance criteria in the typical sense of a clinical trial for an AI/CAD product.
Therefore, the requested information elements related to AI/CAD system performance (e.g., sample size for test set, experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this regulatory submission.
However, I can extract the closest analogous information regarding the evaluation of this medical device.
1. A table of Acceptance Criteria and the Reported Device Performance:
The document describes non-clinical performance data (bench testing) to verify the device's safety and effectiveness. The "acceptance criteria" are implied by the standards used for testing (ASTM F1800-12) and the stated objective to ensure no failure or involuntary dislocation.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Baseplate Tray Region: No failure under fatigue when fully supported by its lateral compartment (per ASTM F1800-12). | Tested per ASTM F1800-12 to ensure the tray would not fail under fatigue when fully supported by its lateral compartment. (Specific results like load cycles or maximum load are not provided in this summary, but the general statement implies successful testing.) |
| Keel and Taper Connection: No failure under fatigue when fully supported by an intramedullary stem (per ASTM F1800-12). | Tested per ASTM F1800-12 to verify that the keel would not fail under fatigue when fully supported by an intramedullary stem. (Specific results not provided, but implies successful testing.) |
| Distal Plug Dislocation: Resists involuntary dislocation from the keel. | Tested to ensure it would resist involuntary dislocation from the keel. (Implies successful resistance.) |
| Distal Plug Insertion/Extraction: Manual insertion and extraction possible in the operating room using available instrumentation. | Tested to ensure it could be manually inserted and extracted in the operating room using available instrumentation. (Implies successful functionality.) |
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 in terms of clinical cases or patient data, as this is bench testing. For bench testing, "sample size" would refer to the number of device components tested, which is not detailed in this summary.
- Data Provenance: Non-clinical bench testing. The country of origin of testing is not specified, but the device is manufactured by a US-based company (Consensus Orthopedics, Inc., El Dorado Hills, California).
- Retrospective/Prospective: Not applicable. This is non-clinical bench testing.
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 this context refers to the physical properties and performance of the device component itself, evaluated through engineering tests, not interpretation by medical experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. This refers to the adjudication of clinical outcomes or diagnostic interpretations, not bench testing results.
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 conventional medical device, not an AI/CAD system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a conventional medical device, not an AI/CAD system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's evaluation is derived from engineering specifications and the established performance standards of ASTM F1800-12 for fatigue testing, as well as functional testing for the distal plug's retention and operability.
8. The sample size for the training set:
Not applicable. This is a conventional medical device, not an AI/CAD system.
9. How the ground truth for the training set was established:
Not applicable. This is a conventional medical device, not an AI/CAD system.
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