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510(k) Data Aggregation
(247 days)
The Genesis II Deep Flexion Cruciate Retaining Articular Insert is intended to be used in conjunction with the components of the Genesis II Total Knee System.
The Genesis II Total Knee System is indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result; failed osteotomies, unicompartmental replacement, or total knee replacement. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are absent or incompetent and the collateral ligaments remain intact.
The Genesis II Deep Flexion Cruciate Retaining Articular Insert is used with existing cemented femoral, tibial tray, and patellar components of the Genesis II Total Knee System cleared via K951987 and K953274. The Genesis II Deep Flexion Cruciate Retaining Articular Insert is for single use only.
The Genesis II Deep Flexion Cruciate Retaining Articular Insert is used with existing cemented patellar and uncemented porous tibial trays and femoral components of the Genesis II Total Knee System cleared via K030612. The Genesis II Deep Flexion Cruciate Retaining Articular Insert is for single use only.
The Genesis II Deep Flexion Cruciate Retaining Articular Inserts are UHMWPE tibial components which provide the ability for greater flexion to those patients who have the anatomical capability to allow a greater flexion range. The insert is used with existing cemented femoral, tibial tray, and patellar components of the Genesis II Total Knee System cleared via K951987 and K953274 or with the system's porous, uncemented femoral and tibial tray components cleared in K030612.
Here's a breakdown of the acceptance criteria and study information based on the provided text for the Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular Insert:
Acceptance Criteria and Device Performance
This 510(k) submission primarily relies on substantial equivalence to predicate devices. As such, the "acceptance criteria" are not explicitly defined as numerical thresholds for specific performance metrics in the same way they might be for a novel device or a detailed clinical trial. Instead, the acceptance criteria are implicitly that the new device performs equivalently to the predicate devices in terms of its mechanical properties and intended use.
The study presented is a mechanical test data review rather than a human-involved clinical study.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Strength & Durability | "capable of withstanding expected in vivo loading without failure" |
| Equivalence to Existing Devices | "equivalent to devices currently used clinically" |
| Indications for Use (same as predicate) | Substantially equivalent to predicate devices (K951987, K953274, K030612, K032295) |
| Design Features (similar to predicate) | Substantially equivalent to predicate devices |
| Operational Principles (similar to predicate) | Substantially equivalent to predicate devices |
| Material Composition (similar to predicate) | Substantially equivalent to predicate devices |
Study Details
Given the nature of this 510(k) summary, which focuses on substantial equivalence based primarily on mechanical testing, many of the typical clinical study parameters are not applicable.
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number of devices. The study refers to "mechanical test data" for the device, implying a set of prototypes or manufactured units were subjected to various tests.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective, though mechanical testing typically occurs in a lab setting.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For mechanical testing, the "ground truth" is typically established by engineering standards and validated testing protocols, not human expert consensus.
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Adjudication method for the test set: Not applicable. Mechanical testing outcomes are typically objectively measured against established engineering specifications, not adjudicated by human experts.
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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 device is a knee implant component, and this type of study is irrelevant to its evaluation.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the mechanical testing would be the established engineering requirements, material properties, and performance benchmarks derived from predicate devices, demonstrated through validated mechanical and material testing.
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The sample size for the training set: Not applicable. There is no "training set" as this is not an AI or algorithm-based device.
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How the ground truth for the training set was established: Not applicable.
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