(72 days)
The Genesis II PS Non-modular and CR Non-modular with cement pocket Femoral Components are indicated for:
- Rheumatoid arthritis. 1.
Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 2.
Failed osteotomies, unicompartmental replacement, or total knee replacement. 3.
Posterior stabilized knee systems are designed for use in patients in primary and revision 4. · surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
The Genesis II PS Non-modular and CR Non-modular with cement pocket Femoral Components are indicated for use only with cement and are single use devices.
Genesis II PS Non-modular and CR Non-modular with cement pocket femoral components are line extension of the Genesis II Total Knee System. It provides a non-modular option of the PS knee which is similar to the nonmodular CR knee in design concept. It is available from size 1-8 and in left and right configuration. The Nonmodular PS/CR femoral components are available with or without the feature of cement pocket. The material is cobalt chromium alloy (ASTM F75-07). The femoral component is a single use device and supplied sterile (Gamma sterilization). The Genesis II PS Non-modular with cement pocket femoral components can be implanted using the standard Genesis II Instrumentation or the Genesis II ECO Instrumentation.
The provided text from the 510(k) summary for the Genesis II PS Non-modular and CR Non-modular with cement pocket Femoral Components does not contain information about acceptance criteria or a study proving that the device meets such criteria in the way typically expected for a software or AI/ML device.
This document describes a medical device, specifically knee joint prostheses, which are physical implants. The regulatory pathway for such devices, especially line extensions of existing devices, often relies on demonstrating substantial equivalence to a predicate device through non-clinical performance testing rather than clinical trials or AI performance evaluations.
Here's an analysis of why the requested information is not present and what is provided:
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Acceptance Criteria and Reported Device Performance:
- Table: A table of acceptance criteria and reported device performance is not present.
- Text: The document states: "Design verification has been performed based on requirements outlined in FDA's Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-Constrained Total Knee Prostheses, dated April 1993. Technical report and justifications provided in the submission demonstrated that the Genesis II PS Non-modular and CR Non-modular with cement pocket Femoral Components met performance requirements and are as safe and effective as the predicate devices."
- This indicates that performance requirements were met, but the specific numeric acceptance criteria (e.g., tensile strength, fatigue life, wear rates) and the actual measured performance are not detailed in this public summary. These are typically covered in technical reports submitted to the FDA, not always in the public 510(k) summary.
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Sample size for the test set and data provenance: Not applicable. This is a physical device, and testing would involve materials testing, mechanical characterization, etc., which have different "sample" considerations than AI/ML algorithms. The summary does not provide details on the number of components tested for design verification. It specifies "Clinical data was not needed to support the safety and effectiveness of the subject devices."
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Number of experts and their qualifications for ground truth: Not applicable. Ground truth, in the context of expert consensus, is mostly relevant for diagnostic or AI/ML-driven devices where an "expert diagnosis" is the target. For a physical implant, "ground truth" refers to its physical and mechanical properties being within specifications, typically verified by engineers and testing labs.
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Adjudication method: Not applicable for a physical implant's design verification.
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Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. MRMC studies are used to evaluate human reader performance, usually when making diagnostic decisions, and are particularly relevant for AI-assisted diagnostic tools. This device is an implant.
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Standalone performance (algorithm only without human-in-the-loop): Not applicable. This is not an algorithm or software.
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Type of ground truth used: For a physical device, the "ground truth" is typically engineering specifications, material standards (e.g., ASTM F75-07 for cobalt chromium alloy), and performance benchmarks established by regulatory guidance and predicate device performance. The performance requirements (referred to in the text) would be the "ground truth" against which the device's design verification results are compared.
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Sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
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How the ground truth for the training set was established: Not applicable for the same reason as above.
In summary, the provided 510(k) document is for a physical medical implant (a knee prosthesis). The "study" proving it meets acceptance criteria is a "Design verification" against "performance requirements" based on FDA guidance and comparison to a "predicate device." This is a different type of evidence than typically presented for software or AI/ML devices, and therefore much of the information requested is not relevant or not present in this document.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.