(157 days)
Genesis II and Profix Knee Systems are 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.
Genesis II and Profix Knee Systems are indicated for use only with cement and are single use devices.
The Genesis II Zirconium Femoral Component and the Profix Zirconium Femoral Component are cruciate retaining components indicated for use with existing Genesis II and Profix System Components. Both are manufactured in a variety of sizes in both left and right orientations.
The provided document is a summary of safety and effectiveness for medical devices (femoral components) and describes preclinical testing of their mechanical properties. It does not describe a study involving acceptance criteria related to device performance in terms of diagnostic accuracy or similar metrics, nor does it involve expert assessment, multi-reader studies, or ground truth for diagnostic purposes.
Therefore, I cannot fulfill the request to describe the acceptance criteria and study that proves the device meets them as defined by the input questions because the provided text pertains to mechanical testing of physical orthopedic implants, not an AI/diagnostic device.
However, I can extract information related to the preclinical testing described, reinterpreting "acceptance criteria" as mechanical performance criteria.
Here's an interpretation based on the given document, acknowledging that most questions are not applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Withstand in vivo loading without failure | "All of the test results indicate that both the Genesis II Zirconium Femoral Component and the Profix Zirconium Femoral Component are capable of withstanding in vivo loading without failure." |
| Meet requirements in knee draft guidance document for mechanical testing | Mechanical testing was performed according to the requirements in the knee draft guidance document; results indicate capability of withstanding in vivo loading. |
| Characterized material properties | Testing was performed to characterize the material properties. |
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 the provided text. The document refers to "testing" which implies a sample of components was tested, but the exact number isn't mentioned.
- Data Provenance: Not specified. This is preclinical testing, likely conducted in a lab environment.
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. This is mechanical testing of a physical implant, not a diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is mechanical testing, not a diagnostic assessment requiring adjudication.
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 mechanical testing of a physical implant and does not involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is mechanical testing of a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" here would be the physical reality of the material properties and mechanical strength as demonstrated under controlled laboratory conditions, complying with established industry standards and guidance. This is not "ground truth" in the diagnostic sense.
8. The sample size for the training set
Not applicable. This is preclinical mechanical testing, not machine learning model training.
9. How the ground truth for the training set was established
Not applicable. This is preclinical mechanical testing, not machine learning model training.
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K96 2557
Summary of Safety and Effectiveness Smith & Nephew Orthopaedics Genesis II Zirconium Femoral Component Profix Zirconium Femoral Component
Substantial Equivalent Information
The Genesis II Zirconium Femoral Component and the Profix Zirconium Femoral Component are similar to the devices listed below.
-
- Genesis II C/R and LDK Femoral Component
-
- Profix C/R Femoral Component
- Genesis I C/R Femoral Component 3.
The devices listed above are similar in design to the Genesis II Zirconium Femoral Component and the Profix Zirconium Femoral Component. The zirconium alloy material used to manufacture the Genesis II Zirconium Femoral Component and the Profix Zirconium Femoral Component is the same material used for both the Zirconium Alloy Femoral Head and the Zirconium Alloy Uni-Polar Head.
Device Description
The Genesis II Zirconium Femoral Component and the Profix Zirconium Femoral Component are cruciate retaining components indicated for use with existing Genesis II and Profix System Components. Both are manufactured in a variety of sizes in both left and right orientations.
Indications for Use
Genesis II and Profix Knee Systems are 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.
Genesis II and Profix Knee Systems are indicated for use only with cement and are single use devices.
Preclinical Testing
Mechanical testing was performed according to the requirements in the knee draft guidance document. Testing was also performed to characterize the material properties. All of the test results indicate that both the Genesis II Zirconium Femoral Component and the Profix Zirconium Femoral Component are capable of withstanding in vivo loading without failure.
JG06246B/19
§ 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.