(28 days)
Joint replacement is indicated for patients suffering from disability due to:
- degenerative, post-traumatic or rheumatoid arthritis;
- avascular necrosis of the femoral condyle;
- post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;
- moderate valgus, varus or flexion deformities;
- treatment of fractures that are unmanageable using other techniques.
This device may also be indicated in the salvage of previously failed surgical attempts. All devices are intended for cemented applications except for the EMPOWR Porous® Knee Femur, EMPOWR Porous® Knee Tibia, and Porous Patella which are intended for cementless applications.
While knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.
The EMPOWR Revision VVC+, e+™ Tibial Insert should be considered for use in total knee arthroplasty for patients under the following indications:
- Absence or loss of both cruciate ligaments
- Moderate varus-valgus or flexion instability that requires a bearing surface with increased constraint in the clinical judgment of the surgeon
- Bone loss that requires supplemental fixation in the clinical judgment of the surgeon
The EMPOWR Revision Knee™ system is intended for use in total knee arthroplasty. The system includes femoral components, tibial components, tibial inserts, cones, stems, stem extenders, and augments. Components are available in various sizes and configurations to accommodate a range of patient anatomies and surgeon preferences.
The purpose of this submission is to obtain clearance for using vaporized hydrogen peroxide (VHP) as a sterilization method for the EMPOWR VVC+, e+ Tibial Insert component. The subject device is identical in design, materials, and intended use to the predicate.
This FDA 510(k) clearance letter pertains to a medical device, the EMPOWR Revision Knee™ system, specifically focusing on the clearance for a new sterilization method (Vaporized Hydrogen Peroxide - VHP) for the EMPOWR Revision VVC+, e+ Tibial Insert component. The document explicitly states that no clinical data or animal studies were submitted for this clearance. Instead, the substantial equivalence to the predicate device is based on non-clinical performance data (verification and validation activities).
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, and standalone performance for a clinical or AI-based study cannot be extracted from this document, as it is not relevant to the type of submission described.
The document discusses the following non-clinical performance data:
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A table of acceptance criteria and the reported device performance:
- This information is not explicitly presented in a table format within the provided document. However, the document states that "Verification and validation activities demonstrate substantial equivalence between the subject and predicate devices." and lists the types of tests conducted. To fully answer this, one would typically need access to the actual verification and validation reports.
Acceptance Criteria (Implied) Reported Device Performance (Implied) Sterilization Efficacy Validated for VHP Shelf-Life Stability Demonstrated stability Packaging Integrity Demonstrated integrity Biocompatibility (Cytotoxicity) Met biocompatibility requirements Material Properties Maintained material characteristics Wear Resistance Comparable to predicate (Pin-on-disk) Fatigue Strength (Lock Detail) Met strength requirements Fatigue Strength (Tibial Post) Met strength requirements -
Sample sizes used for the test set and the data provenance:
- Sample sizes: Not specified in the provided text. These would be detailed in the individual test reports for each verification and validation activity.
- Data provenance: Not specified. This would typically come from internal laboratory testing or contract research organizations. The document indicates these are "Verification and validation activities," implying laboratory-based testing.
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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. This is not a study assessing diagnostic performance or requiring expert ground truth in the traditional sense. The "ground truth" for non-clinical testing refers to established engineering or biological standards.
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Adjudication method for the test set:
- Not applicable. Adjudication is typically for clinical or interpretation-based studies. Non-clinical tests follow predefined protocols and acceptance limits.
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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:
- No. The document explicitly states: "No clinical data submitted." This is not a study involving human readers or AI.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithm-based device.
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The type of ground truth used:
- For the non-clinical tests listed (Sterilization Validation, Shelf-Life Study, Packaging Testing, Cytotoxicity, Material Characterization, Pin-on-disk Wear, Lock Detail Fatigue, Tibial Post Fatigue), the "ground truth" would be established engineering standards, regulatory requirements, and validated testing methodologies.
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The sample size for the training set:
- Not applicable. This is not an AI/machine learning device requiring a training set.
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How the ground truth for the training set was established:
- Not applicable. This is not an AI/machine learning device requiring a training set.
In summary, the provided document is a 510(k) clearance letter for a medical device that highlights a change in sterilization method. The substantial equivalence argument is based entirely on non-clinical performance testing, not clinical trials or AI performance evaluations. Therefore, most of the requested information related to clinical studies, AI performance, expert ground truth, and sample sizes for such studies is not applicable to this specific submission.
§ 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.