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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:

1. 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

2. 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.

3. 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.

4. 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.

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:

   • No. The document explicitly states: "No clinical data submitted." This is not a study involving human readers or AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • No. This is not an algorithm-based device.

7. 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.

8. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device requiring a training set.

9. 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.

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Intended Use:

The EMPOWR Revision Knee™ Symmetric TT Cones are intended for use in skeletally mature patients with bone defect or poor bone quality (osteoporotic bone) or in case of sclerotic bone that requires supplemental fixation in the clinical judgment of the surgeon. The EMPOWR Revision Knee™ Symmetric TT Cones are intended for uncemented fixation to the bone and are fixed to the femoral and tibial implants using bone cement.

Indications for Use:

The EMPOWR Revision Knee™:

Total 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 where bone loss may require the use of augments, sleeves cones or extensions.

The EMPOWR Revision Knee™ Symmetric TT Cones are indicated for the following conditions:

• EMPOWR Revision Knee™ Symmetric TT Cones are indicated for use in skeletally mature patients with bone defect or poor bone quality (osteoporotic bone) or in case of sclerotic bone that requires supplemental fixation in the clinical judgment of the surgeon.
• EMPOWR Revision Knee™ Symmetric TT Cones are indicated for uncemented fixation to the bone and are fixed to the femoral and tibial implants using bone cement.

The EMPOWR Revision Knee™ Symmetric TT (Trabecular Titanium) Cones are an optional accessory in primary or revision Total Knee Arthroplasty. The EMPOWR Symmetric TT Cones are sterile, single-use devices that are compatible for use with the EMPOWR Revision Knee™ components. The EMPOWR Symmetric TT Cones are composed of Ti6Al4V alloy (per ASTM F1472 and ISO 5832-3) and feature a porous Trabecular Titanium (TT) structure on the external surface of the implant. The EMPOWR Symmetric TT Cones are additively manufactured via Electron Beam Melting in the same manner as the reference AMF TT Cones device.

This document is an FDA 510(k) clearance letter for a medical device: the EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones).

It is crucial to understand that this document DOES NOT contain information about acceptance criteria or specific studies proving the device meets those criteria in the context of an AI/ML medical device.

The 510(k) clearance process for this orthopedic implant relies on demonstrating substantial equivalence to a previously cleared predicate device, primarily through bench testing (mechanical performance) and, in some cases, clinical data if significant differences exist. This is a very different type of clearance than for AI/ML devices, which require performance data related to algorithmic accuracy or clinical utility.

Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes for test/training sets, experts, adjudication, MRMC, standalone performance, ground truth establishment) because it is not present in this document.

The document states:

• "No animal data submitted."
• "No clinical data submitted."
• "All testing and evaluations demonstrate that the subject device is substantially equivalent to the primary predicate."

The performance testing listed focuses on mechanical properties (Dynamic Fatigue Testing, MR Conditional Labeling), which are relevant for an orthopedic implant but entirely different from the performance metrics and study designs expected for an AI/ML diagnostic or assistive device.

In summary, the provided document does not support a response to the prompt's specific questions regarding acceptance criteria and performance data for an AI/ML device.

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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 3DKNEE™ Porous Coated Femur, EMPOWR 3DKNEE™ POROUS Femur, 3DKNEE™ Porous Coated Tibia, and EMPOWR POROUS Tibia 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.

EMPOWR Revision Knee™ is intended for total knee prosthesis. The system consists of the sterile implants; EMPOWR Revision Femur, EMPOWR Stem Extender, and EMPOWR Femoral Augments (Distal and Posterior)- Universal. Non-sterile reusable instruments and trials are included as accessories.

The femur component can optionally be used with a stem extender and/or augments to suit a variety of surgeon preferences and patient anatomies.

This FDA 510(k) submission for the EMPOWR Revision Knee™ does not involve an AI/ML device. It is for a traditional medical device, specifically a knee replacement prosthesis.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details in the context of AI/ML is not applicable to this document.

The document describes material and mechanical performance testing for the knee prosthesis against recognized FDA standards and internal protocols to demonstrate substantial equivalence to predicate devices, as specified in Section VII (Performance Testing) on page 4. However, these are not AI/ML performance metrics.

In summary, the provided document does not contain information about an AI/ML device, its acceptance criteria, or the studies proving it meets those criteria.

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