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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;

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 Cones are indicated for the following conditions:

EMPOWR™ Revision Knee™ Symmetric 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 Cones are indicated for uncemented fixation to the bone and are fixed to the femoral and tibial implants using bone cement.

Envois is adding a non-mating modular component accessory to the EMPOWR™ Knee product line and is compatible with the EMPOWR Revision Knee™ Femur (K213793), the EMPOWR PS Knee® Femur (K160342), the EMPOWR ™ Universal Tibial Baseplate (K173723), and the EMPOWR™ Knee Cemented Stems and Extender Accessories (K173723, K213793, and K230441).

The EMPOWR Revision Knee™ Symmetric Cone implants (also known as Cones) are an optional accessory in primary or revision Total Knee Arthroplasty. The Cones are sterile, single-use device that are compatible for use with the EMPOWR Revision Knee™ components. The EMPOWR™ Cones are composed of Ti6Al4V alloy per ASTM F1472 and contain a modified surface composed of commercially pure titanium per ASTM F67. This modified surface (i.e. porous coating) is exactly the same as applied to existing FMP™ Porous Coated Acetabular Shells (K072888).

The EMPOWR Revision Knee™ Symmetric Cones are intended to the mating femoral and/or tibial component using bone cement. The cones are intended for fixation as an assembled construct in the distal femur and/or proximal tibia, without bone cement.

The provided text describes a 510(k) premarket notification for a medical device, EMPOWR Revision Symmetric Knee Cones. It details the device's indications for use, comparison to predicate devices, and the types of testing performed to demonstrate substantial equivalence.

However, the document does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/ML medical device. The product is a physical knee implant accessory, not an AI/ML software device. Therefore, the questions related to AI/ML device performance (such as sample sizes for test sets, expert ground truth establishment, MRMC studies, standalone algorithm performance, training set details, etc.) are not applicable to this submission.

The document states:

• "No animal data submitted."
• "No clinical data submitted."

Instead, substantial equivalence is demonstrated through:

• Biocompatibility testing: In accordance with FDA guidance and ISO 10993 standards.
• Performance Testing:
  • Dynamic Fatigue Testing: ASTM F1800-19e1 (modified)
  • MR Conditional Labeling: ASTM F2052 -21, ASTM F2213-17, ASTM F2119-07(2013), ASTM F2182-10e2, ASTM F2503-20

Therefore, I cannot provide the requested information regarding acceptance criteria and study details relevant to an AI/ML medical device based on the provided text.

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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, 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.

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 judgement of the surgeon
• · bone loss that requires supplemental fixation in the clinical judgement of the surgeon

The EMPOWR Revision VVC+ (Varus / Valgus Constrained) e+ Tibial Insert Implant is a line extension that offers an increased level of femoral / tibial constraint over the EMPOWR VVC Tibial Insert. This tibial insert implant provides additional internal / external and varus / valgus rotational stability.

The sizing architecture for the insert includes 14 sizes (2-11, 4BU, 5BU, 6BD, 7BD) and thicknesses of 10mm, 12mm, 14mm, 16mm, 19mm, 22mm and 25mm with post medial/lateral width of 0.5520 inches for sizes 2-5 and 0.7080 inches for sizes 6 - 11. Along with the post width, the articulating geometry of the proximal side of the tibial insert accommodates an additional amount of internal / external (I/E), varus / valgus (V/V) constraint, and tibial post / femoral cam jump height when interfacing with the EMPOWR Revision Femoral implant. The material (highly crosslinked 75kGy UHMWPE with vitamin E per ASTM F2695/F2565) and distal locking mechanism geometry with the mating tibial baseplate are identical to the predicate.

All tibial insert thickness options are configured to interface with a reinforcement pin accessory made of Wrought CoCr per ASTM F1537. This accessory is configured with a taper interface on the distal end to mate with the EMPOWR UNIVERSAL TIBIAL BASEPLATE, has a diameter and length configured to reinforce the post and thickness for the EMPOWR Revision VVC+ e+ tibial insert, and contains barbs to prevent the pin from backout when fully seated within the post of the EMPOWR Revision VVC+, e+ tibial insert.

This document is a marketing clearance letter from the FDA for a medical device, specifically a knee joint prosthesis. It does not contain information about the acceptance criteria and study proving the device meets those criteria in the context of an AI/ML medical device.

The provided text discusses:

• The FDA's decision regarding substantial equivalence for the EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert.
• Regulatory information about the device (product code, regulation number, class).
• General controls provisions and additional controls that may apply.
• Indications for Use for the device, which describe the patient conditions for which the device is intended.
• A brief description of the device as a line extension offering increased constraint.
• Comparison of technological characteristics with a predicate device.
• Performance testing: This section lists types of performance tests conducted (e.g., CAD Based Range of Motion (ROM), Femoral – Tibial Contact Area Assessment, Femur - Tibial Intrinsic Stability, Femur - Tibial Varus / Valgus Constraint Testing, MR Conditional Labeling), but it does not provide acceptance criteria or the reported results of these tests. It merely states that "The following testing was performed to FDA recognized standards and internal protocols."
• Absence of animal or clinical studies: The document explicitly states "No animal data submitted" and "No clinical data submitted." This indicates that the substantial equivalence determination was based on non-clinical data, likely bench testing and comparisons to the predicate device.

Therefore, based solely on the provided text, it is not possible to answer the detailed questions about acceptance criteria, study methodologies, sample sizes, expert involvement, and ground truth establishment, as these pertain to performance studies that would typically be conducted for AI/ML medical devices or devices requiring clinical evidence for efficacy/safety.

The provided document is a 510(k) clearance letter, which often relies on demonstrating substantial equivalence to a predicate device through non-clinical performance and material characterization, rather than extensive clinical trials or AI/ML specific performance studies. This specific device is a mechanical implant, not an AI/ML-driven diagnostic or therapeutic 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.

The EMPOWR Stem Extender, 50mm implant is a modular accessory of the EMPOWR Revision Knee (K213793). When coupled with the EMPOWR Revision Knee, the Stem Extender is intended to be fixed to the bone by cement. The extender is connected to the mating implant, Revision Femur, by 7/16-20 UNF-2A male threaded connection on the implant, and 7/16-20 UNF-2B female threaded connection on the other side that is used to "extend" the length of cemented stem accessories (K173723) in an identical way as the EMPOWR Stem Extender, 25mm (K213793).

The Stem Extender is also compatible with the EMPOWR Universal Tibial Baseplate (K173723) and will be offered for use as an accessory with the baseplate.

The EMPOWR Stem 50mm Extender comes in a single diameter of 15mm and is offered a length of 50mm (Refer to Figure 1). The EMPOWR Stem Extender, 50mm is made of wrought CoCr alloy per ASTM F1537, which is identical to the material used in the 25mm extender included in the EMPOWR Revision Knee (K213793).

The provided text is a 510(k) summary for the EMPOWR™ Stem Extender, 50mm, which is a medical device. This type of submission is for clearance of a device that is substantially equivalent to a legally marketed predicate device. The document states that no clinical studies or animal studies were submitted to demonstrate the device meets acceptance criteria. Instead, substantial equivalence is claimed based on similar materials, manufacturing, sterilization processes, and performance testing against a recommended consensus standard.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth for the specific device performance study cannot be extracted from this document, as such a study was not presented.

However, I can extract information about the performance testing conducted to demonstrate substantial equivalence, which serves a similar role to proving a device meets acceptance criteria in a 510(k) context.

Here's what can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "An evaluation was performed against the recommended consensus standards for knee implants per the product codes assigned to the subject device. Of those standards, it was determined for this line extension that these additional components should be evaluated against ASTM F2083-21 (Standard Specification for Knee Replacement Prosthesis)." This implies the acceptance criteria are the specifications within ASTM F2083-21, and the reported performance is that the device met these specifications, leading to a conclusion of substantial equivalence.

2. Sample size used for the test set and the data provenance

• Sample size for the test set: Not specified in the provided text.
• Data provenance: Not explicitly stated, but assumed to be laboratory testing conducted by the manufacturer, Encore Medical, L.P.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable, as this was mechanical performance testing against a standard, not a clinical study requiring expert consensus for ground truth.

4. Adjudication method for the test set

• Not applicable, as this was mechanical performance testing.

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 device is not an AI diagnostic or imaging device, and no clinical studies were performed.

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

• Not applicable. This device is not an algorithm or AI.

7. The type of ground truth used

• For mechanical performance: The technical specifications and requirements outlined in the ASTM F2083-21 standard.

8. The sample size for the training set

• Not applicable. No clinical or AI-related training was mentioned.

9. How the ground truth for the training set was established

• Not applicable. No clinical or AI-related training was mentioned.

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