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NovoHip Vitamin E liners are intended for use with the NovoSource NovoHip Total Hip System. NovoSource hip implant components are indicated for use in cementless reconstruction of the articulating surface of femoral and/or acetabular portions of the hip that are severely disabled and/or very painful as a result of:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• Rheumatoid arthritis or traumatic arthritis
• Correction of functional deformity
• Non-union femoral neck fracture
• Trochanteric fractures of the proximal femur with head involvement which is unmanageable using other techniques.
  The components can be used for primary hip arthroplasty or for revision of a failed total hip arthroplasty.

The NovoHip Total Hip System is a non-cemented hip prosthesis that consists of a 4-part total hip replacement system including femoral head, acetabular liner, and acetabular shell components. The femoral head component articulates within the poly acetabular component. The acetabular liner snaps into the acetabular shell component. The design and sizing of the components correspond to natural hip anatomy to restore normal rotation, extension, and flexion.
The NovoHip Vitamin E liners are components to be used with the NovoHip Total Hip System, previously cleared via K132158. The Vitamin E poly acetabular component snaps into the metal acetabular components that were previously cleared with the NovoHip Total Hip System.

The provided document is a 510(k) summary for a medical device called the "NovoHip Vitamin E liner." It describes the device, its intended use, technological characteristics, and importantly, the non-clinical performance data used for its clearance.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format alongside reported device performance. Instead, it lists numerous non-clinical tests performed on the device and concludes that, "Based on testing results and the comparisons provided, the NovoHip Vitamin E liner is considered substantially equivalent to the Zimmer Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners, DePuy Pinnacle Acetabular System, and Wright Medical Lineage Acetabular System in material, construction, and performance characteristics."

This indicates that the acceptance criterion for each test was likely that the NovoHip Vitamin E liner performed commensurately with, or acceptably against, the predicate devices based on the established standards/methods for those tests. The "reported device performance" is summarized by the overall statement of substantial equivalence rather than specific numerical results for each criterion.

Here's a conceptual representation of what such a table might look like, based on the provided information, if specific numerical criteria were explicitly listed:

Study Details:

1. Sample size used for the test set and the data provenance:
   The document lists 28 non-clinical performance tests. For each of these tests, a sample size of the device (NovoHip Vitamin E liners) would have been used. However, the specific sample sizes for each test are not detailed in this 510(k) summary. These would typically be found in the full test reports, which are not included here.
   The data provenance is non-clinical bench testing, meaning the data was generated in a lab setting, not from human or animal subjects. Details like country of origin are not specified, but it's implied the testing was conducted by or for NovoSource Inc. to support regulatory submission in the U.S.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This question is not applicable as the studies were non-clinical (bench testing) rather than clinical studies requiring expert interpretation of medical images or patient outcomes. The "ground truth" for these tests would be the established scientific methods and engineering standards used to measure device properties.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   This question is not applicable for non-clinical bench testing as there is no human interpretation of data requiring adjudication. The results are typically quantitative measurements against defined specifications.

4. 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:
   This question is not applicable. The device is an orthopedic implant (hip liner), not an AI-powered diagnostic or assistive tool. No MRMC study was performed.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   This question is not applicable. The device is a physical implant; there is no AI algorithm involved in its function or assessment.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For these non-clinical tests, the "ground truth" refers to the established scientific and engineering principles, measurement standards (e.g., ISO, ASTM), and the physical properties of the material and device components themselves. Performance was measured against these objective standards and compared to the performance of predicate devices.

7. The sample size for the training set:
   This question is not applicable. This is not a machine learning or AI device that requires a training set. The device is a physical medical implant.

8. How the ground truth for the training set was established:
   This question is not applicable as there is no training set for this device.

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NovoSource hip implant components are indicated for use in cementless reconstruction of the articulating surface of femoral and/or acetabular portions of the hip that are severely disabled and/or very painful as a result of:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• Rheumatoid arthritis or traumatic arthritis
• Correction of functional deformity
• Non-union femoral neck fracture
• Trochanteric fractures of the proximal femur with head involvement which is unmanageable using other techniques.

The components can be used for primary hip arthroplasty or for revision of a failed total hip arthroplasty.

The NovoHip Total Hip System is a non-cemented hip prosthesis that consists of a 4-part total hip replacement system including femoral stem, femoral head, acetabular poly liner, and acetabular metal (or shell) components. The femoral head component articulates within the poly acetabular component. The poly acetabular component snaps into the metal acetabular component. The design and sizing of the components correspond to natural hip anatomy to restore normal rotation, extension, and flexion.

The femoral stem component is made from forged Ti 6AL 4V, with a Ti plasma spray coating. The unipolar femoral head component is made from CoCr, or BIOLOX® delta ceramic, in 28, 32, and 36 mm sizes.

The acetabular poly liner component is made of standard UHMWPE polyethylene in both hooded and non-hooded options. The acetabular poly liner component is offered with different inner and outer diameter combinations to accept various size uni-polar femoral heads and acetabular metal components.

The acetabular metal (or shell) component is made from forged Ti 6AL 4V with a Ti porous coating. It is available in no-hole, cluster-hole, and revision multi-hole styles.

Here's an analysis of the provided text regarding the acceptance criteria and study for the NovoHip Total Hip System:

Summary of Acceptance Criteria and Study Findings

The NovoHip Total Hip System's acceptance criteria are based on its ability to perform comparably to predicate devices through a series of non-clinical mechanical tests. The study demonstrates that all tested components met their required performance specifications, thereby establishing substantial equivalence to existing marketed hip prostheses.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for each of the non-clinical tests. The data provenance is non-clinical laboratory testing, likely conducted by or for the manufacturer (NovoSource, Inc.), and is retrospective in the sense that it evaluates the device's characteristics against predefined specifications rather than observing its performance over time in a living system. The country of origin for the data is implied to be within the US, given the submission to the FDA.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable to this type of submission. The ground truth for mechanical testing is established by engineering standards and predefined performance specifications derived from regulatory guidelines and predicate device performance, not by expert interpretation of data.

4. Adjudication Method for the Test Set

This information is not applicable. Since the tests are objective mechanical performance evaluations against defined specifications, there is no need for expert adjudication. The result is either "meets specification" or "does not meet specification."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human readers interpret medical images or data. The NovoHip Total Hip System is a mechanical implant, and its performance is evaluated through objective physical and mechanical testing.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable as the device is a physical hip implant, not an algorithm or software. The "standalone" performance here refers to the device's mechanical integrity as tested in a laboratory setting. All listed tests are "standalone" in this physical sense, meaning the device's performance was evaluated independently without human surgical interaction during the test itself (though humans designed and conducted the tests).

7. The Type of Ground Truth Used

The ground truth for the non-clinical tests used in this submission is based on:

• Engineering Standards and Specifications: Performance requirements derived from nationally and internationally recognized standards (e.g., ISO, ASTM for medical devices) for hip implants and their components.
• Predicate Device Performance: The performance characteristics of the legally marketed predicate devices (Stelkast Provident Hip System, Smith & Nephew Biolox Delta Ceramic Femoral Head, Wright Medical Lineage Acetabular System) serve as a benchmark for substantial equivalence.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of this device because it is a physical medical implant, not an AI or machine learning model that requires training data.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as point 8.

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The NovoKnee Total Knee System is Indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities.

The NovoKnee Total Knee System may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. The NovoKnee Total Knee System is designed for cemented use only.

The present 510k submission is for a cruciate retaining (CR) version of the NovoKnee Total Knee System. The main predicate device (K123339) is a posterior stabilized (PS) version of the NovoKnee Total Knee System. All implant components are the same between the two versions, except for the tibial inserts and the femoral components. The posterior stabilized version has tibial inserts with posts and femoral components with cams that interact with the posts to help stabilize the knee after the posterior cruciate ligament is removed. The cruciate retaining version of the NovoKnee Total Knee System has tibial inserts and femoral components without posts or cams, allowing the posterior cruciate ligament to be "retained" and provide stability to the knee joint.

The NovoKnee Total Knee System is a Patellofemorotibia, polymer, semi-constrained, cemented knee prosthesis, that consists of a femoral component, tibial tray and patellar component. The femoral component articulates with the tibial insert component. The underside of the tibial insert component is flat and "snaps" into the tibial baseplate component. Each femoral component has the same intercondylar distance and radius of curvature. Each tibial insert component is complimentarily shaped to conform to the femoral components. This allows any size fernoral component to be matched with any size tibial component. The dome shape of each UHMWPE patellar component provides excellent contact with the femoral component and evenly distributes stresses. The dome and sombrero shape of each UHMWPE patellar component provides contact with the femoral component.

This document describes the validation of the NovoKnee Total Knee System, specifically the cruciate-retaining (CR) version, against its predicate device, a posterior-stabilized (PS) version of the same system. The study aims to demonstrate substantial equivalence, not to establish performance against specific acceptance criteria for effectiveness outcomes, but rather to show that new CR components perform comparably to previously cleared components in terms of mechanical integrity and design principles.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria in a typical "threshold" format for clinical performance (e.g., sensitivity, specificity, accuracy). Instead, the acceptance criterion for the performance testing is demonstrating substantial equivalence to the predicate device in specific mechanical tests. The reported device performance is that this substantial equivalence was achieved.

Note: The text explicitly states, "All implant components are the same between the two versions, except for the tibial inserts and the femoral components." Furthermore, for the Femoral/Tibial Insert Contact Area Test, while not explicitly stated, contact area is a fundamental characteristic for knee implants, and the goal for the CR version is to demonstrate comparable contact mechanics to existing designs. The mention that "Each femoral component has the same intercondylar distance and radius of curvature. Each tibial insert component is complimentarily shaped to conform to the femoral components" implies a design intent to maintain similar contact characteristics. The overarching goal is substantial equivalence, which implies comparable performance in these tests to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of patient data. The performance testing described is mechanical (bench) testing of the device components. The sample size for these mechanical tests (e.g., number of implants or constructs tested) is not provided.

The data provenance is not applicable as this is a device modification submission based on mechanical testing and design comparison, not clinical trial data involving patients.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. Ground truth for mechanical testing is established by engineering specifications and objective measurements, not expert consensus.

4. Adjudication Method for the Test Set

Not applicable, as this is mechanical testing, not a clinical study involving human assessment that would require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is a 510(k) submission for a medical device modification (cruciate-retaining version of a total knee system), not an AI/software as a medical device (SaMD) or diagnostic imaging product that would typically involve an MRMC study comparing human readers with and without AI assistance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

No, this is not applicable. The device is a physical knee implant, not an algorithm.

7. Type of Ground Truth Used

For the mechanical performance tests, the "ground truth" implicitly used is the performance characteristics of the legally marketed predicate device (K123339, NovoKnee Total Knee System - PS version). The goal is to demonstrate that the novel CR version performs equivalently in these mechanical tests.

8. Sample Size for the Training Set

Not applicable. There is no "training set" in the context of an algorithm or machine learning for this physical device.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set.

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The NovoKnee Total Knee System is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. The NovoKnee Total Knee System may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. The NovoKnee Total Knee System is designed for cemented use only.

The NovoKnee Total Knee System is of the fixed bearing type with a posterior stabilized design. It is a Patellofemorotibia, polymer/metal/polymer, semi-constrained, cemented knee prosthesis, that consists of a femoral component, tibial tray and patellar component. The femoral component articulates with the tibial insert component. The underside of the tibial insert component is flat and "snaps" into the tibial baseplate component. Each femoral component has the same intercondylar distance and radius of curvature. Each tibial insert component is complimentarily shaped to conform to the femoral components. This allows any size femoral component to be matched with any size tibial component. The dome shape of each UHMWPE patellar component provides excellent contact with the femoral component and evenly distributes stresses. The dome and sombrero shape of each UHMWPE patellar component provides contact with the femoral component.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample sizes used for the mechanical testing (test set) or the data provenance. The studies were likely laboratory-based mechanical performance tests rather than clinical trials with human subjects.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:

Not applicable. The ground truth for this type of mechanical device testing is established through engineering and biomechanical standards and measurements, not expert consensus as would be used in diagnostic studies.

4. Adjudication Method for the Test Set:

Not applicable. This was mechanical performance testing against established engineering standards and comparison to a predicate device, not an adjudication process involving human reviewers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This device is a total knee replacement system, and the studies performed were mechanical performance tests, not studies involving human readers and interpretations of cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device is a physical knee prosthesis, not an algorithm or AI system. The performance testing was for the mechanical integrity and function of the device itself.

7. The Type of Ground Truth Used:

The ground truth used was based on engineering standards and direct physical measurements of the device's mechanical properties and performance. This includes metrics like fatigue life, strength, contact pressures, and range of motion, compared against the known performance of the predicate device (U2 Total Knee System) which has established safety and effectiveness.

8. The Sample Size for the Training Set:

Not applicable. This mechanical device did not involve a "training set" in the context of typical AI/ML studies. The manufacturing and design process would involve iterative testing and refinement, but not a formally defined "training set" as understood in machine learning.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there was no "training set" in the context of AI/ML. For the design and development of the physical device, ground truth would be established through engineering calculations, material science properties, and iterative physical prototyping and testing against design specifications and established biomechanical principles.

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