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Gender Solutions" Natural-Knee® Flex System:

• Components with CSTi porous coating are indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD).
• Components without CST are indicated for cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD), correctable varus-valgus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists.

The Gender Solutions Natural-Knee Flex (N-K Flex) components are semiconstrained, nonlinked condylar knee prosthesis that are designed to have a maximum active flexion of 155 degrees. The N-K Flex femoral provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range.

The provided text describes a 510(k) premarket notification for a medical device, the Gender Solutions™ Natural-Knee® Flex System. This is a type of knee replacement prosthesis. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than conducting a de novo study involving novel performance evaluation criteria for an AI/ML powered device.

Therefore, many of the requested categories related to AI/ML device performance and study design are not applicable to this submission.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

This submission is for a knee prosthesis, not an AI/ML powered diagnostic or prognostic device. As such, the "acceptance criteria" are not reported as specific performance metrics like sensitivity, specificity, or AUC, but rather the demonstration of substantial equivalence to existing, legally marketed predicate devices.

The primary "performance" assessed is mechanical equivalence to the predicate device.

Study Details (Applicability to AI/ML Device Evaluation)

Given that this is a 510(k) submission for a traditional medical device (knee prosthesis), the following points related to AI/ML device evaluation are not applicable and are not discussed in the provided text:

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. The study involves mechanical testing of physical implants, not a "test set" of data for algorithm evaluation.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no concept of a "ground truth" derived from expert consensus in the context of mechanical testing for a knee prosthesis.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is not an AI-assisted diagnostic or prognostic device.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The ground truth for this device is its mechanical properties matching a predicate device.
7. The sample size for the training set: Not applicable. No "training set" in the AI/ML sense.
8. How the ground truth for the training set was established: Not applicable.

Summary of Performance Data from the Submission

The document states:

• Non-Clinical Performance and Conclusions: "Mechanical testing of the subject devices demonstrates that they are substantially equivalent to the predicate devices."
• Clinical Performance and Conclusions: "Clinical data and conclusions were not needed for these devices."

This indicates that the safety and effectiveness of the Gender Solutions™ Natural-Knee® Flex System were established through non-clinical mechanical testing, demonstrating its equivalence to predicate devices that have already established safety and efficacy. No human clinical trials or data interpretation studies were required or performed for this particular 510(k) submission. The modifications from the predicate device were described as "dimensional and material modifications," which implies that the fundamental design and function were maintained, justifying the reliance on mechanical testing for substantial equivalence.

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Gender Solutions "Natural-Knee" Flex System:

• Components with CST porous coating are indicated for uncemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD).
• Components without CSTi are indicated for cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (ID), correctable varus-valgus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists.
• The N-K Flex femoral provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. When used with N-K Flex, NexGen Trabecular Metal" CR Monoblock, 90-prefix NexGen CR, 00-prefix 10, 12 or 14mm or 90-prefix 17 or 20mm Prolong "Highly Crosslinked Polyethylene CR articular surfaces, it is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

NexGen® Complete Knee Solution CR-Flex Gender Solutions™ Femoral Component:

• This device is indicated for patients with severe knee pain and disability due to:
  • Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis,
  • Collagen disorders, and/or 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.
  • The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
• This device is intended for cemented use only.
• Specific uses with CR-Flex GSF femorals:
  • Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range.
  • The CR-Flex GSF femoral, when used with 90-prefix NexGen CR articular surfaces, 00-prefix 10, 12 or 14mm or 90-prefix 17 or 20mm Prolong Highly Crosslinked Polyethylene CR articular surfaces, or with Gender Solutions Natural-Knee Flex Congruent articular surfaces, is designed for use with a functional posterior cruciate ligament and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees.

The Gender Solutions Natural-Knee Flex (N-K Flex) and NexGen CR-Flex GSF components are semiconstrained, nonlinked condylar knee prosthesis that are designed to have a maximum active flexion of 155 degrees. The GSM and GSF femoral component designations indicate that the design of the femoral components has been modified to address specific anatomical features of the distal femur that can be seen in patients of either gender, but are more typical of male and female patients, respectively.

This document describes a 510(k) premarket notification for knee prosthesis components and does not contain information about a study proving a device meets acceptance criteria as typically found in a clinical or AI/device performance study.

Instead, it refers to mechanical testing to demonstrate substantial equivalence to predicate devices, which is a different type of evaluation. No AI/device performance metrics (like sensitivity, specificity, or AUC) are included.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, device performance, sample size, ground truth, expert involvement, or AI-related studies.

Here's a breakdown of why the request cannot be fully fulfilled based on the provided text:

• No Acceptance Criteria or Performance Data for a "Device" in the common sense of an AI/diagnostic device: The document describes new components for a knee replacement system. The relevant "acceptance criteria" here are likely related to mechanical properties, material compatibility, and overall design and manufacturing standards for implants, not diagnostic performance metrics.
• No "Study" in the context of device performance: The document states: "Clinical data and conclusions were not needed for these devices." Instead, it relies on non-clinical performance data (mechanical testing) to show substantial equivalence.
• No AI or diagnostic component: This is a physical medical device (knee implant) and the filing pertains to its design and material characteristics, not its performance in interpreting data or aiding diagnosis.
• No "Ground Truth" or "Experts" in the requested context: Since there's no diagnostic or AI component, there's no ground truth (e.g., pathology report, clinical outcome for diagnostic accuracy) or expert adjudication for interpretive tasks.

Based on the provided text, the available information is as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance: Not applicable. The document refers to mechanical testing, not a diagnostic or clinical test set with human or patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for a diagnostic test set was established.
4. Adjudication method for the test set: Not applicable.
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 not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used: Not applicable in the context of diagnostic accuracy. The "ground truth" for this device would be its mechanical properties meeting engineering specifications and its biomaterial compatibility, demonstrated through pre-clinical mechanical testing and comparison to legally marketed predicate devices.
8. The sample size for the training set: Not applicable. This is not a machine learning device or software.
9. How the ground truth for the training set was established: Not applicable.

Additional Information from the Document:

• Study Type: Non-clinical (mechanical testing) was performed. Clinical data was deemed "not needed."
• Purpose: To demonstrate substantial equivalence to predicate devices for regulatory clearance (510(k)).
• Device Type: Total Knee Prosthesis components (femoral components).
• Key finding: Mechanical testing demonstrates substantial equivalence to predicate devices.

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• Components with CSTi porous coating are indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD).
• Components without CST porous coating are indicated for cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD), correctable varus-valgus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists.
• The N-K Flex femoral provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. When used with N-K Flex articular surfaces, it is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

The Gender Solutions Natural-Knee Flex System is a semiconstrained, nonlinked condylar knee prosthesis that is designed to have a maximum active flexion of 155 degrees. The system includes GSM and GSF femoral components; these designations indicate that the design of the femoral components has been modified to address specific anatomical features of the distal femur that can be seen in patients of either gender, but are more typical of male and female patients, respectively.

Components with CSTi porous coating are indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD).

Components without CSTi porous coating are indicated for cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD), correctable varus-valgus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists.

The N-K Flex femoral provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. When used with N-K Flex articular surfaces, it is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

Except for minor geometrical and material modifications, the proposed components are identical to the predicate devices.

The provided document describes the Zimmer Gender Solutions™ Natural-Knee® Flex System, which is a total knee prosthesis. It details the device's description, indications for use, and a comparison to predicate devices. However, it explicitly states:

"Clinical data and conclusions were not needed for this device."

This type of submission (510(k)) relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies to prove safety and effectiveness from scratch. Therefore, the information you've requested regarding acceptance criteria based on a clinical study, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance does not exist within this document for this specific device.

The document primarily focuses on:

• Substantial Equivalence: The approval is based on the device being substantially equivalent to the NexGen® Complete Knee Solution Knee Gender Solutions Female (GSF) Femoral Components and Natural-Knee II System with Cancellous-Structured Titanium™ (CSTi™) Porous Coating.
• Non-Clinical Performance: "Mechanical testing and Finite Element Analysis of the proposed device demonstrates that it is substantially equivalent to the predicate devices." This likely covers aspects like strength, wear, and other physical properties.

Summary of Requested Information (Based on the Provided Document):

Since no clinical study was needed or performed for this device's 510(k) clearance, most of the requested fields cannot be filled.

1. Table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly stated as performance metrics from a clinical study for this device, but implied to be "substantially equivalent" to predicate devices based on non-clinical testing.
   • Reported Device Performance: Not reported from a clinical study for this device. Mechanical testing and Finite Element Analysis indicated substantial equivalence to predicate devices.

2. Sample sized used for the test set and the data provenance: Not applicable as no clinical test set was used for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set was used for this 510(k) submission.

4. Adjudication method for the test set: Not applicable as no clinical test set was used for this 510(k) submission.

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 a physical knee prosthesis, not an AI-assisted diagnostic tool for human readers.

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.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as no clinical ground truth was established for this device's 510(k) submission. The "ground truth" for clearance was the established safety and effectiveness of the predicate devices.

8. The sample size for the training set: Not applicable as no training set (in the context of machine learning or clinical trials) was used for this 510(k) submission.

9. How the ground truth for the training set was established: Not applicable as no training set was used for this 510(k) submission.

In essence, the "study that proves the device meets the acceptance criteria" in this case is the non-clinical mechanical testing and Finite Element Analysis that demonstrated the device's substantial equivalence to already cleared predicate devices. The acceptance criteria were met by showing that the new device performs similarly in terms of its mechanical properties and design to devices already established as safe and effective.

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