(78 days)
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:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (K070214, K060370) | Mechanical testing demonstrates substantial equivalence to predicate devices. |
| Ability to provide increased flexion capability (up to 155 degrees) | Designed for use when load bearing ROM is expected to be less than or equal to 155 degrees. |
| Compatibility with specific articular surfaces/polyethylene | Designed for use with specified articular surfaces (e.g., NexGen Trabecular Metal CR Monoblock, Prolong Highly Crosslinked Polyethylene CR articular surfaces, Gender Solutions Natural-Knee Flex Congruent articular surfaces) |
| Adherence to indicated uses | The device meets the indications for use as described in the submission. |
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.
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.