(107 days)
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.
| Acceptance Criterion (Implicit for 510(k)) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device in terms of safety and effectiveness | Mechanical testing demonstrates substantial equivalence to predicate devices. |
| Compliance with existing regulations for total knee prosthesis | Device meets the classification for knee joint prostheses (21 CFR § 888.3560, § 888.3565, § 888.3540). |
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:
- 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.
- 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.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- 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.
- The sample size for the training set: Not applicable. No "training set" in the AI/ML sense.
- 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.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.