(43 days)
Total knee components are indicated for:
- Rheumatoid arthritis
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result.
- Failed osteotomies, unicompartmental replacement, or total knee replacement.
- The posterior-stabilized knee system is designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
The Legion Porous + HA Tibial Baseplates are indicated for use without bone cement, and are single use devices.
Subject of this premarket notification is a review of changes to the Profix Porous Tibial Baseplates (previously cleared for market via premarket notification K030623) to result in the Legion Porous + HA Tibial Baseplates. The subject devices are uncemented tibial baseplates manufactured from Ti-6Al-4V material and feature a porous coating of CP Ti beads and an HA coating. The devices will be available in left and right configurations in sizes 2 through 8.
When compared to the predicate Profix Porous Tibial Baseplates, the Legion Porous + HA Tibial Baseplates have been modified as follows:
- Utilization of the Genesis II style periphery, profile, and locking detail
- Addition of HA coating
- Increase in thickness of baseplate
The provided text describes a 510(k) premarket notification for the "Legion Porous + HA Tibial Baseplates." This regulatory document focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a detailed study proving performance against specific acceptance criteria in the way one might see for a novel AI device or a new drug.
Therefore, many of the requested categories regarding acceptance criteria, study design, expert involvement, and training/test sets for AI/algorithms are not applicable to this type of medical device submission. The submission relies on design verification testing to demonstrate that modifications do not introduce new safety or effectiveness issues, in comparison to the predicates.
Here's a breakdown of the available information based on your request, with an emphasis on what is not applicable in this context:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Not explicitly stated in terms of pass/fail numbers) | Reported Device Performance (Summary) |
|---|---|
| Safety and Effectiveness (as per FDA guidance) | Design verification testing demonstrated "no new issues related to the safety or effectiveness of the subject devices." |
| Functional equivalence to predicate devices | "Substantially equivalent" to predicate devices (K030623, K032683). |
- Note: The FDA's 510(k) process for devices like this typically doesn't define quantitative "acceptance criteria" in the same way an AI performance study would. Instead, it relies on demonstrating that design changes do not adversely affect safety and effectiveness compared to predicate devices, often through mechanical testing and comparison of materials and intended use. The "performance" here is primarily about functional equivalence and mechanical integrity, not statistical clinical outcomes.
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable in the traditional sense of a clinical test set. The "testing" appears to be mechanical design verification, which uses physical samples of the device components. The document doesn't specify the number of physical samples, but it's not a "test set" of patient data.
- Data Provenance: Not applicable for patient data. The "data" comes from engineering and mechanical testing of the physical device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. There is no "ground truth" in the clinical data sense for this type of submission. The evaluation is based on engineering principles and regulatory guidelines.
4. Adjudication Method for the Test Set:
- Not Applicable. There's no clinical adjudication process described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. This is not an MRMC study. These studies are typically for diagnostic devices where human readers interpret medical images or data, and AI assistance is evaluated. This submission is for an orthopedic implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not Applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used:
- Not Applicable in the clinical sense. The "truth" in this context is adherence to engineering specifications, material properties, and mechanical performance standards (e.g., fatigue strength, fixation strength) as outlined in FDA guidance documents for knee implants. There's no pathology, expert consensus on images, or outcomes data used to establish "ground truth" for the device's basic function in this submission.
8. The Sample Size for the Training Set:
- Not Applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable.
Summary of the Study/Evaluation:
The submission for the Legion Porous + HA Tibial Baseplates is a 510(k) premarket notification, specifically a "Special 510(k)" which indicates minor changes to a previously cleared device. The "study" proving the device meets criteria is primarily design verification testing and a comparison to predicate devices.
- Purpose: To demonstrate that the modified device (Legion Porous + HA Tibial Baseplates) is substantially equivalent to legally marketed predicate devices (Profix Total Knee System K030623 and Genesis II Porous + HA Knee System K032683).
- Methodology:
- Design Verification Testing: Performed based on FDA guidance documents for knee joint prostheses and modular implant components. This type of testing typically involves mechanical bench tests (e.g., fatigue, static strength, wear) to ensure the device meets engineering specifications and regulatory standards. The document states this testing "demonstrated that there are no new issues related to the safety or effectiveness."
- Substantial Equivalence Argument: The submission argues that despite modifications (Genesis II style periphery, HA coating, increased thickness), the "overall design philosophy, intended use, and material choices" remain unchanged compared to the predicate devices.
- Clinical Data: Explicitly stated as "not needed to support the safety and effectiveness of the subject device," reinforcing that the evaluation relied on non-clinical (mechanical) testing and comparison.
In essence, the "study" is a regulatory submission demonstrating mechanical integrity and equivalence, not a clinical trial or an AI performance study with patient data.
§ 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.