(27 days)
Total Knee components are indicated for rheumatoid arthritis, osteoarthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartment, or total knee replacement. LEGION Porous CR Narrow Femoral Components are indicated for use without bone cement and are single use devices.
The subject devices of this premarket notification are the LEGION Porous CR Narrow Femoral Components, which include catalog item offerings with and without HA Coating. These Femoral Components are indicated for use without bone cement applications. The subject devices are a line extension of the predicate devices listed, which are cleared under 510(k) submission numbers K073325 and K091543, with a modification in their femoral components' outer dimensions making them Narrow Femoral Components (similar to the cleared reference device: LEGION Narrow Oxinium CR and PS Femoral Components and Device Specific Instruments cleared under K112941). The overall design of the subject device is geometrically identical to the predicate devices LEGION Porous Femoral Components (K073325, K091543) with their outer dimensional changes making them Narrow Femoral Components (Reference device K112941).
The provided text describes a 510(k) premarket notification for a medical device, specifically LEGION Porous CR Narrow Femoral Components. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials as would be required for a PMA. As such, the information you're requesting regarding acceptance criteria and performance studies in the context of AI/algorithms, human readers, and ground truth is not applicable to this document.
This document pertains to a Class II orthopedic implant (knee joint prosthesis), which is a physical device, not a software or AI-driven diagnostic tool. The performance testing conducted is engineering bench testing to ensure mechanical equivalence, not statistical performance metrics typically associated with AI.
Here's why the specific questions are not answered by the provided text:
- 1. A table of acceptance criteria and the reported device performance: The document states that "the bench performance testing met the predefined acceptance criteria," but it does not provide the specific acceptance criteria or the quantitative results of the tests (e.g., maximum stress, fatigue cycles, contact area measurements). It lists the types of tests conducted (Tibiofemoral constraint analysis, Tibiofemoral contact area analysis, Patellofemoral resistance to lateral subluxation testing).
- 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This refers to bench testing of physical components, not data-driven studies.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. "Ground truth" for this device is established through engineering specifications and physical measurements, not expert human interpretation.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There are no human adjudicators for the mechanical performance of this implant.
- 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 (expert consensus, pathology, outcomes data, etc): For bench testing, the "ground truth" would be the engineering specifications and physical measurements obtained from calibrated testing equipment. The document does not detail these specifics.
- 8. The sample size for the training set: Not applicable. There is no training set for this type of physical device.
- 9. How the ground truth for the training set was established: Not applicable.
In summary: The provided document is for a medical device clearance based on substantial equivalence to predicate devices, supported by engineering bench testing. It does not involve AI, image analysis, or clinical studies with human readers, and therefore, the questions you've posed are not addressed by this specific regulatory submission.
§ 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.