(30 days)
When a mechanical alignment approach is utilized, 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.
When a Personalized Alignment approach is utilized, 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.
- Moderate valgus, varus, or flexion deformities.
The Personalized Alignment (PA) surgical technique may only be used with Persona cemented and uncemented CR femoral components, Persona CR, Ultra Congruent (UC), and Medial Congruent (MC) articular surface components, the Persona Cemented Stemmed tibial components without a stem extension, and the Persona OsseoTi Keel Tibia and Cemented Keel Tibia.
Porous coated components may be used cemented or uncemented (biological fixation), except for the Persona Osseo Ti Keel Tibia which is for uncemented use only. All other femoral, tibial baseplate and all-polyethylene (UHMVPE and VEHXPE) patella components are indicated for cemented use only.
The purpose of this submission is to add the Personalized Alignment surgical technique indication to the Persona Personalized Knee System
The provided text is a 510(k) summary for the Zimmer® Persona® Personalized Knee System, which is a knee prosthesis. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study proving a device meets specific acceptance criteria for performance as one might expect for a digital health or AI device.
Therefore, the information requested in your prompt regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies is largely not applicable in the context of this 510(k) submission.
Here's why and what can be extracted:
- Acceptance Criteria & Reported Performance: This document does not describe specific performance-based acceptance criteria for the device itself (e.g., accuracy, sensitivity, specificity, or surgical outcome percentages). Instead, it relies on demonstrating that the new indication (Personalized Alignment surgical technique) is substantially equivalent in terms of safety and effectiveness to existing predicate devices.
- Study That Proves the Device Meets Acceptance Criteria: No clinical study demonstrating performance against acceptance criteria in the traditional sense is described. The "performance data" section explicitly states "Non-Clinical Tests" and "Clinical Tests: None provided."
- Algorithm/AI Context: The Persona™ Personalized Knee System is a physical medical device (knee prosthesis), not an AI-powered diagnostic or therapeutic software. Therefore, concepts like "test set," "training set," "data provenance," "number of experts," "adjudication method," "MRMC comparative effectiveness study," and "standalone performance" are not relevant to this type of device submission.
Summary of Extracted Information based on the provided text's context:
Since the provided text is for a physical medical device (knee prosthesis) seeking 510(k) clearance based on substantial equivalence, the questions regarding acceptance criteria, study design, sample sizes, ground truth, experts, and AI analysis are generally not applicable. The submission focuses on comparing the new use of the device to existing predicate devices.
What can be inferred or directly stated from the text:
- Device Type: Zimmer® Persona® Personalized Knee System (Knee Prosthesis)
- Purpose of Submission: To add the "Personalized Alignment surgical technique indication" to the existing Persona Personalized Knee System.
- Basis for Clearance: Substantial Equivalence to predicate devices (K113369, K172524, K221479).
- Rationale for Substantial Equivalence: Based on identical/similar characteristics:
- Intended Use: Identical
- Indications for Use: Similar (expanded with Personalized Alignment)
- Materials: Identical
- Design Features: Identical
- Sterilization: Identical
- Non-Clinical Tests Performed:
- Persona® 0° Keel Tibial and Persona® PPS® Femur Design Validation - Device Comparison.
- Persona 0° Tibia Keel and Peg Perforation Personalized Alignment.
- Clinical Tests: None provided.
- Ground Truth: Not applicable in the context of this submission. The "ground truth" for a physical device is its physical properties and mechanical performance as demonstrated through non-clinical testing and comparison to predicates.
If this were a submission for an AI/digital health product, the information would be very different.
§ 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.