(88 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.
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Collagen disorders, and/or avascular necrosis of the femoral condyle.
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Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
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Moderate valgus, varus, or flexion deformities.
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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.
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Collagen disorders, and/or avascular necrosis of the femoral condyle.
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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 (biological fixation), except for the Persona OsseoTi Keel Tibia and the Persona OsseoTi 3-Peg Patella which are for uncemented use only. All other femoral, tibial baseplate and all-polyethylene (UHMWPE and VEHXPE) patella components are indicated for cemented use only.
The purpose of this submission is to add a new component to the Personalized Knee System, the component is the Persona Ti-Nidium PPS Femurs. The addition of these components do not change the intended use or fundamental scientific technology of the device system.
The Personalized Knee System is a semiconstrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial, and patellar bones. With this submission a new porous coated Ti-6Al-4V femoral component will be added to the system. These femoral components articular surface of the tibial component, as well as, a patellar component, as part of a total knee system. The new femoral come in a variety of sizes to match the needs of a patient's anatomy when performing total knee arthroplasty. These components are provided sterile and single use.
The provided text describes the regulatory clearance for the Persona Ti-Nidium PPS Femurs, a component of the Personalized Knee System, but it does not contain the specific details required to answer your questions about acceptance criteria and study design.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance validation studies with acceptance criteria in the way you've outlined for software or AI-driven medical devices.
Here's why the information you're asking for is not in the text:
- Device Type: This submission is for an orthopedic implant (knee prosthesis components), not a diagnostic software or AI device. The regulatory pathway and what's typically reported in these summaries are different. Performance for orthopedic implants is usually evaluated through biomechanical testing, material characterization, and sometimes clinical follow-up for the overall system, rather than metrics like sensitivity, specificity, or AUC based on expert reads of images.
- Focus of the Document: The document is primarily an FDA clearance letter and a 510(k) summary. It confirms the device's substantial equivalence to previously cleared predicate devices. It lists the types of non-clinical tests performed (e.g., fatigue, wear evaluation, material characterization) but does not provide the acceptance criteria for these tests or detailed results against those criteria. It states that "Clinical Testing Not Applicable," indicating that a clinical study with human subjects for efficacy was not required for this 510(k) clearance.
Therefore, I cannot provide the requested information from the given text. The text does not include:
- A table of acceptance criteria and reported device performance (in the context of AI/software metrics).
- Sample size used for a "test set" (as in expert-labeled data) or data provenance.
- Number or qualifications of experts used to establish ground truth.
- Adjudication method.
- MRMC comparative effectiveness study or effect size.
- Standalone algorithm performance.
- Type of ground truth used (expert consensus, pathology, etc.).
- Sample size for the training set.
- How ground truth for the training set was established.
§ 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.