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The Persona Partial Knee system is limited to the medial tibiofemoral compartment of the knee intended for patients with painful and/or disabling knee joints due to the following indications:

• Noninflammatory degenerative joint disease (NIDJD), e.g., osteoarthritis, avascular necrosis;
• traumatic arthritis;
• previous tibial condyle or plateau fractures with loss of anatomy or function;
• varus deformities; and
• revision of the articular surface of a previously implanted Persona Partial Knee System providing that the tibial plate locking mechanism is not compromised and the femoral and tibial plate components remain well fixed and undamaged.

The Persona Partial Knee System is a single use implant intended for implantation with bone cement.

The purpose of this submission is to add a line extension of Size B to the Persona Partial Knee system (PPK). The Persona Partial Knee System is a partial knee replacement for the medial compartment of the knee and is modular in design consisting of three components: a unicondylar cobalt-chromium-molybdenum (Co-Cr-Mo) alloy femoral component, a unicondylar titanium (Ti-6Al-4V) alloy tibial tray, and a unicondylar articular surface manufactured using the previously cleared Vivacit-E ® Vitamin-E Highly Crosslinked Polyethylene (VEHXPE).

This FDA 510(k) clearance letter for the Persona Partial Knee is for a medical implant (a knee replacement prosthesis), not an AI/software device. Therefore, the information requested in the prompt, such as "number of experts used to establish ground truth" or "multi reader multi case (MRMC) comparative effectiveness study," is not relevant to this type of device.

The clearance is based on the substantial equivalence principle, meaning the device is shown to be as safe and effective as a previously cleared predicate device. The performance data mentioned in the document refers to non-clinical testing (e.g., mechanical tests, material characterization) to ensure the implant meets established engineering and biocompatibility standards, not an AI algorithm's diagnostic performance.

Here's why the prompt's specific questions cannot be fully answered from this document:

• No AI/Software Component: The Persona Partial Knee is a physical medical device (implant), not a digital health product driven by AI or software.
• Substantial Equivalence: The clearance relies on demonstrating the new "Size B" line extension of the Persona Partial Knee is substantially equivalent to its own previously cleared version (K161592). This typically involves showing that the new size has similar design features, materials, and performance characteristics (e.g., strength, durability, biocompatibility) to the predicate.
• Performance Data Type: The "Performance Data" referenced is non-clinical. For an implant, this would involve mechanical testing (e.g., fatigue testing, wear testing), material characterization, biocompatibility testing, etc., to ensure the device performs as intended and is safe when implanted. It does not involve human readers, expert consensus for ground truth, or analysis of diagnostic accuracy.

Therefore, I cannot provide a table of acceptance criteria or details about a study evaluating AI performance from this document because it is not an AI/software device.

The document does state in the "Summary of Performance Data" section:
"The performance data provided in the performance testing section indicate the proposed devices meet the established acceptance criterion; therefore, are as safe and effective and substantially equivalent to the legally marketed predicate devices from a performance standpoint."

However, it does not detail what those acceptance criteria are or how the performance data was generated beyond stating it was "performance testing." For an implant, these acceptance criteria are typically engineering specifications (e.g., minimum load bearing capacity, maximum wear rate, specific material properties) derived from recognized standards (e.g., ISO, ASTM).

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The ACHIEVE PARTIAL KNEE SYSTEM is intended for unicompartmental knee arthroplasty to treat one or more of the following conditions:

• · Moderately disabling joint disease of the knee resulting from painful osteo or post traumatic arthritis.
• · Revision of previous unsuccessful surgical procedures, including prior unicompartmental knee arthroplasty.
• · As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.

The ACHIEVE™ PARTIAL KNEE SYSTEM is a knee joint femorotibial (unicompartmental) prosthesis that is intended for cementless or cemented fixation.
The implant system consists of individually packaged implants: a metal tibial tray (titanium alloy), a polyethylene tibial insert, and a metal femoral component (titanium alloy or cobalt-chromium). All tibial inserts are composed of a Cross-linked, Vitamin E Ultra High Molecular Weight Polyethylene (Cross-Linked, VE UHMWPE).

This document does not contain information about the acceptance criteria and study detailed in the request. The document is a 510(k) premarket notification for a medical device (ACHIEVE™ Partial Knee System) and focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It explicitly states that clinical testing was not necessary to demonstrate substantial equivalence.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes for test or training sets, data provenance, expert qualifications, ground truth, or MRMC studies, as these aspects are typically associated with clinical trials or performance studies involving AI/software devices.

The document describes engineering tests and analyses performed on the physical components of the knee system. For instance:

• Range of Motion (RoM) Evaluation: Acceptance criteria met per ASTM F2083.
• Femoral Fatigue Testing: Acceptance criteria met per modified ASTM F3210 (10 Mc).
• Tibial Tray Fatigue Testing: Acceptance criteria met per modified ASTM F3140 (10 Mc).
• Component Interlock Strength Testing: Acceptance criteria met for static AP and ML shear testing and static tensile pull-off testing.
• Wear Resistance Evaluation: Wear rate does not represent a new worst-case compared to the predicate device per ISO 14243-3.
• Biocompatibility Assessments: Devices found to be biocompatible per ISO 10993-1 and FDA Guidance.
• Porous Structure Characterization: Meets recommendations of Class II Special Controls Guidance Document per ASTM F1044, ASTM F1147, ASTM F1160, ASTM F1978, and ASTM F1854.
• Shelf-Life Evaluation: Five-year shelf life established per ISO 11607-1 and ISO 11607-2.
• Sterilization Validation: Sterility Assurance Level (SAL) of 10-6 found per ISO 11137-1 and ISO 11137-2.

However, these are all engineering benchmarks for the physical orthopedic implant, not performance metrics for a diagnostic AI/software device.

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