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The Scorpio® Inset Patellar Component is intended to articulate with any commercially available Scorpio® Total Knee Femoral Component, any commercially available Osteonics® Series 7000 Total Knee Femoral component, and any commercially available Osteonics® Omnifit® Total Knee Femoral Component. The subject patellar components are single use devices, intended for cemented applications on the surgically prepared posterior patella as part of primary or revision cemented total knee arthroplasty. This component replaces the patellar articulating surface of the knee joint to simulate the normal function of the knee.

Indications:

• . Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis.
• . Post-traumatic loss of knee joint configuration and function.
• . Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
• . Revision of previous unsuccessful knee replacement or other procedure.

The Scorpio® Inset Patellar Component is fabricated from ultra-high molecular weight polyethylene (UHMWPE). The component is available in one thickness (10mm) and four diameters (26mm, 28mm, 30mm, and 32mm). The overall geometry essentially consists of a circular patellar button configuration with a central peg on the anterior surface of the component. The anterior surface also features a pocket and undercuts for cement interdigitation. The subject Scorpio® Inset Patellar Component is mounted to the surface of the surgically prepared patella within a recessed hole when cementing the component into place.

The articular (posterior) surface of this component is identical to the articular surface of the Osteonics® Recessed Patellar Component, found substantially equivalent in premarket notification K863668, and cleared for use with Scorpio femoral components in K962152. The anterior (bone fixation) surface is similar to that of the Duracon® Recessed Patellar Component (#K951655).

This is a medical device submission for the Scorpio® Inset Patellar Component. The document describes the device, its indications for use, contraindications, and explains that substantial equivalence was supported by testing. However, this document does not contain the specific details required to answer your questions about acceptance criteria and a study proving those criteria were met.

Here's why and what can be extracted:

Why the requested information is not fully present:

• Acceptance Criteria and Reported Device Performance: This document states "Testing was presented to support the claim of substantial equivalence," but it does not detail what those tests were, what the acceptance criteria for those tests were, or what the specific performance results were. For example, it doesn't mention fatigue testing limits, wear rates, a certain percentage of successful implantations, or a 95% confidence interval for a specific outcome.
• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): These are all highly detailed aspects of a clinical study or performance study. This 510(k) summary is a high-level overview for regulatory purposes, aiming to demonstrate substantial equivalence to existing predicate devices. It does not include the detailed methodology of any specific study (clinical or non-clinical) in the way a clinical trial report or a comprehensive engineering test report would. For a medical device like a knee implant, the "study" proving it meets acceptance criteria would likely involve a combination of:
  • Bench testing: Mechanical strength, wear, fatigue, material compatibility – these would have acceptance criteria related to engineering standards (e.g., ISO, ASTM).
  • Biocompatibility testing: As per ISO 10993.
  • Possibly a clinical assessment: Though often, for devices seeking substantial equivalence, extensive new clinical trials are not required if predicate devices have established safety and effectiveness. If a clinical study was done, the details you asked for would be in that study protocol and report, not in this 510(k) summary.

What can be extracted from the provided text:

• Device Name: Scorpio® Inset Patellar Component
• Purpose of the "Testing": To support the claim of substantial equivalence to predicate devices (Osteonics® Recessed Patellar Component and Duracon® Recessed Patellar Component).
• Device Type: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
• Material: Ultra-high molecular weight polyethylene (UHMWPE).

In summary, to answer your specific questions, you would need to access the actual "Testing" documents that were presented to the FDA, which are not included in this 510(k) summary. This document confirms that testing was done to support substantial equivalence, but not what that testing entailed or its specific results and criteria.

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