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The Scorpio® CR and PS Femoral Components with Titanium Plasma Spray Coating and the Scorpio Tibial Tray with Titanium Plasma Spray Coating are intended for single-use, and are intended to be marketed for cemented fixation only. These femoral components and tibial tray are intended to be used with Osteonics tibial inserts and patellar components in total knee arthroplasty.

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.

Additional Indications for Posterior Stabilized Components:

• Ligamentous instability requiring implant bearing surface geometries with increased constraint.
• Absent or non-functioning posterior cruciate ligament.

The Scorpio CR and PS Femoral Components with Titanium Plasma Spray Coating, and the Scorpio® Tibial Tray with Titanium Plasma Spray Coating, are substantially equivalent to the predicate Cobalt Chromium alloy (CoCr) MicroStructured® Scorpio® CR (#K974556) and PS (#K962152) femoral components, and the MicroStructured® standard tibial trays of the Osteonics® Series 7000 Total Knee System (#K910990) in all material and design aspects. The following reflect the new characteristics of the subject components:

• The interior surfaces of the subject Scorpio® CR and PS femoral components with Titanium Plasma Spray Coating receive a titanium plasma spray coating instead of the MicroStructured® porous coating. All other design features of the femoral components are identical to the predicate devices.
• For the Scorpio Tibial Tray with Titanium Plasma Spray Coating, the inferior surface of the tibial tray receives a titanium plasma spray coating (as opposed to a MicroStructured® porous coating), and the keel of the tray receives a thin titanium plasma spray coating. The plate of the subject tibial tray is 0.75mm thicker than that of the predicate tibial tray, and has been filled in with cobalt chromium alloy. Also, the screw hole configuration on the titanium plasma sprayed trays has been modified to allow greater angulation of the screws.

This document is a 510(k) summary for the Scorpio® CR and PS Femoral Components and Tibial Tray with Titanium Plasma Spray Coating. It does not describe a study involving an AI/ML device, but rather a medical device (knee implants). Therefore, many of the requested categories for AI/ML studies are not applicable.

Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) submission is for demonstrating substantial equivalence to predicate devices, not for meeting specific performance acceptance criteria for a novel device. The "acceptance criteria" here implicitly refer to the FDA's requirements for demonstrating substantial equivalence.

2. Sample Size Used for the Test Set and the Data Provenance

This document describes a 510(k) submission for a medical device (knee implants), not an AI/ML study. Therefore, the concepts of "test set" and "data provenance" in the context of AI/ML are not applicable here. The "testing" referred to would typically involve mechanical, material, and potentially biological compatibility testing, not data analysis on a clinical dataset in the AI/ML sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. This is not an AI/ML study involving "ground truth" establishment from expert consensus. The "ground truth" for a medical device like a knee implant is established through rigorous engineering standards, material science, and clinical performance over time, not expert labeling of data.

4. Adjudication Method (2+1, 3+1, none) for the Test Set

Not applicable. This is not an AI/ML study.

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 a medical device submission, not an AI/ML comparative effectiveness study.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the AI/ML sense. For this type of device, "ground truth" would be related to:

• Material properties: Established through laboratory testing (e.g., tensile strength, fatigue life, biocompatibility standards).
• Mechanical performance: Established through in-vitro biomechanical testing (e.g., wear testing, fixation strength, range of motion).
• Clinical outcomes (for predicate devices): Long-term clinical data on the safety and effectiveness of the predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML study.

9. How the Ground Truth for the Training Set was Established

Not applicable. This is not an AI/ML study.

Summary of the Document's Purpose:

The provided document is a 510(k) summary for new knee implant components. The primary goal of a 510(k) submission is to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device. This means the device has the same intended use and either has the same technological characteristics as the predicate device or has different technological characteristics that do not raise different questions of safety and effectiveness and demonstrate that the device is as safe and effective as the legally marketed device. The document explicitly states that the new components are "substantially equivalent" to existing predicate devices in terms of materials, design (with minor, justified modifications), and intended use.

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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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