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The Scorpio® Low Profile Tibial Tray is intended to be used with commercially available Scorpio® Cruciate Retaining femoral components, Scorpio® CR and ScorpioFlex CR tibial bearing inserts, and Scorpio® patellar components in primary cemented total knee arthroplasty. The indications/contraindications for the Scorpio® Low Profile Tibial Tray arc outlined below:

Indications

• · Painful, disabling joint discasc of the knee resulting from: degenerative arthritis, theumatoid 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.

The Scorpio® Low Profile Tibial Tray is a sterile, single-use device that is intended to be used with Scorpio® CR femoral components and associated patellar components, and Scorpio® CR and ScorpioFlex CR tibial bearing inserts in primary cemented total knee arthroplasty. The subject Scorpio® Low Profile Tibial Tray is identical in design to the previously cleared Series 7000 Standard Tibial Tray (found substantially equivalent in premarket notification K 910990) with the following exccption: the length of the keel has been decreased to 0.50 inches to allow the implant to be inserted through a smaller incision.

The subject Scorpio® Low Profile Tibial Tray is fabricated from cast cobalt-chromium alloy that conforms to ASTM specification F-75. This tibial tray is offered in eight proportional sizes (sizes 3, 4, 5, 6, 7, 9, 11 and 13) and features the same barb and wire locking mechanism as the previously released Series 7000 Standard tibial tray. The undersurface of the tibial tray has a cast-in waffle surface feature to enhance cement fixation. The waffle pattern interior surface is not an applied coating, but is cast into the cobalt chromium alloy substrate, and consists of a scries of pyramids separated by a distance of 0.53mm, with a pyramid angle of 18°. The keel of the tibial tray utilizes the delta fit keel (swept back normalizations) to provide rotational stability and enhance cement fixation.

Here's an analysis of the provided text regarding the "Scorpio® Low Profile Tibial Tray" and its acceptance criteria and study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific, quantifiable acceptance criteria or detailed results of a performance study for the Scorpio® Low Profile Tibial Tray. Instead, it relies on a demonstration of "substantial equivalence" to a predicate device.

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

The document does not describe a "test set" in the context of clinical or performance data. The primary method of demonstrating acceptable performance for this 510(k) submission was through Finite Element Analysis (FEA) and comparison to a predicate device. Therefore, there's no sample size of patients or images, nor data provenance (country of origin, retrospective/prospective). FEA is a computational method.

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

Not applicable. As noted above, there was no "test set" and no ground truth established by human experts in a traditional sense for this device's performance demonstration. FEA relies on engineering principles and models.

4. Adjudication Method for the Test Set

Not applicable. No "test set" or human adjudication was involved in the performance demonstration described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. The document does not mention a MRMC comparative effectiveness study. This type of study is more common for diagnostic imaging AI devices, not for an implant like a tibial tray where performance is typically assessed through mechanical testing and equivalence to existing devices.

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

Yes, in a way. The "performance" assessment was primarily the Finite Element Analysis (FEA), which is a standalone computational analysis without human-in-the-loop performance in the context of device function. This FEA determined mechanical equivalence to a predicate.

7. The Type of Ground Truth Used

The "ground truth" for the performance claim (substantial equivalence) was based on:

• The established safety and effectiveness of the predicate device (Series 7000 Standard Tibial Tray, K910990).
• Engineering principles and validated computational models used in the Finite Element Analysis (FEA) to confirm that the design modification (shorter keel) did not compromise the mechanical performance compared to the predicate.

8. The Sample Size for the Training Set

Not applicable. There was no "training set" in the context of machine learning or AI development for this device. FEA is a simulation method, not a learning algorithm.

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

Not applicable. As there was no training set, there was no ground truth for it to be established.

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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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