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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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