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The Scorpio® X3™ UHMWPE Cruciate Retaining and Posterior Stabilized tibial inserts and the Scorpio X3™ UHMWPE all polyethylene patcllar components are intended to be used with cemented or cementless Scorpio femoral components, cemented or ccmcntless Series 7000 tibial tray components and cemented Scorpio® tibial tray components in primary or revision total knee arthroplasty. The all polyethylene Scorpio 6 X3™ UHMWPE patellar components are intended for implantation with bone cement only.

The Scorpio® X3™ Total Stabilizer tibial inserts are intended to be used with the cemented Scorpio TS femoral components and the cemented Scorpio or Series 7000 tibial trays in primary or revision total knec arthroplasty.

The Scorpio® Knee System components are for use in total knee atthroplasty as a result of:

• Painful, disabling joint disease of the knee resulting from degencrative athritis, 후 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. .

Additional indications for Total Stabilized (TS) Components:

• Severe anteroposterior and medial/lateral instability of the knee. .

The device includes tibial and patellar components of a total knee system. These components are used for the replacement of the bearing and/or articulating surfaces of the proximal tibia and patclla. The modification to the device subject of this premarket notification is the sequentially crosslinking and annealing of the UHMWPE material by a proprietary process. Tibial inserts will be made in Cruciate Retaining, Posterior Stabilized and Total Stabilizing designs. Patellar components will be made in Medialized Dome, Concentric Dome, Universal Dome, Recessed and Inset designs

The provided text does NOT describe acceptance criteria for a device, nor does it detail a study proving the device meets said criteria in the way typically associated with AI/ML device performance (e.g., sensitivity, specificity, AUC).

Instead, the document is a 510(k) summary for a medical device (Scorpio® X3™ UHMWPE Tibial Inserts and Patellar Components) seeking substantial equivalence to predicate devices. The "Summary of Data" section describes types of tests performed to establish equivalence, but not specific performance metrics or acceptance criteria as would be presented for an AI/ML diagnostic.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types for test/training sets) are not applicable or cannot be extracted from this document as they pertain to a different type of device assessment.

Here's an analysis based on the information available in the provided text, while making it clear where information relevant to AI/ML device assessment is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present acceptance criteria or reported device performance in the form of specific metrics (like sensitivity, specificity, or accuracy) against predefined thresholds, which is common for AI/ML diagnostic tools. Instead, it states that "Testing and analysis includes material properties characterization, wear testing, disassembly force evaluation, multi-axis fatigue testing, patella shear testing and finite element modeling of contact stresses" to demonstrate "equivalence of the subject products to the predicate devices."

The acceptance criteria are implicitly met by demonstrating "substantial equivalence" through these engineering tests, rather than clinical performance metrics. The document does not provide the specific numerical results or thresholds for these tests.

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

This document does not describe a "test set" in the context of an AI/ML algorithm evaluation. The testing described refers to engineering performance tests of the physical device components. Therefore, the concepts of "sample size for the test set" and "data provenance" (country of origin, retrospective/prospective) are not applicable here.

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

Not applicable. "Ground truth" in the context of expert consensus for a test set is specific to diagnostic or interpretive AI/ML devices. This document refers to the physical properties and performance of an orthopedic implant.

4. Adjudication Method for the Test Set

Not applicable. As noted above, there is no "test set" in the AI/ML sense described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This is not an AI/ML assisted diagnostic device, so an MRMC study comparing human readers with and without AI assistance is not relevant.

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

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

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation would be the validated engineering standards, material specifications, and performance characteristics established for orthopedic implants, and in particular, for the predicate devices. This is assessed through physical and mechanical testing, not expert consensus, pathology, or outcomes data in the typical sense used for AI/ML.

8. The Sample Size for the Training Set

Not applicable. There is no AI/ML model that requires a "training set" for this device's evaluation.

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

Not applicable. As there is no AI/ML model, there is no training set or ground truth in this context.

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The Scorpio® Knec System components are for use in total knee arthroplasty as a result of:

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

These components are single use only and are intended for implantation with bone cement.

The device includes the tibial insert components of a total knee system. These components are used for the replacement of the bearing surface of the proximal tibia to relieve pain, instability and the restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid arthritis, failure of other devices or trauma.

The provided document is a 510(k) Premarket Notification for the Scorpio® Knee System - Tibial Inserts. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical trials for efficacy from scratch. Therefore, the information requested, particularly regarding "AI" and "human readers," is not directly applicable to this document, as it pertains to a mechanical orthopedic implant, not a diagnostic or AI-driven system.

Based on the provided information, here's an analysis of the acceptance criteria and the study that proves the device meets them, keeping in mind the context of a 510(k) submission for a mechanical orthopedic implant:

1. Table of Acceptance Criteria and Reported Device Performance

Note: For a 510(k) submission, the primary "acceptance criterion" is often demonstrating substantial equivalence to a predicate device. The performance data provided is typically to support this claim, rather than setting and meeting independent performance targets for a novel device type.

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

The document does not specify exact sample sizes for the mechanical tests (range of constraint, post stress, contact stress/area analysis). However, these types of tests for orthopedic implants typically involve a reasonable number of samples to establish statistical significance for engineering metrics. The data provenance is internal to the manufacturer (Howmedica Osteonics Corp.), indicating these were laboratory/bench tests focusing on the physical properties of the device, rather than human subject data. These would be considered prospective tests (i.e., designed and executed to evaluate the specific design modifications).

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

This concept is not directly applicable here. For mechanical engineering tests of an implant, the "ground truth" is typically established by engineering standards, validated testing methodologies, and objective physical measurements. The "experts" involved would be engineering professionals conducting and interpreting these mechanical tests, not medical professionals establishing a clinical "ground truth."

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies or image-reading scenarios where there's subjectivity and a need to resolve discrepancies between human readers. For the mechanical tests performed, the "results demonstrate equivalence" suggests objective measurements were taken and compared against established benchmarks or the predicate device's performance, without a subjective adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This is a mechanical orthopedic implant, not an AI-driven diagnostic or assistive technology. Therefore, no MRMC study or AI-related improvement analysis would have been performed or is relevant to this submission.

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

Not applicable. As this is a mechanical implant, there is no "algorithm only" performance or "human-in-the-loop" concept relevant to its function.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed (range of constraint, tibial insert post stress, contact stress/area analysis) would be based on engineering specifications, validated mechanical testing methodologies, and the established performance characteristics of the predicate device. The goal was to prove the redesigned components perform equivalently to the existing, legally marketed predicate device.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of mechanical testing for a 510(k) submission of a orthopedic implant. Training sets are relevant for machine learning or AI algorithms.

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

Not applicable, as there is no "training set."

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