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The Scorpio® NRG® Knee System is a sterile, single-use device intended for total knee arthroplasty.

The Scorpio® NRG® Knee 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; .

Additional Indications for Posterior Stabilized Components:

• . 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 Scorpio® NRG® Knee System comprises a series of femoral and tibial insert components. The subject Scorpio® NRG® X3® inserts are available in cruciate retaining (CR) and posterior stabilized (PS) designs and are used for the replacement of the bearing/articulating surfaces of the proximal tibia. The modification to the subject devices is the sequentially crosslinked and annealed X3® UHMWPE material process.

This document is a 510(k) summary for the Scorpio® NRG® Knee System, which is a total knee joint replacement prosthesis. The document states that the device is substantially equivalent to a previously cleared device. Therefore, no studies are provided to prove the device meets acceptance criteria. Only the indications for use and general device description are provided.

Here's the breakdown of why the requested information cannot be provided from the given text:

1. A table of acceptance criteria and the reported device performance:

• Not available. The document is a 510(k) summary for a substantial equivalence determination, not a clinical trial report. It asserts equivalence to a predicate device rather than presenting new performance data against specific acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not available. No new test data is presented in this 510(k) summary. The submission relies on demonstrating equivalence to existing, legally marketed devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not available. No test set or ground truth establishment process is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not available. No test set or adjudication method is described.

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 device is a total knee joint replacement prosthesis, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or included.

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

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not available. No new studies or ground truth establishment are reported in this 510(k) summary.

8. The sample size for the training set:

• Not applicable. This device is a physical implant, not a machine learning model.

9. How the ground truth for the training set was established:

• Not applicable. This device is a physical implant, not a machine learning model.

Summary of what is available:

• Device: Scorpio® NRG® Knee System (Total Knee Joint Replacement Prosthesis)
• Approval Type: 510(k) clearance based on substantial equivalence.
• Predicate Device: Scorpio NRG Knee System (K042343 and K030978).
• Modification: Sequentially crosslinked and annealed X3® UHMWPE material process for the inserts.
• Basis for Equivalence: Identical intended use and indications for use, and similar design to the predicate devices.
• Indications for Use: (Provided in the original text) Painful, disabling joint disease (degenerative, rheumatoid, post-traumatic arthritis), post-traumatic loss of knee joint configuration, moderate deformities where ligaments can be stabilized, revision of previous procedures. For PS components: ligamentous instability, absent or non-functioning posterior cruciate ligament.
• Intended Use: Sterile, single-use device intended for total knee arthroplasty, for implantation with bone cement.

In essence, the document serves as a regulatory submission demonstrating that the modified device is as safe and effective as a previously approved device, thus it does not include new performance studies or data against specific acceptance criteria.

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