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The Symmetric(TM) Total Knee System consists of single use components intended for total knee arthroplasty with the following indications:

1. Rheumatoid arthritis,
2. Post-traumatic arthritis,
3. Osteoarthritis,
4. Degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result.
5. Failed osteotomies, unicompartmental replacement, or total knee replacement.
   All components are for cemented use only.

The Femoral components are cobalt chromium alloy (ASTM F75). Tibial articular inserts and patellar components are UHMWPE (ASTM F648). Tibial trays, metaphyseal and revision stems, femoral and tibial wedges and cones, and screws (K961157), are titanium (ASTM F1472). Coated cobalt chromium and titanium components feature a coating of plasma sprayed titanium (ASTM F1580).
The purpose of this 510(k) is to submit an additional sterilization method of a flexible bag system. Other descriptive details remain unchanged from the predicate.

This document is a 510(k) premarket notification for a medical device called the "Symmetric™ Total Knee System." It's important to note that this submission is for an additional sterilization method for an existing device, not for a new AI/software-driven device. As such, the information typically requested for AI device studies (like sample sizes, ground truth, expert adjudication, MRMC studies, standalone performance, training set details) does not apply to this specific submission.

Therefore, I cannot provide a table of acceptance criteria for AI performance or details of a study proving a device meets AI-specific criteria, as this document pertains to a physical orthopedic implant and its sterilization process, not an AI or software-based medical device.

Here's a breakdown of what the document does provide, and why the requested information isn't present:

Device: Symmetric™ Total Knee System (a knee joint prosthesis)
Purpose of 510(k): To submit an additional sterilization method (flexible bag system) for the device. The core device itself was previously cleared under K080199.

Missing Information (and why it's not applicable here):

1. Table of acceptance criteria and reported device performance: This document doesn't define acceptance criteria for AI performance. The "performance data" mentioned (Section VII) refers to "full sterilization qualification of the flexible bag sterilization vendor," not clinical or AI performance.
2. Sample size, data provenance for a test set: No test set for AI performance is discussed.
3. Number of experts and qualifications for ground truth: Not applicable, as there's no AI ground truth to establish.
4. Adjudication method for the test set: Not applicable.
5. MRMC comparative effectiveness study: Not applicable. Human readers are not using AI assistance with a knee implant.
6. Standalone performance study: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How ground truth for the training set was established: Not applicable.

What the document does state regarding the study (sterilization-related):

• Study: "The full sterilization qualification of the flexible bag sterilization vendor is included in the submission." (Section VII. Performance Data)
• Conclusion: "The technological characteristics/features and performance characteristics for the Symmetric Total Knee System are substantially equivalent to the legally marketed predicate device. This 510(k) is submitted for the addition of the flexible bag chamber sterilization method." (Section VIII. Conclusions)

In summary, this document is about changes to the manufacturing process (sterilization) of a physical medical implant, not the evaluation of an AI or software algorithm.

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The Symmetric™ Total Knee System consist of single use components intended for total knee arthroplasty with the following indications.

1. Osteoarthritis (for cemented use only)
2. Rheumatoid Arthritis (for cemented use only)
3. Traumatic Arthritis (for cemented use only)
4. Where the use of a more conservative procedure has failed or is unacceptable.

The Symmetric™ Total Knee System is intended for the resurfacing of the knee joint. The system consists of metallic femoral and tibial components (including an available metaphyseal stem) and a polyethylene tibial insert and patellar component.

The FEMORAL COMPONENT is designed for left/right orientations. The femoral component is manufactured from cast cobalt chromium/molybdenum (CoCrMo). The femoral component will be available in eight sizes (1-8) and will have a central post (with a 5° valgus angle) and gussets to aid in rotational stability and to increase strength. It will be plasma sprayed with Commercially Pure Titanium (CPTi).

The TIBIAL TRAY is a symmetrically designed component, eliminating the need for left/right orientations. The tibial component is manufactured from wrought titanium alloy (Ti 6Al-4V). The tibial tray features a central post, a pair of gussets, and 2 to 4 pegs on the underside broviding rotational stabilization and increased tray strength. Four screw holes in the tibial tray allow for optional screw fixation. The tibial tray is designed with locking features permitting the UHMWPE tibial insert to be snapped into place. The tibial tray has 8 sizes (1-8) and is plasma sprayed with Commercially Pure Titanium (CPTi).

The TIBIAL INSERT is also a symmetrically designed component manufactured from Ultra-High Molecular Weight Polyethylene (ASTM F648). The inserts' articulating geometry is semiconstrained and is captured in the tibial tray by the mating capture features. The insert is available in nine thicknesses (10, 12, 14, 16, 18, 20, 25, 30, 35mm) and 8 sizes (1-8).

The METAPHYSEAL STEM is designed to be driven onto a tibial tray further increasing the fit and fill of the component allowing for a more stable system.

The REVISION STEM is designed to be driven onto a tibial tray or femoral component further increasing the stability of a revision component.

The PATELLAR COMPONENT is dome shaped and tracks nicely against the femoral component.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states: "No clinical data was utilized for the basis of substantial equivalence."
Therefore, there is no clinical test set, sample size, or data provenance related to clinical data. The evaluation was based solely on non-clinical testing.

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

Not applicable, as no clinical test set or ground truth derived from expert opinion on clinical cases was used. The substantial equivalence was determined through non-clinical testing and comparison to predicate devices.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was performed on human readers as no clinical data was used. The evaluation was based on device performance in non-clinical tests.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This concept is not directly applicable in the context of this traditional medical device (knee implant). The "standalone" performance here refers to the device's physical and mechanical properties as tested in a laboratory setting, without human interaction in a 'use' scenario beyond the testing parameters. The non-clinical testing performed is essentially a standalone evaluation of the device's material and design integrity.

7. Type of Ground Truth Used

The ground truth for proving substantial equivalence was established through:

• Comparison to predicate device specifications: The physical dimensions, materials, and fixation methods were compared to those of the Beacon Cemented and Uncemented Total Knee System (K051510) and the Profix Total Knee System (K933958).
• Non-clinical testing methodologies: Performance was assessed against established engineering standards and guidance documents, specifically "Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA (dated January 16, 2003)."

8. Sample Size for the Training Set

Not applicable, as this is a medical device submission based on substantial equivalence through non-clinical testing and comparison to predicate devices, not an AI/machine learning algorithm that requires a training set.

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

Not applicable, as no training set was used.

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