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Triathlon® PKR X3® Tibial Inserts are components of the Triathlon® PKR System that is indicated for:

• Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis
• Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee prosthesis
• As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis
• Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the femoral condyle/tibial plateau.
  These components are intended for implantation with bone cement.

Mako X3® Uni Onlay Tibial Inserts are components of the RESTORIS™ Multicompartmental Knee (MCK) System that is indicated for single or multi-compartmental knee replacement used in conjunction with RIO®, the Robotic Arm Interactive Orthopedic System, in individuals with osteoarthritis or post-traumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces. The specific knee replacement configurations include:

• Medial unicondylar
• Lateral unicondylar
• Patellofemoral
• Medial bi-compartmental (medial unicondylar and patellofemoral)
  RESTORIS™ Multicompartmental Knee (MCK) System is for single use only and is intended for implantation with bone cement.

The subject Triathlon PKR X3® Tibial Inserts and Mako X3® Uni Onlay Tibial Inserts are identical in design to their currently marketed predicates. The subject inserts will use a different method of terminal sterilization of ethylene oxide per ISO 11135 and will be formed by consolidating GUR1020 resin via conventional methods which meet the specifications of ASTM F648. The device sterilization method is identical to that used for the reference Triathlon X3 Tibial Inserts and Patellar Components.

This FDA 510(k) summary (K180612) describes a premarket notification for new versions of tibial inserts for knee replacement systems. Crucially, the document explicitly states that "Clinical Testing was not required as a basis for substantial equivalence." This means that the device's acceptance criteria and proof of meeting them are not based on clinical performance data (e.g., patient outcomes, diagnostic accuracy of an AI). Instead, the substantial equivalence determination relies on comparisons to legally marketed predicate devices through non-clinical testing.

Therefore, many of the questions you asked, which are relevant to clinical studies (especially those involving AI or human readers), cannot be answered from this document.

Here's an analysis based on the provided text, addressing what can be inferred and explaining why other information is not present:

Device Acceptance Criteria and Performance (Based on Non-Clinical Testing)

Since clinical testing was not required, the acceptance criteria are based on mechanical and material properties, sterilization efficacy, and biocompatibility, demonstrating that the new devices are equivalent to established predicates.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable in the traditional sense of a clinical test set with patient data. The "test set" here refers to physical samples of the device and materials used for the non-clinical laboratory tests. The document does not specify the number of samples used for each test (e.g., how many inserts were subjected to fatigue testing).
• Data Provenance: The data provenance is from laboratory testing performed by the manufacturer (Howmedica Osteonics Corp aka Stryker Orthopaedics). The document does not specify the country of origin of the labs, but it's likely internal or contracted labs supporting the US market submission. The nature of the data is pre-market non-clinical laboratory testing.

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

• Not applicable. There is no "ground truth" in the diagnostic or clinical sense established by human experts in this type of submission. The "ground truth" for non-clinical tests is established by adherence to recognized international standards (e.g., ASTM, ISO) and the physical measurements themselves.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical test sets where there's human interpretation involved. For non-clinical lab tests, results are typically objective measurements against a validated standard, not requiring adjudication.

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

• No, not applicable. This submission is for knee joint implants, not an AI-assisted diagnostic device. The document explicitly states: "Clinical Testing: Clinical testing was not required as a basis for substantial equivalence."

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

• No, not applicable. This is not an algorithmic device.

7. The Type of Ground Truth Used

• For non-clinical testing: The "ground truth" for the non-clinical tests is based on established engineering and material science standards (e.g., ASTM, ISO). For example, the ground truth for material properties is the specified values and tolerances in ASTM F648; for sterilization, it's the sterility assurance level defined in ISO 11135.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not applicable. As above, no training set or AI model.

Conclusion from the Document:

The FDA determined that the Triathlon® PKR X3® Tibial Inserts and Mako X3® Uni Onlay Tibial Inserts are substantially equivalent to their predicate devices (Triathlon PKR System X3 Tibial Inserts - K071881, K172326; Restoris Multicompartmental Knee (MCK) System X3 Tibial Inserts - K150307, K172326). This determination was made based on non-clinical testing that confirmed:

• Identical intended use, indications, design, and operational principles to the predicate devices.
• Material properties meeting the same standards (ASTM F648) as the predicate.
• The only significant change was the terminal sterilization method (from Gas Plasma to Ethylene Oxide), which was validated to meet relevant standards (EN ISO 11135:2014) and found acceptable by comparison to a previously cleared device with the same sterilization change (K172634).
• Other non-clinical tests (biocompatibility, mechanical performance, pyrogenicity, MR safety) were performed and found to support equivalence.

No human clinical data, AI performance metrics, or diagnostic accuracy studies were part of this 510(k) submission.

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