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The intended use of the size one Triathlon™ Posterior Stabilized Tibial Insert is the same as that of the predicate device described in premarket notification K031729 – it is intended for use with Triathlon™ PS femoral components, Triathlon™ Primary Cemented Tibial Tray, and Triathlon™ and/or Duracon® patellar components in primary or revision cemented total knee arthroplasty. Specific indications/contraindications are listed below (these are identical to the predicate):

Indications:

• Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or, rheumatoid 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.
• Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture management techniques

Additional Indications for Posterior Stabilized Components:

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

This premarket notification describes a modification to the articulating surface of the size 1 Triathlon™ Posterior Stabilized Tibial Insert. This insert is intended to be used with the size 1 Triathlon™ Primary Cemented Tibial Tray and the Triathlon™ PS Femoral component in primary or revision total knee arthroplasty. This size 1 tibial insert has been modified for improved rotational constraint with the size 1 insert.

This document is a 510(k) premarket notification for a medical device modification, specifically the Triathlon™ Posterior Stabilized (PS) Tibial Insert. It does not contain information about a study proving the device meets acceptance criteria, nor does it discuss acceptance criteria in terms of performance metrics that would typically be evaluated in a study (e.g., accuracy, sensitivity, specificity for a diagnostic device, or specific physical performance characteristics for a therapeutic device).

Instead, this document focuses on demonstrating substantial equivalence to a predicate device, which is the primary requirement for a 510(k) submission. Therefore, most of the requested information, which pertains to a clinical or performance study, cannot be extracted from the provided text.

Here is an analysis based on the information available in the document:

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

The document does not specify quantitative acceptance criteria or reported device performance in the manner requested (e.g., accuracy percentages, physical test results with pass/fail thresholds). The "acceptance criteria" for a 510(k) submission are primarily centered on demonstrating substantial equivalence to a predicate device. The primary performance metric mentioned is "improved rotational constraint" for the modified tibial insert. However, no quantitative data or specific acceptance criteria for this improvement are provided.

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

Not applicable. The document describes a medical device modification submitted for 510(k) clearance, not a study evaluating performance with a test set of data (clinical or otherwise).

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 applicable. No ground truth establishment is described as there is no performance study presented.

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

Not applicable. No adjudication method is described as there is no performance study presented.

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 document is for a joint replacement component; MRMC studies are not relevant to this type of device.

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

Not applicable. This document is for a joint replacement component; standalone algorithm performance is not relevant to this type of device.

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

Not applicable. No ground truth is mentioned as there is no performance study presented. The comparison is made to a predicate device based on design, materials, and intended use.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this document does not describe the development or evaluation of an AI/ML algorithm.

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

Not applicable.

Summary of Available Information:

The provided document describes a modification to an existing medical device: the size 1 Triathlon™ Posterior Stabilized (PS) Tibial Insert. The purpose of the 510(k) submission is to demonstrate that this modified device is substantially equivalent to a legally marketed predicate device (K031729).

• Acceptance Criteria (Implied by 510(k) process): The primary acceptance criterion for a 510(k) is demonstrating substantial equivalence to a predicate device. This involves showing similar intended use, indications for use, technological characteristics, and safety and effectiveness.
• Device Performance (as stated in document): The modification "has been modified for improved rotational constraint with the size 1 insert." No quantitative data or specific test results proving this improved constraint are provided in this regulatory summary.
• Study: The document does not describe a clinical study or a performance study with acceptance criteria of the kind typically requested for AI/ML or diagnostic devices. Instead, it is a regulatory submission comparing a modified device to a predicate. The "study" implicitly refers to the comparison of the modified device's characteristics (design, materials, intended use) against the predicate.
• Ground Truth / Training Set / Test Set / Experts: These concepts are not applicable to the content of this 510(k) summary, as it is not a performance study of a diagnostic algorithm or a clinical trial.

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