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The Search Evolution (LC) Total Knee System is intended to replace a knee joint in order to relieve pain and restore knee function, for indications such as, osteoarthritis, inflammatory arthritis, traumatic arthritis, varus, valgus or flexion deformities and revision surgery.

The Search Evolution tibial tray and non-porous coated femoral component are designed for use with bone cement.

The Search Evolution porous coated femoral component is designed for use without bone cement.

The Search Evolution (LC) Total Knee System is available with two femoral designs. Each retains the PCL, ligament cruciate (LC) during implantation and both femoral components are manufactured from CoCrMo. One is non-porous coated and is intended to be used with bone cement. The other is porous coated and intended to be used without bone cement. The coating is Ti, which conforms to ISO 5832 and is applied using the plasma spray technique.

This document describes a 510(k) summary for the Search Evolution (LC) Total Knee System (Porous Coated). As such, it focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel performance criteria and proving them through dedicated studies with acceptance criteria, as one would for a new, non-substantially equivalent device or a software-as-a-medical-device (SaMD).

Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the typical sense for a SaMD or a novel device, is not directly applicable to this submission. This is a traditional medical device (implant) where performance is primarily established through compliance with established guidance documents, comparison to existing predicate devices, and standard mechanical testing.

However, I can extract and infer information that aligns with the spirit of your request within the context of a 510(k) submission for a non-active medical device.

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

For devices like total knee systems, "acceptance criteria" are typically defined by compliance with applicable standards and guidance documents, as well as by demonstrating that the device performs at least as safely and effectively as legally marketed predicate devices. The performance data presented here refers to the completion of required testing, not specific quantitative performance metrics against pre-defined acceptance criteria for a novel clinical outcome.

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

This document does not describe a clinical study with a "test set" in the context of observational data or a clinical trial. The "testing" mentioned refers to non-clinical, benchtop mechanical and material testing conducted according to relevant standards and guidance documents. Therefore, sample size, data provenance (country, retrospective/prospective), etc., are not applicable in the way they would be for a clinical study on human subjects or an AI/software device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. "Ground truth" in this context would implicitly be the established scientific and engineering principles codified in the relevant ISO standards and FDA guidance documents for orthopedic implant testing. Engineers and materials scientists involved in the testing would interpret and apply these standards.

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

Not applicable, as there is no "test set" of clinical cases requiring adjudication. Adherence to testing protocols and results interpretation would follow standard engineering practices.

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 passive orthopedic implant, not an AI or imaging device that involves "readers" or "AI assistance."

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

Not applicable. This device is a passive orthopedic implant, not an algorithm.

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

For this type of device, the "ground truth" for performance is primarily established through:

• Compliance with recognized Consensus Standards: e.g., ISO, ASTM, which define test methods and performance requirements for materials and mechanical properties.
• Compliance with FDA Guidance Documents: These provide specific recommendations for mechanical testing and biocompatibility assessments for orthopedic implants.
• Established performance of predicate devices: The "ground truth" for safety and effectiveness is largely based on the historical performance and regulatory clearance of the legally marketed predicate devices.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this device.

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

Not applicable. There is no "training set" in the context of this device.

Summary of Device Performance and Substantial Equivalence:

The document primarily establishes the device's performance through its substantial equivalence to already legally marketed predicate devices and by demonstrating compliance with applicable FDA guidance documents and recognized standards.

The predicate devices used for comparison are:

• Columbus (CR) Total Knee System (K022672)
• Search Evolution Total Knee System (K021313)
• Scorpio Posterior Cruciate Retaining Knee System (K974556)
• Gem Knee System (K994214)

The "performance data" refers to the completion of required non-clinical benchtop testing as outlined in the following guidance documents:

• "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-Constrained Total Knee Prostheses"
• "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement"

This allows the FDA to conclude that the device is as safe and effective as the predicate devices, thereby permitting its marketing.

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