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Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact. The Journey II Total Knee system components are indicated for use only with cement and are single use devices.

The Journey II XR tibial baseplate and inserts were previously cleared for market via premarket notification K141471. Subject of this premarket notification are minor modifications to the insert locking mechanism on the tibial baseplate and insert.

The Journey II XR components are available in medial and lateral cross-linked polyethylene articular inserts which will be available in left and right hand and titanium alloy (Ti-6Al-4V) tibial bases which will be available in left and right hand

The Journey II XR Knee system will use existing Journey II CR femoral components and existing patella components compatible with the Journey II CR femoral as well as device specific instruments.

This document is a 510(k) premarket notification for the "Journey II XR Knee System." It details the submission by Smith & Nephew, Inc. for minor modifications to an existing device.

Here's an analysis of the provided text in response to your questions:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" with numerical targets. Instead, it describes the types of verification testing conducted to demonstrate equivalence to a predicate device. The "reported device performance" is a general statement that the device is equivalent to the predicate.

2. Sample size used for the test set and the data provenance

The document does not specify sample sizes for the mechanical verification tests.
The data provenance is not explicitly stated as in country of origin, nor whether it was retrospective or prospective. Given it's mechanical testing for a medical device submission, it would be laboratory-generated data, likely conducted by or for Smith & Nephew.

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

This question is not applicable to this document. The "ground truth" here is established through mechanical engineering principles and testing protocols, not by medical experts interpreting data like in a diagnostic study.

4. Adjudication method for the test set

This is not applicable. There's no mention of an adjudication method as would be used in a study involving expert interpretation or consensus. The assessment is based on the results of the mechanical tests themselves.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a knee implant, which is a physical device, not an AI-powered diagnostic tool requiring human reader studies. The document explicitly states: "Clinical data was not needed to support the safety and effectiveness of the subject devices."

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

This is not applicable. This is a physical knee implant, not an algorithm or AI system.

7. The type of ground truth used

For this device, the "ground truth" for demonstrating performance is based on mechanical engineering standards and test results, confirming that the modified device's mechanical properties (interlock strength, fatigue strength) are equivalent to those of the predicate device.

8. The sample size for the training set

This is not applicable. There is no training set mentioned or implied for this submission. The evaluation is based on mechanical testing of the physical device.

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

This is not applicable as there is no training set.

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Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement. The Journey II Total Knee system components are indicated for use only with cement and are single use devices.

Subject of this Traditional Premarket Notification are the Journey II XR Knee system. The subject device is a bi-cruciate retaining total knee system which provides the ability for greater flexion to those patients who have the anatomical capability to allow a greater flexion range. Components of this premarket notification include the following components:

• . Medial and lateral cross-linked polyethylene articular inserts which will be available in left and right hand
• o Titanium alloy (Ti-6Al-4V) tibial bases which will be available in left and right hand
  The Journey II XR Knee system will use existing Journey II CR femoral components and existing patella components compatible with the Journey II CR femoral as well as device specific instruments.

The provided text describes a 510(k) premarket notification for the Journey II XR Knee System, which is a medical device (a knee prosthesis). This type of document focuses on establishing substantial equivalence to existing legally marketed devices, rather than a robust clinical study proving performance against specific acceptance criteria for a new AI/software device.

A 510(k) summary for a traditional medical device like a knee implant focuses on demonstrating that the new device is as safe and effective as a predicate device, primarily through comparing technological characteristics and mechanical testing. It does not involve the kind of clinical study with human readers, ground truth establishment, or performance metrics (like sensitivity, specificity, AUC) that would be conducted for an AI/software as a medical device (SaMD).

Therefore, based on the provided document, the following points apply:

1. A table of acceptance criteria and the reported device performance: Not applicable in the context of this 510(k) submission for a knee implant. The "performance" is demonstrated through mechanical testing and comparison to predicates.

   Acceptance Criteria (Implied by 510(k) for mechanical qualities)	Reported Device Performance (Mechanical Testing)
   Withstand expected in vivo loading without failure	* Tibiofemoral Contact Area Analysis
   	* Tibiofemoral Constraint Testing
   	* Construct Fatigue Strength Testing
   	* Static testing of the insert locking mechanism
   	* Tibial base plate fatigue performance
   No new issues related to safety and effectiveness	Testing demonstrated no new issues.

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. "Clinical data was not needed to support the safety and effectiveness of the subject devices" (page 3). The testing was mechanical, not clinical.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/software in a clinical context (e.g., expert consensus on image interpretation) is not relevant to this mechanical device submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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, as this is not an AI/software device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the mechanical testing, the "ground truth" would be the engineering specifications and established test methodologies for evaluating the structural integrity and functional characteristics of knee implants. This is not the same as clinical ground truth.

8. The sample size for the training set: Not applicable, as this is not an AI/software device with a training set.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) clearance letter for a traditional metallic and polymeric knee prosthesis, not an AI/software device. The demonstration of safety and effectiveness relies on mechanical testing and comparison to predicate devices, not on clinical studies involving human readers or AI algorithm performance metrics.

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