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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. Smith & Nephew, Inc. Journey II BCS Knee components are indicated for use only with cement and are single use devices.

Subject of this Abbreviated Premarket Notification is the Journey II BCS Knee system. The Journey II BCS Knee System is a posterior stabilized total knee system which provides the ability for greater flexion (155°) to those patients who have the anatomical capability to allow a greater flexion range. Components of this premarket notification include:

• Posterior stabilized femoral components which will initially be available in sizes 1-10 in right . and left designs in OXINIUM material.
• Posterior stabilized femoral components which will initially be available in sizes 1-9 in right . and left designs in cobalt chrome material
• Posterior stabilized articular inserts which will initially be available in sizes 1-2, 3-4, 5-6, and . 7-8 in right and left designs. Journey II BCS articular inserts will be offered in 9-21 mm thicknesses and manufactured from cross-linked polyethylene (XLPE) material and conventional non-cross-linked Ultra-High Molecular Weight Polyethylene (UHMWPE) material.
  The Journey II BCS Knee system will use existing cemented Journey tibial tray and patellar components currently used with the Journey BCS Knee System (K042515) and may also be used with existing patellar components of the Genesis II Knee System (K951987).

The provided text is a 510(k) Premarket Notification for a medical device, the Journey II BCS Knee System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo clinical study with a full-fledged acceptance criteria and performance study as might be done for a novel device.

Therefore, many of the typical questions regarding acceptance criteria, study design, expert ground truth, and training sets from an AI/imaging device perspective are not applicable to this document. The "study" here refers to mechanical testing for equivalence, not a clinical trial or AI model validation.

Here's a breakdown based on the information provided and addressing the non-applicability:

1. Table of Acceptance Criteria and the Reported Device Performance

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

• Sample Size: Not applicable in the context of clinical data for this 510(k) submission. The "test set" here refers to mechanical testing of device components. The document does not specify the number of components tested for each mechanical analysis, but it's not a human patient "test set."
• Data Provenance: Not applicable for clinical data. The mechanical testing would have been performed in a laboratory setting.

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. Ground truth in this context is established through engineering and mechanical testing standards and comparison to predicate devices, not expert human interpretation of data for diagnostic purposes.

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

• Not applicable. Adjudication methods are typically used for establishing ground truth in clinical studies involving human interpretation or uncertain outcomes. Mechanical testing relies on measurable physical properties and engineering standards.

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 knee prosthesis, a physical implant. It does not involve AI or human readers for diagnostic interpretation. The submission 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

• Not applicable. This is a physical medical device, not an algorithm.

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

• The "ground truth" for this device's performance demonstration is based on mechanical engineering principles and standards, comparison to predicate device performance, and the absence of new safety/effectiveness issues revealed by those mechanical tests.

8. The sample size for the training set

• Not applicable. This is a physical medical device; there is no "training set" in the context of an AI/machine learning model.

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

• Not applicable. As there is no training set for an AI model, this question is not relevant.

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