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Total knee components are indicated for rheumatic arthritis, osteoarthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicoment, 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 Smith & Nephew Journey II Mid-Level Tibial Inserts consist of Journey II Articular Stabilized XLPE Articular Inserts Size 1-8 Right and Left (9mm-21mm) and Journey II Medial Dished XLPE Articular Inserts Size 1-8 Right and Left (9-18mm).

The provided text describes a 510(k) premarket notification for a medical device called "Journey II Mid-Level Tibial Inserts." This submission aims to demonstrate that the new device is substantially equivalent to previously cleared predicate devices. Since this is a submission for substantial equivalence based on similar design, material, and performance characteristics compared to existing devices, it primarily relies on preclinical testing rather than clinical studies involving human patients, multi-reader multi-case (MRMC) comparative effectiveness studies, or extensive standalone algorithm performance evaluations.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" for the overall device in terms of specific performance metrics with numerical thresholds. Instead, the "acceptance criteria" are implied by demonstrating that the new device's performance in various preclinical tests is comparable to or within acceptable limits relative to existing predicate devices. The "reported device performance" is the outcome of these preclinical tests, showing that the subject device performs similarly to the predicates.

• OR-21-060: Journey II BCS femoral component with Journey II AS Inserts compared to Journey II BCS inserts.
• OR-21-061: Journey II CR femoral component with Journey II Medial Dished (MD) Inserts compared to Journey II CR Standard and Deep Dish Inserts. Implicitly, contact area characteristics were found to be comparable. |
  | Tibiofemoral Constraint (A/P Draw, M/L Constraint, Rotary Laxity): Constraint characteristics are comparable to predicate devices. | Tibiofemoral Constraint Testing (OR-21-062): Evaluated A/P draw, medial/lateral (M/L) constraint, and rotary laxity (R/L) torsional constraint of flexion. Implicitly, the Journey II MD insert was found comparable to the Journey II CR insert and the Journey II Deep Dished insert. |

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

The studies described are preclinical tests, meaning they are conducted in a laboratory setting using physical devices, not human patients. Therefore, terms like "test set" in the context of human data, "country of origin," and "retrospective or prospective" do not directly apply here. The "sample size" would refer to the number of device samples tested for each study. While the specific number of units tested per study (e.g., how many AS Inserts were tested for fatigue) is not explicitly provided in this summary, the studies were conducted by Smith & Nephew, Inc. in the US, as indicated by the submission information.

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

This information is not applicable as the studies are preclinical, bench-top tests, not clinical evaluations requiring expert consensus for ground truth. The "ground truth" in these studies is derived from physical measurements and accepted engineering standards (e.g., ASTM F1223-20).

4. Adjudication Method for the Test Set:

This is not applicable as the studies are preclinical tests, not clinical evaluations that typically involve adjudication of human reader findings.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices involving human interpretation of medical images. The device in question is a knee implant component, and the evaluations are preclinical performance tests.

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

This is not applicable. The device is a physical knee implant component, not an algorithm. The "standalone" performance here refers to the physical properties and mechanical performance of the implant itself, which is what the preclinical tests evaluated.

7. The Type of Ground Truth Used:

The ground truth used for these preclinical tests is based on engineering measurements, physical properties, and established industry standards (e.g., ASTM F1223-20 for tibiofemoral constraint testing). The performance of the subject device is compared to these standards or to the known performance of predicate devices.

8. The Sample Size for the Training Set:

This is not applicable. The device is a physical medical implant, not an AI algorithm that requires a "training set."

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

This is not applicable for the same reason as point 8.

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